Contents

The active ingredient in these tablets is bethanechol chloride: 25 mg per tablet. The other ingredients, called excipients, are as follows:

Calcium Sulphate hemihydrate BP Maize Starch BP Talc BP (Iron free) Magnesium Stearate BP

This container holds 100 tablets, strength 25 mg: white in colour with a crossed score line across the top of the tablet.

Mode of action

Myotonine has a specific action on certain parts of the body. Technically it is a choline ester, known as bethanechol chloride, which to some extent mimics the activity of acetylcholine, a substance that occurs naturally in the body and is involved in the transmis-sion of signals between certain nerves and muscles.

These nerves belong to the parasympathetic nervous system that controls some of the actions of such organs as the bladder and the stomach and the intestine, (known as the gastrointestinal tract). Hence effects of Myotonine are to facilitate bladder emptying and increase the motility of the gastrointestinal tract.

The action of Myotonine is rapid, so effects are usually apparent within 30 to 90 minutes of dosing. The speed and duration of its effect will depend on the dosage your doctor has prescribed.

Product licence holder: Glenwood Laboratories Ltd, Jenkins Dale, Chatham, Kent ME4 5RD.

Manufacturer: Sussex Pharmaceuticals Ltd, Charls-wood Road, East Grinstead RH19 2HL.

Indications

Myotonine is taken to treat urinary retention, (for example following an operation or after giving birth), and also in the treatment of reflux oesophagitis.

Precautions and warnings

As with any prescription medication, certain factors must be considered before taking the treatment. Please tell your doctor if any of the following factors apply to you:

• Allergies - especially to any of the ingredients, including the excipients, in the tablets.
• If you are pregnant.
• If you are breast feeding.
• If you are taking any other medicines - including products bought over the counter.
• If you have any other medical condition.

It is very important to remember that a decision to prescribe a medicine must be made based on as much information as possible; your doctor needs to be aware of anything that may cause the chosen treat-ment to be either less effective or sometimes even risky for the patient.

Myotonine should not be taken by patients with intestinal or urinary obstruction, recent heart prob-lems or after recent gastric surgery.

Drug interactions may occur with the following medicines: quinidine and procainamide; cholinergic drugs, e.g. distigmine, carbachol; ganglionic blocking agents, e.g. trimetaphan.

Occasionally, Myotonine may interfere with an individual's ability to drive or operate machinery: if affected you should not drive or use dangerous machinery.

Dosage

The usual adult dosage is 10 to 25 mg taken three to four times a day, orally, half an hour before food.

It is advisable to take the tablets on an empty stomach to reduce the risk of feeling sick.

Your doctor will prescribe the correct dose for you to take; do not change the dosage unless told to do so by your doctor.

If you miss a dose and remember within an hour of when you should have taken it; you can take your usual dose. If, however, you forget and remember after two or more hours, do not take it but wait until the next dose is due. Do not take a double dose in this, or any other situation.

If you take too many tablets, or somebody else accidently swallows them, contact your doctor or nearest casualty department immediately.

There is no specific information on the use of Myotonine in children and older adults, (i.e. those over seventy years of age).

Side effects

Sometimes, some patients may experience side ef-fects due to their medicine. Usually these are only mild and disappear as your body adjusts to the treatment. However, if the side effects continue or they worry you - tell your doctor.

Very rarely, Myotonine may cause nausea, sweat-ing, vomiting and intestinal colic.

If you experience any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

Storage

Store below 25 ° C. Store in containers kept tightly closed.

As with all medicines, it is advisable to keep them out of reach of children.

Do not use tablets that have passed their expiry date (written on the label).

Legal category POM.

Product licence number 0245/5010

Date of leaflet revision November 1996

Original date of preparation July 1995.

MYOTONINE IS ALSO AVAILABLE IN 10 MG STRENGTH - 100 TABLETS PER CONTAINER. PL No: 0245/5009.