Midon 2.5 mg tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Midodrine hydrochloride

Доступна с:

Merit Pharmaceuticals Limited

код АТС:

C01CA; C01CA17

ИНН (Международная Имя):

Midodrine hydrochloride

Фармацевтическая форма:

Tablet

Терапевтические области:

Adrenergic and dopaminergic agents; midodrine

Дата Авторизация:

2022-09-23

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDON
® 2.5 MG TABLETS
(Midodrine hydrochloride)
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. Further 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_)
•
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
proliferative diabetic retinopathy) Men only:
•
have an enlarged prostate that causes problems emptying your
bladder.
You should take your last dose of Midon Tablets at least four hours
before
bedtime. This is because Midon Tablets can cause high blood pressure
if
you are lying down for any period of time (for example, sleeping or
sunbathing)
TAKE SPECIAL CARE
Talk to your doctor before taking these tablets

Характеристики продукта

Health Products Regulatory Authority
28 September 2022
CRN00CZ06
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 Tablets
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Czech Republic:_
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 shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVdC-Aluminium blister pack
Each carton contains 50 or 100 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Health Products Regulatory Authority
28 September 2022
CRN00CZ06
Page 2 of 2
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Merit Pharmaceuticals Limited
C4/C3 Metropoint Point Business Park,
Kettles Lane,
Swords,
Co Dublin,
K67 RH92,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23080/024/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
September 2022
10 DATE OF REVISION OF THE TEXT