Myotonine 10mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Bethanechol chloride

थमां उपलब्ध:

Glenwood GmbH

ए.टी.सी कोड:

N07AB02

INN (इंटरनेशनल नाम):

Bethanechol chloride

डोज़:

10mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 07040100; GTIN: 4260274650011

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
MYOTONINE 10 MG TABLETS
Bethanechol chloride
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 illnes 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 Myotonine Tablets are and what they are used for
2. What you need to know before you take Myotonine Tablets
3. How to take Myotonine Tablets
4. Possible side effects
5. How to store Myotonine Tablets
6. Contents of the pack and other information
1.
WHAT MYOTONINE TABLETS ARE AND WHAT THEY ARE USED FOR
Myotonine Tablets belong to a group of medicines called choline
esters. The active
ingredient in Myotonine
Tablets is bethanechol chloride. They are used to treat urinary
retention (holding urine in the bladder) following, for example, an
operation or after
giving birth, and also in the treatment of reflux oesophagitis
(inflammation of the
oesophagus).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYOTONINE TABLETS
DO NOT TAKE MYOTONINE TABLETS:
•
if you
have
had
a
blockage
of
your
gut.
• if you have had problems passing water due to a blockage.
• if you
have
had
recent
heart
attack.
• if you
have had recent surgery on your stomach.
• if you
are
pregnant
or
breast
feeding.
• if you are elderly (over 70 years of age).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Myotonine Tablets.
CHILDREN AND ADOLESCENTS
MYOTONINE TABLETS ARE NOT RECOMMENDED FOR CHILDREN.
OTHER MEDICINES AND MYOTONINE TABLETS
Tell your doctor or pharmacist if you are taking, have recently taken
or might take
any other medicines.
Please check with your doctor if you

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Myotonine Tablets 10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet weighs 400 mg; total active ingredient 10 mg
bethanechol
chloride USP.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Each 10mg tablet is white, flat with bevelled edge and with a single
score and
embossed “MYO10”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Urinary retention -acute postoperative, postpartum and neurogenic.
Reflux oesophagitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
The experience with children is limited; therefore no recommended
dose is given.
_Adults_
10 mg - 25 mg 3-4 times daily. Taken ½ hr before food. Occasionally
it
may be felt necessary to initiate therapy with a 50 mg dose.
_Elderly_
Adult dosage administered with caution.
Method of administration
Administration orally by tablets.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Intestinal or urinary obstruction, recent myocardial infarction,
recent intestinal
anastomosis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A severe cholinergic reaction is likely to occur if bethanechol
chloride is
administered IV or IM. This reaction has also rarely occurred in cases
of
hypersensitivity or overdose.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Pharmacological interactions may occur with the following when
bethanechol
is
administered.
Quinidine
and
procainamide
which
may
antagonise
cholinergic effects, cholinergic drugs which may have an additive
effect,
particularly cholinesterase inhibitors.
When administered to patients receiving ganglionic blocking compounds,
a
critical
fall
in
blood
pressure
may
occur
preceded
by
severe
abdominal
symptoms.
4.6
FERTILITY, PREGNANCY AND LACTATION
Should not be used during pregnancy or lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
In some cases the ability to drive and operate