Midon 5 mg tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Midodrine hydrochloride

থেকে পাওয়া:

IMED Healthcare Ltd.

এটিসি কোড:

C01CA; C01CA17

INN (আন্তর্জাতিক নাম):

Midodrine hydrochloride

ডোজ:

5 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Tablet

থেরাপিউটিক এলাকা:

Adrenergic and dopaminergic agents; midodrine

অনুমোদন তারিখ:

2021-08-06

তথ্য লিফলেট

PATIENT INFORMATION LEAFLET
MIDON 5 MG TABLETS
midodrine hydrochloride
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. 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 midorine 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 re

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
29 March 2023
CRN00DHHD
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.
Also contains the colourant E110 (Sunset Yellow FCF-Lake)
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
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 (E 110)
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 25ºC.
Store in the original package in order to protect from light.
Health Products Regulatory Authority
29 March 2023
CRN00DHHD
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
- Blister packs of 100 tablets. The push-through blister comprises
aluminium foil faced with PVDC, with vinyl backing also
faced with PVDC.
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
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/160/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
August 2021
10 DATE OF REVISION OF THE TEXT
March 2023