Country: United Kingdom
Language: English
Source: myHealthbox
tafluprost
Santen Oy
S01EE05
tafluprost
15 micrograms
Eye drops, solution in single-dose container
ocular route
30 x 0.3 ml single-dose containers and 90 x 0.3 ml single-dose containers
POM - Prescription Only Medicine
Laboratoire Unither
Antiglaucoma preparations and miotics, prostaglandin analogues
Reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. As adjunctive therapy to beta-blockers
Authorised
2015-07-31
Profile: BO_200x280_EMO_Unither Profile Revision: 1 Profile Revision Date: 261109 Dimensions (mm): 200 x 280 mm Black Technical Info 65NOT2520/G 270215-3 65NOT2520/G 461274A03 Profile PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SAFLUTAN® 15 MICROGRAMS/ML EYE DROPS, SOLUTION IN SINGLE DOSE-CONTAINER Tafluprost 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 SAFLUTAN is and what it is used for 2. What you need to know before you use SAFLUTAN 3. How to use SAFLUTAN 4. Possible side effects 5. How to store SAFLUTAN 6. Contents of the pack and other information 1. WHAT SAFLUTAN IS AND WHAT IT IS USED FOR WHAT KIND OF MEDICINE IS IT AND HOW DOES IT WORK? SAFLUTAN eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. SAFLUTAN lowers the pressure in the eye. It is used when the pressure in the eye is too high. WHAT IS YOUR MEDICINE FOR? SAFLUTAN 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 SAFLUTAN DO NOT USE SAFLUTAN: • if you are allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using SAFLUTAN. Read the complete document
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ead the complete document