देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dorzolamide hydrochloride
Viatris UK Healthcare Ltd
S01EC03
Dorzolamide hydrochloride
20mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5016695003306
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DORZOLAMIDE 20 MG/ML EYE DROPS, SOLUTION Dorzolamide 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 Dorzolamide is and what it is used for 2. What you need to know before you use Dorzolamide 3. How to use Dorzolamide 4. Possible side effects 5. How to store Dorzolamide 6. Contents of the pack and other information 1. WHAT DORZOLAMIDE IS AND WHAT IT IS USED FOR Dorzolamide is supplied as a sterile eye drop solution. Dorzolamide contains dorzolamide, a sulfonamide- related compound, as the active ingredient. Dorzolamide belongs to a group of medicines called ophthalmic carbonic anhydrase inhibitors which reduce high pressure in the eye. Dorzolamide is used to lower raised pressure in the eye and to treat glaucoma (open-angle glaucoma, pseudo- exfoliative glaucoma). Dorzolamide can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE DO NOT USE DORZOLAMIDE if you are allergic to dorzolamide or any of the other ingredients of this medicine (listed in section 6) if you have severe kidney problems. - if you have a disturbance in the pH (acid/alkali balance) of your blood. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Dorzolamide if: - if you have, or have had, liver problems in the past - if you have been told you have a corneal defect - if you have had any allergies to any sulfonamide like medicines e.g. co-trimoxazole - पूरा दस्तावेज़ पढ़ें
OBJECT 1 DORZOLAMIDE/TIMOLOL 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION Summary of Product Characteristics Updated 22-Sep-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Dorzolamide/Timolol 20 mg/ml + 5 mg/ml Eye drops, Solution 2. Qualitative and quantitative composition Each ml contains 20 mg dorzolamide (as dorzolamide hydrochloride) and 5 mg timolol (as timolol maleate). Excipients with known effect: Each ml of eye drops solution contains 0.15 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Eye drops, solution. Clear, slightly viscous, colourless aqueous solution. 4. Clinical particulars 4.1 Therapeutic indications Dorzolamide/Timolol is indicated in the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 Posology and method of administration Posology The dose is one drop of Dorzolamide/Timolol in the conjunctival sac of the affected eye(s) two times daily. If another topical ophthalmic medicinal product is being used, the other agent should be administered at least ten minutes apart. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. _Paediatric population:_ Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of two years has not been established. (for information regarding safety in paediatric patients ≥2 and < 6 years of age, see section 5.1). Method of administration For ocular use. Patients should be instructed to wash their hands before use and avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. In order to secure correct dosage - the dropper tip should not be enlarged. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by com पूरा दस्तावेज़ पढ़ें