NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
GAVISCON, oral suspension in vial
Sodium alginate, sodium bicarbonate
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the instructions 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 contact your doctor if you experience no improvement or feel less well after 7 days.
What is in this leaflet?
1. What is GAVISCON, oral suspension in vial and in which cases is it used?
2. What should I know before taking GAVISCON oral suspension in a vial?
3. How to take GAVISCON, oral suspension in a vial?
4. What are the possible side effects?
5. How to store GAVISCON, oral suspension in a vial?
6. Package contents and other information.
1. WHAT IS GAVISCON, oral suspension in a vial AND IN WHAT CASES IS IT USED?
Other drugs for peptic ulcer and gastroesophageal reflux disease (GERD) - ATC code: A02BX
This medication is indicated for the treatment of gastroesophageal reflux disease which results in heartburn (heartburn), acid reflux, and heartburn.
You should contact your doctor if you experience no improvement or feel less well after 7 days.
2. BEFORE YOU TAKE GAVISCON, drinkable suspension in a vial?
Do not take GAVISCON, oral suspension in a vial:
· if you are allergic to sodium alginate or sodium bicarbonate or any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and Precautions
This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
Please consult your doctor before taking this medication if you have been asked to follow a diet low in sodium especially if you suffer from heart failure.
This medicine contains sodium. This medicine contains 145 mg sodium for 2 teaspoons. To be taken into account in patients controlling their sodium dietary intake.
This medication contains calcium: this medicine contains 160 mg of calcium carbonate for 2 teaspoons. Precautions should be taken in patients suffering from or having suffered from severe renal disease.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Other drugs and GAVISCON, oral suspension in vial
As a precaution, it is appropriate to space the 2-hour catch between GAVISCON and another drug. Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Pregnancy and breast feeding
GAVISCON can be used during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicinal product has no or negligible influence on the ability to drive and use machines.
GAVISCON, oral suspension in vial contains sodium, methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. HOW TO TAKE GAVISCON, oral suspension in a vial?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
2 teaspoons (10 ml) 3 times a day after the main meals and possibly in the evening at bedtime.
This dosage can be doubled in cases of severe oesophageal reflux or inflammation.
Administration mode
This medication should be taken orally.
Shake well before use.
You should contact your doctor if symptoms persist beyond 7 days.
Frequency of Administration
This medication should be taken after meals.
If you take more GAVISCON oral suspension than you should have had, it is unlikely to have any adverse effects on your health, but please consult your doctor or pharmacist.
If you forget to take GAVISCON, oral suspension in vial
Do not take a double dose to make up for a missed dose .
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 medicine may cause side effects, although not everybody gets them.
Very rare (less than 1 case per 10,000 patients): an allergic reaction to the components may occur. Symptoms may include rash, itching, difficulty breathing, dizziness or swelling of the face, lips, tongue or throat.
If any of these symptoms or other side effects occur, stop treatment immediately and see your doctor.
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, oral suspension in a vial?
Store at a temperature not exceeding + 25 ° C.
After first opening the bottle do not keep for longer than 3 months.
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 vial after EXP. The expiry date refers to the last day of that month.
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 contains, oral suspension in a vial
· The active substances are:
Sodium alginate ............................................... .................................................. ......... 5.00 g
Sodium bicarbonate............................................... .................................................. 2.67 g
For 100 ml
1 ml contains 50 mg of sodium alginate and 26.7 mg of sodium bicarbonate
· The other components are:
Calcium carbonate, carbomer (974 P), sodium saccharin, fennel flavor *, erythrosine (E127), sodium hydroxide, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), purified water.
* Composition of the aroma fennel: fennel anethol, benzyl alcohol.
What is GAVISCON, oral suspension in a vial and contents of the pack
This medication is in the form of a drinkable suspension. Bottle of 150 ml, 200 ml, 250 ml, 300 ml, 500 ml or 600 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
RECKITT BENCKISER HEALTHCARE (UK) LTD
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]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council: MAUX D'ESTOMAC
This medication is intended to relieve your stomach ache.
Burns, heartburn, acid reflux may be due to changes in diet (acidic or spicy dishes, alcoholic beverages ...) or to 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:
· avoid tobacco and limit alcohol consumption,
· avoid abundant and high-fat meals,
· eat slowly,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· vary your diet,
· normalize your weight,
· avoid exertion after the meal.