iMedi.co.uk

Bisacodyl Suppositories Bp 10mg

Package leaflet: information for the user


D02985I


Bisacodyl 10mg Suppositories


Bisacodyl


Read all this leaflet carefully before you start using Bisacodyl Suppositories

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

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

•    This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even their symptoms are the same as yours

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

n this leaflet:

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

2.    Before you use Bisacodyl Suppositories.

3.    How to use Bisacodyl Suppositories.

4.    Possible side-effects.

5.    Storing Bisacodyl Suppositories.

6.    Further information.

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

bisacodyl belongs to a group of medicines called axatives. A laxative is a medicine which is used for the treatment of constipation.

3isacodyl Suppositories act as a stimulant axative for short term treatment of constipation and for emptying the bowels before surgery or nvestigational testing procedures.

3isacodyl Suppositories do not help with weight loss.

2.    Before you use Bisacodyl Suppositories.

Do not use Bisacodyl Suppositories if:

•    you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of Bisacodyl Suppositories, listed in section 6 of this leaflet.

•    you have severe abdominal pain with nausea and vomiting

•    you have severe dehydration

•    you have serious abdominal condition called 'ileus' (in the small intestine)

•    you have serious abdominal condition such as appendicitis

•    you have blocked bowel (intestinal obstruction)

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

•    you have cracking of the skin around your back passage (anal fistules)

•    you have inflammation or ulcers around your back passage (ulcerative proctitis)


Taking other medicines

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 Suppositories can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl Suppositories work.

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

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

•    Steroid medicines such as prednisolone Before using Bisacodyl Suppositories, tell your pharmacist or doctor if you are not sure if any of the above applies to you.

Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medication if you are pregnant planning to become pregnant or are breastfeeding.

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.

3. How to use Bisacodyl Suppositories.

Always use Bisacodyl Suppositories exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

To remove a suppository, tear one from the strip along the perforations, then peel the plastic from it by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart.

Bisacodyl Suppositories should not be swallowed

Short-term treatment for constipation Adults (including the elderly) and children over 10 years.

Insert one suppository into the rectum (back passage) or as directed by your doctor.

For preparation of investigational testing procedures and before surgery:

Should only be used under medical supervision.

Adults and children over 10 years

You will normally be given Bisacodyl coated tablets and suppositories by your doctor or hospital prior to you having an investigation procedure or surgery. The usual dose is 2 coated tablets in the morning and 2 coated tablets in the evening and 1 suppository into the rectum (back passage) on the following morning, or as directed by your doctor.

Continued overleaf



The product is not suitable for use by children under 10 years of age.

As with all laxatives, the suppositories should not be used every day for more than 5 days. If you need laxatives every day you should see your doctor.

If you use more Bisacodyl Suppositories than you should

It may be harmful to:

•    take too much of Bisacodyl Suppositories or

•    Take Bisacodyl Suppositories 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 these suppositories are swallowed or if you have exceeded the stated dose of your medicine contact the nearest hospital or your doctor immediately, taking the carton, this leaflet and any suppositories with you.

4. Possible side-effects.

Like all medicines Bisacodyl Suppositories can cause side effects, although not everybody gets them. These include:

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

•    colitis

•    Dehydration

•    Abdominal cramps or pain

•    Nausea

•    Diarrhoea

•    Vomiting

•    Abdominal discomfort

•    Blood in the stools

•    Discomfort inside and around back passage

•    Dizziness

•    Fainting

If any of the side effects get serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5.    Storing Bisacodyl Suppositories.

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

Do not use Bisacodyl Suppositories after the expiry date printed on the carton. The expiry date refers to the last day of that month.

Store in a dry place below 25°C and protected from direct light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information.

