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.
CosmoCol Paediatric 6.9g powder for oral solution
⚠ 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 Macrogol 3350, Potassium chloride, Sodium chloride, Sodium hydrogen carbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
CosmoCol Paediatric is a laxative. This medicine is used to treat: chronic constipation in children aged 2-11 years. impaction in children from 5 years. Impaction is persistent constipation, where a large volume of stools cause a blockage of the rectum and / or colon. A medicine with a higher dose is recommended for children over the age of 12. 2.
What you need to know before you take it
e CosmoCol Paediatric
Do not give CosmoCol Paediatric to your child if your doctor has told you that your child: is allergic to Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in this medicine (listed in section 6). has a blockage in their intestine. has a perforated gut wall. has a severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon. Warnings and precautions Talk to your doctor or pharmacist before giving CosmoCol Paediatric to your child if your child has heart or kidney problems, an impaired gag reflex, difficulty swallowing or suffers from heartburn. When taking CosmoCol Paediatric your child should continue to take plenty of fluids. The fluid content of CosmoCol Paediatric should not replace your child's regular liquid intake. Other medicines and CosmoCol Paediatric Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. V019
Stirling Anglian Pharmaceuticals CosmoCol Paediatric
Module 1.3.1
Some medicines, such as medicines for epilepsy, may be less effective during use of CosmoCol Paediatric. When taking large volumes of CosmoCol Paediatric, (e.g. for faecal impaction), other medicines may be flushed through your digestive system. Your child should not take any other medicines by mouth together with CosmoCol Paediatric and for one hour before and for one hour after taking CosmoCol Paediatric. If you need to thicken fluids in order for your child to swallow them safely, CosmoCol Paediatric may counteract the effect of the thickener. Giving CosmoCol Paediatric with food and drink This medicine can be given at any time with or without food or drink. Pregnancy and breast-feeding CosmoCol Paediatric can be used during pregnancy and breastfeeding. Ask your pharmacist or doctor for advice before giving CosmoCol Paediatric. Cosmocol Paediatric contains potassium This medicine contains 0.31 mmol (12.22 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. CosmoCol Paediatric contains sodium This medicine contains 93.86 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 4.69% of the recommended maximum daily dietary intake of sodium for an adult. May need to be taken into consideration by patients on a sodium controlled diet. CosmoCol Paediatric contains sorbitol (E420) This medicine contains 0.38 mg sorbitol (E420) in each sachet. 3.
How to take it
CosmoCol Paediatric
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Chronic Constipation: The recommended dose depends on your child's age and their response to treatment. For children aged 2 to 6 years, start with a dose of 1 sachet each day. For children aged 7 to 11 years, start with a dose of 2 sachets each day. Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. If the dose needs increasing, do this every other day. Normally, no more than 4 sachets are needed each day. Your child does not need to drink the whole dose at once. If your child prefers, half the dose can be drunk in the morning and half in the evening. Faecal impaction: Before your child takes CosmoCol Paediatric for faecal impaction, your doctor must check to confirm that your child has this condition. The recommended dose is: Age 5-11
Day 1 4 sachets
Day 2 6 sachets
Day 3 8 sachets
Day 4 10 V019
Day 5 12
Day 6 12
Day 7 12
Stirling Anglian Pharmaceuticals CosmoCol Paediatric
Module 1.3.1
years sachets sachets sachets sachets On each day, doses can be spread out over 12 hours (e.g. 8am – 8pm). You will know the medicine has worked when your child passes large volumes of stools and / or watery diarrhoea. Once the medicine has worked, treatment can be stopped. To prevent further problems from faecal impaction, your doctor may advise that you continue to give this medicine to your child. You should give the dose for treating chronic constipation. How to mix Tear open the sachet and pour the contents into a glass. Add about 62.5 ml or a quarter of a glass of water to the glass. Stir well until all the powder has dissolved and the solution is clear or slightly hazy, then give it to your child to drink. If your child is taking CosmoCol Paediatric for faecal impaction it may be easier to dissolve 12 sachets in 750 ml of water. Duration of treatment Chronic constipation: Treatment needs to be for a prolonged period of time, at least 6 – 12 months. Faecal impaction: Treatment can be for up to 7 days. If your child takes more CosmoCol Paediatric than they should Your child may develop excessive diarrhoea. If this occurs, stop your child taking CosmoCol Paediatric and make sure they drink plenty of fluids. If you are worried contact your doctor or pharmacist. If you forget to give CosmoCol Paediatric Give the dose as soon as you remember. Do not give a double dose to make up for a forgotten dose. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop giving CosmoCol Paediatric and tell your doctor immediately if your child has:
- a serious allergic reaction which causes difficulty in breathing, breathlessness or swelling of the face, lips, tongue or throat.
