País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIMOLOL MALEATE; Tafluprost
SANTEN PHARMA MALAYSIA SDN. BHD.
TIMOLOL MALEATE; Tafluprost
0.3mL x 30units Units
Laboratoire UNITHER
TAPCOM-S OPHTHALMIC SOLUTION 15MICROGRAMS/ML + 5MG/ML, SOLUTION IN SINGLE-DOSE CONTAINER Tafluprost + Timolol (as maleate) (15mcg/mL+ 5mg/mL) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Tapcom-S is used for 2. How Tapcom-S works 3. Before you use Tapcom-S 4. How to use Tapcom-S 5. While you are using it 6. Side effects 7. Storage and Disposal of Tapcom-S 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TAPCOM-S IS USED FOR Tapcom-S 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-S WORKS Tapcom-S ophthalmic solution contain 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 to lower the pressure in the eye. Tapcom-S is used when the pressure in the eye is too high. BEFORE YOU USE TAPCOM-S - _When you must not use it _ Do not use Tapcom-S: • 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, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long- standing cough) • if you have a slow heartbeat, heart failure or disorders of the heart rhythm (irregular heartbeats). • If you are using an eye drop that containing omidenepag isopropyl. _ _ - _Before you start to use it _ 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 • disturbances of heart rate su Llegiu el document complet
_TAPCOM_ _®_ _-S OPHTHALMIC SOLUTION_ 1. NAME OF THE MEDICINAL PRODUCT Tapcom-S ophthalmic solution 15micrograms/ml + 5 mg/ml, solution in single-dose container. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains: tafluprost 15micrograms and timolol (as maleate) 5 mg. One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol. One drop (about 30 μl) contains about 0.45micrograms of tafluprost and 0.15 mg of timolol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution in single-dose container (eye drops). A clear, colorless solution with a PH of 6.0-6.7 and an osmolality of 290-370 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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, and who would benefit from preservative free eye drops. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended therapy is one eye drop in the conjunctival sac of the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Tapcom-S is a preservative free sterile solution packaged in a single-dose container. For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. _Paediatric population_ The safety and efficacy of Tapcom-S in children and adolescents below the age of 18 years have not been established. No data are available. Tapcom-S is not recommended for use in children and adolescents below the age of 18 years. _Use in elderly_ No dosage alteration in elderly patients is necessary. _Use in renal/hepatic impairment_ Tafluprost and timolol eye drops have not been studied in patients with renal/hepatic impairment and Tapco Llegiu el document complet