Tear-Gel, Carbomer 974P, 0.3%, Ophthalmic Gel, 10g tube for dry eyes, Théa

1. NAME OF DRUG TEAR GEL, Ophthalmic Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carbomer 974P: 0.300 g Per 100g of Ophthalmic Gel. Dilutant: benzalknium chloride. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic Gel. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for dry eyes. 4.2. Dosage and how to use One drop in each eye 2-4 times per day, and at any time you feel pain in the eye. Children and adolescents up to 18 years: The safety and efficacy of tear-gel at the recommended dosage in adults has been established by clinical experience, but no clinical study data are available. 4.3. Contraindications: Over-sensitivity to active substance or one of its dilutants. Those who wear contact lenses. 4.4. Special warnings and side effects Precautions for use: Those who wear contact lenses should not use this eye gel when using them. Due to the benzalkonium content this medication can cause irritation in the eyes. Avoid contact with contact lenses. Take them out before using the gel then wait 15 minutes before putting them back in. The benzalkonium chloride can discolour the contact lenses. 4.5. Interactions with other drugs Wait 15 minutes in between eyewash treatments. This gel should be the last thing to use. 4.6. Pregnancy and breast feeding Given the data available, using this gel whilst breast-feeding is possible. 4.7. Effects on the ability to drive and operate machinery Brief blurred vision after using this product. 4.8. Side effects A brief blurred vision occurs after using this gel until it has spread out over the surface of the eye. 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 Rinse with a sterile physiological serum. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties TEAR GEL, an ophthalmic gel based on a hydrophilic polymer (Carbomer-974 P) of high molecular weight, forms a transparent, lubricating and wetting film on the surface of the eye. Its pH and osmolality are similar to those of normal tear film. The gel relieves irritation symptoms associated with dry eye syndrome and protects the cornea from dryness. The use of vital dyes allowed us to demonstrate, under treatment with the gel, a regression of the corneal and conjunctival epithelial lesions related to the dryness of the eye. The remanence of the gel on the surface of the eye is longer than that of an artificial tear of low viscosity, which results in an increase in the duration of the effectiveness on the symptoms and thus in a frequency of a lower dose. 5.2. Pharmacokinetics properties Not known. 5.3. Preclinical safety data In animal studies, repeat toxicity studies of the carbomer did not reveal any particular risk to humans. No data on carcinogenicity, mutagenicity or reproductive toxicity are available. Ocular Toxicity: Eye administration of a drop of Gel-Tears 4 times a day for 5 weeks in the animal did not have any local or systemic toxicity. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Benzalkonium chloride, sorbitol, sodium hydroxide, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life Before opening: 3 years. Once opened do not keep the product for more than 4 weeks. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging 5 g or 10g tube (polyethylene-aluminium) with nozzle (polyethylene). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER THEA LABORATORIES 12, RUE LOUIS BLERIOT 63017 CLERMONT-FERRAND CEDEX 2 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 331 947-5: 5 g tube (polyethylene-aluminium) with nozzle (polyethylene). · 331 948-1: 10 g tube (polyethylene-aluminium) with nozzle (polyethylene). 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.