Mandatory information for the Family Book
Abseamed 1,000 IU/0.5 ml / 2,000 IU/1 ml / 3,000 IU/0.3 ml / 4,000 IU/0.4 ml / 5,000 IU/0.5 ml / 6,000 IU/0.6 ml / 8,000 IU/0.8 ml / 10,000 IU/1 ml solution for injection in a pre‑filled syringe. Active substance: Epoetin alfa. Composition: 1 pre‑filled syringe contains 1,000 IU / 2,000 IU / 3,000 IU / 4,000 IU / 5,000 IU / 6,000 IU / 8,000 IU / 10,000 IU corresponding to 8.4 µg / 16.8 µg / 25.2 µg / 33.6 µg / 42.0 µg / 50.4 µg / 67.2 µg / 84.0 µg Epoetin alfa. Other ingredients: Sodium dihydrogen phosphate dihydrate; sodium monohydrogen phosphate dihydrate; sodium chloride; glycine; polysorbate 80; hydrochloric acid (for pH adjustment); sodium hydroxide (for pH adjustment); water for injections. Indications: For the treatment of symptomatic anaemia caused by kidney disease (in children on haemodialysis, in adults on haemodialysis or peritoneal dialysis, in adults with severe anaemia who have not yet undergone dialysis); for the treatment of anaemia in adults receiving chemotherapy for solid tumours, malignant lymphomas or multiple myeloma (bone marrow cancer) and who may require allogeneic blood transfusions; in adults with moderate anaemia who donate part of their blood prior to surgery so it can be given back to them during or after the operation; in adults with moderate anaemia who are scheduled for major orthopaedic surgery (e.g. hip or knee replacement) to reduce the possible need for allogeneic blood transfusions; for the treatment of anaemia in adults with a bone marrow disorder that causes a severe impairment of blood cell formation (myelodysplastic syndrome). Contraindications: Allergic reactions to Epoetin alfa or any of the other listed ingredients; patients in whom erythroblastopenia (insufficient formation of red blood cells in the bone marrow) has been diagnosed during previous treatment with a product that stimulates red blood cell production (including Abseamed); patients with hypertension that cannot be adequately controlled with medication; to stimulate red blood cell production when autologous blood transfusion cannot be received during or after surgery; patients scheduled for major elective orthopaedic surgery (e.g. hip or knee surgery) who suffer from severe heart disease or diseases of the veins and arteries, or who have recently had a heart attack or stroke, or who cannot take anticoagulant medication. Side effects: Severe skin reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis (reddish, target‑like spots or circular patches, often with central blistering on the trunk, detachment of the skin, ulcers of the mouth, throat, nose, genitals and eyes, often initially accompanied by fever and flu‑like symptoms). Very common: diarrhoea; upset stomach; vomiting; fever; respiratory problems (blocked nose and sore throat) in patients with kidney failure who are not yet on dialysis. Common: increased blood pressure; headaches (especially sudden, stabbing migraine‑like headaches); confusion or seizures; blood clots (including deep‑vein thrombosis and embolism) with chest pain, shortness of breath, painful swelling and redness, mostly in the legs; cough; skin rash, which may be caused by an allergic reaction; bone or muscle pain; flu‑like symptoms (headache, joint pain, weakness, chills, fatigue, dizziness); redness, burning and pain at the injection site; swelling of the ankles, feet or fingers; pain in arms or legs. Occasional: high potassium levels in the blood, which can lead to cardiac arrhythmias (very common in dialysis patients); seizures; nasal congestion or airway narrowing; allergic reaction; urticaria. Rare: symptoms of erythroblastopenia (unusual fatigue, drowsiness, dizziness, shortness of breath); particularly at the beginning of treatment, an increase in the number of small blood cells in the blood (platelets, which are normally involved in blood clot formation); severe allergic reactions (swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)); blood disorders that may cause pain, dark urine or increased sensitivity of the skin to sunlight (porphyria); blood clots (thrombosis) in the dialysis shunt or in the haemodialysis system (in haemodialysis patients). Warnings: Keep medicinal products out of the reach of children.
For further details and instructions, see the professional and patient information.
Prescription‑only. Status: 07/2025. Marketing authorisation holder: MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn, www.medice.de
Agakalin® 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg. Active substance: Atomoxetine hydrochloride. Composition: 1 film‑coated tablet contains atomoxetine hydrochloride corresponding to 10 mg / 18 mg / 25 mg / 40 mg / 60 mg / 80 mg / 100 mg atomoxetine. Other ingredients: Calcium hydrogen phosphate, microcrystalline cellulose, tricalcium bis(phosphate), croscarmellose sodium, magnesium stearate (Ph. Eur.) [vegetable], poly(vinyl alcohol), macrogol 4000, talc, titanium dioxide (E171). Indications: Agakalin is used for the treatment of attention‑deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, in adolescents, and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a physician with appropriate expertise in treating ADHD, such as a paediatrician, a specialist in child and adolescent psychiatry, or a psychiatrist. Diagnosis should be made according to the current DSM criteria or ICD guidelines. Contraindications: Known hypersensitivity to the active substance or any of the other ingredients; during or within at least 14 days after taking MAO inhibitors; narrow‑angle glaucoma; severe cardiovascular or cerebrovascular disorders: severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically relevant congenital heart defects, cardiomyopathy, myocardial infarction, arrhythmias and ion channel disorders. Severe cerebrovascular disorders: cerebral aneurysm or stroke. Not to be used in patients with a history of phaeochromocytoma. Side effects: Very common: decreased appetite, insomnia, headache, dry mouth, nausea, increased blood pressure, increased heart rate.
Common: agitation, reduced libido, sleep disturbances, depression and depressed mood, anxiety, dizziness, dysgeusia, paraesthesia, somnolence, tremor, palpitations, tachycardia, hot flushes, abdominal pain, constipation, dyspepsia, flatulence, vomiting, dermatitis, increased sweating, rash, dysuria, pollakiuria, delayed micturition, urinary retention, dysmenorrhoea, ejaculation disorders, erectile dysfunction, prostatitis, pain in the male genital area, asthenia, fatigue, lethargy, chills, feeling of internal restlessness, irritability, thirst, weight loss.
Occasional: suicidal behaviour, aggression, hostility and emotional lability, restlessness, tics, syncope, migraine, hypaesthesia, blurred vision, QT interval prolongation, increased bilirubin levels, feeling of cold in the extremities, dyspnoea, allergic reactions, pruritus, urticaria, muscle cramps, increased urge to urinate, ejaculation failure, irregular menstruation, altered orgasm, feeling cold, chest pain.
Rare: psychosis, seizures, Raynaud’s syndrome, increased liver enzymes, jaundice, hepatitis, liver injury, acute liver failure, priapism.
Unknown frequency: bruxism. Prescription‑only.
For further information, see the professional information. Information status: 11/2024
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn.
Aqualibra® 80 mg / 90 mg / 180 mg film‑coated tablets 1 film‑coated tablet contains:
80 mg dry extract of restharrow root (5–8:1), extraction solvent: water;
90 mg dry extract of orthosiphon leaves (5–7:1), extraction solvent: water;
180 mg dry extract of goldenrod herb (4–7:1), extraction solvent: water. Other ingredients: Povidone K 30, crospovidone, highly dispersed silica, microcrystalline cellulose, magnesium stearate, talc, macrogol 3000, poly(vinyl alcohol), lactose monohydrate, spray‑dried glucose syrup (Ph. Eur.), maltodextrin, titanium dioxide, chlorophyll–copper complex. Indications: For adolescents aged 12 years and above and adults.
For flushing the urinary tract in bacterial and inflammatory diseases of the lower urinary tract.
For flushing to prevent and treat urinary stones and kidney gravel. If blood is present in the urine, fever occurs, or symptoms persist for more than 5 days, a physician must be consulted. Contraindications: Hypersensitivity to the active substances or any of the other ingredients.
Water retention in tissues (oedema) due to impaired cardiac or renal function. Side effects:
Very rare: gastrointestinal complaints (nausea, vomiting, diarrhoea), hypersensitivity reactions (skin rash, itching).
