Midon 5 mg tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Midodrine hydrochloride

Boleh didapati daripada:

Lexon Pharmaceuticals (Ireland) Limited

Kod ATC:

C01CA; C01CA17

INN (Nama Antarabangsa):

Midodrine hydrochloride

Dos:

5 milligram(s)

Borang farmaseutikal:

Tablet

Kawasan terapeutik:

Adrenergic and dopaminergic agents; midodrine

Tarikh kebenaran:

2017-08-25

Risalah maklumat

MIDON 5MG TABLETS
midodrine hydrochloride
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
*
Keep this leaflet. You may need to read it again.
*
If you have any further questions, ask your doctor.
*
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
What Midon Tablets are and what they are used for
Before you take Midon Tablets
How to take Midon Tablets
Possible side effects
How to store Midon Tablets
Further information
WHAT MIDON TABLETS ARE AND WHAT THEY ARE USED FOR
Midon Tablets contain 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.
Midon 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.
BEFORE YOU TAKE MIDON TABLETS
DO NOT TAKE THE TABLETS IF YOU:
*
are allergic (hypersensitive) to midodrine hydrochloride or any of the
other
ingredients in the tablets (_see Section 6 and end of Section 2_)
*
have a tumour near the kidney, known as phaeochromocytoma
*
suffer from the eye disease narrow angle glaucoma
*
have thyroid gland problems called thyrotoxicosis or hyperthyroidism
i.e.
overactive thyroid
*
suffer from high blood pressure or a form of low blood pressure known
as
vasovagal hypotension
*
some types of heart or blood vessel disease
*
have inflammation of the kidneys, kidney disease, poor kidney function
or if
you are having problems passing urine
*
damage to the retina in your eye as a result of diabetes (known as
prolif

Ciri produk

Health Products Regulatory Authority
10 November 2022
CRN00D6FP
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midon 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg midodrine hydrochloride.
Also contains the colourant E110 (sunset yellow FCF (E110)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Czech Republic_
Orange, round, biplanar tablets with bevelled edge. Scored on one side
with marking ‘GU’ above and ‘5.0’ below the score.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA2239/016/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/016/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Magnesium stearate
talc
colloidal anhydrous silica
microcrystalline cellulose
maize starch
sunset yellow (E110)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
10 November 2022
CRN00D6FP
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Store in the original package in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 100 tablets. PVC/PVDC-Al blister in cardboard box.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/013/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
August 2017
10 DATE OF REVISION OF THE TEXT
November 2022