Midodrine Tillomed 5 mg tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Midodrine hydrochloride

Предлага се от:

Tillomed Pharma GmbH

АТС код:

C01CA17

INN (Международно Name):

Midodrine hydrochloride

дозиране:

5 milligram(s)

Лекарствена форма:

Tablet

Терапевтична област:

midodrine

Статус Оторизация:

Marketed

Дата Оторизация:

2021-08-27

Листовка

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

Данни за продукта

Health Products Regulatory Authority
15 February 2024
CRN00DSL4
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midodrine Tillomed 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg midodrine hydrochloride.
Excipients with known effect:
Each tablet contains 0.1 mg Sunset Yellow FCF aluminium lake (E110).
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 rec