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 from 6 years of age, adolescents and adults as part of a comprehensive treatment programme. Treatment must be initiated by a physician experienced in the treatment of ADHD, e.g. a paediatrician, a specialist in child and adolescent psychiatry, or a psychiatrist. Diagnosis should follow 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 diseases: severe hypertension, heart failure, arterial occlusive disease, angina pectoris, haemodynamically relevant congenital heart defect, cardiomyopathy, myocardial infarction, arrhythmias and ion channel disorders.
Severe cerebrovascular diseases: 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 disorders, 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 bladder emptying, urinary retention, dysmenorrhoea, ejaculation disorders, erectile dysfunction, prostatitis, pain in the male genital area, asthenia, fatigue, lethargy, chills, inner 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, feeling cold in extremities, dyspnoea, allergic reactions, pruritus, urticaria, muscle cramps, increased urge to urinate, ejaculation failure, irregular menstruation, altered orgasm, feeling cold, chest pain.
Rare: psychosis, convulsions, Raynaud syndrome, elevated liver enzymes, jaundice, hepatitis, liver injury, acute liver failure, priapism.
Unknown frequency: bruxism. Prescription‑only.
Further information: see professional information.
Information status: 11/2024
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn.

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 strategy for the treatment of attention‑deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when clinical response to previous methylphenidate treatment was insufficient.
Treatment must be supervised by a specialist in behavioural disorders in children and/or adolescents.
Diagnosis must follow DSM‑V or ICD‑10. Not all children with ADHD should be treated with dexamfetamine. The decision must be based on a careful assessment of symptom severity and chronicity, the child’s age, and the potential for misuse, abuse or diversion. 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 disorder; Gilles de la Tourette syndrome or similar dystonias; diagnosis or history of severe episodic (Type I) bipolar affective disorder; pre‑existing cardiovascular disease 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 or alcohol dependence; pregnancy and breastfeeding. Side effects:
Very common: decreased appetite, reduced weight and height gain during long‑term treatment 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, headache, hyperactivity; abnormal behaviour, aggression, agitation and anxiety, depression, irritability.
Rare: angina pectoris; accommodation disturbances, 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; 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.
Also reported (very rare): poorly documented NMS; confusion, delirium, drug dependence, dysphoria, emotional lability, euphoria, impaired cognitive test performance, altered libido, night terrors, obsessive‑compulsive symptoms, panic attacks, paranoia, restlessness; kidney damage; impotence; sweating, alopecia, Raynaud syndrome; cardiovascular collapse. Withdrawal after strong and prolonged amphetamine use may cause withdrawal symptoms. Warning: Contains isomalt (E953).
Prescription‑only. Information status: 08/2022 (5 mg), 08/2024 (10 mg, 20 mg)
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
www.adhs-infoportal.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 for 18/27/54 mg: iron(III) oxide (E172). Additionally for 18/27 mg: iron(III) hydroxide‑oxide x H₂O (E172).
Additionally for 27 mg: indigotine aluminium lake (E132). Printing ink: shellac, iron(II,III) oxide (E172), propylene glycol. Indications: As part of a comprehensive therapeutic strategy for the treatment of 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 ADHD.
Diagnosis should follow DSM criteria or ICD guidelines and be based on a complete patient history and evaluation. Third‑party assessment is desirable. Diagnosis must not rely solely on the presence of individual 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 disorder; 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, appetite loss, moderate reduction in weight and growth during long‑term use in children; affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, sleep‑onset disturbances, 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 ALT; 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 reaction, swelling of the ear, bullous and exfoliative disorders, 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 and scaling skin diseases; myalgia, muscle twitching; haematuria, pollakiuria; thoracic pain; heart murmurs.
Rare: mania, disorientation, libido disorders, confusion; visual accommodation disturbances, 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, choreo‑athetoid movements, reversible ischaemic neurological deficits, poorly documented neuroleptic malignant syndrome; cardiac arrest, myocardial infarction; cerebral arteritis and/or occlusion, peripheral cold, Raynaud syndrome; abnormal 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 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 details: see professional information.
Information status: 07/2023.
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
www.adhs-infoportal.de Instructions for prescribing and materials for medical monitoring 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 and 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 supervised by a specialist in behavioural disorders.
Diagnosis should be made according to current DSM criteria or ICD‑10 guidelines and based on a complete patient history and evaluation. This includes a structured interview with self‑report scales to assess current symptoms. Retrospective evaluation of childhood ADHD must be done using validated tools. Diagnosis must not rely solely on the presence of single 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, moderately reduced 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, swelling of the ear, bullous and exfoliative skin disorders, urticaria, pruritus, 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, blistering skin disorders, exfoliative skin disorders; myalgia, muscle twitching, muscle tension; haematuria; heart murmur.
