Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betaxolol hydrochloride
Immedica Pharma AB
S01ED02
Betaxolol hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5015664049741
Package Leaflet - Information for the User BETOPTIC * 0.5 % w / v eye drops, solution Betaxolol ( as hydrochloride ) 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 your 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What BETOPTIC 0.5 % is and what it is used for 2. Before you use BETOPTIC 0.5 % 3. How to use BETOPTIC 0.5 % 4. Possible side effects 5. How to store BETOPTIC 0.5 % 6. Further information WHAT BETOPTIC * 0.5 % IS AND WHAT IT IS USED FOR 1 BETOPTIC 0.5 % belongs to a group of medicines known as beta blockers. It is used to treat glaucoma or ocular hypertension ( high pressure in the eye ) by reducing the fluid pressure in your eye ( s ). BEFORE YOU USE BETOPTIC 0.5 % 2 Do not use BETOPTIC 0.5 % eye drops, solution... • If you are allergic to betaxolol, beta-blockers or any of the other ingredients listed in section 6. Ask your doctor for advice. • If you have now or have had in the past, respiratory problems such as severe asthma, severe chronic obstructive bronchitis ( severe lung condition which may cause wheeziness, difficulty in breathing and / or long-standing cough ). • If you have a slow heart beat, heart failure or disorders of heart rhythm ( irregular heartbeats ). Take special care... Before you use this medicine, tell your doctor if you have now or have had in the past • coronary heart disease ( symptoms can include chest pain or tightness, breathlessness or choking ), heart failure, low blood pressure ( hypotension ) • disturbances of heart rate such as slow heart beat ( bradycardia ) • breathing problems, asthma or chronic obstructive pulmonary disease ( lung disease which may ca Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betoptic 0.5% w/v eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betaxolol 0.5% w/v (as hydrochloride) Excipients with known effect: 1ml of solution contains 0.1mg benzalkonium chloride. For a full list of excipients see Section 6.1 3 PHARMACEUTICAL FORM Eye Drops, Solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) The usual dose is one drop to be instilled into the affected eye(s) twice daily. Children Betoptic is not recommended for use in children. 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. After cap is removed, if tamper evident snap collar is loose, remove before using product. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients. • Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For ocular use only GENERAL: Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. Due to the beta-adrenergic component, betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2. CARDIAC DISORDERS: In patients with cardiovascular diseases (e.g Přečtěte si celý dokument