NOTICE
ANSM - Last updated: 10/05/2017
Description of the Medicine
GAVISCONPRO MENTHE, oral suspension in sachet
Sodium alginate, Potassium bicarbonate
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Please read this leaflet carefully before you start taking this medication because it contains important information for you.
You should always take this medication exactly as prescribed by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should contact your doctor if you experience no improvement or feel less well after 7 days.
Summary sheet
What this leaflet contains:
1. WHAT IS GAVISCONPRO MENTHE, oral suspension in sachets AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE GAVISCONPRO MENTHE, oral suspension in sachet?
3. HOW TO TAKE GAVISCONPRO MENTHE, oral suspension in sachet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE GAVISCONPRO MENTHE, oral suspension in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS GAVISCONPRO MENTHE, oral suspension in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic Indications
GAVISCONPRO MENTHE belongs to a group of medications called "anti-reflux". Reflux is a process by which the acidic gastric fluid ascends into the esophagus.
Unlike the stomach, the wall of the esophagus does not resist acidity, which is why reflux is causing pain and discomfort as burns.
GAVISCONPRO MENTHE forms a protective layer that floats above the contents of the stomach. This layer helps prevent reflux and keeps the stomach contents away from the esophageal wall which relieves stomach burns and acid regurgitation. They may appear during pregnancy or during hiatal hernia.
They can get worse if you have a fat or very spicy diet. If you drink too much alcohol, if you smoke, if you wear too tight clothing, if you are overweight or lean forward or when you lie down.
2. BEFORE YOU TAKE GAVISCONPRO MENTHE, oral suspension in sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take GAVISCONPRO MENTHE, oral suspension in sachet:
AT· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
Employment precautions; special warnings
Warnings and Precautions
This medicine contains sodium (4.6 mmol per 10 ml), potassium (2.0 mmol per 10 ml) and calcium.
AT· Please consult your physician before taking this medication if you have been advised to follow a poor diet in any of these ingredients.
AT· Considering the presence of these salts in this medication, also consult your doctor if you suffer or have suffered from heart disease or dysfunction, as these salts can interfering with these diseases.
Interactions with other medicines
Other medicines and GAVISCONPRO MENTHE, oral suspension in sachet
As a precaution, the 2-hour catch between GAVISCONPRO MENTHE and another medication 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
GAVISCONPRO MENTHE can be used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medication.
feeding
GAVISCONPRO MENTHE can be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
This medication has no influence on the ability to drive and use machines.
List of excipients with known effect
This medication contains methylated parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic (possibly delayed) reactions.
3. HOW TO TAKE GAVISCONPRO MENTHE, 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
Adults, including the elderly, and children 12 years and over: 1/2 teaspoonful of 10 ml (1 teaspoon) three times a day after meals and if necessary at bedtime. In case of more severe pain, the dose may be increased to 1 sachet of 10 ml (two teaspoons).
Child under 12 years: should be taken only after the advice of a physician.
Administration mode
Oral use.
Swallow the suspension as it is, without diluting or using a teaspoon.
You should contact your doctor if the symptoms persist beyond 7 days.
Symptoms and Instructions for Overdose
If you take more GAVISCONPRO MENTHE, oral suspension in a sachet-dose you should have: You may feel bloated. It is unlikely that this will have negative 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 GAVISCONPRO MENTHE, oral suspension in a sachet-dose: do not take double doses to compensate for the catch you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, this medication can cause side effects, although not everybody gets them.
An allergic reaction to any of the constituents is very rare (<1 / 10,000). 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 occur, stop treatment immediately and consult your doctor or pharmacist.
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 adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE GAVISCONPRO MENTHE, oral suspension in sachet?
Keep this medication out of the reach and sight of children.
Date of filing
Do not use this medication after the expiration date stated on the carton after EXP.
Storage conditions
Do not put to the refrigerator.
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 GAVISCONPRO MENTHE contains, oral suspension in sachet
AT· The active substances are: sodium alginate and potassium bicarbonate.
Each 5 mL oral suspension contains 500 mg of sodium alginate and 100 mg of potassium bicarbonate.
AT· The other components are:
Calcium carbonate, carbamate 974 P, methylated parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavoring, sodium hydroxide (for pH adjustment), purified water.
Pharmaceutical form and content
Aspect of GAVISCONPRO MENTHE and contents of the outer packaging
This medicament is in the form of a whitish and viscous drinkable suspension in a sachet. Box of 2, 4, 10, 12, 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 (UK) LIMITED
INN LANE
HU8 7DS HULL
UK
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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 medicines 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 in force. [in the case of RMPs and FADs]
[To be completed subsequently by the Contractor]
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
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.