Bausch + Lomb Cromoptic 2% single-dose eye drops

LEAFLET ANSM - Updated on: 05/27/2021 Name of the medicinal product CROMOPTIC 2%, eye drops, solution in single-dose container Sodium cromoglicate Box Please read all of this leaflet carefully before using this medicine because it contains important information for you. You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist. Keep this leaflet. You may need to read it again. Ask your pharmacist for advice or information. If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to your doctor if you do not feel better or if you feel worse. What is in this leaflet? 1. What is CROMOPTIC 2%, eye drops, solution in a single-dose container and what is it used for? 2. What you need to know before using CROMOPTIC 2%, eye drops, solution in a single-dose container? 3. How to use CROMOPTIC 2%, eye drops, solution in a single-dose container? 4. Possible side effects? 5. How to store CROMOPTIC 2%, eye drops, solution in a single-dose container? 6. Contents of the pack and other information. 1. WHAT IS CROMOPTIC 2%, eye drops, solution in a single-dose container AND WHAT IS IT USED FOR? Pharmacotherapeutic group: LOCAL ANTI-ALLERGIC (S = sensory organ) - ATC code: S01GX01. This medication is presented as eye drops, solution in a single-dose container. This eye drop is indicated for allergic eye diseases (allergic conjunctivitis). 2. WHAT YOU NEED TO KNOW BEFORE USING CROMOPTIC 2%, eye drops, solution in single-dose containers? Never use CROMOPTIC 2%, eye drops, solution in single-dose containers: · if you are allergic to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using CROMOPTIC 2%, eye drops, solution in single-dose containers. Wash your hands thoroughly before instilling. NEVER KEEP WITHIN REACH OF CHILDREN. DO NOT INJECT OR SWALLOW. Do not exceed the recommended dosage. If there is no improvement or if symptoms persist, seek medical advice. Children In children, medical advice is necessary. Other medicines and CROMOPTIC 2%, eye drops, solution in single-dose container Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine. If taking another eye drop, wait 15 minutes between each instillation. CROMOPTIC 2%, eye drops, solution in single-dose container with food Not applicable. Pregnancy, breastfeeding, and fertility If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine. Driving and using machines Transient visual discomfort may be experienced after instilling the eye drops. In this case, wait until the symptoms disappear before driving a vehicle or operating machinery. CROMOPTIC 2%, eye drops, solution in a single-dose container, contains {name the excipient(s)} Not applicable. 3. HOW TO USE CROMOPTIC 2%, eye drops, solution in a single-dose container? Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure. Dosage Adults and children: Depending on the severity of symptoms, instill 1 drop in each eye, 2 to 6 times a day, at regular intervals. Do not exceed the recommended dosage. Use in children For children, medical advice is required. Method of administration Ophthalmic use. Each single-dose contains enough eye drops to treat both eyes. Wash your hands thoroughly before instilling. · Avoid contact of the tip with the eye or eyelids. · Instill 1 drop of eye drops into the conjunctival sac of the affected eye while looking upwards and gently pulling the lower eyelid downward. · Then, press with a finger into the corner of your eye on the nasal side for 2 minutes. This will reduce the passage of the active ingredient (sodium cromoglicate) into the rest of your body. · With your eye closed, wipe off any excess. · Discard the single-dose container after use. Do not store it for future use. If you are taking another eye drop at the same time, wait 15 minutes between each instillation. Duration of treatment Do not extend treatment without medical advice. If there is no improvement or if symptoms persist, seek medical advice. If you use more CROMOPTIC 2%, single-dose eye drops, solution than you should Consult your doctor or pharmacist. If you forget to take CROMOPTIC 2%, single-dose eye drops, solution Do not take a double dose to make up for a forgotten single dose; but simply continue your treatment. If you stop taking CROMOPTIC 2%, single-dose eye drops, solution Not applicable. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS? Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible occurrence: · allergic reaction to the product's components, · temporary visual discomfort after instilling the eye drops. Reporting of side effects If you experience any side effects, talk to <,> . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr By reporting side effects, you can help provide more information on the safety of this medicine. 5. HOW TO STORE CROMOPTIC 2%, eye drops, solution in single-dose container? Discard the single-dose container after use. Do not reuse a single-dose container that has already been opened. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the bottle after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice any visible signs of deterioration. Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What CROMOPTIC 2%, eye drops, solution in single-dose container contains · The active ingredient is: Sodium cromoglicate............................................................................................................. 2 g Per 100 mL · The other ingredient is: purified water. What CROMOPTIC 2%, eye drops, solution in single-dose container looks like and contents of the outer packaging 0.35 mL in single-dose container (PE). Boxes of 10, 20, or 30 single-dose containers presented in strips of 10 single-dose containers; each strip is overwrapped in a polybag (polyester/aluminum/PE). Not all presentations may be available for sale. Marketing Authorization Holder LABORATOIRE CHAUVIN 416 RUE SAMUEL MORSE – CS99535 34931 MONTPELLIER Marketing Authorization Holder LABORATOIRE CHAUVIN 416 RUE SAMUEL MORSE – CS99535 34931 MONTPELLIER Manufacturer LABORATOIRE CHAUVIN ZONE INDUSTRIELLE DE RIPOTIER 50 AVENUE JEAN MONNET 07200 AUBENAS Names of the medicinal product in the Member States of the European Economic Area Not applicable. This leaflet was last revised: [to be completed later by the holder] {month YYYY}. Other Detailed information on this medicinal product is available on the ANSM website (France).