Cosmocol Half 6.9 G Powder For Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
CosmoCol Half
6.9 g, powder for oral solution
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Read all of this leaflet carefully before you take this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you notice any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What CosmoCol Half is and what it is used for
2. What you need to know before you use CosmoCol Half
3. How to use CosmoCol Half
4. Possible side effects
5. How to store CosmoCol Half
6. Contents of the pack and other information
1. What CosmoCol Half is and what it is used for
CosmoCol Half is a laxative.
This medicine is used to:
- treat chronic constipation.
- treat impaction. Impaction is persistent constipation, where a large volume of stools cause a blockage of the rectum and/or colon.
2. What you need to know before you use 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).
- you have a blockage in your intestine.
- you have a perforated gut wall.
- you have a severe inflammatory bowel disease like ulcerative colitis,
Crohn’s disease or toxic megacolon.
Warnings and precautions
If you have heart or kidney problems, an impaired gag reflex or suffer from heart-burn, talk to your doctor before taking CosmoCol Half.
Other medicines and CosmoCol Half
Some medicines, such as medicines for epilepsy, may be less effective during use of CosmoCol Half. Tell your doctor about any other medicines that you are taking.
Do not take other medicines within one hour of taking CosmoCol Half.
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.
CosmoCol Half contains sodium
Each sachet contains 93.87 mg of sodium. To be taken into consideration by patients on a sodium controlled diet.
CosmoCol Half contains sorbitol (E420)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take CosmoCol Half
Always follow your doctor’s instructions when taking this medicine. Check with your doctor or pharmacist if you are not sure.
Chronic Constipation:
The recommended dose is2to6 sachets daily, taken in divided doses. You should not normally need to take this medicine for more than three 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.
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 water until the glass is about a quarter full.
- Stir until all the powder has dissolved and the solution is clear or slightly hazy, before drinking.
Duration of treatment Chronic constipation:
Treatment usually lasts about 2 weeks. 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.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking CosmoCol Half if you have a serious allergic reaction which causes difficulty in breathing or swelling of the face, lips, tongue or throat.
Very common side effects (more than 1 person in 10)
- stomach pains
- rumbling stomach
Common side effects (more than 1 in100 but less than 1in10 people):
- diarrhoea
- feeling sick or being sick
- pain or discomfort around the bottom
If you are being treated for chronic constipation, diarrhoea will usually improve when the dose is reduced.
Uncommon side effects (more than 1 in 1000 but less than 1 in 100 people)
- feeling bloated
- wind
Rare side effects (less than 1 person in 1000)
- allergic reactions, which may include, breathlessness or difficulty in breathing.
Other side effects reported include:
Skin rash (hives), itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches, indigestion, high or low levels of potassium in the
blood.
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:
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Malta |
United Kingdom |
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ADR Report Website: |
Yellow Card Scheme Website: |
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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. Contents of the pack and other information
What CosmoCol Half contains
One sachet of CosmoCol Half contains the following active ingredients:
Sodium hydrogen carbonate 0.0893 g
When the sachet contents are dissolved in quarter of a glass of water, each sachet gives the equivalent of:
Sodium 65 millimoles/litre
Chloride 53 millimoles/litre
Hydrogencarbonate 17 millimoles/litre
Potassium 5.0 millimoles/litre
This medicinal product contains sodium, equivalent to 93.87 mg per sachet. The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour, and lemon lime flavour. The flavorings contain sorbitol (E420) and alpha-tocopherol (E307).
What CosmoCol Half looks like and contents of the pack
CosmoCol Half is a white powder which comes in a sachet. Boxes of 30, 40, 50, 60 or 100 sachets are available.
Manufacturer
Klocke Pharma-Service GmbH Max-Becker Strasse 6 76356 Weingarten Germany
Marketing Authorisation Holder
Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre 1 Ainslie Road Hillington Glasgow G52 4RU United Kingdom
For any information about this medicine, please contact the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of the EEA under the following names:
Wecol CosmoCol CosmoCol Half CosmoCol Half
Ireland Iceland Malta
United Kingdom
This leaflet was last revised in 12/2015