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Bisacodyl Laxative Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Entrolax®

(Bisacodyl)

Read all this leaflet carefully before you start taking this medicine:

This medicine is available without prescription. You need to take Entrolax as instructed in this leaflet to get the best results fipm it_____________________________________________

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

•    If you have any further questions, ask your doctor or pharmacist.

•    If a side effect occurs and gets troublesome, or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor.

In this leaflet:

1.    What Entrolax is and what it is used for

2.    Before you take Entrolax

3.    How to take Entrolax

4.    Possible side effects

5.    How to store

6.    Further information


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4. POSSIBLE SIDE EFFECTS


Entrolax may cause griping pain and abdominal cramps.

Continued daily use of Entrolax over a long period of time can lead to ‘lazy bowels’ (atonic nonfunctioning colon) a condition in which bowel emptying occurs infrequently and low blood potassium (hypokalaemia), signs of which are fatigue, dizziness and general muscle weakness.


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1. WHAT ENTROLAX IS AND WHAT IT IS USED FOR


Bisacodyl belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Bisacodyl Laxative Tablets are used for the short term relief of constipation.


2. BEFORE YOU TAKE ENTROLAX


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Do not take Entrolax if you

•    are allergic to bisacodyl or to any of the ingredients listed in section 6

•    are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and sucrose)

.• ace_pregnant or_hreastfeeding________________________________________

•    have severe dehydration

•    have a bowel condition called "ileus” in the small intestine

•    have severe abdominal pain with nausea and vomiting

•    have an abdominal condition such as appendicitis

•    have a blocked bowel (intestinal obstruction)

•    have inflammation of the bowel (small or large intestine).

If you are not sure whether the tablets are suitable for you, check with your doctor or pharmacist. Taking other medicines

•    Do not take antacids within one hour after taking these tablets.

•    Do not use suppositories whilst taking Entrolax.

Sugar inteleranee-------------------------------------------------

The tablets contain a small amount of lactose and sucrose in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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


3. HOW TO TAKE ENTROLAX


Swallow the tablets whole with water. The tablets should not be chewed or crushed.

Doses

For constipation:

Adults (including the elderly) and children over 10 years: 1 to 2 tablets at night.

If you take more tablets than you should

If you have taken more than the recommended number of tablets, contact a doctor for advice straight away.

Length of treatment

These tablets should not be used every day for more than 5 days. If you need laxatives every day, then you should see your doctor to find the cause of your constipation.

Continued over page



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Rare side effects (affect less than 1 in 1000 people)

Severe allergic reactions which may cause swelling of the face or throat and difficulty in breathing or dizziness. If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away.

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

•    Dehydration

•    Allergic reactions which may cause a skin rash

•    Fainting

Uncommon side effects (affect less than 1 in 100 people)

•    Blood in the stools

•    Vomiting

•"AbdomLnaftfiscomfort-

•    Discomfort inside and around the back passage

•    Dizziness

Common side effects (affect less than 1 in 10 people)

•    Abdominal cramps or pain

•    Diarrhoea

•    Nausea

If a side effect occurs and gets troublesome or seems serious to you, or if you experience any side effect not ]isted_ in thisjeaflet please tell your pharmacist or doctor. _ _

If you Rave any”of these side”effects orhave” any other” effects,”pTease”teir your” doctor or” phafmacistT ”'


5. HOW TO STORE


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•    Store below 25°C. Keep in original container.

•    Keep all medicines out of the reach and sight of children.

•    Do not use this medicine after the expiry date on the packaging.


6. FURTHER INFORMATION


What is in your tablets

The active ingredient (the”ihg”redfenf which”makes fhTs”medicihe work) is ’bisacodyl.'“Each faiblef ” contains 5mg of bisacodyl.

The tablets also contain: lactose, maize starch, cellulose acetate phthalate, diethyl phthalate, sucrose, povidone, magnesium stearate, pregelatinised maize starch, talc, E171 (titanium dioxide) and E104 (quinoline yellow).


What your tablets look like and the contents of the pack

Entrolax are round yellow, sugar-coated tablets.

They are packed in cylindrical plastic containers or cartons containing blister strips.

Both pack types contain 8,10, 20 or 40 tablets.

If you want to know more about your medicine, ask your doctor or pharmacist who can give you More”ihfbr”mafiba


Marketing authorisation holder and manufacturer

Dr. Reddy’s Laboratories (UK) Limited 6 Riverview Road, Beverley East Yorkshire, HU17 OLD


This leaflet was last approved 15.04.2011

Entrolax


PL 08553/0200


4002435 PC 173 150046935