Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Midodrine hydrochloride
Tillomed Pharma GmbH
C01CA17
Midodrine hydrochloride
2.5 milligram(s)
Tablet
midodrine
Marketed
2021-08-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIDODRINE TILLOMED 2.5 MG TABLETS MIDODRINE TILLOMED 5 MG TABLETS midodrine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 Midodrine Tillomed is and what it is used for 2. What you need to know before you take Midodrine Tillomed 3. How to take Midodrine Tillomed 4. Possible side effects 5. How to store Midodrine Tillomed 6. Contents of the pack and other information 1. WHAT MIDODRINE TILLOMED IS AND WHAT IT IS USED FOR Midodrine Tillomed contains 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. Midodrine Tillomed, is used in adults 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 from such as dizziness, fainting, blurred vision and weakness when you sit or stand up. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDODRINE TILLOMED_ _ DO NOT TAKE MIDODRINE TILLOMED: - if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6); - if you have high blood pressure (hypertension) or a form of low blood pressure known to cause fainting (vasovagal hypotension); - if you have severe heart disease or heart failure; - if you have a high level of thyroid hormones in the blood (thyrotoxicos Baca dokumen lengkapnya
Health Products Regulatory Authority 15 February 2024 CRN00DSL4 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midodrine Tillomed 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg midodrine hydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white, round, scored tablets debossed with 'H' above the score and 'P' below the score on one side and '504' on the other side. The diameter of the tablet is 7.10 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in adults 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 maintenance dosage should be determined individually for each patient to achieve optimal therapeutic effect while reducing the impact of adverse reactions. The maximum daily dose is 30 mg 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. Special populations _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 t Baca dokumen lengkapnya