Contains lactose and glucose. MEDICE Arzneimittel Iserlohn, 08/2022.
Attentin® 5 mg, 10 mg, 20 mg Active substance: Dexamfetamine hemisulfate. Composition:
Each tablet contains 5 mg / 10 mg / 20 mg dexamfetamine hemisulfate. Other ingredients:
Isomalt (E953), magnesium stearate (Ph. Eur.), crospovidone (only in 5 mg), iron(III) hydroxide oxide x H₂O (E172, in 10 mg), iron(III) oxide (E172, in 20 mg). Indications: As part of a comprehensive therapeutic programme for the treatment of attention‑deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when clinical response to prior methylphenidate treatment was inadequate.
Treatment should be supervised by a specialist experienced in behavioural disorders in children and/or adolescents.
Diagnosis must follow DSM‑V or ICD‑10 criteria. Treatment with dexamfetamine is not indicated for all children with ADHD, and the decision to use it must be based on a very careful assessment of the severity and chronicity of symptoms.
The child’s age and the potential for misuse, abuse or diversion must be considered. Contraindications: Known hypersensitivity to dexamfetamine or any other ingredient; known hypersensitivity or idiosyncrasy to sympathomimetic amines; glaucoma; phaeochromocytoma; during or within at least 14 days after taking MAO inhibitors; hyperthyroidism or thyrotoxicosis; diagnosis or history of severe depression, anorexia nervosa / anorectic disorders, suicidal tendencies, psychotic symptoms, severe affective disorders, mania, schizophrenia, psychopathic / borderline personality disorders; Gilles de la Tourette syndrome or similar dystonias; diagnosis or history of severe and episodic (Type I) bipolar affective disorder; pre‑existing cardiovascular disorders including moderate and severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically significant congenital heart defects, cardiomyopathies, myocardial infarction, potentially life‑threatening arrhythmias and channelopathies; pre‑existing cerebrovascular disease; porphyria; patients with a history of or current drug dependence or alcoholism; pregnancy and breastfeeding. Side effects:
Very common: decreased appetite, reduced weight gain and growth during long‑term use in children; insomnia, nervousness.
Common: arrhythmias, palpitations, tachycardia; abdominal pain, nausea, vomiting, dry mouth; changes in blood pressure and heart rate (usually increased); arthralgia; dizziness, dyskinesia, headaches, hyperactivity; abnormal behaviour, aggression, agitation and anxiety, depression, irritability.
Rare: angina pectoris; accommodation disorders, blurred vision, mydriasis; fatigue, growth retardation during long‑term use in children; rash, urticaria.
Very rare: anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura; cardiac arrest; liver dysfunction including elevated liver enzymes, hepatic coma; muscle cramps; convulsions, choreoathetoid movements, intracranial haemorrhage, Tourette syndrome; hallucinations, psychosis / psychotic reactions, suicide attempt (including completed suicide), tics, worsening of pre‑existing tics; erythema multiforme, exfoliative dermatitis, drug rash; cerebral vascular and/or cerebrovascular occlusion.
Not known: cardiomyopathy, myocardial infarction; ischaemic colitis, diarrhoea; chest pain, hyperpyrexia, hypersensitivity including angioedema and anaphylaxis, sudden death; acidosis; rhabdomyolysis; ataxia, drowsiness, dysgeusia; concentration disorders, hyperreflexia, stroke, tremor. Very rare cases of poorly documented NMS; confusion, delirium, drug dependence, dysphoria, emotional lability, euphoria, impaired performance in cognitive tests, altered libido, night terrors, obsessive‑compulsive symptoms, panic attacks, paranoia, restlessness; kidney damage; impotence; sweating, alopecia, Raynaud’s syndrome; cardiovascular collapse. Discontinuation or dose reduction after strong and prolonged use of amphetamines may lead to withdrawal symptoms. Warning: Contains isomalt (E953). Prescription‑only. For further information, see the professional information. Information status: 08/2022 (5 mg), 08/2024 (10 mg, 20 mg).
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn. www.adhs-infoportal.de
Cystinol akut® coated tablets Active substance: Bearberry leaf dry extract. Composition:
1 coated tablet contains 238.7–297.5 mg dry extract of bearberry leaves (3.5–5.5 : 1), corresponding to 70 mg hydroquinone derivatives, calculated as anhydrous arbutin (photometry Ph. Eur. 1998), extraction solvent: 60% ethanol (V/V). Other ingredients:
Microcrystalline cellulose, long‑chain partial glycerides, hypromellose, lactose monohydrate, macrogol 6000, magnesium stearate (Ph. Eur.), highly dispersed silica, quinoline yellow E 104, indigotin E 132, aluminium hydroxide, titanium dioxide E 171. Indications:
Inflammatory diseases of the lower urinary tract. Contraindications: Known hypersensitivity to bearberry leaves or any other ingredient of the medicinal product.
Pregnancy and breastfeeding.
Children under 12 years of age. Side effects:
Rarely, gastrointestinal complaints (nausea and vomiting) in patients with sensitive stomachs.
Very rare allergic reactions. Warning: Contains lactose. Observe the package leaflet.
Status: 03/2021. Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Doregrippin® 500 mg/10 mg film‑coated tablets 1 film‑coated tablet contains: Paracetamol 500 mg, phenylephrine hydrochloride 10 mg.Other ingredients:
Povidone 25, povidone 30, microcrystalline cellulose, pregelatinised maize starch, maize starch, stearic acid, talc, highly dispersed silica, magnesium stearate, macrogol 6000, croscarmellose sodium, crospovidone, poly[butyl methacrylate‑co‑(2‑dimethylaminoethyl)‑methacrylate‑co‑methyl methacrylate] (1:2:1), simeticone emulsion (contains purified water, simeticone, methylcellulose, sorbic acid). Indications: For short‑term treatment of symptoms of colds and influenza‑like infections associated with fever, headache, limb pain and nasal congestion.
For children from 11 years and adults. Contraindications: Doregrippin must not be used in case of known hypersensitivity to the active substances or other ingredients, during pregnancy and breastfeeding, in hyperthyroidism, adrenal medulla tumour, glaucoma, severe impairment of liver function, severe organic heart and vascular disorders, cardiac rhythm disturbances and hypertension, bronchial asthma or chronic obstructive airway diseases, insufficient or impaired respiratory function, obstruction of the urinary tract, disorders of haemoglobin formation, hereditary glucose‑6‑phosphate dehydrogenase deficiency, and in children under 11 years. Side effects:
Rare: increase in blood pressure or persistent headache, slight increase in certain liver enzymes.
Very rare: palpitations, cardiac arrhythmias and angina‑like symptoms; changes in blood counts such as decreased white blood cells, decreased number of platelets or reduced number of all blood cells; hypersensitivity reactions affecting the respiratory tract or, in predisposed individuals, bronchospasm triggered by paracetamol; hypersensitivity reactions such as flushing, angioedema, urticaria, dyspnoea, sweating, nausea, drop in blood pressure up to anaphylactic shock; cases of severe skin reactions; very rare cases of blood and fluid abnormalities occurring when plasma acidity increases if flucloxacillin is used simultaneously with paracetamol, usually in the presence of risk factors. Warning: Do not use longer than stated in the package leaflet without medical advice!
Status: 03/2023.
MEDICE Arzneimittel, 58638 Iserlohn.
Dorithricin® Throat Lozenges Classic Composition:
1 lozenge contains the active substances: Tyrothricin 0.5 mg, benzalkonium chloride 1.0 mg, benzocaine 1.5 mg. Other ingredients:
Sorbitol (Ph. Eur.), talc, sucrose stearate type III, saccharin sodium 2 H₂O, mint oil, povidone (K 25), carmellose sodium (Ph. Eur.), L‑lysine monohydrate. Indications:
For symptomatic treatment of infections of the mouth and throat accompanied by sore throat and difficulty swallowing. Contraindications:
Hypersensitivity to the active substances or any of the other ingredients.
