NOTICE
ANSM - Last updated: 05/07/2017
Name of the medicinal product
MOVICOL CHILDREN, powder for oral solution in sachet-dose
Macrogol 3350, sodium bicarbonate, potassium chloride, sodium chloride
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is MOVICOL CHILD, powder for oral solution in a sachet-dose and in which cases it is used?
2. What should I know before taking MOVICOL CHILDREN powder for oral solution in a sachet-dose?
3. How to take MOVICOL CHILDREN, powder for oral solution in a sachet-dose?
4. What are the possible side effects?
5. How to store MOVICOL CHILDREN, powder for oral solution in a sachet-dose?
6. Package contents and other information.
1. WHAT IS MOVICOL CHILDREN, powder for oral solution in a sachet-dose AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ATC code: A06AD65.
This medication belongs to the class of osmotic laxatives.
This medication is indicated in children from 2 years of age in case of faecal impaction.
Fecal impaction is defined as an accumulation of fecal matter in the rectum with no evacuation for several days.
2. BEFORE YOU TAKE MOVICOL CHILDREN, powder for oral solution in a sachet-dose?
Never take MOVICOL CHILDREN, powder for oral solution in sachet-dose:
· if you or your child are allergic (hypersensitive) to active substances (eg macrogol) or any of the other ingredients of MOVICOL CHILDREN listed in section 6.
· if you or your child are suffering from severe inflammatory bowel or colon disease.
· if you or your child have abdominal pain of indeterminate cause or if you may be suffering from intestinal occlusion (stopping material in a part of the intestine).
Warnings and Precautions
Talk to your doctor or pharmacist before taking MOVICOL CHILDREN, powder for oral solution in a sachet-dose.
The liquid contained in MOVICOL CHILDREN after reconstitution with water does not replace the regular water intake. Sufficient water intake must be maintained.
· Your doctor may decide to discontinue your treatment if you have signs of a change in the amount of mineral salts and water in your body (such as dehydration or heart failure).
· MOVICOL CHILDREN may decrease absorption of other medicines (see Other Medicines and MOVICOL CHILDREN powder for oral solution in sachet-dose).
· One of the active ingredients of this drug is macrogol (also called polyethylene glycol). Very rare allergic manifestations (rash on the skin, itching, swelling) have been reported with products containing polyethylene glycol. If any of these signs occur, contact a doctor immediately.
· In case of diet without salt or low in salt, take into account the sodium content: each sachet contains 95 mg of sodium.
· This medicine contains 13.19 mg of potassium per sachet, tell your doctor if you have kidney failure.
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
The efficacy and safety of MOVICOL CHILDREN in the treatment of fecal matter have not been studied.
children
Not applicable.
Other medicines and MOVICOL CHILDREN, powder for oral solution in sachet-dose
MOVICOL CHILDREN can decrease the absorption of other medicines taken simultaneously, for example medicines treating epilepsy, which can decrease their effectiveness. If you are taking a treatment for epilepsy, talk to your doctor before taking MOVICOL CHILDREN.
Usual oral treatments should not be taken within 1 hour of ingesting MOVICOL CHILDREN.
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
MOVICOL CHILDREN, powder for oral solution in sachet-dose with food and beverages
Not applicable.
Pregnancy and breast feeding
Although the treatment is for children aged 2 to 15 years of age, the following data are provided for information purposes only.
MOVICOL CHILDREN can be used during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
MOVICOL CHILDREN does not influence the ability to drive or use machines.
MOVICOL CHILDREN, powder for oral solution in sachet-dose contains potassium.
3. HOW TO TAKE MOVICOL CHILDREN, powder for oral solution in sachet-dose?
Dosage
The dosage should be adjusted according to the age of the child.
The recommended dose is divided into 2 daily intakes at the rate of:
· From 2 to 3 years: 4 to 5 sachets-doses per day (2 sachets-morning doses, 2 or 3 sachets-doses evening)
· From 4 to 8 years: 6 to 8 sachets-doses per day (3 or 4 sachets-doses morning and evening, in 2 doses)
· From 9 to 15 years: 8 to 10 sachets-doses per day (4 or 5 sachets-doses morning and evening, in 2 doses)
Always take the dose recommended by your doctor. In case of uncertainty consult your doctor or pharmacist.
Administration mode
Oral use.
Each sachet-dose must be opened and its contents dissolved in half a glass of water (62.5 ml). Activate the dissolution of the powder by mixing with a clean spoon until the solution obtained is clear. Get the solution to your child. The reconstituted solution can be stored for 24 hours in a refrigerated container.
Duration of treatment
Treatment will be continued until a satisfactory evacuation of accumulated feces (an average of 6 days of treatment) with a maximum duration of 7 days is obtained.
If your child took more MOVICOL CHILDREN, powder for oral solution in a sachet-dose than it should have
Diarrhea may occur. This usually disappears 24 to 48 hours after discontinuation or after dose reduction. In case of severe fluid loss by vomiting and / or diarrhea, stomach pain, consult your doctor.
If your child has not taken MOVICOL CHILDREN, powder for oral solution in sachet-dose
Do not give a double dose to make up for the missed dose.
Effects that may occur when treatment with MOVICOL CHILD Powder for oral solution in sachet-dose is discontinued
A risk of recurrence of faecal impaction exists when the treatment is discontinued. This risk should be evaluated with your doctor.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Diarrhea,
· Abdominal pain, nausea, vomiting, bloating,
· Very rare cases of allergic manifestations such as rash, itching, urticaria, respiratory disorders and edema or exceptionally anaphylactic reactions,
· redness,
· Headache,
· Hyperkalemia or hypokalaemia,
· Edema (swelling) of the limbs, especially the lower limbs.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MOVICOL CHILDREN, powder for oral solution in sachet-dose?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
After reconstitution: the reconstituted solution may be stored for up to 24 hours at a temperature between + 2 ° C and + 8 ° C (in a refrigerator) in a closed container.
Any solution not used within 24 hours after reconstitution should be discarded.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MOVICOL ENFANTS contains, powder for oral solution in sachet-dose
· The active substances are:
Macrogol 3350 ................................................ .................................................. 6.5630 g
Sodium bicarbonate............................................... .................................................. .. 0.0893 g
Potassium chloride............................................... .................................................. .. 0.0233 g
Sodium Chloride ............................................... .................................................. ....... 0.1754 g
For a sachet-dose.
· The other components are: acesulfame potassium (E950); lemon-lime flavor.
What is MOVICOL ENFANTS, powder for oral solution in sachet-dose and contents of the pack
This medication is in the form of a powder for oral solution in a sachet-dose.
Box of 20, 30 or 100 sachets-doses.
Marketing Authorization Holder
NORGINE BV
HOGEHILWEG 7
1101 CA AMSTERDAM ZO
NETHERLANDS
Marketing Authorization Operator
NORGINE SAS
2 RUE JACQUES DAGUERRE
92500 RUEIL-MALMAISON
Maker
NORGINE LIMITED
NEW ROAD
TIR-Y-BERTH HENGOED
MID GLAMORGAN
WALES CF82 8SJ
UK
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
HOW TO REDUCE THE RISK OF RECOVERY?
To minimize the risk of recurrence, treatment includes:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· rehabilitation of the defecation reflex;
· sometimes, adding sound to the diet.
In all cases and if you have any doubts, do not hesitate to seek advice from your doctor or pharmacist.