Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Apraclonidine hydrochloride
Essential Pharma Limited
S01EA; S01EA03
Apraclonidine hydrochloride
Eye drops, solution
Sympathomimetics in glaucoma therapy1); apraclonidine
Marketed
1996-05-21
1 Iop5mgpermlED-PL-IE-MT-2 PACKAGE LEAFLET - INFORMATION FOR THE USER IOPIDINE ® 5 MG/ML EYE DROPS, SOLUTION APRACLONIDINE (AS HYDROCHLORIDE) 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 your 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 IOPIDINE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IOPIDINE 3. HOW TO USE IOPIDINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE IOPIDINE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT IOPIDINE IS AND WHAT IT IS USED FOR IOPIDINE 5mg/ml Eye drops, solution contain apraclonidine (as hydrochloride) as the active substance. IOPIDINE belongs to a group of medicines known as alpha agonists. IT IS USED IN THE TREATMENT OF chronic glaucoma in people who are already receiving other medicines to treat this disease. In these people, IOPIDINE helps to reduce the fluid pressure in the eye and can delay the need for pressure relieving eye surgery. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE IOPIDINE DO NOT USE IOPIDINE: ● if you have a history of SEVERE or unstable HEART DISEASE or CIRCULATORY PROBLEMS. ● if you are ALLERGIC to apraclonidine, clonidine or any of the other ingredients of this medicine listed in section 6 ● if you are currently taking monoamine oxidase inhibitors antidepressants or tricycylic antidepressants ● if you are currently taking medicines of the class of sympathomimetics that are taken either orally or via injection ● in CHILDREN Ask your doctor for advice. WARNINGS AND PRECAUTIONS 2 Iop5mgpermlED-PL-IE-MT-2 TAKE SPECIAL CARE: ● Only use IOPIDINE for dr Leggi il documento completo
Health Products Regulatory Authority 04 November 2022 CRN00CVV1 Page 1 of 6 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. In patients receiving monoamine oxidase inhibitor therapy, systemic sympathomimetic agents, tricyclic antidepress Leggi il documento completo