Oxomemazine Dry Cough Syrup + Measuring Cup - 150ml Biogaran - Toplexil

1. NAME OF DRUG OXOMEMAZINE BIOGARAN 0.33mg/ml, syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oxomemazine ............................... 0.033 g Per 100ml of syrup. Dilutant: saccharose. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM: Syrup. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment of non-productive coughs that occur specifically at night. 4.2. Dosage and how to use Suitable for adults and, children over the age of 2 years old. Orally. Use the measuring cup. Suitable for adults and children over 40 kg (from the age of 12 years old). 10 ml 4 times per day. For children: The daily dose according to a child’s weight (1ml of syrup per kg per day): · Child between 13-20 kg (between 2-6 years old): 5ml 2-3 times per day. · Child between 20-30 kg (between 6-10 years old): 10 ml 2-3 times per day. · Child between 30-40 kg (between 10-12 years old): 10 ml 3-4 times a day. Repeat if necessary minimum every 4 hours. Due to the sedative effect of oxomemazine it is advisable to take this medication in the evening. 4.3. Contraindications: This drug is not recommended in the following cases: · hypersensitivity to one of its components in particular antihistamines, · due to the presence of oxomemazine: * for a newborn (under 2 years of age), * history of agranulocytosis, * risk of urinary retention linked to urethro-prostatics, * risk of angle-closing glaucoma. 4.4. Special warnings and side effects Special warnings: Productive coughs (which are a fundamental element to broncho-pulmonary defence) must be respected. It is illogical to combine a cough or mucolytic with an antitussive. Before prescribing the antitussive it is advisable to understand the causes of the cough which requires specific treatment. If the cough resists the daily dose of the antitussive you must not increase the dosage but reassess the situation. Precautions for use: This drug contains sucrose. This medication is not recommended for patients with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency. This drug contains 3.7 g of saccharose per 5ml spoon, and 7.3 g per 10 ml. Be aware of the daily dose in the event of a low sugar diet or diabetes. LINKED TO OXOMEMAZINE CONTENT: Since phenothiazines have been considered to have hypothetical risk factors such as sudden infant death, it is not recommended for children under the age of 2 to take this medication. Observation (clinical or possibly electrical) should be enforced for epileptics in case of reduction of the seizure threshold. Promethazine should be used with precaution: · Among elderly people: * greater susceptibility to orthostatic hypotension, vertigo and sedation. chronic constipation (risk of paralytic ileus), * eventual prostatic hyperplasia · Among those with certain cardio-vascular diseases, due to the tachycardia and hypertensive effects of phenothiazines, · Among those with liver impairment and/or severe kidney impairment (due to the risk of accumulation). If used for children, bronchial asthma or gastroesophageal reflux should be ruled out before oxomemazine is used as an antitussive agent. Alcoholic drinks or other drugs containing alcohol (see section 4.5) are strongly not recommended during treatment. Due to the photosensitising effects of phenothiazines, sun exposure is not advisable during the treatment. The H1 antihistamines should be used with caution due to risk of sedation. Combining this drug with other sedative drugs is not recommended (see section 4.5). 4.5. Interactions with other drugs The interactions mentionned are linked to the oxomemazine content. Combinations to avoid: + Alcohol Increase of sedative effect from the antihistamines H1 with alcohol intake. Reduced vigilance can cause dangers when driving and using machinery. Avoid alcoholic drinks and drugs containing alcohol. + Other sedative medication Increase of sedative effect from the antihistamines H1. +Sultopride Heightened risk of ventricular rhythm disorders, notably torsade de pointes, and electrophysiological effects. Combinations to be aware of: + Other depressants of the central nervous system: (antidepressants with sedative effects, barbiturates, benzodiazepines, clonidine and hypnotics, morphine derivatives (analgesic and antitussives), methadone, neuroleptics, tranquilisers)). Increased depression. Reduced vigilance can cause dangers when driving and using machinery. + Atropine and other atropine-like substances (tricyclic antidepressants, antiparkinsonian anticholinergics, atrophic antispasmodics, disopyramide, neuroleptic phenothiazines). Additional atropine-like side effects such as urinary retention, constipation, dry mouth. 