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 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.
for
CosmoCol Half is a laxative. This medicine is used in adults, adolescents and elderly to treat: chronic constipation. impaction. Impaction is persistent constipation, where a large volume of stools cause a blockage of the rectum and / or colon. It is not recommended for children below 12 years of age. 2.
e CosmoCol Half
Do not take CosmoCol Half if you: are allergic to Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients in this medicine (listed in section 6). have a blockage in your intestine. have a perforated gut wall. have a severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon. Warnings and precautions Talk to your doctor or pharmacist before taking CosmoCol Half if you have heart or kidney problems, an impaired gag reflex, difficulty swallowing or suffer from heartburn. When taking CosmoCol Half you should continue to take plenty of fluids. The fluid content of CosmoCol Half should not replace your regular liquid intake. Heart conditions Follow the special instructions in section 3 if you are taking CosmoCol Half for faecal impaction. Other medicines and CosmoCol Half Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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Stirling Anglian Pharmaceuticals
CosmCol Half 6.9 g
Module 1.3.1
Some medicines, such as medicines for epilepsy, may be less effective during use of CosmoCol Half. You should not take any other medicines by mouth together with CosmoCol Half and for one hour before and for one hour after taking CosmoCol Half. If you need to thicken fluids in order to swallow them safely, CosmoCol Half may counteract the effect of the thickener. Taking CosmoCol Half with food and drink This medicine can be taken at any time with or without food or drink. Pregnancy and breast-feeding CosmoCol Half can be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines CosmoCol Half does not affect your ability to drive or use machines. CosmoCol Half 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 Half 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. CosmoCol Half contains sorbitol (E420) This medicine contains 0.38 mg sorbitol (E420) in each sachet. 3.
CosmoCol Half
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Chronic Constipation: The recommended dose is 2 to 6 sachets daily, taken in divided doses. You should not normally need to take this medicine for more than 3 days. Faecal impaction: Before you take CosmoCol Half for faecal impaction, your doctor must check to confirm that you have this condition. The recommended dose is 16 sachets daily, all of which should be consumed within 6 hours for up to 3 days if required. If you have a heart condition, do not take more than 4 sachets in any 1 hour. To prevent further problems from faecal impaction, your doctor may advise that you continue taking this medicine. You should use 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, before drinking.
V019
Stirling Anglian Pharmaceuticals
CosmCol Half 6.9 g
Module 1.3.1
Duration of treatment Chronic constipation: Treatment usually lasts about 2 weeks. If you need to take CosmoCol Half for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson's disease or multiple sclerosis (MS), or if you take medicines that cause constipation, your doctor may recommend that you take this medicine for longer than 2 weeks. If you need to take CosmoCol Half for longer, please see your doctor. Usually for long-term treatment the dose can be lowered to either 2 or 4 sachets daily. Faecal impaction: Treatment can be for up to 3 days. If you take more CosmoCol Half than you should You may develop excessive diarrhoea. If this occurs, stop taking CosmoCol Half and drink plenty of fluids. If you are worried contact your doctor or pharmacist. If you forget to take CosmoCol Half Take the dose as soon as you remember. Do not take a double dose to make up for a forgotten dose. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking CosmoCol Half and tell your doctor immediately if you have:
V019
Stirling Anglian Pharmaceuticals
5.
CosmCol Half 6.9 g
Module 1.3.1
CosmoCol Half
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 Half above 25°C. Once you have made up CosmoCol Half in water, if you cannot drink it straight away, keep it covered and in the fridge (2 – 8°C). Throw away any solution not used within 6 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.
What CosmoCol Half contains One sachet of CosmoCol Half 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 Hydrogen carbonate Potassium
65 millimoles/litre 53 millimoles/litre 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 Half contains potassium/sodium/sorbitol (E420)'. What CosmoCol Half looks like and contents of the pack CosmoCol Half is a white powder which comes in a sachet. CosmoCol Half 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
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Stirling Anglian Pharmaceuticals
CosmCol Half 6.9 g
Module 1.3.1
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
CosmoCol Half 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.
The active substance in CosmoCol Half 6.9g powder for oral solution is macrogol 3350, potassium chloride, sodium chloride, sodium hydrogen carbonate.
Medicines with the same active substance, strength and form include: CosmoCol Paediatric 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.
This leaflet reproduces the patient information leaflet approved for CosmoCol Half 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.
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.
For the treatment of chronic constipation in adults, adolescents and the elderly.
For resolving faecal impaction in adults, adolescents and the elderly. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon confirmed by physical or radiological examination of the abdomen and rectum.
Posology
Chronic constipation
A course of treatment for constipation does not normally exceed two weeks, although this can be repeated if required.
As for all laxatives. Prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular constipating medication, in particular opioids and antimuscarinics.
Adults, Adolescents and the Elderly
2-6 sachets daily in divided doses, according to individual response. For extended use, dose can be adjusted down to 2-4 sachets daily.
Children (below 12 years old)
Not recommended. Alternative products are available for children.
Faecal impaction
Adults, Adolescents and the Elderly
A course of treatment for faecal impaction does not normally exceed 3 days. Dosage is 16 sachets daily, all of which should be consumed within a 6-hour period.
The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction, it is recommended that the patient follows an appropriate bowel management programme to prevent reimpaction.
Children (below 12 years of age)
Not recommended. Alternative products are available for children.
Patients with impaired cardiovascular function
For the treatment of faecal impaction, the dose should be divided so that no more than four sachets are taken in any one hour.
Patients with renal insufficiency
No dosage change is necessary for the treatment of either constipation or faecal impaction.
Method of administration
The contents of each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. For use in faecal impaction the correct number of sachets can be reconstituted in advance and kept covered and refrigerated for up to 6 hours. For example, dissolved 16 sachets in one litre of water for the treatment of faecal impaction.
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.
The fluid content of CosmoCol Half 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 Half 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 Half (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.
This medicine contains 0.38 mg sorbitol (E420) in each sachet.
Absorption of other medicines could be transiently reduced due to an increased rate of gastro-intestinal transit induced by CosmoCol Half (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 Half.
Macrogol raises the solubility of medicines that are soluble in alcohol and relatively insoluble in water.
CosmoCol Half 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.
Pregnancy
There are limited amount of data from the use of CosmoCol Half 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 Half 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 Half can be used during breastfeeding.
Fertility
There are no data on the effects of CosmoCol Half on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).
CosmoCol Half has no influence on the ability to drive and use machines.
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 Compound Macrogol Oral Powder Sugar Free. Mild diarrhoea usually responds to dose reduction.
The frequency of the adverse effects is not known as it cannot be estimated from the available data.
System Organ Class
Adverse Event
Immune system disorders
Allergic reactions, including anaphylactic reactions, dyspnoea and skin reactions (see below).
Skin and subcutaneous tissue disorders
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
Metabolism and nutrition disorders
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders
Headache.
Gastrointestinal disorders
Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort.
General disorders and administration site conditions
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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 anything about CosmoCol Half 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.
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