Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MIDODRINE HYDROCHLORIDE
Takeda Products Ireland Ltd
C01CA; C01CA17
MIDODRINE HYDROCHLORIDE
2.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Adrenergic and dopaminergic agents; midodrine
Marketed
1990-03-26
1 PATIENT INFORMATION LEAFLET MIDON 2.5 MG TABLETS (Midodrine 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. 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: 1. What Midon Tablets are and what they are used for 2. Before you take Midon Tablets 3. How to take Midon Tablets 4. Possible side effects 5. How to store Midon Tablets 6. Further information 1. WHAT MIDON TABLETS ARE AND WHAT THEY ARE USED FOR Midon Tablets contain the active ingredient midodrine hydorchloride, which acts on the blood vessels via the sypatheic 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 nervious 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. 2. BEFORE YOU TAKE MIDON TABLETS _ _ DO NOT TAKE THE TABLETS IF YOU: are allergic (hypersentitive) to midorine hydrochloride or any of the other ingrediemts in the tablets (_see Section 6_) have a tumour near the kidney, known as phaeochromocytoma suffer from the eye disease narrow angle glaucoma have thryoid 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 diabet Prečítajte si celý dokument
Health Products Regulatory Authority 03 February 2021 CRN00C4Z5 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midon 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg Midodrine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white, biplanar tablets with bevelled edge. Scored on one side with ‘GU’ above and ‘2.5’ below the score. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the treatment of severe orthostatic hypotension due to dysfunction of the autonomic nervous system when corrective factors have been ruled out. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Adults: The usual starting dose is 2.5 mg 2-3 times daily. The dose should be increased at weekly intervals in small increments until an optimal response is obtained. Most patients are controlled at or below 30 mg daily given in divided doses. The maximum daily dose is 30mg given in divided doses. Doses in excess of 30mg daily are not recommended. The supine and standing blood pressure should be monitored regularly during initial treatment (at least two times a week) and the use of midodrine should be stopped if supine hypertension increases excessively. Dosing of midodrine should occur during the daytime, when the patient needs to be upright. A dosing schedule of 3-4 hour intervals is suggested. The last dose should be taken at least four hours before bedtime to reduce the risk of supine hypertension. Elderly: Although there is no evidence to suggest that dosage requirements are different in the elderly, it is recommended that the initial dose used be small and that increases in dosage be titrated against the patients’ clinical condition with caution. The administration of midodrine should be stopped and the attending physician notified immediately if the blood pressure in either position increases above 1 Prečítajte si celý dokument