Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Package leaflet Information for use, please, read carefully! BRIMONAL® 0.2% (Brimonidi tartras) Drug form: Eye drops, solution. Marketing authorisation holder: UNIMED PHARMA, JSC, Bratislava, Slovak Republic. Composition: Active substance: Brimonidini tartras (brimonidine tartrate) 2 mg in one mL of solution. 1 mL = 23 drops. Excipients: Benzalkonii chloridum (benzalkonium chloride – a preservative), natrii chloridum (sodium chloride), hypromellosum (hypromellose), acidum tartaricum (tartaric acid), natrii tartras dihydricus (sodium tartrate), natrii hydroxidum (sodium hydroxide – to adjust pH), aqua purificata (purified water). Pharmacotherapeutic group: Ophthalmic, anti-glaucoma agent. Characteristics: Active substance brimonidine tartrate is a selective agonist of alpha-2 adrenergic receptors that decreases pressure in the eye. Indications: BRIMONAL® 0.2% is used to lower increased intraocular pressure in glaucoma or in ocular hypertension without glaucoma (increased pressure in the eyeball). Preparation may be applied alone, or together with other eye drops that reduce intraocular pressure (mainly with beta-blockers). The preparation is indended to be used by adults. Contraindications: BRIMONAL® 0.2% must not be used in hypersensitivity to the active substance, or to any of the other ingredients of the preparation. Patients receiving some drugs for therapy of depression (monoaminoxidase inhibitors, tricyclic and tetracyclic antidepressants) have to avoid this preparation. BRIMONAL® 0.2% must not be applied to children and teenagers under 18 years of age, and to breast-feeding mothers. Safety of the use of the preparation during human pregnancy has not been established to date. BRIMONAL® 0.2% should not be used in pregnancy unless the potential benefit of the preparation for a mother outweighs the potential risk for a developing foetus. Undesirable effects: After application of BRIMONAL® 0.2% some local (ocular) or systemic undesirable effects may occur. Local unwanted possible effects include: sensation of burning, stinging and tingling in the eye, feeling that something is in the eye, feeling of dryness in the eye, painful eyes. Blurred vision, excessive production of tears and increased discharge from eyes may develop as well. Moreover, eye and eyelid redness, paleness of conjunctiva, swelling of eyelids or conjunctiva may be present. Nodules may develop on the conjunctiva. Some of above undesirable effects might be associated with hypersensitivity to one of ingredients of the preparation. Systemic possible undesirable effects include: feeling of dry mouth, dryness of nasal mucosa, headache, tiredness, drowsiness, dizziness, upset stomach, unusual change in taste, general weakness, depressions and pounding heartbeat. If you notice above mentioned undesirable effects, or any other unusual reactions, please inform your doctor. Interactions: The effects of BRIMONAL® 0.2% and those of other drugs used simultaneously may interact with each other. Your doctor should therefore be informed about all drugs you are currently taking or you intend to take, either those on medical prescription, or over-the-counter products. Should another doctor prescribes you a new drug, inform him/her that you use BRIMONAL ® 10% eye drops, solution. Preparation may potentiate inhibiting effect of sleeping pills, medications with calming effects, some pain-relievers and alcohol. It may enhance the effect of bloodpressure-lowering drugs. If you receive also other ophthalmic agents, discuss the suitability of their concomitant use with your ophthalmologist. Dosage: Actual dosage and duration of therapy must be determined by a doctor. If not indicated otherwise, one drop twice a day is recommended, applied 12 hours apart. If you use BRIMONAL® 0.2% together with other eye drops, keep 5-15minute interval before instillation of the other drug. If you miss one dose, apply it as soon as you remember. If it is time for the next regularly scheduled dose, skip the missed dose and continue your regular dosing schedule. Special warnings: BRIMONAL® 0.2% may inducre tiredness and/or drowsiness which may impair the ability to drive motor vehicles and operate machinery. Preparation may enhance inhibiting action of alcohol. A preservative benzalkonium chloride present in this preparation may be absorbed by soft contact lenses, therefore wait at least 15 minutes after using BRIMOVAL® 0.2% to put in your lenses. In case of overdosage or incidental ingestion of the drug by a child seek medical attention immediately. Tell your doctor if you are pregnant or breast-feeding a baby before using this medication. Precautions: Preparation must not be used after the expiry date shown on the pack. Use an open bottle within 28 days. Tighten the cap of the bottle after instillation right away. Package: 1 x 5 mL, 1 x 10 mL, 3 x 5 mL. Storage: Do not refrigerate/freeze. Protect to light. To be stored at temperature below 25°C. Keep out of reach of children. Date of last text revision: April 2005 Oriešková 11, 821 05 Bratislava Slovak Republic