Use should be avoided in the case of larger fresh wounds in the mouth and throat. Side effects:
In rare cases, allergic reactions (skin), especially to para‑aminobenzoic acid esters (benzocaine), may occur.
Methaemoglobinaemia has been reported with topical use, especially in children and when applied to large wound areas. Not known:
In sensitive patients, para‑group sensitisation (e.g. to penicillins, sulfonamides, sun protection cosmetics, p‑aminosalicylic acid) may occur.
In patients sensitised accordingly, mint oil can trigger hypersensitivity reactions (including dyspnoea). Warning: Contains sorbitol and mint oil. Status 08/2023.
MEDICE Arzneimittel, 58638 Iserlohn.
Esberitox® Composition:
1 tablet contains: 3.2 mg dry extract (4–9 : 1) from a mixture of dyer’s broom rhizome : purple coneflower root : pale coneflower root : thuja tops and leaves (4.92 : 1.85 : 1.85 : 1).
Extraction solvent: 30% ethanol (V/V). Other ingredients: Betadex, mannitol (Ph. Eur.), glycerol dibehenate (Ph. Eur.), magnesium stearate (Ph. Eur.) [vegetable], saccharin sodium (Ph. Eur.), citric acid monohydrate, natural lemon flavour. Indication: For supportive treatment of viral colds. Contraindications:
Hypersensitivity to the active substances, any other ingredients, or to composites (Asteraceae).
Not to be taken for fundamental reasons in progressive systemic diseases such as tuberculosis and sarcoidosis; in autoimmune diseases such as collagen diseases, multiple sclerosis; in acquired immunodeficiencies such as AIDS or HIV infection; in immunosuppression (e.g. due to cytostatic therapy or immunosuppressive treatment after transplantation); in haematological disorders of the white blood cell system such as leukaemia and agranulocytosis. Side effects:
Hypersensitivity reactions such as rash, itching, facial swelling, breathlessness, drop in blood pressure; abdominal pain, nausea, diarrhoea; dizziness.
Frequency not known. Status 01/2024.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Femicur® N capsules Active substance: Dry extract of chaste tree fruits. Composition:
1 hard capsule contains: 4 mg dry extract from chaste tree fruits (7–13 : 1), extraction solvent: 60% ethanol (m/m). Other ingredients:
Glucose syrup (dry substance), lactose monohydrate, talc, maize starch, magnesium stearate (Ph. Eur.) [vegetable], highly dispersed silica, gelatine, sodium dodecyl sulfate, purified water, colourings E171, E172. Indications:
Menstrual cycle irregularities, premenstrual complaints, mastodynia. Contraindications:
Hypersensitivity to chaste tree fruits or any of the other ingredients; pituitary tumours; breast cancer. Side effects: Frequency not known: gastrointestinal complaints (nausea, stomach or lower abdominal pain), hypersensitivity reactions (itching, rash, urticaria, angioedema, dyspnoea, swallowing difficulties), headaches. Warnings:
Contains glucose and lactose.
Observe the package leaflet. Status 01/2021.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
FerMed 20 mg/ml solution for injection/infusion Active substance: Iron. Composition:
1 ml FerMed contains 20 mg iron in the form of iron sucrose (iron(III) hydroxide–sucrose complex). Other ingredients:
Water for injections; sodium hydroxide solution. Indication: Intravenous treatment of iron deficiency when oral treatment with iron tablets is not possible or has not worked. Contraindications: Allergic reactions to the active substance or any of the other ingredients; severe hypersensitivity reactions to other injectable iron preparations; anaemia not caused by iron deficiency; excess iron in the body or impaired iron utilisation. Side effects: Allergic reactions:
Drop in blood pressure (dizziness, light‑headedness, blacking out); facial swelling; breathlessness; itching, rash and chest pain, which may indicate a potentially severe allergic reaction known as Kounis syndrome. Common:
Taste disturbances (metallic taste); decreased or increased blood pressure; nausea; reactions at the injection/infusion site (pain, irritation, itching, bruising or long‑lasting skin discolouration after extravasation into the skin). Occasional:
Headache or dizziness; stomach pain or diarrhoea; vomiting; wheezing; breathlessness; itching; rash; muscle twitching, cramps or pain; tingling (“pins and needles”); increased touch sensitivity; phlebitis; skin redness, burning; constipation; joint, limb and back pain; chills; weakness, fatigue; swelling of hands and feet; pain; increased liver enzyme levels (ALT, AST, GGT) in the blood; elevated serum ferritin. Rare:
Fainting; drowsiness or lethargy; palpitations; urine discoloration; chest pain; increased sweating; fever; increased blood lactate dehydrogenase (LDH) levels. Not known:
Reduced responsiveness; confusion; loss of consciousness; anxiety; tremor; swelling of the face, mouth, tongue or throat with possible respiratory problems; slow or fast pulse; circulatory collapse; phlebitis leading to blood clot formation; acute airway constriction; itching; hives; rash; cold sweats; general malaise; pallor; sudden life‑threatening allergic reactions (anaphylactic shock); flu‑like symptoms (typically fever, muscle and joint pain) occurring within hours or several days after administration. Warnings:
Keep medicines out of the reach of children.
For further details, see professional and patient information. Prescription‑only.
Status: 06/2023. Marketing authorisation holder: MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn, www.medice.de
Kinecteen® 18 mg, 27 mg, 36 mg, 54 mg Active substance: Methylphenidate hydrochloride (MPH). Composition: 1 tablet contains: MPH 15.6 mg / 23.3 mg / 31.1 mg / 46.7 mg. Other ingredients with known effect: Lactose monohydrate. Other ingredients: Lactose monohydrate, hypromellose, highly dispersed silica, magnesium stearate (Ph. Eur.), methacrylic acid–methyl methacrylate copolymer (1:1) (Ph. Eur.), methacrylic acid–methyl methacrylate copolymer (1:2) (Ph. Eur.), triethyl citrate, talc, fumaric acid. Film coating: Poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E171); additionally in 18/27/54 mg: iron(III) oxide (E172); additionally in 18/27 mg: iron(III) hydroxide oxide x H₂O (E172); additionally in 27 mg: indigotine aluminium salt (E132). Printing ink: Shellac, iron(II,III) oxide (E172), propylene glycol. Indications: As part of a comprehensive therapeutic strategy for the treatment of attention‑deficit hyperactivity disorder (ADHD) in children aged 6 years and older and in adults when other therapeutic measures alone have proved insufficient. Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD, e.g. an experienced paediatrician, child and adolescent psychiatrist or adult psychiatrist. Diagnosis should be made according to DSM criteria or ICD guidelines and based on a complete history and evaluation of the patient. Assessment by third parties is desirable, and diagnosis must not rely solely on the presence of one or more symptoms. Contraindications: Hypersensitivity to the active substance or any of the other ingredients; glaucoma; phaeochromocytoma; during or within at least 14 days after taking MAO inhibitors; hyperthyroidism or thyrotoxicosis; diagnosis or history of severe depression, anorexia nervosa / anorectic disorders, suicidal tendencies, psychotic symptoms, severe affective disorders, mania, schizophrenia; psychopathic / borderline personality disorders; diagnosis or history of severe episodic (Type I) bipolar affective disorder; pre‑existing cardiovascular disease including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically significant congenital heart defects, cardiomyopathies, myocardial infarction, arrhythmias and channelopathies; pre‑existing cerebrovascular disease. Side effects: Very common: insomnia, nervousness, headache.
