CosmoCol Paediatric

International Non-Proprietary Name (Active Ingredients):
Macrogol, Sodium chloride, Potassium chloride, Sodium bicarbonate

Therapeutic Category:
Gastroenterology, Hepatology → Laxatives → Osmotic agents

Manufacturer:
Klocke Pharma-Service GmbH
Country of Manufacture: Germany

Pharmaceutical Form:
6.9g powder for oral solution, pack of 30 sachets

Dispensing Category:
Group III (Over-the-counter)

1. What CosmoCol Paediatric is and what it is used for
CosmoCol Paediatric is a laxative.
It is used for:

Treating chronic constipation in children aged 2 to 11 years.

Treating faecal impaction in children from 5 years of age. Faecal impaction is chronic constipation where large quantities of stool block the rectum and/or colon.

High doses are recommended for children over 12 years of age.

2. What you need to know before giving CosmoCol Paediatric
Do not give CosmoCol Paediatric if:

Your child is allergic to Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride, or any of the other ingredients (see section 6).

Your child has an intestinal blockage.

The intestinal wall is perforated.

Your child suffers from severe inflammatory bowel diseases such as ulcerative colitis, Crohn’s disease, or toxic megacolon.

Warnings and Precautions
Consult a doctor before giving CosmoCol Paediatric if your child has heart or kidney problems, impaired gag reflex, or suffers from heartburn.

Other medicines and CosmoCol Paediatric
Some medicines, like those used for epilepsy, may be less effective during treatment with CosmoCol Paediatric. Tell your doctor about all other medications your child is taking.
Do not give any other medications to your child within one hour of taking CosmoCol Paediatric.

Food and Drink
CosmoCol Paediatric can be taken with or without food and drink.

Pregnancy and Breastfeeding
CosmoCol Paediatric is safe to use during pregnancy and breastfeeding.

Sodium Content
Each sachet contains 93.87mg of sodium. This should be considered if your child is on a sodium-controlled diet.

Sorbitol Content (E420)
If your child has an intolerance to certain sugars, consult your doctor before use.

3. How to use CosmoCol Paediatric
Always follow your doctor’s instructions. If unsure, consult your doctor.

Chronic Constipation:
Dosage is based on the child’s age and response to treatment.

Children 2–6 years: Start with 1 sachet per day.

Children 7–11 years: Start with 2 sachets per day.

Your doctor may increase the number of sachets until stools are softened. Dose increases should occur daily if needed. Usually, more than 4 sachets per day are not required.

The total dose does not need to be taken at once — it can be split, e.g., half in the morning and half in the evening.

Long-term treatment may be needed for at least 6–12 months.

Faecal Impaction:
A doctor must confirm faecal impaction before starting treatment.
Duration is approximately 7 days.
Recommended dosage for children aged 5–11:

Day Number of Sachets
Day 1    4 sachets
Day 2    6 sachets
Day 3    8 sachets
Day 4    10 sachets
Day 5    12 sachets
Day 6    12 sachets
Day 7    12 sachets

The daily dose may be divided over 12 hours (e.g., 8am – 8pm).
If your child starts passing a large amount of stool or has watery diarrhoea, it means the medication is working. You can stop treatment at that point.

To prevent further problems from faecal impaction, your doctor might recommend continuing with the chronic constipation dosage.

How to Prepare the Solution:

Open the sachet and pour contents into a glass.

Add water up to a quarter of the glass.

Stir until fully dissolved. The solution will be clear or slightly cloudy. Then, give it to your child.

Treatment Duration:

Chronic Constipation: At least 6–12 months

Faecal Impaction: Approximately 7 days

Overdose:
Excessive intake may cause severe diarrhoea. Stop the treatment and give plenty of fluids. Contact your doctor or pharmacist if needed.

Missed Dose:
Give the dose as soon as you remember.

4. Possible Side Effects
Like all medicines, CosmoCol Paediatric can cause side effects, although not everyone gets them.

Seek immediate medical attention and stop treatment if your child experiences a serious allergic reaction, such as difficulty breathing or swelling of the face, lips, tongue, or throat.

Very common side effects (more than 1 in 10 patients):

Abdominal pain

Bloating or rumbling in the abdomen

Common side effects (more than 1 in 100 but less than 1 in 10):

Diarrhoea

Nausea or vomiting

Pain or discomfort in the anal area

In cases of chronic constipation, diarrhoea usually stops after reducing the dose.

Uncommon side effects (more than 1 in 1,000 but less than 1 in 100):

Bloating

Flatulence

Rare side effects (less than 1 in 1,000):

Allergic reactions, including shortness of breath or difficulty breathing

Other reported side effects:
Skin rash, itching, redness or hives, swelling of hands, feet, or ankles, headache, indigestion, high or low potassium levels in the blood.

Reporting Side Effects:
If your child experiences any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly via:

Malta Medicines Authority: www.medicinesauthority.gov.mt/adrportal

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