Rare: mania, disorientation, libido disorders; visual 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, stereotypical behaviours, over‑focusing; convulsions, choreo‑athetoid movements, reversible ischaemic neurological deficit, poorly documented neuroleptic malignant syndrome; 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 bilirubin; reduced platelet count, abnormal white blood cell count.
Not known: pancytopenia; delusions, thought disorders, confusion, dependence, 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; chest discomfort; hyperpyrexia; attention disorders; flu‑like illness; asthenia; thoracic discomfort; increased thyroid‑stimulating hormone; partner or family problems; tinnitus. Notes: Cases of misuse and dependence have been reported, more frequently with immediate‑release formulations. Warning: Contains sucrose. Prescription‑only; controlled substance (BtM).
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 (tablets) 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 ADHD in children aged 6 years and older and adults, when other therapeutic measures alone have proved insufficient. 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 diseases 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 treatment with H₂‑receptor blockers, proton pump inhibitors or antacids. Side effects:
(Identical to those listed under Medikinet® adult – reproduced identically here as required for a 1:1 translation.) Very common: decreased appetite; insomnia, nervousness; headache; nausea, dry mouth.
Common: nasopharyngitis; anorexia, moderately reduced weight and height gain in long‑term treatment in children; abnormal behaviour, aggression, affect lability, agitation, anxiety, depression, irritability, restlessness, sleep disturbances, 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 prolonged use in children, internal restlessness, fatigue, thirst; changes in blood pressure and heart rate; weight loss.
Occasional: gastroenteritis; hypersensitivity (angioneurotic oedema, anaphylactic reaction), ear swelling, bullous and exfoliative skin diseases, urticaria, pruritus, rashes and 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; elevated liver enzymes; angioneurotic oedema; blistering and scaling diseases; myalgia, muscle twitching, muscle tension; haematuria; heart murmur.
Rare: mania, disorientation, libido disorders; eye 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, stereotypical behaviour, over‑focusing; convulsions, choreo‑athetoid movements, reversible ischaemic neurological deficit, poorly documented NMS; cardiac arrest, myocardial infarction; cerebral arteritis and/or vascular 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 bilirubin; reduced platelet count, pathological white blood cell count.
Not known: pancytopenia; delusions, thought disorders, confused states, dependence; logorrhoea; cerebrovascular disorders (including vasculitis, cerebral haemorrhage, stroke, cerebral arteritis, cerebral vessel occlusion); grand mal seizures, migraine, paraesthesia, aphasia, dysphasia; dry eyes, increased intraocular pressure; supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles; chest discomfort; hot flushes; flushing; oropharyngeal pain; epistaxis; gagging; trismus; erectile dysfunction; priapism; increased and prolonged erection; hyperpyrexia; attention disorders; flu‑like illness; asthenia; thoracic discomfort; elevated thyroid‑stimulating hormone; partner problems; family problems; tinnitus. Warning: Contains lactose (tablets) and sucrose (capsules).
Prescription‑only; controlled substance (BtM).
Further information: see professional information.
Status: Medikinet® tablets 5 mg–20 mg: 06/2023; Medikinet® retard capsules 5 mg–60 mg: 06/2025
MEDICE Arzneimittel Pütter GmbH & Co. KG, 58638 Iserlohn.
www.adhs-infoportal.de nstructions and monitoring materials:
http://www.methylphenidate-guide.eu/landing

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 and 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 white blood cell count, reduced platelet count, 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 sensation in the legs (restless legs syndrome), poor sleep quality, fatigue, visual disturbances, blurred vision, increased tear production, dizziness or vertigo, dizziness on standing up or sitting down, faster heartbeat, chest pain due to 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 gastric mucosa, abnormal skin sensation (paraesthesia), skin disorders (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, presence of 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 attention‑deficit hyperactivity disorder (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, lower abdominal pain, digestive disorders, mouth ulceration, dry mouth, hyperbilirubinaemia, dermatitis, pruritus, rash, dry skin, night sweats, pain in the extremities, excretion of 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 secretion, vertigo, dizziness when standing or sitting, angina pectoris, faster heartbeat, hot flushes, acid reflux, gastrointestinal complaints, blistering in the mouth, tongue ulcers, stomach upset, vomiting, abnormal bowel sounds, flatulence, increased saliva production, 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, presence of 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 reaction, 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