- signs of a change in their body's fluid or electrolyte levels (salts levels such as high and low levels of potassium in the blood) such as swelling (mainly in the ankles), shortness of breath, feeling weak, increasingly tired or increased thirst with headache. Other side effects include: Very common side effects (may affect more than 1 in 10 people)
- stomach pains
- rumbling stomach Common side effects (may affect up to 1 in 10 people):
- diarrhoea
- feeling sick or being sick
- pain or discomfort around the bottom If your child is being treated for chronic constipation, diarrhoea will usually improve when the dose is reduced.
V019
Stirling Anglian Pharmaceuticals CosmoCol Paediatric
Module 1.3.1
Uncommon side effects (may affect up to 1 in 100 people)
- feeling bloated
- wind Not known (frequency cannot be estimated from the available data)
- allergic reactions which may cause a skin rash (hives), itching, reddening of the skin or a nettle rash
- indigestion, swollen hands, feet or ankles, headaches, high or low levels of potassium in the blood Reporting of side effects If your child gets 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: 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. 5.
How to store it
CosmoCol Paediatric
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the sachet and carton. The expiry date refers to the last day of the month. Do not store your CosmoCol Paediatric above 25°C. Once you have made up CosmoCol Paediatric in water, if your child cannot drink it straight away, keep it covered and in the fridge (2 – 8°C). Throw away any solution not used within 24 hours. 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 CosmoCol Paediatric contains One sachet of CosmoCol Paediatric contains the following active ingredients: –
Macrogol 3350 6.563 g Sodium chloride 0.1754 g Sodium hydrogen carbonate 0.0893 g Potassium chloride 0.0233 g
When the sachet contents are dissolved in a quarter of a glass (62.5 ml) of water, each sachet gives the equivalent of: –
Sodium Chloride
65 millimoles/litre 53 millimoles/litre
V019
Stirling Anglian Pharmaceuticals CosmoCol Paediatric –
Hydrogen carbonate Potassium
Module 1.3.1
17 millimoles/litre 5.0 millimoles/litre
The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour and lemon lime flavour. The flavourings contain sorbitol (E420) and alpha-tocopherol (E307). This medicinal product contains potassium, sodium and sorbitol (E420). See section 2 'Cosmocol Paediatric contains potassium/sodium/sorbitol (E420)'. What CosmoCol Paediatric looks like and contents of the pack CosmoCol Paediatric is a white powder which comes in a sachet. CosmoCol Paediatric is available in boxes of 30, 40, 50, 60 or 100 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre, 1 Ainslie Road, Hillington, Glasgow G52 4RU, United Kingdom Manufacturer Klocke Pharma-Service GmbH Strassburger Strasse 77 77767 Appenweier Germany For any information about this medicine, please contact the Marketing Authorisation Holder. This leaflet was last revised in August 2024
V019
Frequently asked questions about CosmoCol Paediatric 6.9g powder for oral solution
How do I take CosmoCol Paediatric 6.9g powder for oral solution?
CosmoCol Paediatric 6.9g powder for oral solution comes as oral solution containing 6.9g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in CosmoCol Paediatric 6.9g powder for oral solution?
The active substance in CosmoCol Paediatric 6.9g powder for oral solution is macrogol 3350, potassium chloride, sodium chloride, sodium hydrogen carbonate.
Are there equivalent medicines to CosmoCol Paediatric 6.9g powder for oral solution?
Medicines with the same active substance, strength and form include: CosmoCol Half 6.9g powder for oral solution, Laxido Paediatric Plain 6.9 g, powder for oral solution, Movicol® Paediatric Plain 6.9 g powder for oral solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for CosmoCol Paediatric 6.9g powder for oral solution, 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 CosmoCol Paediatric 6.9g powder for oral solution 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: macrogol 3350, potassium chloride, sodium chloride, sodium hydrogen carbonate
- 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 treatment of chronic constipation in children aged 2 to 11 years.
For the treatment of faecal impaction in children aged 5 years or above. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon.
4.2. Posology and method of administration
Posology
Chronic constipation
Children aged 2 to 6 years: starting dose of 1 sachet daily.
Children aged 7 to 11 years: starting dose of 2 sachets daily.
Adjust dose as required to produce regular, soft stools. Introduce dose increases every other day. Normal maximum dose is 4 sachets daily.
Doses may be reduced or temporarily omitted in cases of loose stools.
Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 - 12 months). However, safety and efficacy of CosmoCol Paediatric has only been proved for a period of up to 3 months. Treatment should be stopped gradually and resume if constipation recurs.
Faecal impaction
A course of treatment with CosmoCol Paediatric takes up to 7 days, as follows:
Daily dose regimen
Number of CosmoCol Paediatric sachets
Age
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
5 – 11 years
4
6
8
10
12
12
12
Take the daily number of sachets as divided doses over a 12 hour period. Stop treatment once disimpaction has occurred. Passage of a large volume of stools indicates disimpaction.
