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Paxeladine 0.2% Syrup, Oxeladin 0.2%, 125ml, Treatment for Dry Coughs
  • Paxeladine 0.2% Syrup, Oxeladin 0.2%, 125ml, Treatment for Dry Coughs

Paxeladine 0.2% Syrup, Oxeladin 0.2%, 125ml, Treatment for Dry Coughs

€3.07
Maximum purchase: 2

Symptomatic treatment for dry-coughs.

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1. NAME OF DRUG PAXELADINE 0.2%, syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oxeladin citrate ................................................ 0.2000 g Per 100ml of syrup. A small measuring spoon (2.5ml) contains 5g of oxeladin citrate. A large measuring spoon (5ml) contains 10g of oxeladin citrate. Dilutants with noticeable effect: 2.125 g of saccharose per small 2.5ml measuring spoon and 4.25 g of saccharose per large 5ml measuring spoon. Ethanol (alcohol): 12g per small 2.5ml measuring spoon 24g per large 5ml measuring spoon. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM: Syrup. Clear & light-yellow syrup. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment of non-productive coughs. 4.2. Dosage and how to use Suitable for adults and, children over the age of 30 months & more than 15kg. The symptomatic treatment must be short (a few days) and limited to times when coughing. The box contains a double measuring spoon of 2.5ml and 5ml. A small measuring spoon (2.5ml) contains 5mg of oxeladin citrate. A large measuring spoon (5ml) contains 10mg of oxeladin citrate. Child between 15-20 kg (between 30months -15 years old): 1 2.5ml spoonful, every 4 hours without exceeding 3-4 spoonfuls per day (according to weight of child). Child between 20-30 kg (between 6-10 years old): 1 5ml spoonful, every 4 hours without exceeding 2-3 spoonfuls per day (according to weight of child). Child between 30-50kg (between 10-15 years old): 1 5ml spoonful, every 4 hours without exceeding 3-5 spoonfuls per day (according to weight of child). Adults: 1 5ml spoonful, every 4 hours without exceeding 5 spoonfuls per day. 4.3. Contraindications: Do not use if allergic to one of its components. 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: · For diabetics or those on a hypoglucidic diet, be aware of the saccharose content: 4.25 g per large 5ml measuring spoon and 2.125 g per 2.5ml small measuring spoon. · This medication should not be administered on a child younger than 30 months old due to the lack of data for this age range. · This drug contains sucrose. This medication is not recommended for patients with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency. · This medication contains weak quantities of ethanol (alcohol): 24mg per large 5ml measuring spoon and 12mg per small 2.5ml measuring spoon. 4.5. Interactions with other drugs The current data available does not suggest any clinical interactions. 4.6. Pregnancy and breast feeding: Pregnancy: There is no clear evidence of malformations detected in animals. In clinical studies there are no particular malformative or fetotoxic effects appeared to date. However monitoring pregnancies exposed to this drug is not enough to rule out any risk. For precaution measures, it is advisable not to take this drug during pregnancy. Breast feeding: Due to the lack of data of knowing if it passes into human milk, it is not recommended to use this medication during breast feeding. 4.7. Effects on the ability to drive and operate machinery No effects on the ability to drive vehicles or use machinery have been found. 4.8. Side effects Hypersensitive reactions have been reported (urticaria, skin outbreak, angioedema). Declaration of suspected side effects The declaration of suspected side effects after drug authorisation is important. It allows continuous observation into the benefits/risks of the drug. Health professionals declare all suspected side effects via the national system of declaration: The ANSM and the network of Regional Centres of Pharmacovigilance- website www.ansm.sante.fr. 4.9. Overdose Limited information on over-dosage; in the few reported cases, no symptoms linked to overdoses have been raised. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTITUSSIVE. (R. Respiratory system) Central antitussive, non-opiate, non-antihistamine. 5.2. Pharmacokinetics properties The data on the oxeladin pharmacokinetics are very weak. 5.3. Preclinical safety data Not known. 6. Pharmaceutical data 6.1. List of dilutants Cocoa flavouring (mixture of natural and synthetic aromas, water and ethanol), saccharose, potassium sorbate, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life Before opening: 3 years. After opening: 6 months. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 125 ml bottle (type III red glass) closed with an aluminium lid with a polyethylene seal. Double measuring spoons made of ivory polystyrene (2.5ml & 5ml). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER IPSEN PHARMA 65, QUAI GEORGES GORSE 92100 BOULOGNE BILLANCOURT 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 328 897-0: 125 ml bottle (red glass) + double measuring spoon (2.5ml & 5ml in polystyrene. 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.

Ipsen
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