Dulcolax Twelve Plus 5 mg Gastro-resistant Tablets (P)

• 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 Dulcolax Twelve Plus Tablets are and what they are used for
2. What you need to know before you take Dulcolax Twelve Plus Tablets
3. How to take Dulcolax Twelve Plus Tablets
4. Possible side effects
5. How to store Dulcolax Twelve Plus Tablets
6. Contents of the pack and other information

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

• 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 and sucrose)
• 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.

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 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.

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

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

Talk to your pharmacist or doctor before taking Dulcolax Twelve Plus Tablets if you are pregnant, planning to become pregnant or are breast feeding.

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.

The tablets contain a small amount of lactose and sucrose in each tablet. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use this medicine. If you have an intolerance to some sugars, contact your doctor before taking this medicine.

These tablets 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.

It may be harmful to

• Take too many Dulcolax Twelve Plus Tablets or
• Take Dulcolax Twelve Plus 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• Each tablet contains 5 mg of bisacodyl as the active ingredient
• The other ingredients are: lactose monohydrate, maize starch, sucrose (approximately 21 mg per tablet), glycerol, magnesium stearate, talc (E553b), acacia (powdered), white beeswax (E901), shellac (E904), carnauba wax (E903), titanium dioxide (E171), yellow iron oxide (E172), methacrylic acid-methyl methacrylate copolymer, castor oil and macrogol 6000

Dulcolax Twelve Plus Tablets are yellow.

They are packed in cartons containing blister strips.

The cartons contain 40, 60 or 100 tablets.

Not all pack sizes may be marketed.