Cosmocol Paediatric 6.9 G Powder For Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
CosmoCol Paediatric
6.9 g, powder for oral solution
Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
Read all of this leaflet carefully before you give this medicine to your child 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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your childs.
- If you or your child 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 Paediatric is and what it is used for
2. What you need to know before you give CosmoCol Paediatric
3. How to use CosmoCol Paediatric
4. Possible side effects
5. How to store CosmoCol Paediatric
6. Contents of the pack and other information
1. What CosmoCol Paediatric is and what it is used for
CosmoCol Paediatric is a laxative.
This medicine is used to:
- treat chronic constipation in children aged 2-11 years.
- treat impaction in children from 5 years. Impaction is persistent constipation, where a large volume of stools cause a blockage of the rectum and/or colon.
A medicine with a higher dose is recommended for children over the age of 12.
2. What you need to know before you give CosmoCol Paediatric
Do not give CosmoCol Paediatric to your child if your doctor has told you that:
- your child is allergic to Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in this medicine (listed in section 6).
- your child has a blockage in their intestine.
- your child has a perforated gut wall.
- your child has a severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.
Warnings and precautions
If your child has heart or kidney problems, an impaired gag reflex or suffers from heart-burn, talkto your doctor before giving CosmoCol Paediatric.
Other medicines and CosmoCol Paediatric
Some medicines, such as medicines for epilepsy, may be less effective during use of CosmoCol Paediatric. Tell your doctor about any other medicines that your child is taking.
Do not give your child other medicines within one hour of giving CosmoCol Paediatric.
Giving CosmoCol Paediatric with food and drink
This medicine can be given at any time with or without food or drink.
Pregnancy and breast-feeding
CosmoCol Paediatric can be used during pregnancy and breastfeeding. CosmoCol Paediatric contains sodium
Each sachet contains 93.87 mg of sodium. To be taken into consideration by patients on a sodium controlled diet.
CosmoCol Paediatric contains sorbitol (E420)
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine to your child.
3. How to give CosmoCol Paediatric
Always follow your doctor’s instructions when giving this medicine to your child. Check with your doctor or pharmacist if you are not sure.
Chronic Constipation:
The recommended dose depends on your child’s age and their response to
treatment.
- For children aged 2to6 years, start with a dose of 1 sachet each day.
- For children aged 7to11 years, start with a dose of 2 sachets each day.
Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. If the dose needs increasing, do this every other day. Normally, no more than 4 sachets are needed each day.
Your child does not need to drink the whole dose at once. If your child prefers, half the dose can be drunk in the morning and half in the evening.
Your child will need treatment over a long period of time, at least 6-12 months.
Faecal impaction:
Before your child takes CosmoCol Paediatric for faecal impaction, your doctor must check to confirm that your child has this condition.
A treatment course for faecal impaction lasts up to 7 days. The recommended dose is:
|
Age |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
|
5 - 11 |
4 |
6 |
8 |
10 |
12 |
12 |
12 |
|
years |
sachets |
sachets |
sachets |
sachets |
sachets |
sachets |
sachets |
On each day, doses can be spread out over 12 hours (e.g. 8am-8pm). You will know the medicine has worked when your child passes large volumes of stools and/or watery diarrhoea. Once the medicine has worked, treatment can be stopped.
To prevent further problems from faecal impaction, your doctor may advise that you continue to give this medicine to your child. You should give the dose fortreating 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, then give it to your child to drink.
Duration of treatment Chronic constipation:
Treatment needs to be for a prolonged period, at least 6-12 months.
Faecal impaction:
Treatment can be for up to 7 days.
If your child takes more CosmoCol Paediatric than they should
Your child may develop excessive diarrhoea. If this occurs, stop your child taking CosmoCol Paediatric and make sure they drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to give CosmoCol Paediatric
Give 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 giving CosmoCol Paediatric if your child has 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 your child is 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 your child gets 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 |
|
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 Paediatric
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 Paediatric above 25°C.
Once you have made up CosmoCol Paediatric in water, if your child cannot drink it straight away, keep it covered and in the fridge (2-8°C). Throw away any solution not used within 24 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 Paediatric contains
One sachet of CosmoCol Paediatric 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 Paediatric looks like and contents of the pack
CosmoCol Paediatric 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:
Ireland Wecol Paediatric
Iceland CosmoCol Paediatric
Malta CosmoCol Paediatric
United Kingdom CosmoCol Paediatric
This leaflet was last revised in 12/2015