Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAXOLOL HYDROCHLORIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
BETAXOLOL HYDROCHLORIDE
5ml mL
S.A. ALCON-COUVREUR N.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ BETOPTIC S EYE SUSPENSION _ _ Betaxolol Hydrochloride (2.5mg/ml) ____________________________________________________________________________________ ____________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What BETOPTIC S is used for 2. How BETOPTIC S works 3. Before you use BETOPTIC S 4. How to use BETOPTIC S 5. While you are using BETOPTIC S 6. Side effects of BETOPTIC S 7. Storage and Disposal of BETOPTIC S 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BETOPTIC S IS USED FOR BETOPTIC S is used in people with increased eye pressure such as chronic open-angle glaucoma and ocular hypertension. HOW BETOPTIC S WORKS BETOPTIC S works by lowering pressure in the eye. BEFORE YOU USE _- When you must not use it _ Do not use BETOPTIC S • If you are allergic to betaxolol or any of the other ingredients of this medicine. • If you have a slow heart beat, heart failure or irregular heart beats. _Pregnancy and lactation _ If you are pregnant or breast- feeding, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use BETOPTIC S if you are pregnant unless your doctor considers it necessary. If you are breastfeeding, BETOPTIC S may get into your milk. _ _ _- Before you start to use it _ _ _ Talk to your doctor or pharmacist or nurse before using BETOPTIC S: • Before you use this medicine, tell your doctor if you have now or have had in the past: o coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), low blood pressure o breathing problems, asthma o poor blood circulation disease o diabetes as betaxolol may mask signs and symptoms of low blood sugar o overactivity of the thyroid gland as betaxolol may mask signs and symptoms o muscle weakness o liver or kidney problems • Tell your doctor before you have an operation that you are us Baca dokumen lengkap
InDesign CS6 140 x 504 / 140 x 22 mm AANTAL KLEUREN : 1 WS 20-04-2016 MAL RECTO-verso Betoptic S 0,25% 5 ml GLOBAL 45477-3 BELGIUM V5 PMS ZWART À 100% 45477-3 BETOPTIC * 0.25% Eye Drops, Suspension 1. NAME OF THE MEDICINAL PRODUCT BETOPTIC* S 0.25%, Eye Drops, Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of BETOPTIC S Suspension contains 2.5 mg betaxolol base (equivalent to 2.8 mg betaxolol hydrochloride) Preservative: 1 ml suspension contains 0.1 mg benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM BETOPTIC S 0.25% Eye Drops, Suspension is formulated as a sterile, multiple-dose suspension for topical ophthalmic use. It is a white to off-white suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications BETOPTIC S Suspension has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and ocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications. 4.2 Posology and method of administration Posology Use in adults (including elderly) The recommended dose is one or two drops of BETOPTIC S Suspension in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to BETOPTIC S Suspension may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised. If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with other anti-glaucoma agents can be instituted. Use in hepatic and renal impairment The safety and efficacy of BETOPTIC S Suspension in patients with hepatic and renal impairment have not been established. Method of administration For ocular use. Shake well before use. To prevent contamination of the dropper tip and suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use. If more than one topical ophth Baca dokumen lengkap