Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Apraclonidine hydrochloride
Novartis Ireland Limited
S01EA; S01EA03
Apraclonidine hydrochloride
1 percent weight/volume
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Sympathomimetics in glaucoma therapy1); apraclonidine
Marketed
1996-05-21
1 PACKAGE LEAFLET : INFORMATION FOR THE USER IOPIDINE 1%W/V EYE DROPS SOLUTION (APRACLONIDINE HYDROCHLORIDE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What IOPIDINE is and what it is used for 2. Before you are given IOPIDINE 3. How IOPIDINE is given to you 4. Possible side effects 5. How IOPIDINE is stored 6. Further information IOPIDINE EYE DROPS WILL BE PUT IN BY YOUR DOCTOR. THIS LEAFLET IS PROVIDED TO GIVE YOU INFORMATION ON YOUR MEDICINE. 1. WHAT IOPIDINE IS AND WHAT IT IS USED FOR IOPIDINE eye drops contain apraclonidine which is used to control or prevent the pressure in the eye increasing after laser surgery. 2. BEFORE YOU ARE GIVEN IOPIDINE This medicine may not be suitable for you. If it is not suitable your doctor may want to give you another medicine so it is important you check all of the points below: IOPIDINE WILL NOT BE USED * in children (this medicine is not for anyone under the age of 18); ** If you are ALLERGIC to clonidine, apraclonidine or any of the ingredients listed in the “ OTHER INGREDIENTS ” section of this leaflet (section 6) * if you have a history of any severe or unstable and uncontrolled heart disease (including chest pain, angina, heart attacks or heart failure); * if you are currently taking monoamine oxidase inhibitor antidepressants If you think any of the above conditions apply to you or if you are not sure, talk to your doctor first. SPECIAL CARE WILL BE TAKEN USING IOPIDINE. ASK YOUR DOCTOR FOR ADVICE IF: * YOU SUFFER FROM, OR ARE TAKING MEDICATION FOR: - heart disease (including chest pain, angina, heart attacks or heart failure; - high blood pressure; - circulatory problems (including stroke, Raynaud’s disease or Buerger’s disease); - vasovagal attacks (fainting Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT IOPIDINE 1%w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Apraclonidine 1% w/v (10mg/ml) (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution IOPIDINE 1% is a pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IOPIDINE 1% is indicated to control or prevent post surgical elevations in intraocular pressure that occur in patients after anterior segment laser surgery. (Clinical trials have been conducted in trabeculoplasty, iridotomy and capsulotomy). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical ophthalmic use only. ADULTS (INCLUDING THE ELDERLY): One drop of IOPIDINE 1% should be instilled into the eye scheduled for operation one hour before initiating anterior segment laser surgery. A second drop should be instilled into the same eye immediately upon completion of the laser surgical procedure. If for any reason, the drop of IOPIDINE 1% does not remain in the eye, repeat the dose by placing another drop in the eye. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic side effects. There are no special precautions for administration to the elderly. PAEDIATRIC POPULATION Safety and effectiveness of IOPIDINE in children have not been established and therefore IOPIDINE 1% is not recommended for use in children. If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last. 4.3 CONTRAINDICATIONS In patients with a history of severe or unstable and uncontrolled cardiovascular disease. For use in children, H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Διαβάστε το πλήρες έγγραφο