Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
betaxolol hydrochloride 2.5 mg/ml
S.A Alcon-Couvreur N.V.
S01ED02
betaxolol hydrochloride
eye drops, suspension
Authorised
2006-01-19
PACKAGE LEAFLET - INFORMATION FOR THE USER BETOPTIC S, 2.5 MG/ML, EYE DROPS, SUSPENSION Betaxolol hydrochloride equiv. betaxolol base 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 S IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE BETOPTIC S 3. HOW TO USE BETOPTIC S 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BETOPTIC S 6. FURTHER INFORMATION 1 WHAT BETOPTIC S IS AND WHAT IT IS USED FOR BETOPTIC S, eye drops, suspension is specially formulated for improved ocular comfort upon administration and is packed in droptainers of 5 and 10 ml. BETOPTIC S are eye drops against elevated eye pressure. BETOPTIC S eye drops is indicated for lowering the intraocular pressure (pressure inside the eye) in patients with chronic open-angle glaucoma and/or elevated ocular pressure. It may be used alone or in combination with other ocular pressure lowering medications. 2 BEFORE YOU USE BETOPTIC S DO NOT USE BETOPTIC S EYE DROPS, SUSPENSION ... - if you are allergic to betaxolol, beta-blockers or any of the other ingredients. . - if you have now or have had in 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 Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BETOPTIC S, 2.5 mg/ml, eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BETOPTIC S.: betaxolol hydrochloride equiv. betaxolol base 2.5 mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. Isotonic, sterile, aqueous suspension for topical ocular administration, specially formulated for improved ocular comfort upon administration. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS BETOPTIC S ophthalmic suspension lowers the intraocular pressure and is indicated in patients with chronic open-angle glaucoma and/or ocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Shake well before each use. After cap is removed, if tamper evident snap collar is loose, remove before using product. The recommended dosage is one drop of BETOPTIC S in the treated eye(s), twice daily. In some patients, the intraocular pressure lowering responses to BETOPTIC S. may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised. 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. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, epinephrine or carbonic anhydrase inhibitors can be instituted. Page 1 of 10 Use in children There are limited clinical studies to establish the safety and efficacy in children . 4.3 CONTRAI Baca dokumen lengkapnya