Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
brinzolamide
Lusomedicamenta Sociedade Tecnica Farmaceutica
S01EC04
brinzolamide
10mg/ml
drops eye (suspension)
plastic vial 5ml
Prescription
Registered
2022-11-03
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRINZOLAMIDE MOOSMANN 10 MG/ML EYE DROPS, SUSPENSION brinzolamide 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 Brinzolamide Moosmann is and what it is used for 2. What you need to know before you use Brinzolamide Moosmann 3. How to use Brinzolamide Moosmann 4. Possible side effects 5. How to store Brinzolamide Moosmann 6. Contents of the pack and other information 1. WHAT BRINZOLAMIDE MOOSMANN IS AND WHAT IT IS USED FOR Brinzolamide Moosmann contains the active ingredient brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors. It reduces pressure within the eye. Brinzolamide Moosmann are used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma. If the pressure in the eye is too high, it can damage your sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRINZOLAMIDE MOOSMANN DO NOT USE BRINZOLAMIDE MOOSMANN : • if you have severe kidney problems. • if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to medicines called sulfonamides. Examples include medicines used to treat diabetes and infections and also diuretics (water tablets). Brinzolamide may cause the same allergy. • if you have too much acidity in your blood (a condition called hyperchloraemic acidosis) If you have further questions ask your doctor for advice. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse b Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Brinzolamide Moosmann 10 mg/ml Eye Drops, Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide. Excipient(s) with known effect: Each ml of suspension contains 0.15 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brinzolamide Moosmann is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta- blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology When used as monotherapy or adjunctive therapy, the recommended dose is one drop of Brinzolamide Moosmann in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. _Special populations _ _ _ _Elderly population _ No dose adjustment in elderly patients is necessary. _Patients with hepatic and renal impairment _ Brinzolamide Moosmann has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. Brinzolamide Moosmann has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, Brinzolamide Moosmann is therefore contra-indicated in such patients (see also section 4.3). _Paediatric population _ The efficacy and safety of brinzolamide in infants, children and adolescents aged 0 to 17 years has not been established. Currently available data are described in sections 4.8 and 5.1. Brinzolamide is not recommended for use in infants, children and adolescents. Method o Прочетете целия документ