Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tafluprost; TIMOLOL MALEATE
SANTEN PHARMA MALAYSIA SDN. BHD.
Tafluprost; TIMOLOL MALEATE
2.5 ml
Santen Pharmaceutical Co., Ltd., Shiga Plant
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TAPCOM OPHTHALMIC SOLUTION Tafluprost (15 micrograms/ml), Timolol (5mg/ml) WHAT IS IN THIS LEAFLET 1. What TAPCOM is used for 2. How TAPCOM works 3. Before you use TAPCOM 4. How to use TAPCOM 5. While you are using it 6. Side effects 7. Storage and Disposal of TAPCOM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TAPCOM IS USED FOR TAPCOM is used to treat a type of glaucoma called open angle glaucoma and also a condition known as ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye and eventually they may affect your eyesight. HOW TAPCOM WORKS TAPCOM ophthalmic solution contains tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogues and timolol belongs to a group of medicines called beta blockers. Tafluprost and timolol work together and lower the pressure in the eye. TAPCOM is used when the pressure in the eye is too high. BEFORE YOU USE TAPCOM - _When you must not use it _ Do not use TAPCOM: • if you are allergic to tafluprost, timolol, beta blockers or any of the other ingredients of this medicine (listed in section “Ingredients”). • if you have now or have had in the past respiratory problems such as asthma, bronchospasm, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). • if you have a slow heartbeat, heart failure, atrioventricular block or cardiogenic shock. - _Before you start use it _ Before you use this medicine, tell your doctor if you have now or have had in the past: • If you have bronchial asthma/history of bronchial asthma, bronchospasm, chronic obstructive pulmonary disease, heart failure, sinus bradycardia, atrioventricular block, cardiogenic shock, diabetes, intraocular inflammation (iritis, uveitis), or aphakia/ pseudophakia eyes. • If you wear contact lenses. • If you are pregnan Đọc toàn bộ tài liệu
TAPCOM ® OPHTHALMIC SOLUTION (Tafluprost 15micrograms/ml + Timolol 5mg/ml) DESCRIPTION TAPCOM ® ophthalmic solution is a clear, colorless, sterile aqueous ophthalmic solution. Each mL contains 0.015mg of Tafluprost and 6.83mg of Timolol maleate (equivalent to 5mg Timolol). It also contains sodium dihydrogen phosphate dihydrate, Polysorbate 80, Disodium edetate hydrate, Concentrated Glycerin, Benzalkonium Chloride, Sodium Hydroxide, Dilute Hydrochloric acid and Purified Water. INDICATIONS Reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta- blockers or prostaglandin analogues and require a combination therapy. DOSAGE AND ADMINISTRATION Instill 1 drop in the affected eye(s) once daily. CONTRAINDICATIONS 1) Patients with bronchial asthma or a history of bronchial asthma, bronchospasm, or severe chronic obstructive pulmonary disease [Asthmatic attack may be aggravated or induced due to bronchial smooth muscle contraction caused by β-receptor blockage]. 2) Patients with poor-controlled cardiac failure, sinus bradycardia, second- or third- degree atrioventricular block, or cardiogenic shock [These symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage]. 3) Patients with a history of hypersensitivity to any of the ingredients in this product. WARNINGS AND PRECAUTIONS _1._ _ _ _CAREFUL ADMINISTRATION (THIS PRODUCT SHOULD BE ADMINISTERED WITH CARE TO THE _ _FOLLOWING PATIENTS.) _ 1) Patients with right ventricular failure caused by pulmonary hypertension [Symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage.] 2) Patients with congestive heart failure [Symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage.] 3) Patients with diabetic ketoacidosis or metabolic acidosis [This product may enhance the depression of myocardial contraction caused by acidosis Đọc toàn bộ tài liệu