দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Midodrine hydrochloride
Lexon Pharmaceuticals (Ireland) Limited
C01CA; C01CA17
Midodrine hydrochloride
5 milligram(s)
Tablet
Adrenergic and dopaminergic agents; midodrine
2017-08-25
MIDON 5MG TABLETS midodrine hydrochloride PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor. * This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: What Midon Tablets are and what they are used for Before you take Midon Tablets How to take Midon Tablets Possible side effects How to store Midon Tablets Further information WHAT MIDON TABLETS ARE AND WHAT THEY ARE USED FOR Midon Tablets contain the active ingredient midodrine hydrochloride, which acts on the blood vessels via the sympathetic nervous system to correct imbalances of blood distribution, such as preventing too much blood pooling in the legs when standing up. Midon Tablets are used to stop the fall in your blood pressure as a result of your sympathetic nervous system not working correctly. This should help to relieve the symptoms which you might be suffering such as dizziness, fainting, blurred vision and weakness when you sit or stand up. BEFORE YOU TAKE MIDON TABLETS DO NOT TAKE THE TABLETS IF YOU: * are allergic (hypersensitive) to midodrine hydrochloride or any of the other ingredients in the tablets (_see Section 6 and end of Section 2_) * have a tumour near the kidney, known as phaeochromocytoma * suffer from the eye disease narrow angle glaucoma * have thyroid gland problems called thyrotoxicosis or hyperthyroidism i.e. overactive thyroid * suffer from high blood pressure or a form of low blood pressure known as vasovagal hypotension * some types of heart or blood vessel disease * have inflammation of the kidneys, kidney disease, poor kidney function or if you are having problems passing urine * damage to the retina in your eye as a result of diabetes (known as prolif সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 10 November 2022 CRN00D6FP Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midon 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg midodrine hydrochloride. Also contains the colourant E110 (sunset yellow FCF (E110) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Czech Republic_ Orange, round, biplanar tablets with bevelled edge. Scored on one side with marking ‘GU’ above and ‘5.0’ below the score. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA2239/016/002 5 PHARMACOLOGICAL PROPERTIES As per PA2239/016/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Magnesium stearate talc colloidal anhydrous silica microcrystalline cellulose maize starch sunset yellow (E110) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 10 November 2022 CRN00D6FP Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Store in the original package in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 100 tablets. PVC/PVDC-Al blister in cardboard box. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING 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 PPA23176/013/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 th August 2017 10 DATE OF REVISION OF THE TEXT November 2022 সম্পূর্ণ নথি পড়ুন