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- Movicol® Bambini Senza Aroma
For the treatment of
CHRONIC CONSTIPATION AND FAECALOMA IN CHILDREN
- Laxative in 6.9 g sachet
- Does not contain colorants, flavours or sweeteners
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ProductProduct
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IngredientsIngredients
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Instruction for useInstruction for use
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Reporting reactionsReporting reactions
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Other productsOther products
MOVICOL, NORGINE and the sail logo are registered trademarks of Norgine Group companies. Authorization of 11/11/2022. IT-GE-MOV-2200016
PRODUCT
MOVICOL® BAMBINI SENZA AROMA
MOVICOL® Bambini Senza Aroma, 6.9 g sachet, powder for oral solution is a laxative for the treatment of chronic constipation in children from 1 to 11 years and for the treatment of severe constipation (called fecaloma) in children from 5 to 11 years.
It is a non prescription medicine (SOP) which can be delivered by the pharmacist only. Listen to your pharmacist.
It is a medicine, please carefully read the leaflet.
Packaging: 20 sachets
MOVICOL, NORGINE and the sail logo are registered trademarks of Norgine Group companies.
Authorization of 11/11/2022. IT-GE-MOV-2200016
INGREDIENTS
Each 6.9 g sachet of MOVICOL® Bambini Senza Aroma, powder for oral solution, contains the following:
|
Macrogol 3350 |
6.563 g |
|
Sodium Chloride |
0.1754 g |
|
Sodium hydrogen carbonate |
0.0893 g |
|
Potassium Chloride |
0.0251 g |
MOVICOL® Bambini Senza Aroma does not contain colorants, flavours or sweeteners.
When dissolved in a quarter glass of water (62.5 ml), each sachet provides the equivalent of:
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Sodium
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65 millimoles/litre
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Chloride |
53 millimoles/litre |
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Potassium |
5.4 millimoles/litre |
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Bicarbonate |
17 millimoles/litre |
INSTRUCTIONS FOR USE
Chronic constipation
The dose of MOVICOL® Bambini Senza Aroma depends on the age of the child and response to treatment.- As a starting dose, in children aged from 1 to 6 years, should be given 1 sachet (= 1 dose) per day.
- Children aged from 7 to 11 years should be given 2 sachets per day.
Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. If it is necessary to increase dosage, this should be done every other day. This normally does not require more than 4 sachets per day. It is not necessary to take all of the drink at one time, if the child prefers it, half the drink can be taken in the morning and half in the evening.
Faecaloma
Before your child takes MOVICOL® Bambini Senza Aroma for the treatment of faecaloma, it should be confirmed medically that your child has this condition. A course of treatment with MOVICOL® Bambini Senza Aroma is as follows:
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Age: 5-11 years |
Number of MOVICOL® Bambini Senza Aroma |
|---|---|
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Day 1 |
4 |
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Day 2 |
6 |
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Day 3 |
8 |
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Day 4 |
10 |
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Day 5 |
12 |
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Day 6 |
12 |
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Day 7 |
12 |
The daily number of sachets should be taken in divided doses, all consumed over a 12-hours period (e.g. 8:00am – 8:00pm). Each sachet should be dissolved in 62.5 ml (1/4 of a glass) of water. Treatment can be stopped when the medicine has worked. This is shown by your child passing large volumes of stool and/or watery diarrhoea.
REPORTING OF ADVERSE DRUG REACTIONS
Reporting of adverse drug reactions can be done by doctors, healthcare professionals, citizens, according to the instructions indicated on Aifa website www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Forms for adverse drug reactions reporting (for healthcare professional or citizen) are available in section “Modulistica” www.aifa.gov.it/moduli-segnalazione-reazioni-avverse.
The reporting forms can be electronically filled and sent by e-mail or fax to the Pharmacovigilance contact point of your facility (www.aifa.gov.it/responsabili-farmacovigilanza), otherwise it is possible to report directly online through the website www.vigifarmaco.it following the guided procedure.
Alternatively, the report can be notified to the Marketing Authorization Holder of the drug suspected of having caused the adverse drug reaction. Doctors, healthcare professionals or citizens willing to report an adverse drug reaction can write to the e-mail address farmacovigilanza.italia@norgine.com
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MOVICOL® Bambini gusto Cioccolato
MOVICOL, NORGINE and the sail logo are registered trademarks of Norgine Group companies.
Authorization of 11/11/2022. IT-GE-MOV-2200016
