MOVICOL*FLAVOURLESS BB 20SACHETS

MOVICOL Paediatric Plain 6.9 g, powder for oral solution
Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride

What it is and what it is used for
The name of this medicine is Movicol Paediatric Plain, 6.9 g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 1 to 11 years and for the treatment of severe constipation (called faecal impaction) in children aged 5 to 11 years.

Movicol Paediatric Plain helps your child to have adequate bowel movements even if constipation has been prolonged.

What you need to know before taking this medicine
Do not give Movicol Paediatric Plain if your doctor has told you that your child has:
- a bowel blockage (intestinal obstruction, ileus)
- a perforation of the intestinal wall
- a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease or toxic megacolon
- an allergy to the active ingredients of Movicol Paediatric Plain (listed in section 6)

If your child has heart or kidney problems, an impaired pharyngeal reflex or reflux oesophagitis (heartburn caused by stomach contents returning into the oesophagus), ask your doctor for advice before giving Movicol Paediatric Plain.

Warnings and precautions
When taking Movicol Paediatric Plain, you should continue to drink plenty of fluids.
The fluid content of Movicol does not replace regular fluid intake.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately and stop taking Movicol Paediatric Plain if your child:
• has a severe allergic reaction that causes difficulty breathing, or swelling of the face, lips, tongue or throat.

Very common side effects (more than 1 in 10 people):
• stomach ache
• stomach rumbling

Common side effects (more than 1 in 100 but less than 1 in 10 people):
• diarrhoea
• vomiting (feeling sick)
• nausea (feeling unwell)
• anal irritation (feeling of discomfort around the anus)
If your child is being treated for chronic constipation, diarrhoea usually improves by reducing the dose.

Uncommon side effects (more than 1 in 1000 but less than 1 in 100 people):
• bloated stomach
• flatulence

Rare side effects (less than 1 in 1000 people):
• allergic reactions, which may include shortness of breath or difficulty breathing.

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.