Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MIDODRINE HYDROCHLORIDE
NOVUGEN PHARMA SDN. BHD.
MIDODRINE HYDROCHLORIDE
100 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ MIRON TABLETS Midodrine Hydrochloride _ _ 2.5mg, 5mg, 10mg 1 WHAT IS IN THIS LEAFLET 1. What Miron is used for 2. How Miron works 3. Before you use Miron 4. How to use Miron 5. While you are using Miron 6. Side effects 7. Storage and Disposal of Miron 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT MIRON IS USED FOR Miron is a medicine is used to treat severe forms of low blood pressure in adults when other treatments have not worked. HOW MIRON WORKS Miron containing Midodrine HCl which is belongs to a group of medicines called adrenergic agents. It works by raising your blood pressure. BEFORE YOU USE MIRON − _When you must not use it _ Do not take this medicine: • if you have high blood pressure • if you have kidney disease • if you have difficulty passing urine • if you have hormonal disorders caused by a rare tumour in the adrenal gland, which sits near the kidney (phaeochromocytoma) • if you have an overactive thyroid gland (thyrotoxicosis) If any of the above applies to you, tell your doctor or pharmacist before taking Miron. - _Before you start to use it _ Talk to your doctor before taking Miron if you have or have been told you have high blood pressure when you lie down. If this applies to you then: Regular monitoring of your blood pressure will be required when you are lying down and standing up as there may be a risk of your blood pressure rising when you lie down, for example, at night. If your blood pressure rises when you lie down and reducing the dose does not correct this problem, then treatment with this medicine must be stopped. Tell your doctor if you have or have had any of the following medical conditions: • elevated pressure in the eye (glaucoma) or poor vision because of damage to the eye caused by diabetes • slow pulse Your doctor will perform some tests such as checking your kidney function and blood pressure before you start using this medicine. TELL YOUR DO Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Miron 2.5mg Tablets Miron 5mg Tablets Miron 10mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MIRON 2.5MG Tablets: Each tablets contains 2.5mg of Midodrine Hydrochloride MIRON 5MG Tablets: Each tablets contains 5mg of Midodrine Hydrochloride MIRON 10MG Tablets: Each tablets contains 10mg of Midodrine Hydrochloride For the full list of excipients, see section List of excipients. 3. PHARMACEUTICAL FORM Tablets. MIRON 2.5MG TABLETS: White to off-white, round, scored tablets debossed with 2.5 above the score on one side of the tablet and N on the other side MIRON 5MG TABLETS: White to off-white, round, scored tablets debossed with 5 above the score on one side of the tablet and N on the other side MIRON 10MG TABLETS: White to off-white, round, scored tablets debossed with 10 above the score on one side of the tablet and N on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets’ effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lees het volledige document