Midon 2.5 mg Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Midodrine hydrochloride

متاح من:

Originalis B.V.

ATC رمز:

C01CA; C01CA17

INN (الاسم الدولي):

Midodrine hydrochloride

الشكل الصيدلاني:

Tablet

المجال العلاجي:

Adrenergic and dopaminergic agents; midodrine

تاريخ الترخيص:

2024-03-15

نشرة المعلومات

Read all of this leaflet carefully before you start using 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.
What you need to know 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 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.
Midon Tablets are used to stop the fall in your blood pressure as a
result of
your sympathetic nervious 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 Midon Tablets
Do NOT take the tablets if you:
•
are allergic (hypersentitive) to midorine hydrochloride or any of
the other ingrediemts in the tablets (_see Section 6_)
•
have a tumour near the kidney, known as phaeochromocytoma
•
suffer from the eye disease narrow angle glaucoma
•
have thryoid 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 p

خصائص المنتج

Health Products Regulatory Authority
15 March 2024
CRN00F20L
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midon 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg Midodrine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Romania._
Round, white, biplanar tablets with bevelled edge. Scored on one side
with 'GU' above and '2.5' 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 PA2239/016/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/016/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Colloidal anhydrous silica
Microcrystalline cellulose
Maize starch
Talc
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°C.
Blister packs: store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Health Products Regulatory Authority
15 March 2024
CRN00F20L
Page 2 of 2
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.,
Joop Geesinkweg 901,
1114 AB Amsterdam-Duivendrecht,
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/032/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of authorisation: 15
th
March 2024
10 DATE OF REVISION OF THE TEXT