Uncommon side effects (seen in less than I in 100 patients)

•    Vomiting

•    Blood in stools

•    Abdominal discomfort

•    Discomfort inside and around the back passage Unknown frequency

•    Dehydration - symptoms may include thirst and production of only small amounts of urine (oliguria).

•    Colitis (inflammation of the large intestine that causes pain and diarrhoea)

If any of these side effects get serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. How to store Bisacodyl Tablets

•    Keep out of sight and reach of children.

•    Do not store above 25°C.

•    Store in the original package

•    Do not use Bisacodyl tablets after the expiry date on the labelling.

•    Medicines should not be disposed off via waste water or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further Information What Bisacodyl tablets contain

The other ingredients in Bisacodyl tablets are: Lactose, Maize starch, Liquid paraffin, Magnesium stearate, Coating: Polyvinyl alcohol-Part hydrolysed, titanium dioxide (El71), Macrogol/PEG 3350, Talc, Silica, Methylacrylic acid Copolymer, Sodium Lauryl sulphate, Triethyl citrate, Quinoline yellow aluminium lake (El04), Simethicone 30% emulsion, Shellac (E904), Beeswax (E90I), Carnuba wax yellow (E903)

The tablets are biconvex, yellow, enteric coated, gastro-resistant tablets.

Bisacodyl tablets are available in blister packs of 20,40,60,100 and 500 and securitainers of 500 or 1000 tablets. Not all pack sizes may be marketed

Bisacodyl 5mg Tablets PL 21880/0019 Leaflet prepared: January 2015

Marketing Authorisation Holder and Manufacturer:

MMEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK.

E-mail: info@medreich.co.uk

Bisacodyl 5 mg Tablets

Read all of this leaflet carefully before taking this medicine:

•    This medicine is available without prescription. However, you still need to use it carefully to get the best results from it

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    Contact a doctor if your symptoms worsen or do not improve after 5 days.

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet:

1.    What Bisacodyl Tablets are and what they are used for

2.    Before you take Bisacodyl Tablets

3.    How to take Bisacodyl Tablets

4.    Possible side effects

5.    How to store Bisacodyl Tablets

6.    Further information

1.    What Bisacodyl Tablets are and what they are used for

Bisacodyl is a laxative used for the short term relief of constipation. It can also be used in a hospital to empty a person’s bowel before surgery, labour or radiological investigation.

Bisacodyl works by stimulating the muscles in the bowel to increase the movement of waste products through the body helping you go to the toilet.

Bisacodyl tablets do not help with weight loss

Eating a healthy diet, drinking plenty of water and getting regular gentle exercise can all help maintain good bowel function.

2.    Before you take Bisacodyl Tablets Do not take Bisacodyl Tablets if you:

•    are allergic (hypersensitive) to Bisacodyl or any of the other ingredients listed in Section 6

•    have a bowel condition called ‘ileus’

•    have a blocked bowel (intestinal obstruction)

•    have a serious abdominal condition such as appendicitis

•    suffer from inflammatory bowel disease

•    have severe abdominal pain associated with nausea and vomiting

•    are severely dehydrated Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including herbal medicines and medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    Water tablets (diuretics)

•    Steroid medicines (adreno-corticosteriods) such as prednisolone

•    Antacids (these can cause Bisacodyl tablets to dissolve too quickly and irritate the stomach. Do not take antacids within one hour of taking Bisacodyl tablets)

Taking Bisacodyl Tablets with food and drink

Milk can cause the tablets to dissolve too quickly and irritate the stomach. Take Bisacodyl tablets at least an hour before or after milk.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before taking these tablets if you are pregnant or breastfeeding.They will decide if this medicine is suitable for you to take.

Driving and using machines

Bisacodyl tablets have no effect on the ability to drive or use machinery.

Important information about some of the other ingredients in your medicine

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product as the tablet contains lactose.

3. How to take Bisacodyl Tablets

Always take your medicine exactly as instructed. Ask your doctor or pharmacist if you are not sure.

Taking the tablets

Bisacodyl tablets are for short term use. Do not use the tablets every day for more than 5 days. Talk to your doctor or pharmacist if you still have problems after 5 days.

Swallow the tablets whole with water.

Children aged 10 years or younger

Children aged 10 years or younger must only be treated under the guidance of a physician. Bisacodyl must not be used in children under 2 years of age.

Dosage for Short term treatment of constipation:

•    Adults and children over 10 years: Start with I tablet at bed time and increase to 2 if necessary.

•    Children aged 2 to 10 years: I tablet at bedtime

Dosage to empty your bowels before tests, labour or surgery:

When used for these purposes, Bisacodyl must only be used under medical supervision. Bisacodyl will be used in combination with a suppository that will be supplied with your Bisacodyl tablets.

•    Adults and children over 10 years: 2 tablets in the morning and 2 tablets in the evening followed by I suppository (lOmg) on the following morning

•    Children 2 to 10 years: I tablet in the evening and I suppository (5mg) on the following morning

If you take more Bisacodyl Tablets than you should

It may be harmful to

*    Take too much of Bisacodyl or

*    Take Bisacodyl for too long

This is because taking too much for too long may lead to:

-    A 'lazy bowel', where the muscle in the bowel becomes too relaxed.This means that bowel emptying happens less often.This can lead to long-term constipation.

-    Imbalance of fluid and salts in the body.This can affect the tightness of muscle such as those in the bowel. It can also affect the salts in the blood.

-    Low levels of potassium in the blood (called 'hypo-kalaemia').This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.

-    Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass enough urine.

If you take too many tablets contact your doctor immediately or go to the nearest hospital casualty department. Take this leaflet or some tablets with you so the doctor will know what you have taken.

If you forget to take Bisacodyl Tablets

If you have forgotten to take your Bisacodyl tablets wait until it is time to take the next dose and then continue as usual. Do not take a double dose to make up for a forgotten dose.

Ask your doctor or pharmacist if you have any other questions on the use of this product.

4. Possible side effects

Like all medicines, Bisacodyl tablets can have side effects.

Serious Allergic Reactions

Serious allergic reactions can occur and may cause:

•    Swelling of the face, throat, lips or tongue

•    Severe skin rashes

•    Difficulty breathing

If you experience any of these side effects contact your doctor IMMEDIATELY or go to your nearest hospital casualty department.

Other possible side effects

Common side effects (seen in less than I In 10 patients)

•    Abdominal pain or cramps

•    Nausea

•    Diarrhoea    -r..    ^    ■    .    , ,

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