Phenergan 2%, Promethazine, 30g tube

1. NAME OF DRUG PHENERGAN, 2%, CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Promethazine ................................................................ 2.00 g Per 100g of cream. Dilutants with known effect: wool fat (lanolin), methyl parahydroxybenzoate, cetostearyl alcohol. 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 pruritus, in particular insect bites. 4.2. Dosage and how to use Apply a thin coat 2 to 3 times a day. 4.3. Contraindications: · hypersensitivity to one of its components (promethazine, paraben, lanolin or wool fat), · seeping dermatosis · infected dermatosis · eczema 4.4. Special warnings and side effects Special warnings: The only symptom is itchiness. Present in all research and its aetiology. Be aware of any potential allergenic substances of this drug, the risks should be weighed up against the possible benefits. Be aware of the presence of promethazine, there is a risk of a skin reaction and photosensitisation. In case of a skin reaction from the promethazine in the cream, cross-sensitisation may occur after a course of phenothiazines. Precautions for use: Avoid sun and U.V.A exposure during treatment. This drug contains lanolin (wool fat) and can cause local skin reactions (for example: eczema). This drug contains cetostearyl alcohol and can cause local skin reactions (for example: eczema). This drug contains methyl parahydroxybenzoate and can cause local skin reactions (for example: eczema). 4.5. Interactions with other drugs From a medical point of view promethazine for topical use should not cause any significant drug interactions with the recommended doses. 4.6. Pregnancy and breast feeding: Pregnant and breast feeding women should use this drug with caution due to the atrophic properties and sedatives in promethazine. Do not apply onto the breasts during breast feeding. 4.7. Effects on the ability to drive and operate machinery Warning, especially to users of machinery, of risk of drowsiness associated to the use of this drug particularly at the beginning of the treatment. The effect is heightened with the consumption of alcoholic drinks or other drugs containing alcohol. It is advisable to start the treatment of the allergic symptoms in the evening. 4.8. Side effects Risk of sensitisation to the different components of the drug: promethazine, lanolin or wool fat, paraben. 4.9. Overdose · Signs of a promethazine 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 Pharmaco-therapeutic class: ANTIHISTAMINE, H1, 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 Stearic acid, mix of cetostearyl alcohol and sulfate sodium cetostearyl (Kolliphore, CS, A), cholesterol, wool fat, trolamine, glycerol, methyl parahydroxybenzoate, coumarin, essential oil of lavender, distilled water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 30 g varnished tube with a polythene cap. 6.6. Precautions for handling 7. THE MARKETING AUTHORISATION HOLDER FAMEL LABORATORY 102, AVENUE PHILIPPE AUGUSTE 75011 PARIS 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 308 226-3: 30 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.