Midon 5mg Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

MIDODRINE HYDROCHLORIDE

Dostupno od:

Lexon (UK) Ltd

ATC koda:

C01CA; C01CA17

INN (International ime):

MIDODRINE HYDROCHLORIDE

Doziranje:

5 milligram(s)

Farmaceutski oblik:

Tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Adrenergic and dopaminergic agents; midodrine

Status autorizacije:

Authorised

Datum autorizacije:

2017-08-25

Uputa o lijeku

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
prol

Svojstava lijeka

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 PA1547/006/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1547/006/002
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.
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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 DISP