Summary of medicine characteristics - MYOTONINE TABLETS 10 MG
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 ^ 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 machinery may be impaired.
4.8 Undesirable effects
Nausea, vomiting, sweating and intestinal colic.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseSymptoms: Include nausea, salivation, lachrymation, eructation, involuntary defecation and urination, transient dyspnoea, palpitation, bradycardia and peripheral vasodilation leading to hypertension, transient heart block and a feeling of constriction under the sternum.
Emergency Procedure: The stomach should be emptied by aspiration and lavage.
Give atropine sulphate 1–2 mg intravenously, intramuscularly or subcutaneously to control muscarinic effects. This dose may be repeated every 2–4 hours as necessary.
Supportive treatment includes intravenous administration of diazepam 5–10 mg, muscle twitching may be controlled by small doses of tubocararine (together with assisted respiration), oxygen may be required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Parasympathomimetics, Choline esters, Bethanechol, ATC code: N07AB02
Mechanism of action
Bethanechol is a synthetic choline ester of carbamic acid which possesses a significant acetylcholine-like activity. It is active after oral administration. As a consequence of the very slow hydrolysation by acetylcholinesterase, bethanechol has a prolonged action as has been demonstrated on the urinary tract. The onset of action after oral administration of bethanechol chloride occurs within one hour.
Pharmacodynamic effects
The major pharmacological effects of bethanechol result from interaction of
the drug with muscarinic receptor sites of smooth muscles, especially those of the urinary bladder and gastrointestinal tract. In addition, minor but important nicotinic effects have been noted.
5.2 Pharmacokinetic properties
In usual therapeutic doses, bethanechol does not cross the blood brain barrier.
Studies addressing pharmacokinetic- pharmacodynamic are not available.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Calcium sulfate dihydrate BP;
Maize starch BP;
Purified talc BP
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
None.
Keep out of reach of children.
6.5 Nature and contents of container
The container consists of blister strips of PVC/aluminium foil packed in boxes.
Each container holds 100 tablets.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone
7 MARKETING AUTHORISATION HOLDER
Glenwood GmbH
Arabellastr. 17
81925 München
Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 22824/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
04 December 1973 / 20 March 2015