Midon 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midodrine hydrochloride

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

C01CA; C01CA17

INN (International Name):

Midodrine hydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Adrenergic and dopaminergic agents; midodrine

Authorization status:

Marketed

Authorization date:

1990-03-26

Patient Information leaflet

1
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 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

Summary of Product characteristics

Health Products Regulatory Authority
30 July 2021
CRN00C49N
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midon 5mg 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
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
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of severe orthostatic hypotension due to
dysfunction of the autonomic nervous system when
corrective factors have been ruled out.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
The usual starting dose is 2.5 mg 2‑3 times daily. The dose should
be increased at weekly intervals in small increments until an
optimal response is obtained. Most patients are controlled at or below
30 mg daily given in divided doses. The maximum daily
dose is 30mg given in divided doses. Doses in excess of 30 mg daily
are not recommended. The supine and standing blood
pressure should be monitored regularly during initial treatment (at
least two times a week) and the use of midodrine should be
stopped if supine hypertension increases excessively. Dosing of
midodrine should occur during the daytime, when the patient
needs to be upright. A dosing schedule of 3-4 hour intervals is
suggested. The last dose should be taken at least four hours
before bedtime to reduce the risk of supine hypertension
Elderly:
Although there is no evidence to suggest that dosage requirements are
different in the elderly, it is recommended that the
initial dose used be small and that increases in dosage be titrated
against the patients clinical condition with caution.
_ _
The administration of midodrine should be stopped and the attending
physician notified immediatel