Midon 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midodrine hydrochloride

Available from:

Originalis B.V.

ATC code:

C01CA17

INN (International Name):

Midodrine hydrochloride

Pharmaceutical form:

Tablet

Therapeutic area:

midodrine

Authorization date:

2023-12-08

Patient Information leaflet

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 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.
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 and end of _
_Section 2)_
•
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 proliferative diabetic
retinopathy)
Men only

Summary of Product characteristics

Health Products Regulatory Authority
11 December 2023
CRN00DRDJ
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
Corn starch
Talc
orange-yellow aluminum varnish (E110)
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blisterand 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.
Blister packs: store in the original package in order to protect from
light.
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.
Health Products Regulatory Authority
11 December 2023
CRN00DRDJ
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/029/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8
th
December 2023
10 DATE OF REVISION OF THE TEXT