Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Dulcolax Twelve Plus Pico Liquid
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium picosulfate monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
Possible side effects
Like all medicines, Dulcolax Twelve Plus Pico Liquid 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:
Uncommon side effects (affects less than 1 in 100 people)
- Nausea
- Vomiting
- Dizziness Reporting of side effects 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.
5. How to store Dulcolax Twelve Plus Pico Liquid
- Keep this medicine out of the sight and reach of children
- Do not take Dulcolax Twelve Plus Pico Liquid after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month
- Keep the bottle within the outer carton
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. Contents of the pack and other information What Dulcolax Twelve Plus Pico Liquid contains
- 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 What Dulcolax Twelve Plus Pico Liquid looks like and contents of the pack 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. The Marketing Authorisation is held by: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Tel: 0800 035 2525 Email: [email protected] Dulcolax Twelve Plus Pico Liquid is manufactured at: Istituto De Angeli S.r.l. Località Prulli n. 103/c 50066 Reggello (FI), Italy Revision date: April 2024 ®Registered trade mark For electronic version of this leaflet scan the QR code. This paper leaflet might not be the latest version and thus different to the electronic leaflet which is the last updated version available
Isolated events (some side effects are so rare that it is not known how many people may be affected)
- 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. 439142/GB/5
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Contents of the pack and other information
1. What Dulcolax Twelve Plus Pico Liquid is and what it is used for Dulcolax Twelve Plus Pico Liquid is used for the relief of short-term occasional constipation. Dulcolax Twelve Plus Pico Liquid contains sodium picosulfate and 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 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
2. What you need to know before you take Dulcolax Twelve Plus Pico Liquid Do not take Dulcolax Twelve Plus Pico Liquid if:
- 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. Does this help with weight loss? 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. Other medicines and Dulcolax Twelve Plus Pico Liquid 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
File information GMID code:
769369 / 769370
Plant PM code:
10048774
Second Plant PM code:
439142/GB/5
Version of artwork:
V2
PM type:
PI
Market:
GB
Format:
160 x 305 mm folded at 36
Issue date of artwork:
12/Mar/2024
Print colors:
Black
Number of print colors:
1
Used font:
Bliss 2
Min. font size:
8 pt
p2e number:
932001-U03
PITCH CODE
Technical colors Diecut-Legendcase
Free area
Glue points
Additional Requirements of Packaging Site
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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.
Very common side effects (affects 1 in 10 people or more)
- Diarrhoea
Pregnancy and breast-feeding 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.
Common side effects (affects less than 1 in 10 people)
- Abdominal discomfort, cramps or pain
Important information about some of the ingredients in Dulcolax Twelve Plus Pico Liquid 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.
3. How to take Dulcolax Twelve Plus Pico Liquid 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. Adults and children over 12 years: one to two 5 ml spoonfuls at night. This should not be used in children and adolescents under the age of 12 years. If you have not taken Dulcolax Twelve Plus Pico Liquid before, start with one 5 ml spoonful and increase to two if necessary. When your bowel regularity has returned to normal, the dose can usually be stopped. Length of treatment 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. If you take more Dulcolax Twelve Plus Pico Liquid than you should 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. If you have any questions on the use of this product, ask your pharmacist or doctor.
Frequently asked questions about Dulcolax Twelve Plus Pico Liquid
What is the active substance in Dulcolax Twelve Plus Pico Liquid?
The active substance in Dulcolax Twelve Plus Pico Liquid is sodium picosulfate monohydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Dulcolax Twelve Plus Pico Liquid, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Dulcolax Twelve Plus Pico Liquid without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium picosulfate monohydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the short-term relief of occasional constipation.
4.2. Posology and method of administration
For oral administration
The following dosages are recommended to be taken at night to produce evacuation the following morning.
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools.
The maximum recommended daily dose should not be exceeded.
Adults and children over 12 years of age:
One to two 5 ml spoonfuls (5 - 10 mg) per day.
Should not be used in children and adolescents under the age of 12 years.
In the management of constipation, once regularity has restarted dosage should be reduced and can usually be stopped.
Diluent: Can be diluted with purified water.
4.3. Contraindications
DULCOLAX PICO is contraindicated in patients with:
• Ileus or intestinal obstruction
• Severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting
• Acute inflammatory bowel diseases
• Severe dehydration
• Known hypersensitivity to sodium picosulfate or any other component of the product
• Rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4).
4.4. Special warnings and precautions for use
Should not be used in children and adolescents under the age of 12 years.
As with all laxatives, sodium picosulfate should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.
Long-term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.
Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) sodium picosulfate should be discontinued and only be restarted under medical supervision.
Stimulant laxatives (including sodium picosulfate) do not help with weight loss.
If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted.
Dizziness and/or syncope have been reported in patients who have taken Dulcolax. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of sodium picosulfate itself.
Dulcolax® Pico Liquid contains 4.8 vol % ethanol (alcohol) i.e. up to 480 mg per dose, equivalent to 10.4 ml beer, 4.3 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Dulcolax® Pico Liquid contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
The leaflet will state:
“Before you take this medicine” section
Does this help with weight loss?
Stimulant laxatives (including sodium picosulfate) 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.
The label will state:
Front of pack:
• Does not help with weight loss.
• Overuse can be harmful.
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX are taken.
Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.
Concurrent administration of antibiotics may reduce the laxative action of this product.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.
Lactation
Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.
Nevertheless, as with all medicines, DULCOLAX PICO should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.
Fertility
No studies on the effect on human fertility have been conducted.
Non-clinical studies did not reveal any effect on fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that due to a vasovagal response (for example, due to abdominal spasm), dizziness and /or syncope may be experienced. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
4.8. Undesirable effects
Adverse events have been ranked under headings of frequency using the following convention:
Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000); not known – cannot be estimated from the available data.
Immune system disorders
Not known: Hypersensitivity*
Nervous system disorders
Uncommon: Dizziness
Not known: Syncope*
Dizziness and syncope occurring after taking sodium picosulfate appear to be consistent with a vasovagal response (for example, due to abdominal spasm, defaecation).
Gastrointestinal disorders
Very common: Diarrhoea
Common: Abdominal discomfort, abdominal pain, abdominal cramps.
Uncommon: Nausea, vomiting.
Skin and subcutaneous tissue disorders
Not known: Skin reactions* such as angioedema*, drug eruption*, rash*, pruritus*.
*This adverse event has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon, but might be lower. A precise frequency estimation is not possible as the adverse event did not occur in a clinical trial database of 1020 patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.
4.9. Overdose
Symptoms: If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.
Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of DULCOLAX considerably higher than those recommended for the routine management of constipation.
Laxatives when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.
Therapy: Within a short time of ingestion, absorption can be minimised or prevented by inducing vomiting or by gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.
Administration of antispasmodics may be of some value.
💬 Ask about this leaflet
Ask anything about Dulcolax Twelve Plus Pico Liquid. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.