What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL42582/0007.

CosmoCol Half 6.9g 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 is 2 to 6 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 in 100 but less than 1 in 10 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:

Malta

ADR Report
Website: www.medicinesauthority.gov.mt/adrportal

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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:

  • 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 ¼ of a glass of water, each sachet gives the equivalent of:

  • Sodium 65 millimoles/litre
  • Chloride 53 millimoles/litre
  • Hydrogen carbonate 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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Stirling Anglian Pharmaceuticals Limited
Hillington Park Innovation Centre
1 Ainslie Road
Hillington
Glasgow
G52 4RU
United Kingdom

Manufacturer:

Klocke Pharma-Service GmbH
Max-Becker Strasse 6
76356 Weingarten
Germany

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:

Ireland Wecol

Iceland CosmoCol

Malta CosmoCol Half

United Kingdom CosmoCol Half

This leaflet was last revised in 12/2015.