MYOTONINE TABLETS 10 MG - patient leaflet, side effects, dosage

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 are allergic to bethanechol chloride or any of the other ingredients of this medicine (listed in section 6).
• 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 are taking any of the following before taking Myotonine Tablets:

• medicines used to treat abnormal heart rhythms (e.g. quinidine and procainamide)
• other medicines used to treat urinary retention (e.g. distigmine and carbachol)
• medicines that are used to reduce high blood pressure in emergency situations (e.g. trimethaphan).

Myotonine Tablets with food and drink

It is advisable to take Myotonine Tablets on an empty stomach to reduce the risk of feeling sick. They should be taken half an hour before food.

Pregnancy and breast feeding

Do not take Myotonine Tablets if you are pregnant, think you are pregnant or are trying to become pregnant.

Do not take Myotonine Tablets if you are breast feeding.

Driving and using machines

Occasionally Myotonine Tablets may interfere with an individual’s a­bility to drive or operate machinery. If affected, you should not drive or operate machinery.

3. how to take myotonine tablets

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

• The usual dose for adults is 10 to 25 mg taken three to four times a day.
• Myotonine Tablets should be swallowed whole with a glass of water. They should be taken half an hour before food.
• It is advisable to take Myotonine Tablets on an empty stomach to reduce the risk of feeling sick.
• Myotonine Tablets are not recommended for children or the elderly.

If you take more Myotonine Tablets than you should

If you take too many tablets, or somebody else accidentally swallows your tablets, contact your doctor or the nearest hospital casualty department immediately.

If you forget to take Myotonine Tablets

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 to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects include feeling and being sick, sweating and stomach pains/spasms.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the

Yellow Card Scheme at:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store myotonine tablets

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the label.
• The expiry date refers to the last day of that month.
• Store in the original packaging.

6. contents of the pack and other information

What Myotonine Tablets contain

The active substance is bethanechol chloride.

Each tablet contains 10 mg of the active ingredient.

The other ingredients are calcium sulfate dihydrate BP, maize starch BP and talc BP (iron free).

What Myotonine Tablets look like and the contents of the pack

Myotonine Tablets are white in colour with a single score line across the tablet and the embossment “MYO10”.

Each pack contains 100 tablets.

Marketing Authorisation Holder and Manufacturer

GLENWOOD GMBH Pharmazeutische Erzeugnisse

Arabellastr. 17, 81925 Munchen, Germany

Product License Number: PL 22824/0005

The leaflet was last revised in october 2018.

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