After disimpaction, it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosage for prevention of recurrence follows dosage for chronic constipation; see above).
CosmoCol Paediatric is not recommended for children below 5 years of age for the treatment of faecal impaction, or in children under 2 years of age for the treatment of chronic constipation. For patients of 12 years of age and above, it is recommended to use Cosmocol.
Patients with impaired cardiovascular function
There are no clinical data in this group of patients. Use of CosmoCol Paediatric for the treatment of faecal impaction is not recommended in children with impaired cardiovascular function.
Patients with renal impairment
There are no clinical data in this group of patients. Use of CosmoCol Paediatric for the treatment of faecal impaction is not recommended in children with renal insufficiency.
Method of administration
The contents of each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml of water.
4.3. Contraindications
Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory bowel diseases such as Crohn's disease, ulcerative colitis and toxic megacolon.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
The fluid content of CosmoCol Paediatric when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
Confirm diagnosis of faecal impaction / faecal loading of the rectum by physical or radiological examination of the abdomen and rectum.
Rarely in adults taking macrogol there have been reports of symptoms indicating a shift of fluid and electrolyte balance, e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure. If these symptoms occur, stop treatment with CosmoCol Paediatric immediately. Measure electrolytes and treat any abnormality with appropriate counter measures.
When using high doses of this medicine to treat faecal impaction, use caution in patients with impaired gag reflex, reflux oesophagitis or reduced levels of consciousness.
In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by CosmoCol Paediatric (see section 4.5).
This medicine contains 0.31 mmol (12.22 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicinal product contains 93.86 mg sodium per sachet, equivalent to 4.69% of the WHO recommended maximum daily intake of 2 g sodium for an adult. May need to be taken into consideration by patients on a sodium controlled diet.
This medicine contains 0.38 mg sorbitol (E420) in each sachet.
4.5. Interaction with other medicinal products and other forms of interaction
Medicines in solid-dose form that are taken within one hour of administration of CosmoCol Paediatric may be flushed from the gastro-intestinal tract and not absorbed.
Macrogol raises the solubility of medicines that are soluble in alcohol and relatively insoluble in water.
Absorption of other medicines could be transiently reduced due to an increased rate of gastro-intestinal transit induced by CosmoCol Paediatric (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicines, e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking CosmoCol Paediatric.
CosmoCol Paediatric may result in a potential interactive effect when used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of CosmoCol Paediatric in pregnant women. Studies in animals have shown indirect reproductive toxicity (see Section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.
CosmoCol Paediatric can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated, since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.
CosmoCol Paediatric can be used during breastfeeding.
Fertility
There are no data on the effects of CosmoCol Paediatric on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).
4.7. Effects on ability to drive and use machines
CosmoCol Paediatric has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Reactions related to the gastrointestinal tract occur most commonly.
These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of CosmoCol Paediatric.
In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.
Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for faecal impaction. Vomiting may be resolved if the dose is reduced or delayed.
The frequency of the adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1000); and very rare (<1/10,000); not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse Event
Immune system disorders
Rare
Allergic reactions, including anaphylactic reaction.
Not known
Dyspnoea and skin reaction (see below)
Skin and subcutaneous tissue disorders
Not known
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
Metabolism and nutrition disorders
Not known
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders
Not known
Headache.
Gastrointestinal disorders
Very common
Abdominal pain, borborygmi.
Common
Diarrhoea, vomiting, nausea and anorectal discomfort.
Uncommon
Abdominal distension, flatulence.
Not known
Dyspepsia and peri-anal inflammation.
General disorders and administration site conditions
Not known
Peripheral oedema.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Severe abdominal pain or distension can be treated by nasogastric suction. Extensive fluid loss through diarrhoea or vomiting may require correction of electrolyte imbalance.
💬 Ask about this leaflet
Ask anything about CosmoCol Paediatric 6.9g powder for oral solution. 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.
Medicines containing Macrogol 3350, Potassium chloride, Sodium chloride, Sodium hydrogen carbonate
- CosmoCol Half 6.9g powder for oral solution
- Cosmocol lemon and lime flavour powder for oral solution
- Cosmocol orange flavour powder for oral solution
- Cosmocol orange, lemon and lime flavour powder for oral solution
- CosmoCol Plain powder for oral solution
- Movicol Chocolate 13.7g powder for oral solution
- MOVICOL Liquid Orange flavour, concentrate for oral solution
- MOVICOL Paediatric Chocolate flavour 6.8g powder for oral solution
- MOVICOL Plain 13.7g, powder for oral solution
- MOVICOL Ready to Take oral solution in sachet
- Movicol® Paediatric Plain 6.9 g powder for oral solution