Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Brimonidine tartrate
Lexon Pharmaceuticals (Ireland) Limited
S01EA05
Brimonidine tartrate
0.2 percent weight/volume
Eye drops, solution
brimonidine
2017-03-31
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 What ALPHAGAN is and what it is used for What you need to know before you use ALPHAGAN How to use ALPHAGAN Possible side effects How to store ALPHAGAN Contents of the pack and other information WHAT ALPHAGAN IS AND WHAT IT IS USED FOR ALPHAGAN is used to reduce pressure within the eye. The active ingredient in ALPHAGAN is brimonidine tartrate which belongs to a group of medicines called alpha-2 adrenergic receptor agonists and works by reducing pressure within the eyeball. It can be used either alone, when beta-blocker eye drops are contraindicated, or with another eye drop, when a single medicine is not enough to lower the increased pressure in the eye, in the treatment of open angle glaucoma or ocular hypertension. WHAT YOU NEED TO KNOW BEFORE YOU USE ALPHAGAN DO NOT USE ALPHAGAN • If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6). • If you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressants. You must inform your doctor if you are taking any antidepressant drug. • If you are breast-feeding. • In infants/babies (from birth until 2 years). WARNINGS AND PRECAUTIONS Talk to your doctor before using ALPHAGAN • If you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder. • If you have or have had in the past kidne Lue koko asiakirja
Health Products Regulatory Authority 23 February 2022 CRN00CT8T Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alphagan 0.2% w/v (2 mg/ml) eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient with known effect Benzalkonium chloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from Spain_ Clear, greenish-yellow to light greenish-yellow solution. 4 CLINICAL PARTICULARS As per PA0148/006/001 5 PHARMACOLOGICAL PROPERTIES As per PA0148/006/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Poly (vinyl alcohol) Sodium chloride Sodium citrate Citric acid monohydrate Purified water Sodium hydroxide or hydrochloric acid for pH adjustment 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the market in the country of origin. After first opening use within 28 days. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Health Products Regulatory Authority 23 February 2022 CRN00CT8T Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Plastic bottle containing 5ml of eye drop solution. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Harcourt Road Dublin 2 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/007/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 st March 2017 10 DATE OF REVISION OF THE TEXT February 2022 Lue koko asiakirja