Bisacodyl suppositories BP 10 mg – patient leaflet, side effects, dosage

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

Bisacodyl is used for the short-term relief of occasional constipation. Bisacodyl belongs to a group of medicines known as stimulant laxatives, which increase bowel movements. This medicine does not help with weight loss. What is constipation?

Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like

for you, it is best that your bowel movement has a regular

pattern.

• Constipation is an occasional problem for some people.
• For others, it may happen more often
• It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be

associated with:

• Sudden change of diet
• A diet with not enough fibre
• Not drinking enough fluids
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally “off colour”. Sometimes it causes headaches.

It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation happening:

• Eat a balanced diet including fresh fruit and vegetables
• Drink enough water so that you do not become dehydrated
• Keep up your exercise and stay fit
• Make time to empty your bowels when your body tells you

2. What you need to know 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)

Do not take this medicine if any of the above applies to you. Do not use in children under the age of 12 years. If you are not sure, talk to your pharmacist or doctor before taking this medicine.

Does this help with weight loss?

Stimulant laxatives Bisacodyl do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Overuse of laxatives must be avoided as it may harm the intestinal function.

Other medicines and Bisacodyl Suppositories

Please tell your pharmacist or doctor if you are taking or, have recently taken or might take 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
• Other laxative medicines

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 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.

3. How to use Bisacodyl Suppositories

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

Bisacodyl Suppositories should not be swallowed

1. 1.

   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.

2. 2.

   Lie on one side and pull your knees up towards your

   chest. Keep one leg drawn up more than the other

3. 3.

   Use your first finger (index finger) or middle finger to

   push in the suppository

4. 4.

   Gently push the suppository as far as possible into

   your back passage, pointed end first

5. 5.

   Once it is as far as it will go, push it side-ways to make

   sure it touches the wall of the bowel

6. 6.

   Lower your legs to a comfortable position whilst the

   suppository is retained in place

7. 7. Keep the suppository inside you for at least 30 minutes If you feel the suppository might come out straight away:

You may not have put it in high enough. Push it in as far as possible. Try to keep it in for 30 minutes, even if you feel like you urgently need to go to the toilet. This is how long it takes to work.

How much to use

Adults and children 12 years and over:

Put one 10 mg suppository into the back passage for immediate effect. Only use one suppository per day. This product should not be used in children or adolescents under the age of 12 years.

Length of treatment

These suppositories 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.

Overuse can be harmful

If you use more Bisacodyl Suppositories than you should

It may be harmful to:

• Use too many 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. If you experience any of the following side effects, please stop taking the medicines and see your doctor straight away:

• 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 via the Yellow Card Scheme, website www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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.
• Do not store above 25°C and protect from direct light.
• Keep the blister within the outer carton.
• 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. Contents of the pack and other 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 suppositories. Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd

Bampton Road, Harold Hill, Romford

RM3 8UG, United Kingdom

Manufacturer

Phoenix Healthcare Limited,

Cookstown Industrial Estate, Tallaght, Dublin 24 Product Licence Number: PL 00156/0045

Date of revision: May 2022

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

D05767

Bisacodyl 10

mg

Suppositories

Bis

aco

dyl

Continued overleaf

100mm Measurement Verification Bar 5767-A