Toplexil Oxomemazine 0,33 mg/ml Syrup Sanofi, 150ml bottle

1. NAME OF DRUG TOPLEXIL 0.33mg/ml, drinkable solution sweetened with asulfame potassium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oxomemazine ............................... 0.033 g Per 100ml of syrup. 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. · in association with sultopride (see section 4.5), 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: 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). This drug contains saccharose. 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. This drug contains sodium. This medication contains 8.25 mg of sodium per 5ml of syrup and 16.50mg of sodium per 10ml of syrup: patients on a strict low-salt diet should take precaution. 4.5. Interactions with other drugs Medication reduce the epiloptogen threshold The joint use of proconvulsant drugs, or lowering the seizure threshold, should be carefully weighed, due to the severity of the risk involved. These drugs are represented by most anti-depressants (imipraminic, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion, tramadol. Atropine-like medication Consideration should be given to the fact that atropine substances can increase the side effects and more easily result in urinary retention, acute glaucoma, constipation, dry mouth, etc. The various atropinic drugs are represented by imipraminic antidepressants, most atropinic H1 antihistamines, antiparkinsonian anticholinergics, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics as well as clozapine. Sedative medication Consideration should be given to the fact that many medicines or substances can add up to their depressant effects of the central nervous system and help to reduce alertness. These include morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (for example, meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserin, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensive agents, baclofen and thalidomide. Inadvisable combinations (see section 4.3). + Dopaminergic, excluding Parkinson (cabergoline, quinagolide) Reciprocal antagonism of the dopaminergic agonist and neuroleptics. Combinations to avoid (see section 4.4). + Other sedative medication Increase of sedative effect from the antihistamines H1. + Alcohol consumption Increase by alcohol of sedative effect from anti-tussives. Reduced vigilance can cause dangers when driving and using machinery. Combinations to be aware of + Gastrointestinal, Antacid and Coal Topics Decreased digestive absorption of phenothiazine neuroleptics. Take gastrointestinal and antacid topicals away from phenothiazine neuroleptics (more than 2 hours, if possible). Combinations to be aware of: + Antihypertensives Increased risk of hypotension, especially orthostatic. + Beta-blockers (except esmolol and sotalol) Vasodilator effect and risk of hypotension, especially orthostatic (additive effect). + Beta-blockers in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol) Vasodilator effect and risk of hypotension, especially orthostatic (additive effect). + Nitrated and related derivatives Increased risk of hypotension, especially orthostatic. 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. Due to the glycerol content, possibility of digestive and diarrhoea problems. 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 Sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel flavouring (heliotropin (piperonal), vanilla, propyleneglycol, alcohol, maltol, water), liquid maltitol, potassium acesulfame, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. Keep in its original packaging away from heat. Keep for a maximum of 6 months from opening the bottle. 6.5. Nature and contents of outside packaging 150 ml bottle (brown glass type III) with a measuring device (polypropylene) with lid (aluminium). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER SANOFI-AVENTIS FRANCE 1-13, BOULEVARD ROMAIN ROLLAND 75014 PARIS 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 359 578-4: 150 ml bottle (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.