Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
TIMOLOL, LATANOPROST
Alapis S.A. 2 Aftokratoros Nikolaou Street, 17671 Athens, Greece
S01ED51
TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml
EYE DROPS, SOLUTION
TIMOLOL 5 mg/ml LATANOPROST 50 µg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2011-04-11
PACKAGE LEAFLET: INFORMATION FOR THE USER LATANEAU PLUS 50 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION LATANOPROST/TIMOLOL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. EVEN IF YOU HAVE ALREADY USED LATANEAU PLUS OR A SIMILAR MEDICINE BEFORE, WE ADVISE YOU TO READ THIS TEXT CAREFULLY. THE INFORMATION MAY HAVE BEEN CHANGED. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Lataneau Plus is and what it is used for 2. Before you take Lataneau Plus 3. How to take Lataneau Plus 4. Possible side effects 5. How to store Lataneau Plus 6. Further information 1. WHAT LATANEAU PLUS IS AND WHAT IT IS USED FOR Lataneau Plus 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. Lataneau plus 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 eye, eventually affecting your eyesight. Your doctor will usually prescribe you Lat Belgenin tamamını okuyun
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lataneau Plus 50 microgram/ml + 5 mg/ml Eye Drops, Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.83 mg equivalent to 5 mg timolol. It contains 0.412 mg/ml of benzalconium chloride solution 50%. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution The solution is a clear colourless, odorless solution, free from visible particles. pH 5.5-6.5 Osmolality 260-320 mOsm/hg 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 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. Administration: Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). Page 2 of 11 If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Use in children and adolescents Safety and effectiveness in children and adolescents has not been established. 4.3 CONTRAINDICATIONS Lataneau Plus is contraindicated in patients with: - Reactive airway disease includin Belgenin tamamını okuyun