Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium cromoglicate
DE Pharmaceuticals
S01GX01
Sodium cromoglicate
20mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040200
PACKAGE LEAFLET: INFORMATION FOR THE USER Sodium Cromoglicate 2% w/v Eye Drops, solution Sodium cromoglicate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What this medicine is and what it is used for 2. What you need to know before you use this medicine 3. How to use this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR This medicine contains sodium cromoglicate which belongs to a group of medicines called anti-allergics. It works by stopping the release of the natural substances in your eyes that can lead to an allergic reaction. Signs of an allergic reaction include itchy, watery, red or inflamed eyes and puffy eyelids. This medicine is used for the prevention, relief and treatment of eye allergies. This includes: • Short and long term allergic conjunctivitis (inflammation of parts of the eye) • More severe cases of conjunctivitis (‘vernal keratoconjunctivitis’). Signs include bumps inside the upper eyelid, sensitivity to light and severe itching. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE Do not use this medicine: • If you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (listed in Section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid. Do not use this medicine সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Cromoglicate 2% w/v Eye Drops, Solution Opticrom Aqueous 2% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of eye drops contains Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate). Excipients with known effect: 0.1mg benzalkonium chloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye Drops, Solution A clear colourless to pale yellow solution for administration to the eye. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ocular use Adults and Children: One or two drops to be administered into each eye four times daily or as indicated by the doctor. Elderly There is no evidence to suggest that dosage alteration is required for elderly patients. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Discard any remaining contents four weeks after opening the bottle. This medicine contains Benzalkonium Chloride As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period. From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use 4.5 INTERACTION WITH OTHER MEDICINAL PRODUC সম্পূর্ণ নথি পড়ুন