Midodrine Hydrochloride Morningside 2.5 mg tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Midodrine hydrochloride

Dostupné s:

Morningside Healthcare (Malta) Limited

ATC kód:

C01CA17

INN (Mezinárodní Name):

Midodrine hydrochloride

Léková forma:

Tablet

Terapeutické oblasti:

midodrine

Stav Autorizace:

Not marketed

Datum autorizace:

2022-09-16

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDODRINE HYDROCHLORIDE MORNINGSIDE 2.5 AND 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 Hydrochloride Morningside 2.5 and 5 mg Tablets are and
what are they
used for
2.
What you need to know before you take Midodrine Hydrochloride
Morningside 2.5 and 5
mg Tablets
3.
How to take Midodrine Hydrochloride Morningside 2.5 and 5 mg Tablets
4.
Possible side effects
5.
How to store Midodrine Hydrochloride Morningside 2.5 and 5 mg Tablets
6.
Contents of the pack and other information
1.
WHAT MIDODRINE HYDROCHLORIDE MORNINGSIDE 2.5 AND 5 MG TABLETS ARE AND
WHAT
ARE THEY USED FOR
Midodrine Hydrochloride Morningside 2.5 and 5 mg 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.
Midodrine Hydrochloride Morningside 2.5 and 5 mg Tablets are used 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 such
as dizziness, fainting,
blurred vision and weakness when you sit or stand up.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDODRINE HYDROCHLORIDE
MORNINGSIDE
2.5 AND 5 MG TABLETS
_ _
DO NOT TAKE MIDODRINE HYDROCHLORIDE MORNINGSIDE 2.5 AND 5 MG TABLETS
IF YOU:
•
are allergic to midodrine hydroch

Charakteristika produktu

Health Products Regulatory Authority
16 September 2022
CRN00CDH2
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midodrine Hydrochloride Morningside 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet, diameter approximately 7 mm with M2 debossed on
one side and score line on the other side.
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
For use in adults for 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 3 times daily. 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. 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 3 divided doses. The maximum daily dose is 30 mg given in 3 divided
doses. Doses in excess of 30 mg 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.
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 pressu