What Bisacodyl Suppositories contain

The active substance is 10 milligrams (mg) of Bisacodyl BP

The other ingredient is Witepsol H15 What Bisacodyl Suppositories look like and contents of the pack

The suppositories are sealed in a plastic strip within a cardboard carton in packs of 12 or 150 suppositories.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals Ltd Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

Product Licence Number: PL 00156/0045 Date of approval: April 2015


MARTINDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK


o


100mm Measurement Verification Bar


2985-C


Package leaflet: information for the user


D02984I


Bisacodyl 10mg Suppositories


Bisacodyl


Read all this leaflet carefully before you start using Bisacodyl Suppositories

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

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

•    This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even their symptoms are the same as yours

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

n this leaflet:

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

2.    Before you use Bisacodyl Suppositories.

3.    How to use Bisacodyl Suppositories.

4.    Possible side-effects.

5.    Storing Bisacodyl Suppositories.

6.    Further information.

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

Bisacodyl belongs to a group of medicines called axatives. A laxative is a medicine which is used ,:or the treatment of constipation.

Bisacodyl Suppositories act as a stimulant axative for short term treatment of constipation and for emptying the bowels before surgery or nvestigational testing procedures.

3isacodyl Suppositories do not help with weight loss.

2.    Before you use Bisacodyl Suppositories.

Do not use Bisacodyl Suppositories if:

•    you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of Bisacodyl Suppositories, listed in section 6 of this leaflet.

•    you have severe abdominal pain with nausea and vomiting

•    you have severe dehydration

•    you have serious abdominal condition called 'ileus' (in the small intestine)

•    you have serious abdominal condition such as appendicitis

•    you have blocked bowel (intestinal obstruction)

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

•    you have cracking of the skin around your back passage (anal fistules)

•    you have inflammation or ulcers around your back passage (ulcerative proctitis)


Taking other medicines

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 Suppositories can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl Suppositories work.

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

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

•    Steroid medicines such as prednisolone Before using Bisacodyl Suppositories, tell your pharmacist or doctor if you are not sure if any of the above applies to you.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medication if you are pregnant planning to become pregnant or are breastfeeding.

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.

3. How to use Bisacodyl Suppositories.

Always use Bisacodyl Suppositories exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

To remove a suppository, tear one from the strip along the perforations, then peel the plastic from it by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart.

Bisacodyl Suppositories should not be swallowed

Short-term treatment for constipation Adults (including the elderly) and children over 10 years.

Insert one suppository into the rectum (back passage) or as directed by your doctor.

For preparation of investigational testing procedures and before surgery:

Should only be used under medical supervision.

Adults and children over 10 years

You will normally be given Bisacodyl coated tablets and suppositories by your doctor or hospital prior to you having an investigation procedure or surgery. The usual dose is 2 coated tablets in the morning and 2 coated tablets in the evening and 1 suppository into the rectum (back passage) on the following morning, or as directed by your doctor.

Continued overleaf



The product is not suitable for use by children under 10 years of age.

As with all laxatives, the suppositories should not be used every day for more than 5 days. If you need laxatives every day you should see your doctor.

If you use more Bisacodyl Suppositories than you should

It may be harmful to:

•    take too much of Bisacodyl Suppositories or

•    Take Bisacodyl Suppositories 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 these suppositories are swallowed or if you have exceeded the stated dose of your medicine contact the nearest hospital or your doctor immediately, taking the carton, this leaflet and any suppositories with you.

4. Possible side-effects.

Like all medicines Bisacodyl Suppositories can cause side effects, although not everybody gets them. These include:

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

•    colitis

•    Dehydration

•    Abdominal cramps or pain

•    Nausea

•    Diarrhoea

•    Vomiting

•    Abdominal discomfort

•    Blood in the stools

•    Discomfort inside and around back passage

•    Dizziness

•    Fainting

If any of the side effects get serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5.    Storing Bisacodyl Suppositories.

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

Do not use Bisacodyl Suppositories after the expiry date printed on the carton. The expiry date refers to the last day of that month.

Store in a dry place below 25°C and protected from direct light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information.

What Bisacodyl Suppositories contain

The active substance is 10 milligrams (mg) of Bisacodyl BP

The other ingredient is Witepsol H15

What Bisacodyl Suppositories look like and contents of the pack

The suppositories are sealed in a plastic strip within a cardboard carton in packs of 12 or 150 suppositories.

Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

Manufacturer

Ricesteele Manufacturing Limited,

Cookstown Industrial Estate, Tallaght, Dublin 24

Product Licence Number: PL 00156/0045 Date of approval: April 2015


MARTINDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK


o


100mm Measurement Verification Bar


2984-C