Common: nasopharyngitis, upper respiratory tract infection, sinusitis, anorexia, loss of appetite, moderate reduction in weight gain and growth during long‑term use in children; anorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, sleep‑onset disorders, depressed mood, decreased libido, tension, bruxism, panic attack; dizziness, dyskinesia, psychomotor hyperactivity, somnolence, paraesthesia, tension headache, accommodation disorders, vertigo; arrhythmia, tachycardia, palpitations, hypertension; cough, oropharyngeal pain; upper abdominal pain, diarrhoea, nausea, abdominal discomfort, vomiting, dry mouth, dyspepsia; increased alanine aminotransferase; alopecia, pruritus, rash, urticaria, hyperhidrosis; arthralgia, muscle tension, muscle spasms; erectile dysfunction; fever, growth retardation during long‑term use in children; fatigue, irritability, feeling excited, asthenia, thirst; changes in blood pressure and heart rate; weight loss. Occasional:
Hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, swelling of the ears, bullous and exfoliative conditions, urticaria, pruritus, rash and skin eruptions; psychotic disorders; auditory, visual and tactile hallucinations; anger, suicidal ideation, depressed mood, restlessness, tearfulness; worsening of existing tics or Tourette syndrome; logorrhoea, hypervigilance, sleep disorders, sedation, tremor, lethargy; blurred vision, dry eyes; chest pain, hot flushes, dyspnoea; constipation; elevated liver enzymes; angioneurotic oedema; blistering diseases and scaling disorders; myalgia, muscle twitching; haematuria, pollakiuria; thoracic pain, heart murmurs. Rare:
Mania, disorientation, libido disorders, confusion; difficulties with visual accommodation, visual impairment, diplopia; angina pectoris; macular rash, erythema; gynaecomastia. Very rare:
Anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura; suicide attempt (including completed suicide), temporary depressed mood, abnormal thinking, apathy, repetitive behaviours, over‑focusing; convulsions, choreoathetoid movements, reversible ischaemic neurological deficits, poorly documented neuroleptic malignant syndrome; cardiac arrest, myocardial infarction; cerebral arteritis and/or occlusion, peripheral coldness, Raynaud syndrome; impaired liver function including acute liver failure and hepatic coma; erythema multiforme, exfoliative dermatitis, fixed drug eruption; muscle cramps; sudden cardiac death; reduced platelet count, abnormal leukocyte count. Not known: Pancytopenia; delusions, thought disorders, misuse, dependence; cerebrovascular disorders (including vasculitis, cerebral haemorrhage, stroke, cerebral arteritis, cerebral vessel occlusion); grand mal seizures, migraine, dysphasia; supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles; epistaxis; trismus; incontinence; priapism, increased erection and prolonged erection; thoracic complaints, hyperpyrexia. Warning: Contains lactose.
Prescription‑only. Further information: see professional information.
Information status: 07/2023.
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
www.adhs-infoportal.de
Instructions for prescribing and monitoring materials can be found at: http://www.methylphenidate-guide.eu/landing
Medikinet® adult 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Active substance: Methylphenidate hydrochloride. Composition:
1 hard capsule contains methylphenidate hydrochloride 5 mg / 10 mg / 20 mg / 30 mg / 40 mg / 50 mg / 60 mg. Other ingredients:
Capsule contents: sucrose, maize starch, methacrylic acid–ethyl acrylate copolymer, talc, triethyl citrate, poly(vinyl alcohol), macrogol 3350, polysorbate 80, sodium hydroxide, sodium dodecyl sulfate, simeticone, highly dispersed silica, methylcellulose, sorbic acid, indigotine aluminium hydroxide.
Capsule shell: gelatine, titanium dioxide, sodium dodecyl sulfate, purified water; additionally in 10 mg and 20 mg: erythrosine, patent blue V; additionally in 30 mg, 40 mg, 50 mg, 60 mg: erythrosine, iron(II,III) oxide, indigotine. Indications: As part of a comprehensive therapeutic strategy for the treatment of attention‑deficit hyperactivity disorder (ADHD) persisting from childhood in adults aged 18 years and older when other therapeutic measures alone have proved insufficient. Treatment must be carried out under the supervision of a specialist in behavioural disorders. Diagnosis should be made according to DSM criteria or ICD‑10 guidelines and based on a complete history and examination of the patient. This includes a structured interview with self‑assessment scales to record current symptoms. Retrospective assessment of childhood ADHD must be conducted using validated instruments. Diagnosis must not rely solely on the presence of one or more symptoms. Contraindications: Hypersensitivity to the active substance or any other ingredient; glaucoma; phaeochromocytoma; during or within at least 14 days after taking MAO inhibitors; hyperthyroidism or thyrotoxicosis; diagnosis or history of severe depression; anorexia nervosa / anorectic disorders; suicidal tendencies; psychotic symptoms; severe affective disorders; mania; schizophrenia; psychopathic / borderline personality disorders; diagnosis or history of severe episodic (Type I) bipolar affective disorder; pre‑existing cardiovascular disease including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically significant congenital heart defects, cardiomyopathies, myocardial infarction, arrhythmias and channelopathies; pre‑existing cerebrovascular disease; known pronounced gastric anacidity with pH > 5.5 during therapy with H₂‑receptor blockers, antacids or proton pump inhibitors. Side effects: Very common: decreased appetite; insomnia, nervousness; headache; nausea, dry mouth.
Common: nasopharyngitis; anorexia, moderate reduction in weight and height gain during long‑term use in children; abnormal behaviour, aggression, affect lability, agitation, anxiety, depression, irritability, restlessness, sleep disorders, decreased libido, panic attacks, stress, bruxism; tremor, somnolence, dizziness, dyskinesia, psychomotor hyperactivity; tachycardia, palpitations, arrhythmia; hypertension, peripheral coldness; cough, throat and laryngeal pain, dyspnoea; abdominal pain, diarrhoea, stomach discomfort and vomiting; dyspepsia, toothache; hyperhidrosis, alopecia, pruritus, rash, urticaria; arthralgia; fever, growth retardation during long‑term use in children, internal restlessness, fatigue, thirst; changes in blood pressure and heart rate, weight loss. Occasional:
Gastroenteritis; hypersensitivity reactions such as angioneurotic oedema, anaphylactic reaction, ear swelling, bullous and exfoliative skin disorders, urticaria, itching, rashes and eruptions; hypervigilance, auditory, visual and tactile hallucinations, mood changes and fluctuations, anger, suicidal ideation, tearfulness, psychotic disorders, tics, worsening of pre‑existing tics or Tourette syndrome, tension; sedation, akathisia; diplopia, blurred vision; chest pain; constipation; elevated liver enzymes; angioneurotic oedema, bullous skin disorders, exfoliative skin disorders; myalgia, muscle twitching, muscle tension; haematuria; heart murmur. Rare:
Mania, disorientation, libido disorders; accommodation problems, mydriasis, visual disturbances; angina pectoris; macular rash, erythema; gynaecomastia. Very rare:
Leukopenia, thrombocytopenia, anaemia, thrombocytopenic purpura; suicide attempt (including completed suicide), transient depressed mood, abnormal thinking, apathy, stereotyped behaviours, over‑focusing; convulsions, choreoathetoid movements, reversible ischaemic neurological deficit, neuroleptic malignant syndrome (poorly documented); cardiac arrest, myocardial infarction; cerebral arteritis and/or vessel occlusion, Raynaud phenomenon; impaired liver function including hepatic coma; erythema multiforme, exfoliative dermatitis, fixed drug eruption; muscle cramps; sudden cardiac death; elevated alkaline phosphatase and elevated bilirubin; reduced platelet count, abnormal white blood cell count. Not known:
Pancytopenia; delusions, thought disorders, confusion, logorrhoea; cerebrovascular disorders (including vasculitis, cerebral haemorrhage, stroke, cerebral arteritis, cerebral vessel occlusion); grand mal seizures, migraine, dysphasia; supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles; epistaxis; trismus; incontinence; menstrual disorders, erectile dysfunction, priapism, increased erection and prolonged erection; thoracic discomfort, hyperpyrexia. Notes: Cases of misuse and dependence have been reported, more frequently with immediate‑release formulations. Warning: Contains sucrose. Prescription‑only.
Further information: see professional information.
Status: 04/2023.
MEDICE Pharma GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn.
www.adhs-infoportal.de
Instructions for prescribing and monitoring materials can be found at: http://www.methylphenidate-guide.eu/landing
Medikinet® 5 mg, 10 mg, 20 mg Active substance: Methylphenidate hydrochloride (MPH). Composition:
1 tablet contains: MPH 5 / 10 / 20 mg. Other ingredients: Microcrystalline cellulose, pregelatinised starch (maize), calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate.
