Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Citric acid, anhydrous, Magnesium oxide light, Sodium picosulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Picolax® is a powder that contains sodium picosulfate, a laxative that works by increasing the activity of the intestine. Picolax® also contains magnesium citrate, another type of laxative that works by holding back fluid in the bowel to provide a wash-out effect. Picolax® is used in adults, adolescents and children from the age of 1 year to clear the bowel before an x-ray examination, endoscopy or surgery when judged clinical necessary.
e Picolax® Do not take Picolax® if you:
If you have an early time of the day procedure, you might need to take the second dose during night and possible sleep disturbance may occur. The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and mineral imbalance in the body. Other medicines and Picolax® Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor if you are taking:
Picolax® Always take Picolax® exactly as your doctor has told you. Check with your doctor if you are not sure. Picolax® powder should be dissolved in a cup of cold water (approximately 150ml). Stir for 2-3 minutes and then drink the solution. Sometimes the solution becomes warm as Picolax® dissolves. If this happens, wait until it cools sufficiently before drinking it. Adults (including elderly) and children 9 and over The recommended dose is one sachet taken 10 to 18 hours before your procedure and one sachet taken 4 to 6 hours before your procedure. The first sachet taken, should be followed by at least five 250 ml drinks of clear liquids (not only water) spread over several hours and the second sachet taken, should be followed by at least three 250 ml drinks of clear liquids (not only water) spread over several hours. You may drink clear liquids (not only water) until 2 hours before your procedure. Do not drink only water. Children (under 9 years) For the timing of dosing in children, refer to the instructions given for adults A measuring spoon is provided with the product. From 1 and below 2 years: first dose is 1 spoonful, second dose is 1 spoonful From 2 and below 4 years: first dose is 2 spoonfuls, second dose is 2 spoonfuls From 4 and below 9 years: first dose is 1 sachet (taken as described under 'adults'), second dose is 2 spoonfuls 9 years and above: adult dose.
XXXXXXXXXX
To measure the dose with the measuring spoon:
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately in case of the following side effects as these might be severe:
If any of the side effects gets serious contact your doctor or nurse. If you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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.
Picolax® Keep this medicine out of sight and reach of children. Store in the original packaging in order to protect from moisture. Single use only. Discard any unused contents. Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. 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.
What Picolax® contains The active substances of 1 sachet are 10 mg sodium picosulfate, 3.5 g magnesium oxide light and 12 g citric acid. The other ingredients are potassium hydrogen carbonate, saccharin sodium which includes acacia gum, lactose, ascorbic acid, butylated hydroxyanisole. What Picolax® looks like and contents of the pack Your medicine is called Picolax®. It is a powder for oral solution. It is supplied in packs of 2 sachets, 100 sachets (50 packs, each containing 2 sachets), or 300 sachets (150 packs, each containing 2 sachets). A measuring spoon is included in the pack, in order to ensure correct dosing for children. The spoon is used to measure 4 g of powder (4.75 ml). You should only use the spoon if you are dosing a child under 9 years. Not all pack sizes may be marketed. Marketing Authorisation Holder Ferring Pharmaceuticals Limited, Drayton Hall, Church Road, West Drayton, UB7 7PS, UK. Manufacturers Ferring GmbH, Wittland 11, D-24109 Kiel, Germany This medicinal product is authorised in the Member States of EEA under the following names Picolax® United Kingdom Picoprep® Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands. Norway, Portugal, Romania, Slovak Republic, Spain, Sweden Feb 2025
Rare (affects less than 1 in 1,000 but more than 1 in 10,000 patients):
Date: 20 Mar 2025 Title
PICOLAX powd for oral sol 10mg sachet 20x 16.1g GB x 18 March 2025 PIL
Perigord No 876080 Proof No 01
N-MS N°/ Version 3003/03 Colours P. Pro Black.
Barcode No N/A Approving Country GB Dimensions 147 x 413 mm
The active substance in Picolax is citric acid, anhydrous, magnesium oxide light, sodium picosulfate.
This leaflet reproduces the patient information leaflet approved for Picolax, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
PICOLAX is indicated in adults, adolescents and children from the age of 1 year:
• To clean the bowel prior to X-ray examination or endoscopy.
• To clean the bowel prior to surgery when judged clinically necessary (see section 4.4 regarding open colorectal surgery).
Posology
Adults (including elderly):
The two PICOLAX sachets (see Method of Administration section below for reconstitution guidance) are taken dependent on the planned time of the procedure:
• The first reconstituted sachet is taken 10 to 18 hours before the procedure, followed by at least 5 x 250 ml drinks of clear liquids (not only water), spread over several hours
• The second reconstituted sachet is taken 4 to 6 hours before the procedure, followed by at least 3 x 250 ml drinks of clear liquids (not only water), spread over several hours
• Clear liquids (not only water) may be consumed until 2 hours before the time of the procedure
Special populations
Limited data is available for treatment of patients with low body weight (BMI less than 18). The rehydration regimen above has not been tested in such individuals and therefore monitoring of their hydration status is required and the regimen may need to be altered appropriately (see section 4.4).
Paediatric population:
A measuring spoon is provided with the product. It is recommended that a narrow flat edge, for example the back of a knife blade, is drawn across the top of a heaped measuring spoon to obtain a flat surface of the measure. This will give ¼ of a sachet (4 g powder) per spoonful.
