NOTICE
ANSM - Last updated: 10/05/2017
Name of the medicinal product
GAVISCON MENTHE, chewable tablet
Sodium Alginate, Sodium Bicarbonate, Sodium Carbonate
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 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 7 days.
Review summary
What this leaflet contains:
1. What is GAVISCON MENTHE, chewable tablet and in which cases it is used?
2. What should I know before taking GAVISCON MENTHE, chewable tablet?
3. How to take GAVISCON MINT, chewable tablet?
4. What are the possible side effects?
5. How to store GAVISCON MINT, chewable tablet?
6. Additional information.
1. WHAT IS GAVISCON MINT, chewable tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
GAVISCON MINT, a chewable tablet, provides rapid relief from pain and discomfort caused by heartburn and acid reflux.
These symptoms may, for example, occur after meals or during pregnancy, or during inflammation of the esophagus.
2. BEFORE YOU TAKE GAVISCON MENTHE, chewable tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take GAVISCON MENTHE, chewable tablet in the following case:
If you are allergic to the active ingredient (s) or to any of the other ingredients of this medication mentioned in section 6, very rare cases of skin irritation and breathing difficulties have been reported very rarely .
Precautions for use; special warnings
Special warnings with GAVISCON MENTHE, chewable tablet
Taking two tablets contained 246 mg of sodium (10.6 mmol) and 320 mg of calcium carbonate (3.2 mmol). PLEASE CONSULT YOUR DOCTOR BEFORE TAKING THIS MEDICINE if you have been asked to follow a low-sodium diet especially if you have heart failure or calcium, especially if you have a high level of calcium in the blood, or if you suffer from kidney stones.
Take special precautions with GAVISCON MENTHE, chewable tablet:
If you have phenylketonuria, you should know that this medicine contains aspartame, a source of phenylalanine.
Interaction with other medicines
Other medications and GAVISCON MENTHE, chewable tablet
As a precaution, it is advisable to space the 2-hour catch between GAVISCON MENTHE and another medication.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
GAVISCON MINT, chewable tablet can be used during pregnancy or during breastfeeding.
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.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
GAVISCON MINT, chewable tablet contains aspartame (E951).
3. HOW TO TAKE GAVISCON MINT, chewable tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults, including the elderly, and children over 12 years : one to two tablets, after main meals and at bedtime.
Duration of the treatment
You should contact your doctor if symptoms persist beyond 7 days
Administration mode
Oral use.
Thoroughly chew the tablet before swallowing.
Symptoms and Instructions for Overdose
If you take more GAVISCON MINT, chewable tablet than you should: It is unlikely that this will adversely affect your health, however consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take GAVISCON MENTHE, chewable tablet: do not take double doses to compensate for the simple intake you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, GAVISCON MINT, chewable tablet is likely to have side effects, although not everyone is subject to it.
Do not take this medication if you are aware that you are allergic to any of its constituents as very rare cases of allergy to constituents (less than 1/10 000) have been reported. Symptoms may include rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue, or throat.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
Declaration of side effects
If you notice any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed 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
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE GAVISCON MENTHE, chewable tablet?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Storage conditions
Store at a temperature not exceeding 30 ° C.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What GAVISCON MENTHE contains, chewable tablet
· The active ingredients are: sodium alginate, sodium bicarbonate and calcium carbonate.
Each tablet contains 500 mg of sodium alginate, 267 mg of sodium bicarbonate and 160 mg of calcium carbonate.
· The other components are:
Mint flavor, macrogol 20,000, mannitol (E421), aspartam (E951), magnesium stearate, copovidone, acesulfame potassium (E950).
These tablets do not contain sugar or gluten.
Pharmaceutical form and content
Aspect of GAVISCON MENTHE, chewable tablet and contents of the pack
This medication is in the form of a chewable, whitish to cream, slightly spotted tablet.
This medicine is available in packs of 12, 20, 24, 40 and 60 tablets.
Not all pack sizes 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 (UK) LIMITED
INN LANE
HU8 7DS - HULL
UK
exploiting
RECKITT BENCKISER HEALTHCARE France
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Maker
RECKITT BENCKISER HEALTHCARE (UK) LIMITED
INN LANE
HULL, HU8 7DS
UK
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
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 medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION
This medication is intended to relieve your stomach ache.
Burns, heartburn, acid uplifts can be due to modifications of the diet (acidic or spicy dishes, alcoholic beverages ...) or to the taking of certain medicines (aspirin, anti-inflammatories ...) . 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,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· eat slowly,
· vary your diet,
· normalize your weight,
· avoid exertion after the meal.
YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.