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• label-leaflet MAH GENERIC_PL 04917-0142
• leaflet MAH GENERIC_PL 04917-0142

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PATIENT INFORMATION LEAFLET CO-DANTHRUSATE SUSPENSION Co-danthrusate (dantron and docusate sodium)

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. Do not pass it on to others.

It may harm them, even if their symptoms 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 Co-danthrusate Suspension is and what is it used for

2.    What you need to know before you take Co-danthrusate Suspension

3.    How to take Co-danthrusate Suspension

4.    Possible side effects

5.    How to store Co-danthrusate Suspension

6.    Contents of the pack and other information.

1.    What Co-danthrusate Suspension is and what it is used for Co-danthrusate Suspension is used to treat constipation in terminally ill patients. It contains two active ingredients, dantron and docusate sodium. Dantron is a laxative which stimulates the lower bowel and encourages normal bowel movement. Docusate sodium helps to produce soft stools which are easier to pass. Together they encourage normal bowel movement.

2.    What you need to know before you take Co-danthrusate Suspension Do not take Co-danthrusate Suspension:

•    if you are allergic to dantron or docusate sodium or any of the other ingredients of this medicine (listed in section 6)

•    if you are allergic to any of die other ingredients in Co-danthrusate suspension (listed in section 6)

•    if you have stomach pain which the doctor has been unable to diagnose

•    if your doctor suspects you have an obstruction in your intestines

•    if you are pregnant or breastfeeding.

If any of the above applies to you talk to your doctor or pharmacist. Warning and precautions

Talk to your doctor before taking Co-danthrusate Suspension:

•    if you are incontinent

•    if you are on a low-sodium diet

•    if you are intolerant to Sorbitol

Other medicines and Co-danthrusate Suspension:

Tell your doctor if you are taking, have recently taken or might take any other medicine, including medicines obtained without a prescription. Pregnancy and breast-feeding

Do not take Co-danthrusate suspension if you are pregnant, trying to become pregnant or breast-feeding.

Warnings about some of the ingredients

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

The suspension contains the preservatives methyl and propyl parahydroxybenzoate. These can sometimes cause allergic reactions (possibly delayed).

The suspension contains 13.28 mg of sodium in 5 ml. This may be harmful to people on a low sodium diet.

If any of the above applies to you, talk to your doctor.

3. How to take Co-danthrusate Suspension

Always take Co-danthrusate Suspension exactly as your doctor has told you. Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Remember to shake the bottle before taking this medicine.

Adults

•    Take one to three 5 ml spoonfuls at bedtime.

Children

•    Take one 5 ml spoonful at bedtime.

Co-danthrusate Suspension normally works 8 hours after a dose is taken.

Do not take more than your doctor has recommended. If you are still constipated after a few days, tell the doctor. Long term use of laxatives is not recommended.

If you take more Co-danthrusate Suspension than you should

If you accidentally take too much, drink plenty of water and tell your doctor.

If you forget to take a dose

If you forget to take a dose one night, take it the next night. Never

double-up on the next dose to make-up for the one missed.

If you have any other questions about taking this medicine, ask your

doctor or pharmacist.

4. Possible side effects

Like all medicines Co-danthrusate suspension can cause side effects,

although not everybody gets them.

•    A few people will find that they get an orange colour in their urine. This is due to the dantron in Co-danthrusate and is not a cause for concern.

•    If you are incontinent you might find that the skin around your bottom gets red.

•    At higher doses the sorbitol in the medicine may cause stomach upset and diarrhoea.

•    Dantron may cause growths in the bowel and liver. This may make you bleed from the back passage, have stomach pains or diarrhoea. There is a possible, but very small, risk of this happening.

• With prolonged use or high doses of this medicine you may have a 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Co-danthrusate Suspension

Keep out of the sight and reach of children. Do not use Co-danthrusate Suspension after the expiry date on the pack. The expiry date refers to the last day of that month. Store below^r 25°C. Keep the suspension in its original pack to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6.    Contents of the pack and other information

What Co-danthrusate Suspension contains

The suspension contains two active substances.

Each 5 ml contains 50 mg of dantron and 60 mg of docusate sodium.

The other ingredients are methylcellulose, xanthan gum, glycerol, methyl and propyl parahydroxybenzoates, sorbitol, saccharin sodium, disodium hydrogen orthophosphate, sodium dihydrogen orthophosphate, peppermint oil and purified water.

What Co-danthrusate Suspension looks like Co-danthrusate Suspension is an orange yellow colour with a smell of peppermint. It comes in either a 30 ml or a 200ml bottle. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.    The leaflet was last revised 08/2015

If this leaflet is difficult to see or read or you would like it in a different format, please contact Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

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