Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Tafluprost; TIMOLOL MALEATE
Santen OY
S01ED51
Tafluprost; TIMOLOL MALEATE
15/5 microgram(s)/millilitre
Eye drops, solution
timolol, combinations
Not marketed
2020-12-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAPTIQOM 15 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION tafluprost/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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What TAPTIQOM is and what it is used for 2. What you need to know before you use TAPTIQOM 3. How to use TAPTIQOM 4. Possible side effects 5. How to store TAPTIQOM 6. Contents of the pack and other information 1. WHAT TAPTIQOM IS AND WHAT IT IS USED FOR WHAT KIND OF MEDICINE IS IT AND HOW DOES IT WORK? TAPTIQOM eye drops contain tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogues and timolol belongs to a group of medicines called beta blockers. Tafluprost and timolol work together and lower the pressure in the eye. TAPTIQOM is used when the pressure in the eye is too high. WHAT IS YOUR MEDICINE FOR? TAPTIQOM is used to treat a type of glaucoma called open angle glaucoma and also a condition known as ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye and eventually they may affect your eyesight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TAPTIQOM DO NOT USE TAPTIQOM: if you are allergic to tafluprost, timolol, beta blockers or any of the other ingredients of this medicine (listed in section 6.) if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing co Lue koko asiakirja
Health Products Regulatory Authority 31 March 2022 CRN00CS4D Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TAPTIQOM 15 micrograms/ml + 5 mg/ml eye drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 15 micrograms tafluprost and 5 mg timolol (as timolol maleate). One drop (about 0.03 ml) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution (eye drops). A clear, colourless solution, practically free from visible particles with a pH of 6.0-6.7 and an osmolality of 290-370 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended therapy is one eye drop in the conjunctival sac of 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. TAPTIQOM is a preservative free sterile solution packaged in a multi-dose container. _Paediatric population_ The safety and efficacy of TAPTIQOM in children and adolescents below the age of 18 years have not been established. No data are available. TAPTIQOM is not recommended for use in children and adolescents below the age of 18 years_._ _Use in elderly_ No dosage alteration in elderly patients is necessary. _Use in renal/hepatic impairment_ Tafluprost and timolol eye drops have not been studied in patients with renal/hepatic impairment and TAPTIQOM should therefore be used with caution in such patients. Method of administration OCULAR USE Patients should be informed of the correct handling of the bottle. When using for the first time, before delivering a drop to the eye, the patient should first of all practise using the b Lue koko asiakirja