Midodrine Hydrochloride 5 mg tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Midodrine hydrochloride

Dostupné s:

Milstein C.V.

ATC kód:

C01CA17

INN (Mezinárodní Name):

Midodrine hydrochloride

Léková forma:

Tablet

Terapeutické oblasti:

midodrine

Datum autorizace:

2022-02-11

Informace pro uživatele

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

Charakteristika produktu

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