Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Timolol Maleate; Latanoprost
Bausch Health Ireland Limited
S01ED; S01ED51
Timolol Maleate; Latanoprost
50mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Beta blocking agents1); timolol, combinations
Not marketed
2011-08-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TIMLATAN50 MICROGRAM/ML + 5 MG/ML EYE DROPS, SOLUTION [To be completed nationally] 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 effects 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 Timlatan is and what it is used for 2. What you need to know before you use Timlatan 3. How to use Timlatan 4. Possible side effects 5. How to store Timlatan 6. Contents of the pack and other information 1. WHAT TIMLATAN IS AND WHAT IT IS USED FOR Timlatan 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. Timlatan 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 Timlatan when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIMLATAN Timlatan 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 TIMLATAN: if you are allergic (hypersensitive) to either of the medicines (latanoprost or timolol), beta- blockers, or any of the other ingredients of this medicine ( Belgenin tamamını okuyun
Health Products Regulatory Authority 17 December 2019 CRN009D8D Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Timlatan 50 micrograms/ml + 5 mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. One drop contains approximately 1.5 micrograms latanoprost and 150 micrograms timolol. Excipients with known effect: benzalkonium chloride 0.2 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 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 (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 Latanoprost/timolol 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 Belgenin tamamını okuyun