Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Brimonidine tartrate
Genus Pharmaceuticals Ltd
S01EA05
Brimonidine tartrate
2mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000
BRIMONIDINE TARTRATE 0.2% w/v Eye drops Brimonidine tartrate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. l Keep this leaflet. You may need to read it again. l If you have any further questions, ask your doctor, pharmacist or nurse. l 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. l If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. l Your medicine, Brimonidine Tartrate 0.2% w/v Eye Drops will be referred to as Brimonidine in this leaflet. What is in this leaflet: 1. What Brimonidine is and what it is used for 2. What you need to know before you use Brimonidine 3. How to use Brimonidine 4. Possible side effects 5. How to store Brimonidine 6. Contents of the pack and other information 1. WHAT BRIMONIDINE IS AND WHAT IT IS USED FOR Brimonidine Eye Drops are a sterile, preserved, aqueous solution used as eye drops. The active ingredient brimonidine tartrate works by reducing pressure within the eyeball. It is used to reduce pressure in the eye in the conditions of glaucoma or ocular hypertension. The medicine may be used alone or in conjunction with another eye drop that reduces pressure in the eye. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRIMONIDINE Do not use Brimonidine l if you are allergic (hypersensitive) to Brimonidine or any of the other ingredients of this medicine (listed in section 6). l if you are taking a monoamine oxidase (MAO) inhibitors medicine or a tricyclic antidepressants medicine (you should check with your doctor if you are taking any medicines for depression) l if you are breast feeding l in new born babies or children under 2 years Warnings and precautions Talk to your doctor or pharmacist or nurse before using Brimonidine l if you suffer from depression l if you suffer from heart disease or heart problems l if you Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brimonidine Tartrate 0.2% w/v Eye Drops. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Brimonidine tartrate 0.2% w/v (2.0 mg/ml). Excipients include Benzalkonium chloride 0.005% w/v. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, greenish-yellow solution. 4.1 THERAPEUTIC INDICATIONS For 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 contra- indicated. - As adjunctive therapy to other intraocular pressure lowering medications when the target intraocular pressure is not achieved with a single agent. (See section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population _ No clinical studies have been performed in adolescents (12 to 17 years). Brominidine eye drops shoud not be used in children aged below 12 years and are contraindicated in neonates and infants (less than 2 years of age) (see sections 4.3, 4.4 & 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of brimonidine has not been established in children. _Adults including the elderly: _ One drop into the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required in elderly patients. To reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctul occlusion) for one minute immediately after the instillation of each drop. If more than one topical ophthalmic drug is to be administered, they should be instilled 5 to 15 minutes apart. _Patients with renal and hepatic impairment: _ Brimonidine eye drops have not been studied in patients with renal or hepatic impairment (see section 4.4). Method of administration _Precautions to be taken before handling or administering the medicinal product _ _ _ 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) Lees het volledige document