Eurax 10% Crotamiton, Itching, 40g cream

1. NAME OF DRUG EURAX 10% CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Crotamiton: 10 g Per 100g of cream. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Cream. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment of pruritis, in particular insect bites. 4.2. Dosage and how to use Local use. 1 application 2-3 times per day. One application for children is enough. 4.3. Contraindications · allergy to one of its components, · infected or irritated dermatosis, · seeping cuts. 4.4. Special warnings and side effects Special warnings: The only symptom is itchiness. Present in all research and its aetiology. Itching that persists or worsens can be linked to an allergy to one of the ingredients. Due to lack of data, the risk of effects cannot be excluded. It is even more to be feared that the topical is used on a large surface, under an occlusive dressing, on a damaged skin (especially burnt skin), a mucous membrane, premature or infant skin (due to the surface / weight ratio and of the effect of occlusion of the layers at the level of the seat). Do not apply onto eyelids. In case of contact with the eyes, wash them well with water. This formula contains propyleneglycol and can cause skin irritations. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding Pregnant and breast feeding women should use this drug with caution due to lack of clinical data. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects - risk of allergy - risk of methemoglobinemia (see section 4.4). 4.9. Overdose In case of accidental ingestion, signs of acute intoxication such as nausea, vomiting, mouth, oesophagien and stomach pains can appear. General measures need to be taken to eliminate the medication and reduce its absorption. Very low risk of methemoglobinemia if accidental ingestion or excessive absorption. Symptoms tend to disappear once treatment is stopped but in serious cases, the use of blue methylene can be used. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: ANTI-PRURITIC (D. Dermatology) 5.2. Pharmacokinetics properties Not known. 5.3. Preclinical safety data Not known. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Glycerol stearate, isopropyl myristate, cetostearylic alcohol, macrogol 2000 stearate, liquid paraffin, propyleneglycol, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 5 years. 6.4. Storage precautions Store in a place below 30°C. 6.5. Nature and contents of outside packaging Alumunium tube either 40g or 60g with an interious varnish of epoxyphenolic. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER NOVARTIS SANTE FAMILIALE SAS 10 rue Louis Blériot 92500 RUEIL MALMAISON 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 329 064-2: 40 g tube (aluminium). · 303 862-9: 60 g tube (aluminium). 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.