Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betaxolol hydrochloride
Immedica Pharma AB
S01ED02
Betaxolol hydrochloride
2.5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5015664035003
Continued over BETOPTIC * 0.25% w/v eye drops, suspension Betaxolol (as hydrochloride) Package Leaflet - Information for the User BETOPTIC 0.25 % belongs to a group of medicines known as beta blockers. It is used to treat chronic open-angle glaucoma or ocular hypertension ( high pressure in the eye ) by reducing the fluid pressure in your eye ( s ). 1. What BETOPTIC 0.25 % is and what it is used for 2. Before you use BETOPTIC 0.25 % 3. How to use BETOPTIC 0.25 % 4. Possible side effects 5. How to store BETOPTIC 0.25 % 6. Further information Do not use BETOPTIC 0.25 % eye drops, suspension... • If you are allergic to betaxolol, beta-blockers or any of the other ingredients listed in section 6. • 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 heart beats ). Ask your doctor for advice. 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 cause wheeziness, difficulty in breathing and / or long-standing cough ). • poor blood circulation disease ( such as Raynaud’s disease or Raynaud’s syndrome ) • diabetes, as betaxolol may mask the signs and symptoms of low blood sugar • overactivity of the thyroid gland as betaxolol may mask the signs and symptoms • angle-closure glaucoma • dry eyes ( Sicca Syndrome ) Tell your doctor before you have an operation that you are using BETOPTIC 0.25 % as betaxolol may change the effects of some medicines used during anaesthesia. I Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BETOPTIC 0.25% w/v Eye Drops, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betaxolol 0.25% w/v (as hydrochloride) Excipients with known effect: 1ml of suspension contains 0.1mg benzalkonium chloride. For a full list of excipients see Section 6.1 3 PHARMACEUTICAL FORM Eye Drops, Suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BETOPTIC SUSPENSION lowers the intraocular pressure and is indicated in patients with chronic open-angle glaucoma and ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS (INCLUDING ELDERLY) The recommended dose is one drop in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to BETOPTIC SUSPENSION may require a few weeks to stabilise. Careful monitoring of glaucoma patients is advised. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics and/or adrenaline (epinephrine) and/or carbonic anhydrase inhibitors can be instituted. CHILDREN Safety and effectiveness in children have not been established. The volume of each drop dispensed is 24 μ l. 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 ophthalm Read the complete document