Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sodium cromoglicate
Opella Healthcare France SAS T/A Sanofi
S01GX; S01GX01
Sodium cromoglicate
2 percent weight/volume
Eye drops, solution
Other antiallergics; cromoglicic acid
Not marketed
1975-12-15
08/07/2021 12:36 - VISTAlink folder 4155066 - Page 1/5 DRIVING AND USING MACHINES You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly. Using Opticrom Eye drops may cause eye irriation. If this happens, do not drive or use any tools or machines. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF OPTICROM Opticrom contains benzalkonium chloride. This may cause your eyes to become irritated. It may also change the colour of your contact lenses. In order to avoid contact with soft contact lenses, remove contact lenses prior to application and wait at least 15 minutes before reinsertion. 3. HOW TO USE OPTICROM Always use Opticrom exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. HOW TO USE THIS MEDICINE • Wash your hands • Remove the cap from the bottle • Tilt your head back • Squeeze one or two drops inside the lower lid without touching your eye • Close your eye • Wipe away any excess liquid from the eyes with a clean tissue • Always put the cap back on the bottle as soon as you have used it • Repeat in the other eye if needed HOW MUCH TO USE (ADULTS, ELDERLY AND CHILDREN) • One or two drops in each eye four times a day, or as directed by your doctor • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor IF YOU FORGET TO USE OPTICROM If you forget a dose, use your drops as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. IF YOU STOP USING OPTICROM Keep using the eye drops until your doctor tells you to stop. Do not stop using the eye drops just because your eyes feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Opticrom can cause side effects, although not everybody gets the Read the complete document
Health Products Regulatory Authority 24 April 2023 CRN00DGVV Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Opticrom 2 % w/v Eye Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Cromoglicate 2.0% w/v. Excipients: Also includes benzalkonium chloride 0.01% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. A clear, colourless to pale yellow, sterile, aqueous solution in a dropper bottle for ocular use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief and treatment of allergic conjunctivitis and vernal keratoconjunctivitis (vernal or spring catarrh). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One to two drops into each eye four times daily or as instructed by the physician. Care should be taken to avoid contamination of the contents during use. 4.3 CONTRAINDICATIONS Use in patients sensitive to sodium cromoglicate or any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses during treatment with Opticrom Eye Drops. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION As with all medication, caution should be exercised, especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should only be used in pregnancy on the advice of a physician and where there is a clear need. It is not known whether sodium cromoglicate is excreted in the breast milk, but on the basis of its physico-chemical properties this is considered unlikely. There is no evidence to suggest that the use of sodium cromoglicate has any undesirable effects on the baby. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Health Products Regulatory Authority 24 April 2023 CRN00DGVV Page 2 of 3 As with all eye drops, instillation of Opti Read the complete document