Medikinet® retard 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Active substance: MPH. Composition:
1 hard capsule contains MPH 5 / 10 / 20 / 30 / 40 / 50 / 60 mg. Other ingredients:
Capsule contents: sucrose, maize starch, methacrylic acid–ethyl acrylate copolymer (1:1) (Ph. Eur.), talc, triethyl citrate, poly(vinyl alcohol), macrogol 3350, polysorbate 80, sodium hydroxide, sodium dodecyl sulfate, simeticone, highly dispersed silica, methylcellulose, sorbic acid (Ph. Eur.), indigotine aluminium salt.
Capsule shell: gelatine, titanium dioxide, sodium dodecyl sulfate, purified water; additionally in 10 mg and 20 mg: erythrosine, patent blue V; in 30/40/50/60 mg: erythrosine, iron(II,III) oxide, indigotine. Indications:
As part of a comprehensive therapeutic strategy for the treatment of attention‑deficit hyperactivity disorders (ADHD) in children aged 6 years and older and in adults when other therapeutic measures alone have proved insufficient. Contraindications:
Hypersensitivity to the active substance or any of the other ingredients; glaucoma; phaeochromocytoma; during or within at least 14 days after taking MAO inhibitors; hyperthyroidism or thyrotoxicosis; diagnosis or history of severe depression, anorexia nervosa / anorectic disorders, suicidal tendencies, psychotic symptoms, severe affective disorders, mania, schizophrenia; psychopathic / borderline personality disorders; diagnosis or history of severe and episodic (Type I) bipolar affective disorder; pre‑existing cardiovascular disease including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically significant congenital heart defects, cardiomyopathies, myocardial infarction, arrhythmias and channelopathies; pre‑existing cerebrovascular disease; (additionally for Medikinet® retard: known pronounced gastric anacidity with pH > 5.5 during therapy with H₂‑receptor blockers, proton pump inhibitors, or antacids). Side effects:
Very common: decreased appetite, insomnia, nervousness, headache, nausea, dry mouth.
Common: nasopharyngitis; anorexia, moderately reduced weight gain and linear growth during long‑term use in children; abnormal behaviour, aggression, affect lability, agitation, anorexia, anxiety, depression, irritability, restlessness, sleep disorder, decreased libido, panic attacks, stress, bruxism; tremor, somnolence, dizziness, dyskinesia, psychomotor hyperactivity; tachycardia, palpitations, arrhythmia; hypertension, peripheral coldness; cough, throat and laryngeal pain; dyspnoea; abdominal pain, diarrhoea, stomach discomfort and vomiting, dyspepsia, toothache; hyperhidrosis, alopecia, pruritus, rash, urticaria; arthralgia; fever, growth retardation during long‑term use in children, feeling of internal restlessness, fatigue, thirst; changes in blood pressure and heart rate, weight loss.
Occasional: gastroenteritis; hypersensitivity reactions, anaphylactic reaction, swelling of the ear, bullous and exfoliative disorders, urticaria, pruritus, rash, skin eruptions; hypervigilance, auditory, visual and tactile hallucinations, mood changes and fluctuations, anger, suicidal ideation, tearfulness, psychotic disorders, tics or worsening of pre‑existing tics or Tourette syndrome, tension; sedation, akathisia; diplopia, blurred vision; chest pain; constipation; increase in liver enzymes; angioneurotic oedema, blistering disorders, scaling disorders; myalgia, muscle twitching, muscle tension; haematuria; heart murmur; elevated liver enzymes.
Rare: mania, disorientation, libido disorders; difficulties with visual accommodation, mydriasis, visual impairment; angina pectoris; macular rash, erythema; gynaecomastia.
Very rare: leukopenia, thrombocytopenia, anaemia, thrombocytopenic purpura; suicide attempt (including completed suicide), transient depressed mood, abnormal thinking, apathy, repetitive behaviours, excessive focusing; convulsions, choreo‑athetoid movements, reversible ischaemic neurological syndrome, cases of poorly documented neuroleptic malignant syndrome; cardiac arrest, myocardial infarction; cerebral arteritis and/or occlusion, Raynaud syndrome; abnormal liver function including hepatic coma; erythema multiforme, exfoliative dermatitis, fixed drug eruption; muscle cramps; sudden cardiac death; elevated alkaline phosphatase and elevated bilirubin in the blood; reduced platelet count, pathological leukocyte count.
Not known: pancytopenia; delusions, thought disorders, confusional states, dependence, logorrhoea; cerebrovascular disease; grand mal seizures, migraine, paraesthesia, aphasia, dysphasia; dry eyes, increased intraocular pressure; supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles; cardiac discomfort, hot flushes, flushing; oropharyngeal pain, epistaxis, gagging, trismus; erectile dysfunction, priapism, increased erection and prolonged erection; chest pain, hyperpyrexia; attention disorders, influenza‑like illness, asthenia, thoracic discomfort; increased thyroid‑stimulating hormone in the blood; problems with partner, problems with family; tinnitus. Warnings:
Contains lactose (tablets) and sucrose (capsules).
Prescription‑only, narcotic.
Further information: see professional information.
Information status: Medikinet® tablets 5 mg–20 mg 06/23; Medikinet® retard capsules 5 mg–60 mg 06/25
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
www.adhs-infoportal.de
Instructions for prescribing and monitoring materials can be found at http://www.methylphenidate-guide.eu/landing
Meditonsin® Extract herbal cold tablets Composition:
1 tablet contains: 16 mg dry extract (4–9 : 1) from a mixture of dyer’s broom rhizome : purple coneflower root : pale coneflower root : thuja tops and leaves (4.92 : 1.85 : 1.85 : 1), extraction solvent: 30% ethanol (V/V). Other ingredients:
Mannitol (Ph. Eur.), betadex, lemon flavour, glycerol dibehenate (Ph. Eur.), magnesium stearate (Ph. Eur.) [vegetable], citric acid monohydrate, saccharin sodium (Ph. Eur.).
Meditonsin® Extract Junior herbal cold tablets Composition:
1 tablet contains: 3.2 mg dry extract (4–9 : 1) from a mixture of dyer’s broom rhizome : purple coneflower root : pale coneflower root : thuja tops and leaves (4.92 : 1.85 : 1.85 : 1).
Extraction solvent: 30% ethanol (V/V). Other ingredients:
Betadex, mannitol (Ph. Eur.), glycerol dibehenate (Ph. Eur.), magnesium stearate (Ph. Eur.) [vegetable], saccharin sodium (Ph. Eur.), citric acid monohydrate, natural lemon flavour. Indication (for both Meditonsin® Extract and Meditonsin® Extract Junior):
For supportive treatment of viral colds. Contraindications (for both):
Hypersensitivity to the active substances, any of the other ingredients or to composites (Asteraceae).
Not to be taken on fundamental grounds in progressive systemic diseases such as tuberculosis and sarcoidosis; in autoimmune diseases such as collagen diseases, multiple sclerosis; in acquired immunodeficiencies such as AIDS, HIV infection; in immunosuppression e.g. due to cytostatic therapy or immunosuppressive treatment e.g. after transplantation; in haematological disorders of the white blood cell system such as leukaemia and agranulocytosis. Side effects (for both):
Hypersensitivity reactions such as rash, itching, facial swelling, shortness of breath, drop in blood pressure; abdominal pain, nausea, diarrhoea; dizziness.
Frequency not known. Status 06/2025.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Meditonsin® Drops Composition:
10 g mixture (19 drops/g) contain: Aconitinum Dil. D5 (HAB, V.5a) 1 g, Atropinum sulfuricum Dil. D5 5 g, Mercurius cyanatus Dil. D8 4 g.
Aconitinum D2 to D4, Atropinum sulfuricum D2 to D4 and Mercurius cyanatus D4 to D7 each potentised with a mixture of ethanol 94% (m/m) / glycerol 85% / purified water (5:10:85).
Meditonsin® Globules Composition:
In 10 g globules (size 5) are processed: Aconitinum Dil. D5 [HAB, monograph 5a, solution D2 with ethanol 86% (m/m)] 10 mg, Atropinum sulfuricum Dil. D5 50 mg, Mercurius cyanatus Dil. D8 40 mg.
