BISACODYL 5 MG TABLETS - patient leaflet, side effects, dosage

Other possible side effects

Common side effects (seen in less than 1 in 10 patients)

• Abdominal pain or cramps
• Nausea
• Diarrhoea

Uncommon side effects (seen in less than 1 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 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:

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), Macrogoi/PEG 3350, Talc, Silica, Methylacrylic acid Copolymer, Sodium Lauryl sulphate, Triethyl citrate, Quinoline yellow aluminium lake (E I 04), Simethicone 30% emulsion, Shellac (E904), Beeswax (E90 I), Camuba wax yellow (E903)

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

Bisacodyl tablets are available in blister packs of 20, 40, 60 and 100 tablets.

Also available in securitainers of 500 or 1000 tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only)

Please be ready to give the following information:

Product name Reference number

Bisacodyl 5mg Tablets PL 49565/0018

This leaflet was last revised in 10/2020.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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. See section 4.

• 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 stimulant laxative used for the short term relief of constipation.

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.

What is constipation?

• A normal and regular bowel movement is important for most people. However this varies from person to person. Some people may experience this more regularly than others. Whatever it is for you, it is best to have a regular pattern of bowl movement. Constipation is an occasional problem for some people and for others it may occurs more often
• It happens when the normal muscle in the bowel (large intestine) slow down. This can mean that materials are not easily removed from the body.

The cause of constipation is often unknown. However, it can be associated with:

• Sudden change in your diet
• A low fibre diet
• Not drinking enough fluid
• A loss of ‘tone’ of the bowel muscle in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of regular exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally “off colour”. It can sometimes cause 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 help prevent constipation:

• Eat a balanced diet including fresh fish and vegetables
• Drink enough water so you do not become dehydrated

Have regular exercise and stay fit

Make time to empty your bowels when your body tells you

• 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

Do not take this medicine if you are under the age of 12 years. If you are unsure, talk to your pharmacy or doctor before taking this medicine

Does this help with weight loss?

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

Over use of laxatives may damage your health by:

• Causing disturbances of electrolyte and minerals 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.
• Laxative dependency occurs from overuse and can cause the colon to stop reacting to usual doses of laxatives so that larger amounts of laxatives may be needed to produce bowel movements

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 follow ing:

• 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 w ith 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, planning to become 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. 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

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. Overuse can be harmful.

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

Children aged 12 years or younger

Bisacodyl must not be used in children under 12 years of age.

Dosage for Short term treatment of constipation:

• Adults (including the elderly) and children 12 years and over: Start with 1 tablet and increase to 2 if necessary.

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