CosmoCol Plain powder for oral solution

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.

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

• are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6)
• have a perforated gut (bowel) wall
• have a blockage in your intestine (gut obstruction, ileus)
• have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon

If any of these apply to you, please talk to your doctor or pharmacist for further advice.

Talk to your doctor or pharmacist before using CosmoCol Plain if you have heart or kidney problems, an impaired gag reflex, difficulty swallowing or suffer from heartburn.

When taking CosmoCol Plain you should continue to take plenty of fluids. The fluid content of CosmoCol Plain should not replace your regular liquid intake.

Follow the special instructions in section 3 if you have a heart condition and are taking CosmoCol Plain for faecal impaction.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If you need to thicken fluids in order to swallow them safely, CosmoCol Plain may counteract the effect of the thickener.

CosmoCol Plain can be taken at any time with or without food or drink.

CosmoCol Plain can be taken during pregnancy and whilst breastfeeding.

If you are pregnant, trying to become pregnant or breastfeeding, ask your pharmacist or doctor for advice before taking CosmoCol Plain.

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

The recommended dose for constipation is 1 sachet taken 1 – 3 times daily.

Duration of treatment

This course of treatment for constipation should not normally last longer than 2 weeks. If you need to take CosmoCol Plain 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 CosmoCol Plain for longer than 2 weeks. If you need to take CosmoCol Plain for longer, please see your doctor. Usually for long-term treatment the dose can be lowered to either 1 or 2 sachets a day.

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 for up to 3 days if required. If you have a heart condition, do not take more than 2 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.

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 ( ¼ pint ) of water to the glass. Stir well until the powder has dissolved and then drink it. If you are taking CosmoCol Plain for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

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 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.

• a serious allergic reaction which causes difficulty in breathing or swelling of the face, lips, tongue or throat.
• signs of a change in your body’s fluid or electrolyte levels such as swelling (mainly in the ankles), shortness of breath, feeling weak, increasingly tired or increased thirst with headache.

• Allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash.
• Sometimes you may have indigestion, stomach ache or rumbles. You may also feel bloated, suffer from wind, feel sick or vomit, may also experience soreness of the anus (bottom) and may have mild diarrhoea when starting to take CosmoCol Plain. These side effects generally get better if you reduce the amount of CosmoCol Plain you take.

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.

One sachet of CosmoCol Plain contains the following active ingredients:

Macrogol 3350 13.125 g

Sodium chloride 0.3507 g

Sodium hydrogen carbonate 0.1785 g

Potassium chloride 0.0466 g

When the sachet contents are dissolved in 125 ml ( ¼ pint ) 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

The other ingredients are colloidal anhydrous silica.

This medicinal product contains potassium and sodium. See section 2 ‘CosmoCol Plain contains potassium / sodium’.

CosmoCol Plain is a white powder.

Each sachet contains 13.8 g of powder and is packed in cartons containing 20, 30, 50, 60 (2x30) and 100 (2x50) sachets. Not all pack sizes may be marketed.