Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
TIMOLOL, LATANOPROST
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
S01ED51
TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml
EYE DROPS, SOLUTION
TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2011-08-23
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER LAPROL 0.05/5.0 MG/ML EYE DROPS, SOLUTION Latanoprost /timolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATIONFOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Laprol is and what it is used for 2. What you need to know before you use Laprol 3. How to use Laprol 4. Possible side effects 5. How to store Laprol 6. Content of the pack and other information 1. WHAT LAPROL IS AND WHAT IT IS USED FOR Laprol 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. Laprol 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 and increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you Laprol when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LAPROL Laprol can be used in adult men and women (including the elderly), but is not recommended for use if you a Læs hele dokumentet
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Laprol 0.05 /5.0 mg/ ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 50 microgram latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. Excipient with known effect: Benzalkonium chloride 0.2 mg/ml (see section 4.4) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear, colourless liquid. Osmolality: 280~320 mOsmol/kg pH: 5.0 – 7.0 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 or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Recommended dosage for 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: _ Safety and effectiveness in children and adolescents has not been established. Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. 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. Page 2 of 11 If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. 4.3. CONTRAINDICATIONS Laprol eye drops, solution is contraindicate Læs hele dokumentet