Aconitinum D2 and D3, Atropinum sulfuricum D2 and D3 and Mercurius cyanatus D4 to D6 each potentised with a mixture of ethanol 94% (m/m) / glycerol 85% / purified water (5:10:85); Aconitinum D4, Atropinum sulfuricum D4 and Mercurius cyanatus D7 each potentised with ethanol 73% (m/m).
Other ingredients: sucrose. Indications (Drops and Globules): The indications are derived from the homeopathic drug pictures. These include: acute inflammations of the throat, nose and pharynx. Contraindications: Hypersensitivity to the active substances or any of the other ingredients; infants under 7 months; infants from 7 to 12 months only after consulting a physician.
Meditonsin® Drops: Not to be used in alcoholics.
Meditonsin® Globules: Not to be used in patients with the rare hereditary fructose intolerance, glucose‑galactose malabsorption or sucrase‑isomaltase deficiency. Side effects: After use of Meditonsin® Drops and Globules, salivation may occur; the medicinal product should then be discontinued. Hypersensitivity reactions (e.g. itching and rash) may occur. In such cases, discontinue the medicinal product. Note: When taking homeopathic medicines, existing symptoms may temporarily worsen (initial aggravation). In this case, the medicinal product should be discontinued and a doctor consulted. Warnings: Meditonsin® Drops contain 6% alcohol by volume.
Meditonsin® Globules contain sucrose.
Status: 01/2022 and 02/2022 respectively.
MEDICE Arzneimittel, 58638 Iserlohn.
Mellozzan® 1 mg/ml oral solution Active substance: Melatonin. Composition:
1 ml oral solution contains 1 mg melatonin and 1 mg methyl 4‑hydroxybenzoate. Other ingredients:
Glycerol (E 422), potassium sorbate (Ph. Eur.) (E 202), hydrochloric acid 3.6% (for pH adjustment), methyl 4‑hydroxybenzoate (Ph. Eur.) (E 218), purified water. Indications: For the treatment of sleep disorders in children and adolescents aged 6–17 years with attention‑deficit hyperactivity disorder (ADHD), when other healthy sleep routines have been insufficient, and for short‑term treatment of jet lag in adults. Contraindications: Hypersensitivity to the active substance or any of the other ingredients. Side effects: Common: Headache, somnolence. Occasional: Irritability, nervousness, restlessness, sleep disturbances, abnormal dreams, nightmares, night sweats, anxiety, agitation, physical weakness, lack of energy or drive, migraine, dizziness, hypertension, mouth ulcers, dry mouth, nausea, stomach pain, digestive disorders, skin disorders (dermatitis, pruritus, rash, dry skin), pain in arms and legs, menopausal symptoms, chest pain, excretion of glucose in the urine, excess protein in the urine, changes in blood composition which may cause yellowing of the skin and eyes, abnormal liver function tests, weight gain. Rare: Shingles (herpes zoster), reduced number of white blood cells, reduced platelets, low calcium or sodium levels in the blood, high blood lipid levels, mood swings, aggression, agitation, crying, stress symptoms, confusion (disorientation), early morning awakening, increased sexual desire (increased libido), low mood, depression, fainting, memory disorders, attention disorders, dreaminess, unpleasant sensations in the legs (restless legs syndrome), poor sleep quality, fatigue, visual disturbances, blurred vision, increased tear production, dizziness or vertigo, dizziness on standing or sitting down, rapid heartbeat, chest pain caused by angina pectoris, acid reflux, gastrointestinal complaints, blistering in the mouth, tongue ulcers, stomach upset, vomiting, abnormal bowel sounds, increased saliva production, bad breath, flatulence, stomach discomfort, inflammation of the stomach lining, abnormal skin sensations (paraesthesia), skin conditions (eczema, redness, dermatitis of the hands, psoriasis, itchy rash), nail disorders, sudden feeling of heat (hot flushes), pain, joint inflammation, muscle cramps, neck pain, night‑time cramps, increased urine output, red blood cells in the urine, night‑time urination, persistent erection (priapism), inflammation or swelling of the prostate (prostatitis), thirst, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests. Not known: Hypersensitivity reactions and angioedema with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties; abnormal milk secretion; high blood sugar. Prescription‑only.
Further information: see professional information.
Status: 03/2024.
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn.
www.gemeinsam-adhs-begegnen.de
Mellozzan® 0.5 mg, 2 mg, 3 mg, 5 mg tablets Active substance: Melatonin. Composition:
1 tablet contains 0.5 mg / 2 mg / 3 mg / 5 mg melatonin. Other ingredients:
Pregelatinised starch (maize), microcrystalline cellulose, highly dispersed silica, magnesium stearate (Ph. Eur.) [vegetable]. Indications:
For the treatment of sleep disorders in children and adolescents aged 6–17 years with ADHD, when other healthy sleep routines have been insufficient. Contraindications:
Hypersensitivity to the active substance or any of the other ingredients. Side effects: Common:
Headache, somnolence. Occasional:
Irritability, nervousness, restlessness, anxiety, sleep disturbances, abnormal dreams, nightmares, migraine, dizziness, nausea, lack of drive, psychomotor hyperactivity, hypertension, abdominal pain, digestive disorders, mouth ulceration, dry mouth, hyperbilirubinaemia, dermatitis, pruritus, rash, dry skin, night sweats, pain in the extremities, glucose in the urine, excess protein in the urine, menopausal complaints, weakness, chest pain, weight gain. Rare: Herpes zoster, leukopenia, thrombocytopenia, low calcium or sodium levels in the blood, high blood lipid levels, mood swings, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased libido, depressed mood, depression, fainting, memory disorders, attention disorders, dreaminess, restless legs syndrome, poor sleep quality, paraesthesia, visual disturbances, blurred vision, increased tear production, vertigo, dizziness on standing or sitting, angina pectoris, rapid heartbeat, hot flushes, acid reflux, gastrointestinal complaints, oral blistering, tongue ulcers, stomach upset, vomiting, abnormal bowel sounds, flatulence, increased saliva, bad breath, stomach discomfort, inflammation of the gastric mucosa, eczema, erythema, dermatitis of the hands, itchy rash, psoriasis, nail disorders, joint inflammation, muscle cramps, neck pain, night‑time cramps, increased urine output, night‑time urination, red blood cells in the urine, persistent erection – which may be painful – without sexual stimulation, swelling of the prostate (prostatitis), fatigue, pain, thirst, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests. Not known: Hypersensitivity reactions, hyperglycaemia, angioedema, oral oedema, tongue oedema, galactorrhoea. Prescription‑only. Further information: see professional information.
Status: 11/2024.
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn.
www.gemeinsam-adhs-begegnen.de
Nephrotrans® 500 mg gastro‑resistant soft capsules Active substance: Sodium hydrogen carbonate. Composition:
500 mg sodium hydrogen carbonate in a gastro‑resistant soft capsule. Other ingredients:
Yellow wax, hydrogenated soybean oil (Ph. Eur.), partially hydrogenated soybean oil (DAB), refined rapeseed oil, (3‑sn‑phosphatidyl)choline from soybeans, iron(II,III) oxide (E 172), titanium dioxide (E 171), glycerol 85%, gelatine, solution of partially dehydrated sorbitol (Ph. Eur.), hydrochloric acid 25%, triethyl citrate (Ph. Eur.), methacrylic acid–ethyl acrylate copolymer (1:1) (Ph. Eur.), polysorbate 80, sodium dodecyl sulfate, glycerol monostearate, purified water. Indications:
For the treatment of metabolic acidosis (metabolic over‑acidification of the blood) and for maintenance therapy to prevent recurrence of metabolic acidosis in chronic renal insufficiency (impaired kidney function). Contraindications:
Allergic reactions to sodium hydrogen carbonate, soy, peanuts or any other ingredient; elevated alkali levels in the blood (metabolic alkalosis); low potassium levels (hypokalaemia); high sodium levels (hypernatraemia); children under 14 years. Side effects: Very rare: allergic reactions to soybean oil. Other side effects: gastrointestinal complaints (flatulence, abdominal pain); long‑term use may promote the formation of calcium or magnesium phosphate stones in the kidneys. Warnings:
Keep medicines out of the reach of children.
