Midon 5 mg Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Midodrine hydrochloride

Διαθέσιμο από:

PCO Manufacturing Ltd.

Φαρμακολογική κατηγορία (ATC):

C01CA; C01CA17

INN (Διεθνής Όνομα):

Midodrine hydrochloride

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Adrenergic and dopaminergic agents; midodrine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-09-16

Φύλλο οδηγιών χρήσης

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDON
® 5 MG TABLETS
midodrine hydrochloride
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:
1.
What Midon Tablets are and what they are used for
2.
Before you take Midon Tablets
3.
How to take Midon Tablets
4.
Possible side effects
5.
How to store Midon Tablets
6.
Contents of the pack and other information
1.
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.
2.
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 uri

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
14 February 2024
CRN00F30F
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midon 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg midodrine hydrochloride.
Excipient(s) with known effect:
Sunset Yellow FCF-Lake (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Slovakia, Bulgaria and Czech Republic:_
Orange, round, biplanar tablets with bevelled edge. Scored on one side
with marking 'GU' above and '5.0' below the score.
The scoreline 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
Colloidal anhydrous silica
Microcrystalline cellulose
Maize starch
Talc
Sunset yellow FCF – Lake (E110)
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 ºC.
Store in the original package in order to protect from light.
Health Products Regulatory Authority
14 February 2024
CRN00F30F
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from Slovakia_
Blisters of 50 tablets
_Product imported from Bulgaria and Czech Republic_
Blisters of 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/276/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
September 2011
10 DATE OF REVISION OF THE TEXT
February 202