NOTICE
ANSM - Last updated: 31/07/2017
Name of the medicinal product
GAVISCON INFANTS, oral suspension in bottle
Sodium alginate, sodium bicarbonate
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 your child has 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 contact your doctor if you do not see improvement after 7 days of treatment.
· Do not use this medication for children.
What is in this leaflet?
1. What is GAVISCON NOURRISSONS, oral suspension in vial and in which cases is it used?
2. What should I know before using GAVISCON INFANTS, oral suspension in a vial?
3. How to use GAVISCON INFANTS, oral suspension in vial?
4. What are the possible side effects?
5. How to store GAVISCON INFANTS, oral suspension in vial?
6. Package contents and other information.
1. WHAT GAVISCON INFANTS, oral suspension in a vial AND WHAT CASES IS IT USED FOR?
Other drugs for peptic ulcer and gastroesophageal reflux disease (GERD) - ATC code: A02BX
This drug is indicated for the treatment of gastroesophageal reflux disease, which results in regurgitation and episodes of vomiting after meals.
You should contact your doctor if you do not see improvement after 7 days of treatment.
2. BEFORE YOU USE GAVISCON INFANTS, drinkable suspension in a vial?
Never give GAVISCON INFANTS, oral suspension in vial:
· if your child is allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6, as skin irritation and difficulty breathing have been reported.
· if your child has known or suspected renal dysfunction because the sodium content may increase the risk of hypernatremia.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Take special care with GAVISCON INFANTS, oral suspension in bottle:
DO NOT LEAVE THIS MEDICINE TO THE REACH AND SIGHT OF CHILDREN
· This medicine contains sodium. This medicine contains 14.5 mg per ml. To be taken into account in patients controlling their sodium dietary intake.
· This medicine contains calcium: 16 mg of calcium carbonate per ml. Particular attention should be paid to the treatment of children with hypercalcemia, nephrocalcinosis or recurrent renal calcium lithiasis.
· This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions.
· Ask for medical advice before simultaneous use with thickeners. Observe the use of the thickener and the dosages indicated for each product.
Consult your doctor if there is a significant change in the child's food transit, for example, diarrhea or constipation.
In addition to the use of this medication, it is recommended to follow certain hygiene-dietetic rules:
· thicken the diet,
· avoid chocolate porridge,
· split meals,
· avoid over-tightening the layers,
· avoid family smoking,
· remove orange juice and soft drinks.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Other drugs and GAVISCON INFANTS, oral suspension in vial
As a precaution, it is advisable to space the 2-hour catch between GAVISCON INFANTS and another medication.
Inform your doctor or pharmacist if your child is taking or has recently taken or could take any other medication.
GAVISCON INFANTS, drinkable suspension in bottle with food and drinks
Simultaneous use with thickeners or infant formulas containing thickeners may lead to excessive thickening of the contents of the stomach.
Take medical advice before concomitant administration of thickened or thickened milk and Gaviscon Infants.
Pregnancy and breast feeding
This medication is for infants and children (up to 6 years).
However, if used in exceptional circumstances in women of childbearing age, this medication may be prescribed during pregnancy and lactation, if necessary.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Driving and using machines
Not applicable.
GAVISCON INFANTS, oral suspension in vial contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium.
3. HOW TO USE GAVISCON INFANTS, oral suspension in vial?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Your doctor will prescribe this medication according to the weight of your child and its number of meals, as an indication:
· from 0 to 1 month: 1 ml after each of the 6 meals
· 1 to 2 months: 1.5 ml after each of the 5 meals
· 2 to 4 months: 2 ml after each of the 5 meals
· 4 to 18 months: 2.5 ml after each of the 4 meals
· after 18 months: 5 ml after each of the 4 meals
This medication should be taken orally, not mixed with milk or food. Shake the bottle well before use.
The pipette is graduated in ml. The dose taken corresponds to the dose administered after each meal. The first manipulation of the pipette does not make it possible to restore the desired dose. The fact of raising and lowering the pipette before taking the first sample makes it possible to avoid this phenomenon.
Disassemble the plunger from the syringe body. Rinse and dry the pipette thoroughly after each use. Once dry, reassemble the plunger in the body of the syringe.
This medication should be taken after meals.
If you have given more GAVISCON INFANTS, oral suspension in a bottle than you should have
Excessive use may result in the formation of a mass in the stomach (bezoar).
If you have given your child more GAVISCON INFANTS, drinkable suspension in a bottle than you should, consult your doctor or pharmacist immediately.
If you forget to give a dose of GAVISCON INFANTS, oral suspension in bottle
Do not give a double dose to make up for the missed dose.
If you stop taking GAVISCON INFANTS, drinkable suspension in vial:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
· gastrointestinal reaction: constipation, nausea, diarrhea, intestinal obstruction, flatulence, abdominal distension;
· in case of prolonged use, risk of an increase in calcium in the blood;
· allergic reactions (urticaria, itching, redness, difficulty breathing).
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 GAVISCON INFANTS, oral suspension in vial?
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 after Exp.
This medication should be stored at a temperature not exceeding 25 ° C.
Do not store for more than 30 days after opening the bottle.
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 GAVISCON INFANTS contains, oral suspension in vial
· The active substances are:
Sodium alginate ............................................... .................................................. ........ 5.00 g
Sodium bicarbonate............................................... .................................................. ... 2.67 g
For 100 ml
· The other ingredients are: calcium carbonate, carbomer, sodium saccharin, fennel flavoring, banana flavor, sodium hydroxide, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), purified water
What is GAVISCON INFANTS, oral suspension in bottle and contents of the pack
This medication is in the form of a drinkable suspension; bottle of 100 ml or 150 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
RECKITT BENCKISER HEALTHCARE
INN LANE
HU8 7DS HULL
UK
Marketing Authorization Operator
RECKITT BENCKISER HEALTHCARE FRANCE
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Maker
GLAXO WELLCOME PRODUCTION
100, ROUTE DE VERSAILLES
78163 MARLY LE ROI CEDEX
Or
GLAXO WELLCOME PRODUCTION
440, AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
Or
RECKITT BENCKISER HEALTHCARE (UK) LIMITED
INN LANE - HULL
EAST YORKSHIRE
HU8 7DS
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]
{MM / YYYY}.
Other
Health Education Council:
STOMACH ACHE
This medication is intended to relieve stomach upset.
Burns, heartburn, acid uplifts may be due to changes in the diet or the taking of certain medications (aspirin, anti-inflammatory ...). Do not hesitate to talk to your doctor or pharmacist.
In order to limit the onset of symptoms, respect the following hygiene rules as much as possible:
· thicken the diet,
· avoid chocolate porridge,
· split meals,
· avoid over-tightening the layers,
· avoid family smoking,
· remove orange juice and soft drinks.