NOTICE
ANSM - Last updated: 10/05/2017
Description of the Medicine
GAVISCON, oral suspension in sachet
Sodium Alginate / Sodium Bicarbonate
© framed
Please read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
AT· Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
AT· If symptoms worsen or persist, consult a physician.
AT· If you notice any side effects not listed in this leaflet, or if you notice any of the side effects listed as severe, please inform your doctor or pharmacist.
Summary sheet
In this notice :
1. WHAT IS GAVISCON, oral suspension in sachets AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE GAVISCON, oral suspension in sachets?
3. HOW TO USE GAVISCON, oral suspension in sachet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE GAVISCON, oral suspension in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS GAVISCON, oral suspension in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
OTHER MEDICINAL PRODUCTS FOR PEPTIC ULCER AND GASTRO-ESOPHAGEAL REFLUX (GERD).
Therapeutic Indications
This medication is indicated in the treatment of gastroesophageal reflux disease which results in burning of the stomach (pyrosis), acid ascites or referrals and heartburn.
2. BEFORE YOU USE GAVISCON, oral suspension in sachets?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take GAVISCON, oral suspension in sachets:
AT· if you are allergic to any of the active ingredients or any of the excipients contained in this medication, listed in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment precautions; special warnings
Warnings and Precautions
This medication contains propyl parahydroxybenzoate and parahydroxybenzoate and may cause allergic reactions (possibly delayed)
Please consult your doctor before taking this medication if you have been advised to follow a diet low in sodium especially if you suffer from cardiac insufficiency.
This medicine contains sodium. This medicine contains 145 mg sodium per sachet. To be taken into account in patients controlling their sodium dietary intake. This medication contains calcium. Each sachet contains 160 mg of calcium carbonate. Precautions should be taken in patients suffering from or suffering from a serious renal disease.
IN CASE OF DOUBT, DO NOT HESITATE TO REQUEST THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST
Interactions with other medicines
Other medicines and GAVISCON oral suspension in sachet
As a precaution, the 2-hour catch between GAVISCON and another medicinal product should be shortened.
Inform your doctor or pharmacist if you are taking, have recently taken or could take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
GAVISCON can be used during pregnancy and breast-feeding
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 medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
This medication has no or negligible effect on the ability to drive and use machines.
List of excipients with known effect
GAVISCON oral suspension in sachet contains methylated parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and sodium. See "Warnings and Precautions for Use".
3. HOW TO USE GAVISCON, oral suspension in sachet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
1 sachet 3 times a day after the 3 main meals and possibly in the evening at bedtime.
This dosage may be doubled in severe oesophageal reflux or inflammation.
Method and route of administration
This medication should be taken orally. Mix well before opening.
Frequency and Timing at which the Medication is to be Administered
This medication should be taken after meals.
Symptoms and Instructions for Overdose
If you take more GAVISCON, oral suspension in sachet than you should have:
You may feel bloated. It is unlikely that this will have any harmful consequences for your health, however if symptoms persist consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take GAVISCON, oral suspension in sachet:
Do not take a double dose to make up for the missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, this medication is likely to have undesirable effects, although not everyone is subject to it.
Very rare (less than 1 case per 10,000 patients): an allergic reaction to the components may occur. Symptoms may include skin rash, stomach upset, difficulty breathing, dizziness or swelling of the face, lips, tongue or throat.
If any of these symptoms or other undesirable effects appear, stop treatment immediately and consult your doctor.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Pharmacovigilance Regional Centers - Website: www.ansm.sante.fr
By reporting undesirable effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE GAVISCON, oral suspension in sachet?
Keep out of the reach and sight of children
Date of filing
Do not use this medication after the expiration date stated on the outer package after EXP. The redemption date refers to the last day of that month.
Storage conditions
Keep at a temperature not exceeding 25 ° C.
If necessary, warnings against some visible signs of deterioration
Do not throw any medicines into the sewer or into the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What GAVISCON contains, oral suspension in sachet
AT· The active substances are:
Sodium alginate ............................................... .................................................. .......................... 500 mg
Sodium bicarbonate ............................................... .................................................. 267 mg
For a bag
AT· The other components are:
Calcium carbonate, 974P carbomer, sodium saccharine, natural mint flavor, sodium hydroxide, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water.
Pharmaceutical form and content
Aspect of GAVISCON, oral suspension in sachet and contents of outer packaging
This medication is in the form of a drinkable suspension in a sachet.
This medication is available in 20, 24 or 48 sachets.
Not all presentations may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
RECKITT BENCKISER HEALTHCARE
Dansom lane
HU8 7DS Â- Hull
UK
exploiting
RECKITT BENCKISER HEALTHCARE France
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Maker
RECKITT BENCKISER HEALTHCARE (UK) LTD
The
HU8 7DS HULL
UK
Names of medicines in the Member States of the European Economic Area
Not applicable
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.
AMM under exceptional circumstances
Not applicable
Internet Information
Detailed information on this medicinal product can be found on the website of the ANSM (France).
Information for health professionals
Not applicable
Other
SANITARY EDUCATION COUNCILS
STOMACH ACHE
ANTIACIDE ONLY
This medication is intended to relieve your stomach ache.
Burns, heartburn, acid reflux may be due to dietary changes (acidic or spicy foods, alcoholic beverages ...) or to the intake of certain medications (aspirin, anti-inflammatories ...). Do not hesitate to talk to your doctor or pharmacist.
In order to limit the occurrence of symptoms, respect as much as possible the following hygiene rules:
AT· Avoid tobacco and limit alcohol consumption,
AT· Avoid abundant meals and high in fat,
AT· eat slowly,
AT· Avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
AT· vary your diet,
AT· normalize your weight,
AT· Avoid the practice of a major effort just after the meal.