For further details, see professional and patient information. Prescription‑only.
Status: 05/2023.
Marketing authorisation holder:
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn www.medice.de
Perenterol® forte 250 mg capsules Active substance: Dry yeast from Saccharomyces cerevisiae HANSEN CBS 5926
(Synonym: Saccharomyces boulardii). Composition: 1 hard capsule contains: 250 mg dry yeast from Saccharomyces cerevisiae HANSEN CBS 5926,
minimum 1.8 × 10¹⁰ viable cells/g lyophilisate. Other ingredients: Lactose monohydrate, magnesium stearate (Ph. Eur.), gelatine, sodium dodecyl sulfate, colouring: titanium dioxide (E171). Indications: For treatment of symptoms of acute diarrhoeal diseases, for prevention and treatment of travellers’ diarrhoea, and diarrhoea during tube feeding.
As adjuvant therapy for long‑lasting forms of acne. For adults and children aged 2 years and older. Contraindications: Known hypersensitivity to ingredients, yeast allergy, especially to Saccharomyces boulardii; patients with central venous catheter (CVC); severely ill or immunosuppressed patients due to risk of fungaemia.
Infants and toddlers under 2 years must not be self‑medicated and may only be treated after consulting a doctor.
Pregnancy and breastfeeding: not to be used. Side effects: Very rare: fungaemia in patients with CVC and in severely ill or immunosuppressed patients. Frequency not known: hypersensitivity reactions such as itching, urticaria, local or generalised rash, angioedema, dyspnoea and anaphylactic shock; sepsis; flatulence; constipation. Warning:
Contains lactose. Status: 08/2024.
MEDICE Arzneimittel, 58638 Iserlohn.
Perenterol® Junior 250 mg powder Active substance: Dry yeast from Saccharomyces cerevisiae HANSEN CBS 5926 (synonym: Saccharomyces boulardii). Composition:
1 sachet contains: 250 mg dry yeast from Saccharomyces cerevisiae HANSEN CBS 5926,
minimum 1.8 × 10¹⁰ viable cells/g lyophilisate. Other ingredients: Lactose monohydrate, fructose (Ph. Eur.), highly dispersed silica, tutti‑frutti flavour, powder, artificial. Indications:
For treatment of symptoms of acute diarrhoeal diseases, including traveller’s diarrhoea and diarrhoea during tube feeding.
For prevention of traveller’s diarrhoea.
For use in children and adults aged 2 years and older, and in infants from 6 months after consulting a doctor.
For prevention of traveller’s diarrhoea from 12 years of age. Contraindications:
Known hypersensitivity to ingredients; yeast allergy, especially to Saccharomyces boulardii; patients with central venous catheter (CVC); severely ill or immunosuppressed patients due to risk of fungaemia.
Pregnancy and breastfeeding: not to be used. Side effects: Very rare: fungaemia in patients with CVC and in severely ill or immunosuppressed patients.
Frequency not known: hypersensitivity reactions such as itching, urticaria, local or generalised rash, angioedema, dyspnoea and anaphylactic shock; sepsis; flatulence; constipation. Warning:
Contains lactose, fructose and sorbitol.
Status: 08/2024.
MEDICE Arzneimittel, 58638 Iserlohn.
Remifemin® Active substance:
Dry extract of black cohosh rhizome (Cimicifuga). Composition: 1 tablet contains: 2.5 mg dry extract of Cimicifuga rhizome (6–11 : 1),
extraction solvent: propan‑2‑ol (40% V/V). Other ingredients: Cellulose powder, potato starch, lactose monohydrate, magnesium stearate. Indications: Remifemin® is used to improve menopausal psychological and neurovegetative symptoms such as hot flushes, sweating and sleep disturbances. Contraindications:
Hypersensitivity to Cimicifuga rhizome or any of the other ingredients. Side effects: Rare: gastrointestinal complaints (dyspeptic symptoms, diarrhoea); allergic skin reactions (urticaria, pruritus, rash); swelling of the face or limbs (facial or peripheral oedema); weight gain.
Frequency not known: cases of liver damage with Cimicifuga‑containing medicines, increase in liver enzymes (transaminases). Warning:
Contains lactose. Refer to the package leaflet.
Status: 01/2020.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Remifemin® plus St. John’s wort Composition:
1 film‑coated tablet contains as active substances: 70 mg dry extract of St. John’s wort (3.5–6 : 1), extraction solvent: ethanol 60% (V/V), and 3.75 mg dry extract of Cimicifuga rhizome (6–11 : 1), extraction solvent: 2‑propanol 40% (V/V). Other ingredients:
Microcrystalline cellulose, glycerol dibehenate (Ph. Eur.), highly dispersed silica, lactose monohydrate, lactose, ascorbic acid, sodium ascorbate, poly(vinyl alcohol), (3‑sn‑phosphatidyl)choline (soybean), xanthan gum, talc.
Colourings: titanium dioxide (E171), iron(III) hydroxide‑oxide (E172), indigotine (E132). Indications: For relief of hot flushes and excessive sweating during menopause when these symptoms are accompanied by menopausal psychological complaints such as low mood, nervousness and irritability. Contraindications: Therapy with immunosuppressants (ciclosporin, tacrolimus for systemic use), anti‑HIV medicines (protease inhibitors such as indinavir and fosamprenavir), cytostatics such as irinotecan, anticoagulants such as warfarin.
Known allergy to soy, peanut, or any ingredient. Side effects: Rare: gastrointestinal complaints (dyspepsia, diarrhoea) and allergic skin reactions (urticaria, pruritus, rash).
Frequency not known: sunburn‑like skin reactions, especially in fair‑skinned individuals after strong UV exposure without adequate protection; facial or peripheral oedema; fatigue; weight gain; cases of liver damage with Cimicifuga‑containing medicines, elevated liver enzymes (transaminases); restlessness.
(3‑sn‑phosphatidyl)choline (soybean) may very rarely cause allergic reactions. Warning:
1 film‑coated tablet contains 163 mg lactose and 0.5 mg (3‑sn‑phosphatidyl)choline (soybean).
Refer to the package leaflet.
Status: 04/2023.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Remisens® film‑coated tablets Active substance:
225 mg dry extract of damiana leaves. Composition:
1 film‑coated tablet contains: 225 mg dry extract of damiana leaves (5–7 : 1),
extraction solvent: ethanol 90% (V/V). Other ingredients: Spray‑dried acacia gum, microcrystalline cellulose, silica hydrate, croscarmellose sodium, highly dispersed silica, crospovidone Type A, poly(vinyl alcohol), macrogol 3350, magnesium stearate (Ph. Eur.) [vegetable], talc, riboflavin (E101i), titanium dioxide (E171), brilliant blue FCF aluminium lake (E133). Indications: Traditional herbal medicinal product used as an aphrodisiac for decreasing sexual desire.
Remisens® is a traditional medicine registered exclusively based on long‑standing use. Contraindications: Hypersensitivity to damiana or other Turnera species or any of the other ingredients. Side effects: Allergic reactions (frequency: not known). Status: 02/2020.
Schaper & Brümmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter.
Soventol® Gel 20 mg/g gel Composition:
1 g gel contains 20 mg bamipine (RS)-lactate. Other ingredients: Purified water, hypromellose, poly(oxyethylene)-6-glycerol(mono, di)alkanoate (C8–C10), propylene glycol. Indications:
For relief of mild to moderately pronounced reactions to insect bites (e.g. mosquito bites) with itching. Contraindications:
Allergy to bamipine lactate or any other ingredients; pregnancy and breastfeeding. Side effects: Very rare: hypersensitivity reactions; slight burning after application, usually subsiding within minutes and masked by the cooling and anti‑itch effect of the gel; restlessness and confusion as well as pupil dilation in children; in adults mainly fatigue. Side effects typically resolve fully after discontinuation.
