Midotense 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Midodrine hydrochloride

Available from:

Transdermal Ltd

ATC code:

C01CA17

INN (International Name):

Midodrine hydrochloride

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02070200; GTIN: 5060052450197

Patient Information leaflet

item code 21466 & pc 2006
MIDOTENSE 2.5MG TABLETS
Midodrine hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Midotense Tablets are and what they are used for
2. Before you take Midotense Tablets
3. How to take Midotense Tablets
4. Possible side effects
5. How to store Midotense Tablets
6. Contents of the pack and other information
1. WHAT MIDOTENSE TABLETS ARE AND WHAT THEY ARE USED FOR
Midotense Tablets contain the active ingredient midodrine
hydrochloride which belongs to a group of medicines
called adrenergic and dopaminergic agents. It works by
raising your blood pressure and is used to treat certain
severe forms of low blood pressure in adults when other
treatments have not worked.
2. BEFORE YOU TAKE MIDOTENSE TABLETS
DO NOT TAKE MIDOTENSE TABLETS IF:
• you are allergic to midodrine hydrochloride or any of
the other ingredients of Midotense (see section 6 for
details)
• you have high blood pressure
•
you have certain forms of heart disease (such as angina)
or have suffered a
heart attack
• you have a slow pulse
• you have difficulty
urinating
• you have increased
pressure in the eye
(glaucoma)
• you have poor vision
as a result of diabetes
• you have an over-active thyroid gland
• you have tumour near the kidney causing hormonal
disorders (also known as pheochromocytoma)
• you have severe or acute kidney disease or problems
• you have an enlarged prostate
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharm

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Midotense 2.5mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
White to off-white, 7 mm round, flat tablet with scoreline on one
side.
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
Midotense 2.5 mg tablets are indicated in adults for the treatment of
severe orthostatic
hypotension due to autonomic dysfunction when corrective factors have
been ruled
out and other forms of treatment are inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Initial dose: 2.5 mg 3 times a day. Depending on the results of supine
and standing
blood pressure recordings, this dose may be increased weekly up to a
dose of 10
mg three times a day. This is the usual maintenance dosage.
A careful evaluation of the response to treatment and of the overall
balance of
the expected benefits and risks needs to be undertaken before any dose
increase
and advice to continue therapy for long periods.
The last daily dose should be taken at least 4 hours before bedtime in
order to
prevent supine hypertension (see also section 4.4).
Midotense 2.5 mg tablets may be taken with food (see section 5.2).
Paediatric population
The safety and efficacy of midodrine in children has not been
established. No data
are available.
Elderly population
There is limited data on dosing in the elderly and there are no
specific studies
which have focused on a possible dose reduction in the elderly
population.
Cautious dose titration is recommended.
Patients with renal impairment
There are no specific studies that have been focused on a possible
dose reduction
in patients with renal impairment.
Typically, midodrine is contraindicated in
patients with acute renal impairment and severe renal impairment (see
section 4.3).
Patients with hepatic impairment
There are no specific st