Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LATANOPROST; TIMOLOL MALEATE
UPJOHN (MALAYSIA) SDN. BHD.
LATANOPROST; TIMOLOL MALEATE
5ml mL; 2.5 ml mL
PFIZER MANUFACTURING BELGIUM NV,
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XALACOM ® EYE DROPS Latanoprost/Timolol (50 micrograms/mL and 5 mg/mL) 1 WHAT IS IN THIS LEAFLET 1. What XALACOM is used for 2. How XALACOM works 3. Before you use XALACOM 4. How to use XALACOM 5. While you are using it 6. Side Effects 7. Storage and Disposal of XALACOM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT XALACOM IS USED FOR Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta- blockers. XALACOM is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you XALACOM when other medicines have not worked adequately. HOW XALACOM WORKS XALACOM contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye. BEFORE YOU USE XALACOM XALACOM can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age. _- When you must not use it_ Do not use XALACOM: - if you are allergic (hypersensitive) to either of the medicines in XALACOM (latanoprost or timolol) or any of the other ingredients of XALACOM (see Section Product Description). - if you have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). - if you have serious heart problems or heart rhythm disorders. _Pregnancy and lactat Lees het volledige document
Pfizer Confidential 1 PFIZER XALACOM ® LATANOPROST, TIMOLOL MALEATE 1. NAME OF THE MEDICINAL PRODUCT Xalacom eye drops, solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. Excipients with known effects: Benzalkonium chloride 0.2 mg/mL. Disodium phosphate (E339ii), Sodium dihydrogen phosphate monohydrate (E339i) (containing total phosphate 6.3 mg/mL). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_ Recommended therapy is one eye drop in 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. _Paediatric population_ The safety and efficacy of Xalacom in children and adolescents has not been established. Pfizer Confidential 2 Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic drug is being used, the drugs 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. 4.3 CONTRAINDICATIONS Xalacom 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 w Lees het volledige document