Midon 2.5 mg tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Midodrine hydrochloride

可用日期:

PCO Manufacturing Ltd.

ATC代码:

C01CA; C01CA17

INN（国际名称）:

Midodrine hydrochloride

剂量:

2.5 milligram(s)

药物剂型:

Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Adrenergic and dopaminergic agents; midodrine

授权状态:

Authorised

授权日期:

2011-07-22

资料单张

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDON
® 2.5 MG TABLETS
midodrine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.If you get any side
effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS 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
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.
WHAT YOU NEED TO KNOW 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

产品特点

Health Products Regulatory Authority
12 July 2022
CRN00D0NW
Page 1 of 3
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Germany and Bulgaria _
Round, white, biplanar tablets with bevelled edge. Scored on one side
with 'GU' above and '2.5' below the score.
_Product imported from Italy_
Round, white, tablets. Scored on one side with 'Gutron' and a star
symbol on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
Asper PA 2239/016/001
5 PHARMACOLOGICAL PROPERTIES
Asper PA 2239/016/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Germany and Bulgaria _
Magnesium stearate
Talc
Colloidal anhydrous silica
Microcrystalline cellulose
Maize starch
_Product imported from Italy_
Magnesium stearate
Talc
Colloidal anhydrous silica
Microcrystalline cellulose
Starch
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
12 July 2022
CRN00D0NW
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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 ºC.
Store in the original package in order to protect from moisture and
light.
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from Germany and Bulgaria_
10 blisters of 10 tablets - pack size 100 tablets.
_Product imported from Italy_
6 blisters of 15 tablets - pack size 90 tablets
Not all pack sizes may be marketed.
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.
Health Products Regulatory Authority
12 July 2022
CRN00D0NW
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