CosmoCol Plain 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 Plain carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days.
• 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:

1. What CosmoCol Plain is and what it is used for
2. What you need to know before you take CosmoCol Plain
3. How to take CosmoCol Plain
4. Possible side effects
5. How to store CosmoCol Plain
6. Contents of the pack and other information

Do not take CosmoCol Plain

• if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in CosmoCol Plain
• if you have a perforated gut (bowel) wall
• if you have a blockage in your intestine (gut obstruction, ileus)
• 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.

Other medicines and CosmoCol Plain

Some medicines, e.g. anti-epileptics, may not work as effectively during use with CosmoCol Plain powder for oral solution.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

CosmoCol Plain with food and drink

CosmoCol Plain 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 Plain.

Driving and using machines

CosmoCol Plain has no effect on the ability to drive or use machinery.

CosmoCol Plain contains potassium

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.

CosmoCol Plain contains sodium

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 561mg 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 Plain on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

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 Plain 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.

If you take more CosmoCol Plain than you should

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 CosmoCol Plain

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.

If you stop taking CosmoCol Plain

To get the most benefit from CosmoCol Plain, 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 experience any of the following side effects, stop taking CosmoCol Plain and see your doctor immediately:

• signs of an allergy, such as a rash, itching, shortness of breath or difficulty in breathing.
• 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:

• abdominal (stomach) pain
• mild diarrhoea (when starting to take CosmoCol Plain, this usually stops if you reduce the number of sachets you take)
• nausea (feeling sick)
• vomiting
• swelling of your abdomen (feeling bloated)
• stomach rumbling
• flatulence (wind)
• 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: 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.

What CosmoCol Plain looks like and contents of the pack

CosmoCol Plain is a white powder.

Each sachet contains 13.8 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100 (2x50) sachets.

Not all of these pack sizes are marketed.

Marketing Authorisation Holder

Manufacturer