מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Brimonidine tartrate
CST Pharma Ltd
S01EA05
Brimonidine tartrate
2mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5055946806389
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ALPHAGAN ® EYE DROPS BRIMONIDINE TARTRATE 0.2% EYE DROPS (brimonidine tartrate) Your medicine is avaliable using one of the above names but will be referred to as Alphagan throughout the leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Alphagan is and what it is used for 2. Before you use Alphagan 3. How to use Alphagan 4. Possible side effects 5. How to store Alphagan 6. Further information 1. WHAT ALPHAGAN IS AND WHAT IT IS USED FOR Alphagan is used to reduce pressure within the eye. It can be used either alone, when beta-blocker eye drops are contraindicated, or with another eye drop, when a single medicine is not enough to lower the increased pressure in the eye, in the treatment of open angle glaucoma or ocular hypertension. The active ingredient in Alphagan is brimonidine tartrate, which works by reducing pressure within the eyeball. 2. BEFORE YOU USE ALPHAGAN DO NOT USE ALPHAGAN If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Alphagan. If you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressant drug. If you are breast-feeding. In infants/babies (from birth until 2 years). TAKE SPECIAL CARE WITH ALPHAGAN Before you take this medicine, tell your doctor: If you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder. קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alphagan 0.2% w/v (2 mg/ml) eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient(s): Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, greenish-yellow to light greenish-yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. − As monotherapy in patients in whom topical beta-blocker therapy is contraindicated. − As adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent (see Section 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Recommended dosage in adults (including the elderly) The recommended dose is one drop of Alphagan in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart. _Use in renal and hepatic impairment _ Alphagan has not been studied in patients with hepatic or renal impairment (see section 4.4). _Use in paediatric subjects _ No clinical studies have been performed in adolescents (12 to 17 years). Alphagan is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Alphagan have not been established in children. 4. קרא את המסמך השלם