• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 5 days treatment

1. What Dulcolax Twelve Plus Pico Liquid is and what it is used for
2. What you need to know before you take Dulcolax Twelve Plus Pico Liquid
3. How to take Dulcolax Twelve Plus Pico Liquid
4. Possible side effects
5. How to store Dulcolax Twelve Plus Pico Liquid
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 fluid
• 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 sodium picosulfate or any of the other ingredients in the product (listed in Section 6: Contents of the pack and other information)
• 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 and/or fever
• You have a blocked bowel (intestinal obstruction)
• You have inflammation of the bowel (small and large intestine)

Do not take Dulcolax Twelve Plus Pico Liquid 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 Dulcolax Twelve Plus Pico Liquid) 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 Pico Liquid can affect the way some other medicines work. Also, some other medicines can affect the way Dulcolax Twelve Plus Pico Liquid works.

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

• Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide)
• Steroid medicines such as prednisolone
• Antibiotics – used for infections

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

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

Dulcolax Twelve Plus Pico Liquid contains 4.8 vol % ethanol (alcohol), i.e. up to 480 mg per 10 ml dose, equivalent to 10.4 ml beer or 4.3 ml of wine per 10 ml dose. This may be harmful for people with a drink problem (alcoholism). This should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as those with liver disease or epilepsy.

Dulcolax Twelve Plus Pico Liquid contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate. These ingredients may cause allergic reactions, possibly delayed. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems.

This medicine contains 1.48 mg sodium (main component of cooking/table salt) in each 5ml, that is to say essentially ‘sodium free.

This product 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 much Dulcolax Twelve Plus Pico Liquid
• Take Dulcolax Twelve Plus Pico Liquid for too long

This is because taking too much 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 heartbeat.
• 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.

• Syncope (feeling faint)
• Allergic reaction
• Skin reactions (rash, itching)

If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems.

Very common side effects (affects 1 in 10 people or more)

• Diarrhoea

Common side effects (affects less than 1 in 10 people)

• Abdominal discomfort, cramps or pain

Uncommon side effects (affects less than 1 in 100 people)

• Nausea
• Vomiting
• Dizziness

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 5 ml contains 5 mg of sodium picosulfate (present as sodium picosulfate monohydrate) as the active ingredient
• The other ingredients are: carmellose sodium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, tutti frutti flavour, saccharin sodium, ethanol, sodium hydroxide (for pH adjustment) and water

Dulcolax Twelve Plus Pico Liquid is a clear, colourless to yellowish or slightly yellowish-brown viscous fruit flavoured solution. It is available in packs of 90 ml, 100 ml, 250 ml and 300 ml.

Not all pack sizes are marketed.