CosmoCol Half 6.9g powder for oral solution

• 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.

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 take CosmoCol Half
4. Possible side effects
5. How to store CosmoCol Half
6. Contents of the pack and other information

• 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).
• have a blockage in your intestine.
• have a perforated gut wall.
• have a severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.

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

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

Follow the special instructions in section 3 if you are taking CosmoCol Half for faecal impaction.

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

Some medicines, such as medicines for epilepsy, may be less effective during use of CosmoCol Half.

You should not take any other medicines by mouth together with CosmoCol Half and for one hour before and for one hour after taking CosmoCol Half.

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

This medicine can be taken at any time with or without food or drink.

CosmoCol Half can be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

CosmoCol Half does not affect your ability to drive or use machines.

This medicine contains 0.31 mmol (12.22 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 93.86 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 4.69 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 0.38 mg sorbitol (E420) in each sachet.

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 3 days.

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 for up to 3 days if required. If you have a heart condition, do not take more than 4 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.

• Tear open the sachet and pour the contents into a glass.
• Add about 62.5 ml or a quarter of a glass of water to the glass.
• Stir well until all the powder has dissolved and the solution is clear or slightly hazy, before drinking.

Chronic constipation:

Treatment usually lasts about 2 weeks. If you need to take CosmoCol Half 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 this medicine for longer than 2 weeks. If you need to take CosmoCol Half for longer, please see your doctor.

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.

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.

Take the dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

• a serious allergic reaction which causes difficulty in breathing, breathlessness or swelling of the face, lips, tongue or throat.
• signs of a change in your body’s fluid or electrolyte levels (salts levels such as high and low levels of potassium in the blood) 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, swollen hands, feet or ankles, headaches.
• 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 mild diarrhoea.

If you are being treated for chronic constipation, diarrhoea will usually improve when the dose is reduced.

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

United Kingdom

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 Half contains the following active ingredients:

Macrogol 3350 06.563 g

Sodium chloride 0.1754 g

Sodium hydrogen carbonate 0.0893 g

Potassium chloride 0.0233 g

When the sachet contents are dissolved in a quarter of a glass (62.5 ml) 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, saccharin sodium, orange flavour and lemon lime flavour. The flavourings contain sorbitol (E420) and alpha-tocopherol (E307).

This medicinal product contains potassium, sodium and sorbitol (E420).

See section 2 ‘CosmoCol Half contains potassium / sodium / sorbitol (E420)’.

CosmoCol Half is a white powder which comes in a sachet.

CosmoCol Half is available in boxes of 30, 40, 50, 60 or 100 sachets.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the Marketing Authorisation Holder.