When applied over large areas, especially on inflamed skin, systemic effects may occur due to increased absorption of bamipine. Status: 07/2022 MEDICE Arzneimittel, 58638 Iserlohn.
Soventol® HydroCort 0.5% (5 mg/g) cream Composition: 1 g cream contains 5 mg hydrocortisone. Other ingredients:
Light liquid paraffin, cetostearyl alcohol (Ph. Eur.), white petrolatum, cetomacrogol 1000, emulsifying wax, propylene glycol, phenoxyethanol (Ph. Eur.), potassium sorbate (Ph. Eur.), sorbic acid (Ph. Eur.), disodium edetate (Ph. Eur.), purified water. Indications:
For treatment of all skin diseases responsive to corticosteroids, e.g. inflammatory, allergic or itching dermatoses (skin inflammations, eczema). Contraindications: Allergy to hydrocortisone or any other ingredients; children under 6 years (treatment only on prescription, no occlusive conditions such as nappies); syphilitic or tuberculous skin diseases; chickenpox and vaccination reactions.
If bacterial or fungal skin infection is present, it must be treated separately. Side effects:
Soventol HydroCort 0.5% is generally very well tolerated. Very rare: allergic skin reactions (hypersensitivity). Not known: blurred vision. Warning: Contains sorbic acid, potassium sorbate, cetostearyl alcohol, sodium dodecyl sulfate and propylene glycol. Status: 07/2022
MEDICE Arzneimittel, 58638 Iserlohn.
Soventol® Hydrocortisone acetate 0.25% (2.5 mg/g) cream Composition:
1 g cream contains 2.5 mg hydrocortisone acetate (Ph. Eur.). Other ingredients:
Purified water, propan‑2‑ol, decyl oleate, macrogol 400, isopropyl myristate (Ph. Eur.), heavy liquid paraffin, Carbopol 1382 polymer, perfume oil, ammonia, disodium edetate (Ph. Eur.). Indications: For the treatment of inflammatory and allergic dermatoses (skin inflammations and eczema) with mild to moderate symptom severity that respond to topical treatment with weak corticosteroids. Contraindications:
Allergy to hydrocortisone acetate (Ph. Eur.) or any of the other ingredients; without medical prescription in children under 6 years; syphilitic or tuberculous skin diseases; chickenpox and vaccination reactions. Side effects:
Soventol® Hydrocortisone acetate 0.25% is generally very well tolerated.
In particularly sensitive patients, very rare cases of allergic skin reactions (hypersensitivity reactions) may occur.
Not known: blurred vision. Status: 07/2022.
MEDICE Arzneimittel, 58638 Iserlohn.
Tannacomp® 500 mg / 50 mg film‑coated tablets Active substances: Tannic acid albumin, ethacridine lactate monohydrate. Composition:
1 film‑coated tablet contains: tannic acid albumin 500 mg, ethacridine lactate monohydrate 50 mg. Other ingredients: Microcrystalline cellulose (Ph. Eur.), sodium carboxymethyl starch (Type A) (Ph. Eur.), highly dispersed silica, talc (Ph. Eur.), magnesium stearate [vegetable] (Ph. Eur.), purified water, poly(vinyl alcohol), macrogol 3350, titanium dioxide, iron(III) hydroxide‑oxide x H₂O, iron(III) oxide. Indications: Treatment of acute non‑specific diarrhoea; prevention and treatment of travellers’ diarrhoea. Contraindications:
Allergy to tannic acid albumin (contains egg albumin), ethacridine lactate monohydrate or any of the other ingredients.
During pregnancy and breastfeeding, intake should only be under medical supervision. Side effects: In rare cases, allergic reactions (hypersensitivity reactions) to tannic acid albumin (contains egg albumin) and ethacridine lactate monohydrate. Note:
Intestinal contents may take on a yellowish colour after intake due to the ethacridine lactate monohydrate component. Status: 09/2022.
MEDICE Arzneimittel, Iserlohn.
Vafseo® 150 mg / 300 mg / 450 mg film‑coated tablets Active substance: Vadadustat. Composition: 1 film‑coated tablet contains: 150 / 300 / 450 mg vadadustat. Other ingredients:
Microcrystalline cellulose (E 460), sodium poly(o‑carboxymethyl) starch, hypromellose (E 464), highly dispersed silica (E 551), magnesium stearate, poly(vinyl alcohol) (E 1203), macrogol (E 1521), talc (E 553b), titanium dioxide (E 171), iron(III) hydroxide‑oxide x H₂O (E 172) (Vafseo 300 mg film‑coated tablets), iron(III) oxide (E 172) (Vafseo 450 mg film‑coated tablets), iron(II,III) oxide (E 172) (Vafseo 450 mg film‑coated tablets). Indication:
Vafseo is used in adult patients on chronic maintenance dialysis for the treatment of symptomatic anaemia (low red blood cell count or haemoglobin in the blood) associated with chronic kidney disease (CKD). Contraindications:
Hypersensitivity to the active substance or any of the other ingredients. Special warnings: see section 4.4 of the professional information. Side effects: Very common: hypertension, blood clots (thromboembolic events), diarrhoea.
Common: headache, seizures, hypotension, hypersensitivity, cough, constipation, nausea, vomiting, upper abdominal pain, increased liver enzymes.
Occasional: increased bilirubin in the blood. Warnings: For further details, see professional and patient information.
Prescription‑only.
Status: 03/2025.
Marketing authorisation holder:
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn, www.medice.de
Velariq® 1 mg/ml solution for intravesical use Active substance: Oxybutynin hydrochloride. Composition: 1 ml solution contains 1 mg oxybutynin hydrochloride; a graduated pre‑filled syringe with 10 ml solution contains 10 mg oxybutynin hydrochloride. Other ingredients:
Hydrochloric acid 10%, 0.9% sodium chloride solution. Indication: For suppression of neurogenic detrusor overactivity (NDO) in children from 6 years and in adults who empty their bladder by clean intermittent catheterisation and who are not adequately controlled with oral anticholinergics. Contraindications:
Hypersensitivity to the active substance or any of the other ingredients; severe gastrointestinal diseases (e.g. severe ulcerative colitis and toxic megacolon); myasthenia gravis; narrow‑angle glaucoma and patients at risk for these conditions; concomitant oxygen therapy. Side effects: Urinary tract infection, asymptomatic bacteriuria, hyperprolactinaemia, prolactin increased (single case), apathy, hallucinations, cognitive disorders, hyperactivity, insomnia, agoraphobia, disorientation, attention disorders, dizziness, headache, somnolence, fatigue, dysgeusia, clouded consciousness, loss of consciousness, anticholinergic syndrome, seizure, vertigo, dry eye, abnormal ocular sensation, accommodation disorder, supraventricular tachycardia, hypotension, flushing, constipation, dry mouth, abdominal discomfort, lower and upper abdominal pain, nausea, dyspepsia, diarrhoea, hypohidrosis, rash, night sweats, urgency, proteinuria, haematuria, voiding disorders, pain at the instillation site, thirst, chest discomfort, feeling cold.
Decreased oxygen saturation in the context of oxygen therapy.
Children may be more sensitive to the effects of the product, particularly regarding psychiatric and central nervous system adverse reactions. Adverse reactions of anticholinergic therapy not observed with intravesical oxybutynin:
Vomiting, anorexia, decreased appetite, dysphagia, gastro‑oesophageal reflux disease, pseudo‑obstruction in at‑risk patients (elderly or those with constipation and on medicines that reduce intestinal motility), confusional state, agitation, anxiety, nightmares, paranoia, symptoms of depression, dependence on oxybutynin (in patients with a history of drug or substance abuse), arrhythmia, heat stroke, narrow‑angle glaucoma, increased intraocular pressure, dry skin, angioedema, urticaria, photosensitivity, hypersensitivity. Warnings:
Contains the excipient with known effect sodium (3.5 mg/ml). Prescription‑only.
For further details and information, see professional and patient information.
Information status: 06/2024.
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
No special storage conditions required; cartons contain pre‑filled syringes and sterile adapters as application aid.
Further information at www.velariq.de