Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LATANOPROST; TIMOLOL MALEATE
Aspen Medical Products Malaysia Sdn Bhd
LATANOPROST; TIMOLOL MALEATE
2.5ml ml
RAFARM S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 COMBI-PROST EYE DROPS Latanoprost 50mcg/ml and timolol (as timolol maleate) 5mg/ml WHAT IS IN THE LEAFLET? 1. What Combi-Prost is used for 2. How Combi-Prost works 3. Before you use Combi-Prost 4. How to use Combi-Prost 5. While you are using it 6. Side effects 7. Storage and Disposal of Combi-Prost 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT COMBI-PROST IS USED FOR Combi-Prost is used to lower the pressure in your eye, if you have conditions known as open angle glaucoma and eye pressure is high, but does not works with eye drops which is contains beta-blockers (e.g. timolol). HOW COMBI-PROST WORKS Combi-Prost contains two active ingredient called Latanoprost and timolol(as timolol maleate). Latanoprost allows more fluid to flow out from within your eye. Timolol lowers the pressure in the eye by reducing the production of fluid. Although Combi-Prost helps control your glaucoma, it does not cure it. So you must keep using it until your doctor tells you to stop. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. Combi-Prost is not recommended for use in children. The safety and effectiveness of Combi-Prost in children have not been established. BEFORE YOU USE COMBI-PROST - _When you must not use it_ Do not use this medicine if you have an allergy to: • The active ingredients, Latanoprost and timolol • any of the other ingredients listed at the end of this leaflet Do not use Combi-Prost if you have: • asthma or a history of asthma or other breathing problems • certain heart conditions, such as a very slow heart rate, an irregular heart beat or heart failure Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start using thi Lesen Sie das vollständige Dokument
1 COMBI-PROST LATANOPROST & TIMOLOL NAME OF THE MEDICAL PRODUCT Combi-Prost Eye Drops QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 50mcg of Latanoprost and 6.8 mg of timolol maleate, equivalent to 5.0 mg timolol. PHARMACEUTICAL FORM Eye drop solution. The solution is a clear, colourless liquid. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. POSOLOGY AND METHOD OF ADMINISTRATION _Recommended dosage for adults (including the elderly): _ The recommended dose is one eye drop in the affected eye(s), once daily. If a dose is missed, treatment should continue with the next dose as normal. The dose should not exceed one drop in each affected eye daily. _Administration: _ Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart. 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. _ _ Use in children and adolescents: The safety and efficacy in children and adolescents have not been established. 2 CONTRAINDICATIONS Combi-Prost is contraindicated in patients with: − Reactive airway disease including bronchial asthma or a history of 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. − Hypersensitivity to the active substances or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE SYSTEMIC EFFECTS Like other topically applied ophthalmic agents, Combi-Prost is absorbed systemically. Due to the beta-adrenergic com Lesen Sie das vollständige Dokument