Patient leaflet - COSMOCOL ORANGE LEMON AND LIME FLAVOUR POWDER FOR ORAL SOLUTION
CosmoCol
Powder for oral solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. However, you still need to take CosmoCol Orange Lemon & Lime Flavour carefully to get the best results from it. – Keep this leaflet. You may need to read it again.
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– Ask your pharmacist if you need more information or advice.
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– You must contact a doctor if your symptoms worsen or do not improve after 14 days.
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– If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
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1. What CosmoCol Orange Lemon & Lime Flavour is and what it is used for
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2. What you need to know before you take CosmoCol Orange Lemon & Lime Flavour
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3. How to take CosmoCol Orange Lemon & Lime Flavour
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4. Possible side effects
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5. How to store CosmoCol Orange Lemon & Lime Flavour
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6. Contents of the pack and other information
CosmoCol Orange Lemon & Lime Flavour is a laxative used for the treatment of long term (chronic) constipation and faecal impaction (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. Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes (salts) help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation.
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– if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in CosmoCol Orange Lemon & Lime Flavour
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– if you have a perforated gut (bowel) wall
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– if you have a blockage in your intestine (gut obstruction, ileus)
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– if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon
If any of these applies to you, please talk to your doctor or pharmacist for further advice.
Some medicines, e.g. anti-epileptics, may not work as effectively during use with CosmoCol Orange Lemon & Lime Flavour.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
CosmoCol Orange Lemon & Lime Flavour can be taken at any time with or without food or drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding talk to your doctor before taking CosmoCol Orange Lemon & Lime Flavour.
Driving and using machines
CosmoCol Orange Lemon & Lime Flavour has no effect on the ability to drive or use machinery.
This medicine contains 0.63 mmol (25 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains 187 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 9.35 % of the recommended maximum daily dietary intake of sodium for an adult.
When used to treat chronic constipation, the maximum recommended daily dose of this medicinal product contains 561 mg sodium (found in table salt). This is equivalent to 28.05 % of the adult recommended maximum daily dietary intake for sodium.
Talk to your pharmacist or doctor if you need CosmoCol Orange Lemon & Lime Flavour on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.
This medicine contains 0.76 mg sorbitol (E420) in each sachet.
Treatment of chronic constipation in adults, children (aged 12 years and above) and the elderly:
The recommended dose for constipation is one sachet taken one to three times daily.
Duration of treatment
This course of treatment for constipation should not normally last longer than 2 weeks.
Treatment of faecal impaction in adults, children (aged 12 years and above) and the elderly:
Before you take CosmoCol Orange Lemon & Lime Flavour for faecal impaction, your doctor must check to confirm that you have this condition.
The recommended dose is 8 sachets daily, all of which should be consumed within 6 hours.
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.
Duration of treatment
The course of treatment for faecal impaction should be stopped when a large volume of stools is passed and does not normally last longer than 3 days.
How to mix
Open the sachet and pour the contents into a glass. Add about 125 ml or a quarter pint of water to the glass. Stir well until the powder has dissolved and then drink it.
This can cause severe pain and swelling in your abdomen (stomach), or vomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.
If you forget to take a dose, take it as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose.
To get the most benefit from CosmoCol Orange Lemon & Lime Flavour, always finish the course of treatment according to the directions in this package leaflet. This will make sure that your constipation is cleared, otherwise the symptoms you are suffering from may persist.
You must contact a doctor if your symptoms worsen or do not improve after 14 days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, CosmoCol Orange Lemon & Lime Flavour can cause side effects, although not everybody gets them.
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– signs of an allergy, such as a rash, itching, shortness of breath or difficulty in breathing.
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– signs of a change in your body’s fluid or electrolyte levels (salts levels), such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache
The following side effects are also possible:
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– abdominal (stomach) pain
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– mild diarrhoea (when starting to take CosmoCol Orange Lemon & Lime Flavour, this usually stops if you reduce the number of sachets you take)
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– nausea (feeling sick)
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– vomiting
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– swelling of your abdomen (feeling bloated)
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– stomach rumbling
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– flatulence (wind)
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– soreness of the anus (bottom)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
6. contents of the pack and other information
The active substances are:
Each sachet contains:
The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (Orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol) and lemon lime flavour (Lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica).
This medicinal product contains potassium, sodium and sorbitol (E420).
See section 2 ‘CosmoCol Orange Lemon & Lime Flavour contains potassium/sodium/sorbitol (E420)’.
CosmoCol Orange Lemon & Lime Flavour is a white powder.
| Each sachet contains 13.8 g of powder and is packed in cartons containing 20, 30, 50, 60 (2×30) and 100 (2×50) sachets. Not all of these pack sizes are marketed. | ||
| Marketing Authorisation Holder | Manufacturer | |
| Stirling Anglian Pharmaceuticals Ltd | Klocke Pharma-Service GmbH | |
| Hillington Park Innovation Centre | Strassburger Strasse 77 | |
| 1 Ainslie Road Hillington Park Glasgow G52 4RU United Kingdom | 77767 Appenweier Germany Hermes Pharma Ges.m.b.H. Schwimmschulweg 1a | |
9400 Wolfsberg
Austria
This leaflet was last revised in September 2020
71395 E 60008627