Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Brimonidine tartrate
PCO Manufacturing Ltd.
S01EA05
Brimonidine tartrate
0.2 percent weight/volume
Eye drops, solution
Eye instillation
5 ml bottle
Product subject to prescription which may be renewed (B)
PCO Manufacturing
Sympathomimetics in glaucoma therapy
brimonidine
Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension
Authorised
2015-07-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ALPHAGAN ® 0.2% W/V (2 MG/ML) EYE DROPS, SOLUTION brimonidine tartrate 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 ALPHAGAN is and what it is used for 2. What you need to know before you use ALPHAGAN 3. How to use ALPHAGAN 4. Possible side effects 5. How to store ALPHAGAN 6. Contents of the pack and other information 1. 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 2. 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 suppl Lue koko asiakirja
Health Products Regulatory Authority 23 December 2022 CRN00D9HP 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(s) with known effect: Contains benzalkonium chloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from the Czech Republic, Netherlands and Poland:_ Clear, greenish-yellow to light greenish-yellow solution. 4 CLINICAL PARTICULARS As per PA1824/007/001 5 PHARMACOLOGICAL PROPERTIES As per PA1824/007/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Poly(vinyl alcohol) Sodium chloride Sodium citrate Citric acid monohydrate Purified water Hydrochloric acid (for pH-adjustment) or Sodium hydroxide for (pH-adjustment) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer carton of the product as marketed in the country of origin. After first opening: Use within 28 days. Health Products Regulatory Authority 23 December 2022 CRN00D9HP Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. 6.5 NATURE AND CONTENTS OF CONTAINER White dropper bottles with a tip. The cap is either a conventional polystyrene screw cap or a Compliance Cap (C-Cap). One 5 ml bottle in a cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/413/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 st July 2015 10 DATE OF REVISION OF THE TEXT December 2022 Lue koko asiakirja