NOTICE
ANSM - Last updated: 11/08/2016
Name of the medicinal product
IMPORTAL YOUNG CHILDREN 2.5 g, oral powder in sachet
Lactitol monohydrate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use 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 of the 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 contact your doctor if you experience no improvement or feel less well after 8 days.
Do not use this medication for children.
What is in this leaflet?
1. What is IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet and in which cases is it used?
2. What should be known before taking IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet?
3. How to take IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet?
4. What are the possible side effects?
5. How to store IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet?
6. Package contents and other information.
1. WHAT IS IMPORTANT YOUNG CHILDREN 2.5 g, oral powder in sachet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ATC code: A06AD12.
HYPOAMMONIEMIOUS OSMOTICAL LAXATIF
(A: digestive system and metabolism)
This medication is indicated for the symptomatic treatment of constipation
2. BEFORE YOU USE IMPORTANT YOUNG CHILDREN 2.5 g oral powder in sachet?
Never use IMPORTAL YOUNG CHILDREN 2.5 g, oral powder in sachet:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· If you have a bowel or colon disease, such as ulcerative colitis, Crohn's disease.
· If you have or suspect occlusion or intestinal perforation
· If you have abdominal pain (stomach pain) of undetermined cause
· In the case of galactosemia, in breast-fed infants and in young children with fructose intolerance (rare hereditary disease).
· In case of pre-existing hydro-electrolyte disorder.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet .
IN THE CONTEXT OF CONSTIPATION NO EXTENDED USE (ABOVE 8 DAYS) WITHOUT MEDICAL ADVICE.
Occasional constipation
It may be related to a recent change in lifestyle (eg travel).
The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation)
It can be linked to two causes:
· a bowel disease that requires management by the physician
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· an increase in the consumption of water and fruit juices
· an increase in physical activities (sports, walking ....)
· rehabilitation of defecation reflex
· sometimes, the addition of sound to food
children
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.
BEFORE USING DO NOT HESITATE TO ASK FOR YOUR DOCTOR OR PHARMACIST.
Precautions for use
The use of this medication is not recommended in patients with fructose intolerance, galactose intolerance, galactosemia or glucose-galactose malabsorption syndrome (rare hereditary diseases).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Other drugs and IMPORTAL YOUNG CHILDREN 2.5 g
Laxatives should not be taken at the same time as other medicines: after taking a medication, wait at least 2 hours before taking the laxative.
IMPORTAL with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine
Due to the absence of absorption, no effect is expected during pregnancy and lactation, so IMPORTAL can be used during pregnancy and lactation.
Sport
Not applicable.
Driving and using machines
Not applicable.
IMPORTAL YOUNG CHILDREN 2.5 g contains:
Not applicable.
3. HOW TO USE IMPORTANT YOUNG CHILDREN 2.5 g oral powder in sachet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is:
· Infants from 0 to 12 months: 1 sachet per day.
· Children from 1 to 6 years: 2 sachets per day, in a single dose.
· Children from 7 to 14 years: 4 sachets per day, in a single dose.
Method and route of administration
Oral use
The bags should be dissolved in a drink or mixed with the food.
Duration of treatment
The duration of treatment varies according to the symptomatology.
If you take more IMPORTAL YOUNG CHILDREN 2.5 g than you should:
Not applicable.
If you forget to take IMPORTAL YOUNG CHILDREN 2.5 g:
Not applicable.
If you stop taking IMPORTAL YOUNG CHILDREN 2.5 g:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
At the beginning of the treatment, IMPORTAL can cause abdominal discomfort, such as flatulence or more rarely, abdominal pain or even in some cases a feeling of bloating. Such discomfort disappears or an improvement is noted after several days of treatment with IMPORTAL.
Due to inter-individual differences, some patients, even when taking the recommended dose, may suffer from diarrhea. Reducing the dose will solve this problem.
Rare side effects (affect 1 to 10 of 10,000 patients):
· Abdominal pain
· bloating
· Diarrhea
· Flatulence
· vomiting
Very rare side effects (affect less than 1 in 10,000 patients):
· nausea,
· Abnormal gastrointestinal sounds,
· Anal Pruritus.
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 IMPORTANT YOUNG CHILDREN 2.5 g, oral powder in sachet?
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 package.
This medication should be stored away from moisture.
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 IMPORTAL YOUNG CHILDREN contain 2.5 g, oral powder in sachet
· The active substance is:
Lactitol monohydrate ................................................ .................................................. 2.5 g
for a bag
What is IMPORTAL YOUNG CHILDREN 2.5 g oral powder in sachet and contents of the pack
This medication is in the form of an oral powder in a 2.5 g sachet.
Boxes of 10 and 20 bags.
Marketing Authorization Holder
AZIENDE CHIMICHE RIUNITE ANGELINI FRANSCESCO ACRAF SpA
VIA AMELIA 70
00181 ROME
ITALY
Marketing Authorization Operator
SERB
40 AVENUE GEORGES V
75008 PARIS
LA FRANCE
Maker
LAMP SAN PROSPERO
VIA DELLA PACE 25 / A
41030 SAN PROSPERO S / S (MODENA)
ITALY
or
FAMAR ORLEANS
5 AVENUE DE CONCYR
45071 ORLEANS CEDEX 2
or
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA
22 VIA VECCHIA DEL PINOCCHIO
60100 ANCONA (AN)
ITALY
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
Not applicable.