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

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Patient leaflet - BISACODYL 5 MG GASTRO-RESISTANT TABLETS

5. how to store bisacodyl tablets

  • Keep out of the 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 of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment

6. contents of the pack and other informationwhat bisacodyl tablets containthe other ingredients in bisacodyl tablets are: lactose, maize starch, liquid paraffin, magnesium stearate, coating: polyvinyl alcohol-part hydrolysed, titanium dioxide (e171), macrogol/peg 3350, talc, silica, methylacrylic acid copolymer, sodium lauryl sulphate, triethyl citrate, quinoline yellow aluminium lake (e104), simethicone 30% emulsion, shellac (e904), beeswax (e901), carnuba 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:

Key Pharmaceuticals Ltd.

Galen House, 83 High Street,

Somersham, Cambridgeshire, PE28 3JB, UK

Manufacturer:

Medreich PLC,

Warwick House,

Plane Tree Crescent,

Feltham, TW13 7HF, UK

This leaflet was last revised in September 2020.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisacodyl 5 mg Gastro-resistant Tablets

bisacodyl

Your medicine is called Bisacodyl 5mg Gastro-resistant Tablets, but it will be referred to as Bisacodyl Tablets throughout this leaflet.

Read all of this leaflet carefully before 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
  • 1. What Bisacodyl Tablets are and what they are used for

  • 2. What you need to know before you take Bisacodyl Tablets

  • 3. How to take Bisacodyl Tablets

  • 4. Possible side effects

  • 5. How to store Bisacodyl Tablets

  • 6. Contents of the pack and other information

  • 1. What Bisacodyl Tablets are and what they are used for

Bisacodyl Tablets are used for the short-term relief of occasional constipation. Bisacodyl Tablets contain bisacodyl and belong 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 take bisacodyl tablets

Do not take Bisacodyl Tablets if:

  • You are allergic (hypersensitive) to bisacodyl or any of the other ingredients in the product (listed in Section 6: Contents of the pack and other information)
  • You are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose)
  • You have severe dehydration
  • You have a bowel condition called “ileus” (blockage in the intestine)
  • You have a serious abdominal condition such as appendicitis
  • You have severe abdominal pain with nausea and vomiting
  • You have a blocked bowel (intestinal obstruction)
  • You have inflammation of the bowel (small or large intestine)

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 (including 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 function 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 Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bisacodyl Tablets can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl Tablets work.

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

  • Water tablets (diuretics) such as bendroflumethiazide or furosemide (frusemide)
  • Steroid medicines such as prednisolone
  • Other laxative medicines

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

Pregnancy and breast feeding

Talk to your pharmacist or doctor before taking Bisacodyl 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 Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take bisacodyl tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your pharmacist if you are not sure.

For constipation: Adults (including the elderly) and children over 12 years: 1 to 2 tablets at night

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  • Swallow the tablets whole with water. The tablets should not be chewed or crushed
  • Milk, antacids or proton pump inhibitors (medicines which reduce stomach acid) should not be taken within one hour before or after taking Bisacodyl Tablets. This is because they will stop the Bisacodyl Tablets from working properly

If you have not taken Bisacodyl Tablets before, start with one tablet and increase to two if necessary. When your bowel regularity has returned to normal, the dose can usually be stopped.

Length of treatment

These tablets should not be taken 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 take more Bisacodyl Tablets than you should

It may be harmful to:

  • Take too many Bisacodyl Tablets or
  • Take Bisacodyl Tablets for too long

This is because taking too many for too long may lead to:

  • 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 ‘hypokalaemia’). 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 straight 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 Tablets 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:

Rare side effects (may affect up to 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 (may affect up to 1 in 100 people)

  • Blood in the stools
  • Vomiting
  • Abdominal discomfort
  • Discomfort inside and around the back passage
  • Dizziness

Common side effects (may affect up to 1 in 10 people)

  • Abdominal cramps or pain
  • Diarrhoea
  • Nausea

Bisacodyl Tablets - 5 mg - S/L Leaflet Dimension: 185 x 285 mm