For the timing of dosing in children, refer to the instructions given for adults
from 1 up to 2 years: first dose is 1 spoonful, second dose is 1 spoonful
from 2 up to 4 years: first dose is 2 spoonfuls, second dose is 2 spoonfuls
from 4 up to 9 years: first dose is 1 sachet, second dose is 2 spoonfuls
9 years and above: adult dose
Maintaining hydration in children is very important. Guidelines for treating dehydration in children should be followed to ensure adequate hydration during treatment with PICOLAX.
Method of administration
Route of administration: Oral
A low residue diet is recommended on the day prior to the procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration, it is important to follow the liquid intake recommendation as advocated together with the PICOLAX dosing whilst the effects of PICOLAX persist (see section 4.2, Posology). Apart from the liquid intake together with the treatment regimen (PICOLAX + additional liquids), a normal, thirst driven intake of clear liquids is recommended.
Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Liquid intake should not be restricted to only drinking water.
Directions for reconstitution in adults (including elderly):
Reconstitute the contents of one sachet in a cup of water (approximately 150 ml). Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.
Directions for reconstitution in children:
Reconstitute the required amount of powder in a cup containing approximately 50 ml water per spoonful. Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.
Discard the remaining contents of the sachet.
For directions on reconstitution of the full sachet for children of 4-9 years, refer to the instructions given for adults.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- Congestive cardiac failure
- Gastric retention
- Gastro-intestinal ulceration
- Toxic colitis
- Toxic megacolon
- Ileus
- Nausea and vomiting
- Acute surgical abdominal conditions such as acute appendicitis
- Known or suspected gastro-intestinal obstruction or perforation.
- Severe dehydration
- Rhabdomyolysis
- Hypermagnesaemia
- Active inflammatory bowel disease
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.
An insufficient or excessive oral intake of water and electrolytes could create clinically significant abnormalities, particularly in less fit patients. In this regard patients with low body weight, children, the elderly, debilitated individuals and patients at risk of hypokalaemia or hyponatremia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hypokalaemia or hyponatremia.
Drinking only water to replace the fluid losses may lead to electrolyte imbalance, which may in severe cases lead to complications such as seizures and coma. In rare cases, PICOLAX can cause severe or life-threatening electrolyte problems or impaired renal function in fragile or debilitated patients.
Few episodes of severe hypermagnesaemia have been reported following the use of PICOLAX. In the majority of the cases this occurred in association with other factors (e.g. renal impairment or concomitant medication).
Care should also be taken in patients with recent gastro-intestinal surgery, renal impairment, heart disease or inflammatory bowel disease.
Use with caution in patients on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium (see 4.5).
PICOLAX may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see 4.5 and 4.8).
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
For an early time of the day procedure it may be required to take the second dose during the night and possible sleep disturbance may occur.
This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains lactose as a component of the flavour. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.
PICOLAX should not be used as a routine laxative.
As a purgative, PICOLAX increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may be decreased during the treatment period (see 4.4). Medicines with the potential to chelate with magnesium (e.g. tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine) should be taken not later than 2 hours before and within 6 hours following administration of PICOLAX.
The efficacy of PICOLAX is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when PICOLAX is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.
Pregnancy
For PICOLAX no clinical data on exposed pregnancy are available.
Studies in animals have shown reproductive toxicity (see section 5.3). As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of PICOLAX during pregnancy.
Breastfeeding
There is no experience with the use of PICOLAX in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with PICOLAX may be considered for females who are breastfeeding.
Fertility
There are no data on the effect of PICOLAX on fertility in humans.
Male and female rat fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg (see section 5.3).
Not relevant.
The most common adverse reactions are vomiting, nausea, abdominal pain and headache. Hyponatraemia is rare but is the most commonly reported serious adverse reaction.
Adverse reactions from spontaneous reports are presented by frequency category based on incidence in clinical trials when known. Frequency from spontaneous reports for adverse reactions never observed in clinical trials is based on an algorithm as recommended in the European Commission SmPC guideline, 2009, rev 2.
MedDRA Organ Class
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Immune system disorder
Anaphylactic reaction, hypersensitivity
Metabolism and nutrition disorders
Hypermagnesaemia
Hypokalaemia
Hyponatraemia
Nervous system disorders
Headache
Epilepsy, generalised tonic-clonic seizurea, seizure, Loss of or depressed level of consciousness, syncope, dizziness, Confusional state including disorientation
Presyncope
Gastrointestinal disorders
Vomiting, nausea, abdominal pain
Diarrhoeab
Ileal ulcerc, anal incontinence, proctalgia
Skin and subcutaneous tissue disorders
Rash (including erythematous rash and maculo-papular rash, urticaria, purpura)
a In epileptic patients, there have been isolated reports of seizure/generalised tonic-clonic seizure without associated hyponatraemia.
b Isolated cases of severe diarrhoea have been reported post-marketing.c Isolated cases of mild reversible aphthoid ileal ulcers have been reported.
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, website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose would lead to profuse diarrhoea. Treatment is by general supportive measures and correction of fluid and electrolyte balance.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Citric acid, anhydrous, Magnesium oxide light, Sodium picosulfate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Citric acid, anhydrous, Magnesium oxide light, Sodium picosulfate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Picolax. 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.
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