Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Latanoprost; TIMOLOL MALEATE
Rowex Ltd
S01ED; S01ED51
Latanoprost; TIMOLOL MALEATE
50mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Beta blocking agents1); timolol, combinations
Not marketed
2011-05-20
PACKAGE LEAFLET: INFORMATION FOR THE USER LATOP-COMP 50 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION Latanoprost/Timolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR 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 effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Latop-Comp is and what it is used for 2. What you need to know before you use Latop-Comp 3. How to use Latop-Comp 4. Possible side effects 5. How to store Latop-Comp 6. Contents of the pack and other information 1. WHAT LATOP-COMP IS AND WHAT IT IS USED FOR Latop-Comp 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. Latop-Comp 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 Latop-Comp when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATOP-COMP Latop-Comp 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. _DO NOT USE LATOP-COMP IF YOU _ are allergic to latanoprost or timolol, to beta-blockers or any of the other ingredients of this medicine (listed in section 6) have now or have had in the past Prečítajte si celý dokument
Health Products Regulatory Authority 10 May 2019 CRN008JGS Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latop-Comp 50 micrograms/ml + 5 mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. Excipient with known effect benzalkonium chloride 0.20 mg/ml is included as a preservative. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Latop-Comp is indicated in adults for the 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 _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. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least 5 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 Latop-Comp is contraindicated in patients with: ● hypersensitivity to the active substances or to any of the excipients listed in section 6.1 ● reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease ● sinus bradycardia, sick sinus syndrome, Prečítajte si celý dokument