MIDON 5 Milligram Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

MIDODRINE HYDROCHLORIDE

Διαθέσιμο από:

Takeda UK Limited

Φαρμακολογική κατηγορία (ATC):

C01CA17

INN (Διεθνής Όνομα):

MIDODRINE HYDROCHLORIDE

Δοσολογία:

5 Milligram

Φαρμακοτεχνική μορφή:

Tablets

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Adrenergic and dopaminergic agents

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-03-22

Φύλλο οδηγιών χρήσης

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 midodrine 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

Αρχείο Π.Χ.Π.

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 inc