Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Midodrine hydrochloride
Milstein C.V.
C01CA17
Midodrine hydrochloride
Tablet
midodrine
2022-02-11
PATIENT INFORMATION LEAFLET MIDODRINE HYDROCHLORIDE 2.5 MG & 5 MG TABLETS _ _ 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. IN THIS LEAFLET: 1. What Midodrine Hydrochloride is and what it is used for 2. What you need to know before you take Midodrine Hydrochloride Tablets 3. How to take Midodrine Hydrochloride Tablets 4. Possible side effects 5. How to store Midodrine Hydrochloride Tablets 6. Contents of the pack and other information 1. WHAT MIDODRINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR The name of this medicine is Midodrine Hydrochloride Tablets. The active ingredient is midodrine hydrochloride. This belongs to a group of medicines called adrenergic and dopaminergic agents. Midodrine Hydrochloride is a medicine that raises your blood pressure and is used to treat certain severe forms of low blood pressure in adults when other treatments have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDODRINE HYDROCHLORIDE TABLETS DO NOT TAKE MIDODRINE HYDROCHLORIDE TABLETS IF: You are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6 of this leaflet) You have high blood pressure, or a form of low blood pressure known as vasovagal hypotension You have severe heart disease including slow pulse, heart attack, heart failure, heart rhythm disorders, widening of the aorta (aortic aneurysm) You have difficulty in urinating You have certain forms of cardiovascular disease You have elevated pressure in the eye (glaucoma) or poor vision as a resu Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 11 February 2022 CRN0096WM Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midodrine Hydrochloride 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of midodrine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, round biconvex tablets, debossed with "MI" above the score line and "5" below the score line, and plain on other side. Diameter 7.1 mm and thickness 3.9 – 4.5 mm. The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midodrine Hydrochloride Tablets are indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods. Midodrine Hydrochloride Tablets may be taken with food (see Olvassa el a teljes dokumentumot