Myopridin 3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pridinol mesilate

Available from:

Mibe Pharma UK Ltd

ATC code:

M03BX03

INN (International Name):

Pridinol mesilate

Dosage:

3mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10020200; GTIN: 5060608410071 5060608410088

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYOPRIDIN 3 MG TABLETS
Pridinol
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 Myopridin is and what it is used for
2. What you need to know before you take Myopridin
3. How to take Myopridin
4. Possible side effects
5. How to store Myopridin
5. Contents of the pack and other information 1. WHAT MYOPRIDIN IS AND WHAT IT IS
USED FOR
Myopridin is a medicine that relaxes the mus­
cles. This effect occurs via the central nervous
system.
Myopridin is used in adults for the treatment
of cramp­like muscle tension (central and pe­
ripheral muscle spasms):
–
Low back pain (lumbago)
–
Neck spasm (torticollis)
–
General muscle pain 2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE MYOPRIDIN
DO NOT TAKE MYOPRIDIN
–
if you are allergic to pridinol or any of the
other ingredients of this medicine (listed in
section 6).
–
if you have any of the following diseases:
• Glaucoma
• Benign enlargement of the prostate tis­
sue (prostate hypertrophy)
• Problems emptying the bladder (urinary
retention)
• Blockage of the gastrointestinal trac
• Irregular heartbeat (arrhythmia)
–
in the first 3 months of pregnancy
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before ta­
king Myopridin.
TAKE SPECIAL CARE
–
if you have liver or kidney problems
In these circumstances, the active substance
may be available in your body at a higher
concentration and/or for a longer period
than usual.
–
if you are 65 years and older
–
if you suffer from

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Myopridin 3 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.02 mg pridinol (as 4 mg pridinol mesilate).
Excipient(s) with known effect
One tablet contains 143.5 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round tablet with a score line on one side
Diameter 9.0 - 9.2 mm
Height 2.5 - 2.7 mm
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Central and peripheral muscle spasms: lumbar pain, torticollis,
general muscle pain, in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1.5 – 3 mg pridinol 3 times daily
The duration of administration is decided by the treating doctor.
Administration is independent of meals, with the onset of the effect
being faster when
the medicinal product is taken before meals.
Patients who suffer from hypotension should take the tablets after
meals to reduce the
risk of fainting.
Children and adolescents
No data are available
Method of administration
For oral use.
The tablets should be taken with sufficient fluid (e.g. 1 glass of
water) and not
chewed.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1
-
Glaucoma
-
Prostate hypertrophy
-
Syndrome with urinary retention
-
Gastrointestinal obstructions
-
Arrhythmia
-
First trimester of pregnancy
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The medicinal product must be used with caution in the elderly, and in
patients with
severe renal and/or hepatic insufficiency, because higher and/or
longer-lasting blood
levels must be expected.
In patients who suffer from hypotension, the risk of circulatory
problems (fainting)
may be increased.
Myopridin contains lactose. Patients with the rare hereditary problems
of galactose
intolerance, total lactase deficiency or glucose-galactose
malabsorption should not
take this medicinal product.
4.5
INTERACT