NOTICE
ANSM - Last updated: 10/05/2017
Name of the medicinal product
GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium
Sodium alginate, Sodium bicarbonate, Calcium carbonate
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet. You might need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 7 days, consult a physician.
· 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.
What is in this leaflet?
1. What is GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium and in which cases it is used?
2. What should I know before taking GAVISCONELL WITHOUT SUGAR MINT, a chewable tablet sweetened with aspartame and acesulfame potassium?
3. How to take GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium?
4. What are the possible side effects?
5. How to store GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium?
6. Package contents and other information.
1. WHAT IS GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium AND WHAT IT IS USED FOR?
GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium forms a protective layer that floats above the contents of the stomach. This layer prevents reflux and keeps the stomach contents away from the esophageal wall, relieving the sensation of heartburn, the feeling of discomfort in the throat and mouth. Heartburn can occur after a meal (eg after a high-fat or spicy meal), or during pregnancy, or in patients with symptoms of inflammation of the esophageal wall (eg, difficulty and / or pain in swallowing, mouth ulcers, vomiting).
This medication is used to treat symptoms of gastroesophageal reflux disease such as acid regurgitation, heartburn and difficult (reflux-related) digestion, such as after meals or during pregnancy, or during oesophagitis.
2. BEFORE YOU TAKE GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium?
Never take GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium:
· If you are allergic to any of the ingredients of this medication, very rare cases of skin irritation and breathing difficulties have been reported (see below for complete information).
Warnings and Precautions
This medicine contains sodium (5.3 mmol for 2 tablets) and calcium (1.6 mmol for 2 tablets).
- Please consult your doctor before taking this medication if you have been asked to adhere to a diet low in one of these ingredients.
- Due to the presence of these salts in this medication, please also consult your doctor if you suffer or have suffered from heart disease or kidney dysfunction since these salts can interfere with these diseases.
If symptoms persist after 7 days, consult your doctor.
Other drugs and GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium.
It is advisable to space the 2-hour catch between this product and another medication taken orally as it may interfere with the action of certain other medications.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Pregnancy and breast feeding
GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium 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.
GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium contains aspartame.
If you have phenylketonuria, you should know that this medicine contains aspartame, a source of phenylalanine .
3. HOW TO TAKE GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium?
Oral use.
Thoroughly chew the tablet before swallowing.
Adults, including the elderly, and children from 12 years: in case of symptoms, two to four tablets, after main meals and in bedtime, up to four times a day.
Children under 12 years of age : treatment to be taken on medical advice .
If you take more GAVISCONELL WITHOUT MINT SUGAR, chewable tablet you should:
It is unlikely that this will cause you unwanted effects. You may feel bloated.
Immediately consult your doctor or pharmacist.
If you forget to take GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium: do not take double dose the next time. Take exactly as prescribed in the dosage.
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 you experience these side effects, stop taking this medicine and see your doctor immediately.
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 GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium?
Keep this medicine out of the reach and sight of children.
Do not use GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium after the expiry date stated on the box. The expiry date refers to the last day of that month.
Store at a temperature not exceeding + 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What GAVISCONELL contains NO MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium
· The active substances are:
Sodium alginate ............................................... .................................................. 250 mg
Sodium bicarbonate............................................... .................................................. 133.50 mg
Calcium carbonate............................................... .................................................. ........ 80.00 mg
· Other ingredients are mannitol (E421), macrogol 20 000, copovidone, aspartame (E951), mint flavor, magnesium stearate, acesulfame potassium (E950).
These tablets do not contain sugar or gluten.
What is GAVISCONELL WITHOUT MINT SUGAR, chewable tablet sweetened with aspartame and acesulfame potassium and contents of the pack
This medication is in the form of a chewable tablet. Boxes of 4, 6, 8, 12, 16, 18, 20, 22, 24, 32, 36, 40, 44, 48 and 64 tablets.
Marketing Authorization Holder
RECKITT BENCKISER HEALTHCARE (UK) LTD
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
HU8 7DS HULL
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 in force.
[To be completed at a later date by the holder]
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Health Education Council
STOMACH ACHE
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 the practice of an important effort just after the meal.