Camphrice du Canada, Camphor 4%, stick for local application, 25g

1. NAME OF DRUG CAMPHRICE DU CANADA 4%, stick for local application 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Racemic camphor: 4.0 g Per 100g. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Stick for local application. 4. CLINICAL DATA 4.1. Therapeutic Indications Supplementary treatment for irritative dermatitis. 4.2. Dosage and how to use Apply two times per day on cleaned skin. 4.3. Contraindications · for a child under 30 months old, · seeping dermatosis · infected dermatosis · do not use on mucous membranes. Linked to terpene derivatives: · for a child under 30 months old, · children with a history of convulsions. 4.4. Special warnings and side effects Special warnings: Due to the camphor content and the convulsion risk on children, this medication must be used with precaution for children under 12 years. Do not use on a large area or on nose or lips. This medication contains terpene derivatives which can lead to excessive doses of neurological convulsion-like symptoms among infants and children. Follow the dose and advice of us carefully: · Do not apply the gel on large areas of your body, · Do not apply onto the breasts during breast feeding. Precautions for use Due to the terpene derivatives in this drug, patients with a history of epilepsy need to be careful. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding It is not advisable to take this drug during breast feeding due to: - lack of kinetic data on the passing of the terpene derivatives into the human milk, - the potential neurological toxicity for the baby. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Local allergic reactions possible. Due to the terpene derivative content and not respecting the prescribed dose: - Risk of convulsions for children and babies, - Possibility of agitation and confusion among elderly patients. 4.9. Overdose In case of an overdose, there is a risk of convulsions. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: SKIN PROTECTOR. (D. Dermatology) This medication contains terpene derivatives which can decease the seizure threshold. 5.2. Pharmacokinetics properties Not known. 5.3. Preclinical safety data Not known. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Thyme essential oil, terpinol, solid paraffin, vaseline. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 30G Applicator tube in polystyrene with a polystyrene lid with an interior polyethylene cupule. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER PHARMACIE ET LABORATOIRES DE L'HOMME DE FER 2, PLACE DE L'HOMME DE FER 67000 STRASBOURG 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 316 103-4: stick for local application, 30g tube (polstyrene). 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.