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Bisacodyl Laxative Tablets

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Document: leaflet MAH GENERIC_PL 08553-0200 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Bisacodyl 5mg Laxative Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

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

-    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.

-    You must talk to a doctor if you do not feel better or if you feel worse after five days.

What is in this leaflet:

1.    What Bisacodyl 5mg Laxative Tablets are and what they are used for

2.    What you need to know before you take Bisacodyl 5mg Laxative Tablets

3.    How to take Bisacodyl 5mg Laxative Tablets

4.    Possible side effects

5.    How to store Bisacodyl 5mg Laxative Tablets

6.    Contents of the pack and other information

1. What Bisacodyl 5mg Laxative Tablets are and what they are used for

Bisacodyl belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Bisacodyl Laxative Tablets are used for recent or long term constipation. They can also be used to clear the bowels before surgery, labour or radiological investigation. Bisacodyl Laxative Tablets do not help with weight loss.

2. What you need to know before you take Bisacodyl 5mg Laxative Tablets

Do not take Bisacodyl 5 mg Laxative Tablets if you:

•    are allergic (hypersensitive) 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)

•    have severe dehydration

•    have a bowel condition called “ileus” (blockage in the intestine)

•    have a serious abdominal condition such as appendicitis

•    have severe abdominal pain with nausea and vomiting

•    have a blocked bowel (intestinal obstruction)

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

Do not take this medicine if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking this medicine.

Other medicines and Bisacodyl 5mg Laxative Tablets

Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Bisacodyl 5mg Laxative Tablets can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl 5mg Laxative Tablets work.

In particular, tell your doctor or pharmacist if you are taking:

•    Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide)

•    Steroid medicines such as prednisolone.

If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking Bisacodyl 5mg Laxative Tablets.

Pregnancy and breast feeding

Talk to your pharmacist or doctor before taking Bisacodyl 5mg Laxative Tablets if you are pregnant, planning to become pregnant or are breast feeding.

Driving and using machines

Some people may feel dizzy or faint while taking this medicine. If this happens to you, wait until these feelings go away before driving or using machines.

Bisacodyl 5mg Laxative Tablets contain lactose and sucrose

The tablets contain both lactose and sucrose. If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Bisacodyl 5mg Laxative Tablets

If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or are not sure, ask your pharmacist or doctor.

As with all laxatives, Bisacodyl 5mg Laxative Tablets should not be taken every day for more than five days. If you need laxatives every day or if you have abdominal pain which does not go away, you should see your doctor.

Taking this medicine

•    Swallow the tablets whole with water

•    Milk, antacids or proton pump inhibitors (medicines which reduce stomach acid) should not be taken within one hour before or after taking Bisacodyl 5mg Laxative Tablets. This is because they will stop the Bisacodyl 5mg Laxative Tablets from working properly.

How much to take

Adults and children over 10 years

•    Take one or two tablets (5 to 10mg) daily before bedtime

•    If you have not taken Bisacodyl 5mg Laxative Tablets before, start with one tablet and increase to two if necessary

•    When the bowel regularity has returned to normal, the dose can usually be stopped.

Children aged between 4 and 10 years

Bisacodyl 5mg Laxative Tablets should only be given to children between the ages of 4 and 10 if recommended by a doctor. The usual dose for children is:

•    One tablet (5mg) daily before bedtime.

Children under 4 years

Bisacodyl 5mg Laxative Tablets are not recommended for children under 4 years.

If you take more Bisacodyl 5mg Laxative Tablets than you should

It may be harmful to

•    Take too much Bisacodyl Laxative Tablets

•    Take Bisacodyl Laxative Tablets 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 muscles 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 more of this medicine than you should, talk to a doctor or go to a hospital away. Take the medicine pack with you, this is so the doctor knows what you have taken.

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

4. Possible side effects

Like all medicines, Bisacodyl Laxative Tablets can cause side effects although not everybody gets them. The following side effects may happen with this medicine:

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

•    Abdominal discomfort

•    Discomfort inside and around the back passage

•    Dizziness

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

•    Abdominal cramps or pain

•    Diarrhoea

•    Nausea

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 Bisacodyl 5mg Laxative Tablets

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

•    Do not take Bisacodyl 5mg Laxative Tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month

•    Do not store above 25°C

•    Keep the blister within the outer carton

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

6. Contents of the pack and other information

What is in your tablets

The active ingredient (the ingredient which makes this medicine work) is Bisacodyl. Each tablet 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

Bisacodyl Laxative Tablets 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, 28, 30, 50, 56, 60, 84, 100, 250, 500 or 1000 tablets.

Not all pack sizes may be marketed.

If you want to know more about your medicine, ask your doctor or pharmacist who can give you more information.

Marketing authorisation holder    This leaflet was revised in September 2016

and manufacturer    Bisacodyl 5 mg Laxative Tablets PL 08553/0200

Dr. Reddy’s Laboratories (UK) Limited    ©Dr. Reddy’s Laboratories (UK) Ltd

6 Riverview Road, Beverley East Yorkshire, HU17 0LD