Package leaflet: Information for the patient

Co-danthrusate 50/60mg Capsules

(Danthron and Docusate Sodium)

What Co-danthrusate Capsule is and what it is used for

Co-danthrusate belongs to a group of medicines known as stimulant laxatives. Co-danthrusate Capsules contain danthron and docusate sodium. Danthron is a laxative which stimulate the lower bowel and encourage normal bowel movement. Docusate sodium helps to produce soft stools which are easier to pass. Together they help your bowels to work normally without causing irritation.

These capsules are used to treat constipation in terminally ill patients.

What you need to know before 12 you take Co-danthrusate Capsule

Do not take Co-danthrusate Capsule if:

■    You are allergic to danthron or docusate sodium or to any of the other ingredients of this medicine (listed in section 6)

■    You have stomach pain and your doctor does not know what is causing it

■    You have blockage of the intestines

(intestinal obstruction). Symptoms include stomach cramps, feeling or being sick, lack of bowel movement or passing of gas, swelling and/or tenderness of abdomen, fever

■    You are pregnant or breast-feeding

Warnings and precautions

■    if you are unable to control your urine or bowel movements (incontinent)

Other medicines and Co-danthrusate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without prescription.

■    Do not use liquid paraffin whilst taking this medicine (used for constipation and to lubricate faeces)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, ask your doctor for advice before taking this medicine.

Co-danthrusate Capsules should not be used during pregnancy or while breast-feeding.

Driving and using machines

Co-danthrusate Capsules have no known influence on your ability to drive and use machines.

Co-danthrusate contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

■    The capsules are to be taken orally

■    These capsules should be swallowed whole (not chewed)

■    Co-danthrusate Capsules take about 8 hours to work

■    Co-danthrusate Capsules should not be taken for long periods of time (more than a few days)

The recommended dose is:

Adults and elderly patients:

1to3 capsules at bedtime

Children aged 6to12 years:

1 capsule at bedtime

Children under 6 years:

This medicine is not recommended for children under 6 years.

If you forget to take your Co-danthrusate Capsules

If you forget to take a dose one night, take it the next night. Do not take a double dose to

make up for a forgotten dose.

If you take Co-danthrusate Capsules than you should

If you accidentally take too many capsules, drink plenty of water and contact a doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet and any remaining capsules with you.

Possible side effects

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

Tell your doctor if you suffer from a mild griping feeling in the abdomen for more than a few days.

Other side effects (frequency not known)

■    red or orange coloured tint in urine (this is due to the dantron in the capsules)

Side effects due to long term use

■    fluid or electrolyte imbalance (usually detected through blood or urine tests)

■    muscle weakness of the bowel wall

■    'lazy bowels' (colonic atony) a condition in which bowel emptying occurs infrequently due to muscle weakness of the bowel wall

■    skin rash, skin irritation, skin discolouration peeling of skin around the back passage (anus)

discolouration of the lining of your bowel

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

0How to store

Co-danthrusate Capsule

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

■    Store in a dry place, below 25°C. Store in the original package in order to protect from moisture.

■    Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.

■    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help to protect the environment.

[c Contents of the pack and other information

What Co-danthrusate Capsules contain:

■ The active substances are: Each capsule contains 50mg Danthron and 60mg Docusate Sodium

■ The other ingredients are: lactose, pre-gelatinised starch, colloidal silicon dioxide, sodium benzoate (E211) and magnesium stearate

What Co-danthrusate Capsules look like and the contents of the pack

Co-danthrusate Capsules are brown capsules coded CDN in white on cap and body containing a yellow powder.

Co-danthrusate Capsules are available in blister packs containing 21,28, 42, 56 or 63 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road, Eaton Socon,

St Neots, Cambridgeshire PE19 8ET UK

Product Licence Number:

PL 11311/0371

Date of last revision March 2016

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Till-Ver.4s