4.6. Pregnancy and breast feeding: The oxomemazine content influences whether it should be taken during pregnancy and breast feeding. Pregnancy: Malformative aspect There is no clear evidence of malformations detected in animals. There is not sufficient data to evaluate the malformation and foetal-toxic effect of oxomemazine when taking during pregnancy. Foetal-toxic aspect There were rare cases of digestive functional problems in relation to the atrophic properties among newborns of mothers who were prescribed strong doses of anticholinergic antihistamines (abdominal distension, meconium ileus, delayed development of meconium, difficulty in digesting food, tachycardia, neurological disorders...). For precautionary measures avoid taking this drug during the first trimester of pregnancy. During the third trimester it will only be prescribed if needed on a one time use basis. If this drug is taken at the end of the pregnancy a period of observation of the neurological and digestive functions will be carried out on the newborn. Breast feeding: The passing of oxomemazine into human milk is not known. This drug is not recommended during the breast feeding period due to the risk of sedation or paradoxal excitement, and increased risk of sleep apnea. 4.7. Effects on the ability to drive and operate machinery For drivers and users of machinery, be aware of the risk of drowsiness from taking this drug especially at the beginning of the treatment. The effect is heightened with the consumption of alcoholic drinks or other drugs containing alcohol. 4.8. Side effects The pharmacological characteristics of oxomemazine cause side effects of unequal intensity and are dose-related (see section .): Neuro-vegetative effects - Sedation or drowsiness,more noticeable at the beginning of the treatment; - Anti-cholinergic effects such as drying out of mucous, constipation, difficulties with accommodation, mydriasis, cardiac palpitations, risk of urinary retention, - Orthostatic hypotension, - Memory and concentration difficulties, troubles with balance, vertigo (more frequent amongst elderly people), - Lack of coordination, shivers, - Mental confusion, hallucinations, - Occasional effects on excitement: agitation, nervousness, insomnia, Sensitisation reactions - Erythema, eczema, itchiness, purpura, severe urticaria, - Oedema, angioedema, - Anaphylactic shock, - Photosensitisation; Haematological problems - Leukopenia, neutropenia, agranulocytosis as an exception, - Thrombocytopenia, - Hemolytic anemia. 4.9. Overdose Signs of a oxomemazine overdose: convulsions (especially for babies and children), disorientation, coma; Symptomatic treatment will be set-up in specific settings. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties ANTIHISTAMINES A SYSTEMATIC USAGE, Code ATC: R06AD08. (R: Respiratory system). Oxomemazine: Antihistamine H1, phenothiazine with aliphatic side chain, which is characterized by: · a sedative effect from usual doses, histaminergic and adrenolytic origins, · anticholinergic effect from outlying adverse effects. · adrenolytique effect, which might be haemodynamic (risk of orthostatic hypotension). Antihistamines have in common the property of opposing the effects of histamine on the vessels, skin and conjunctival, bronchial and intestinal mucous membranes. 5.2. Pharmacokinetics properties Lack of pharmacokinetic data on oxomemazine. For all antihistamines, especially phenothiazines, general elements can be provided: · Bioavailability is generally average. · The metabolism may be intense, with the formation of many metabolites, which explains the very low percentage of the product found in the urine. · The half-life is variable but often a prolonged effect, allowing a single daily dose. · The liposolubility of these molecules is at the origin of the high value of the volume of distribution. Pathophysiological variation: risk of capacity problems of antihistamines among patients with renal and heptatic impairment. 5.3. Preclinical safety data Not applicable. 6. Pharmaceutical data 6.1. List of dilutants Glycerol, saccharose, monohydrous citric acid, sodium citrate, sodium benzoate, caramel flavouring*, caramel colourant (E150c). *Composition of the caramel flavouring: vanilla, éthylvanillin, benzaldehyde and propylene glycol. 6.2. Incompatibilities Not applicable. 6.3. Shelf life Before opening: 3 years. After opening: 6 months. 6.4. Storage precautions Before opening: no specific storage precautions. After opening: store in a place below 25°C. 6.5. Nature and contents of outside packaging 150Ml bottle (type III brown glass) with a measuring cup (polypropylene) with a lid (polyethylene). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER BIOGARAN 15 BOULEVARD CHARLES DE GAULLE 92707 COLOMBES CEDEX 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER 368 954-5 or 34009 368 954 5 4: 150 ml vial (brown glass) + measuring cup (polypropylene) 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.