Gavisconnell 12 sugar-free mint-flavored single-dose packets is a liquid medication that quickly relieves pain and reduces the discomfort caused by heartburn and acid reflux
For warnings, precautions, and contraindications, please refer to the package insert.
Stress, large meals or meals eaten on the go, parties with a little too much to drink… our busy lifestyles tend to take a toll on the stomach and lead to heartburn and acid reflux. These symptoms may be common, but they’re bothersome and can really ruin your day. Here’s an overview of these minor stomach issues…
Acid reflux, heartburn… These are two typical symptoms of gastroesophageal reflux disease (GERD). GERD occurs when some of the stomach’s acidic contents flow back into the esophagus. The stomach is lined with a mucus layer that protects it from acidity, but the esophagus has no such protection: when acid reflux occurs, the sensations can be extremely unpleasant.
Gaviscon sugar-free mint-flavored single-dose packets provide rapid relief from the pain and discomfort caused byheartburn, acid indigestion, andacid reflux or regurgitation.
This medication is intended to relieve yourstomach discomfort.
For adults and children over 12 years of age
Take this medication at least 2 hours apart from other medications
Oral use
Gaviscon oral suspension is available for infants.
Box of 12 sugar-free single-dose packets
Please note: This medication is not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 10/05/2017
Name of the medicinal product
GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension in sachet sweetened with saccharin sodium
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 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 GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised sweetened with saccharin sodium and in which cases it is used?
2. What should I know before taking GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised sweetened with saccharin sodium?
3. How to take GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium?
4. What are the possible side effects?
5. How to store GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium?
6. additional information.
1. WHAT GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised sweetened with sodium saccharin AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
OTHER MEDICINAL PRODUCTS FOR PEPTIC ULCER AND GASTRO-ESOPHAGEAL REFLUX (GERD).
Therapeutic indications
GAVISCONELL MENTHE WITHOUT SUGAR is indicated in heartburn, acid reflux or referral (heartburn) and heartburn.
These symptoms may, for example, occur after meals or during pregnancy, or during inflammation of the esophagus.
2. BEFORE YOU TAKE GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium:
· If you are allergic to the active ingredients or to any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Warnings and Precautions
In the absence of symptom improvement after seven days, the clinical situation should be reconsidered.
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 per sachet (6.3 mmol per sachet). To be taken into account in patients controlling their sodium dietary intake.
This medicine contains calcium: Each sachet contains 160 mg of calcium carbonate (1.6 mmol per 10 ml). 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.
Interaction with other medicines
Other drugs and GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised sweetened with saccharin sodium
As a precaution, it is appropriate to space the 2-hour catch between GAVISCONELL MENTHE WITHOUT SUGAR 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
This medicine may 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.
Sport
Not applicable.
Effects on ability to drive or use machines
This medicinal product has no or negligible influence on the ability to drive and use machines.
List of excipients with known effect
GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised with saccharin sodium contains sodium, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). See "Warnings and Precautions for Use".
3. HOW TO TAKE GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults, including elderly, and children over 12 years: 1 sachet 3 times a day, after the 3 main meals and eventually the evening at bedtime.
This dosage may be doubled in severe oesophageal reflux or inflammation.
Children under 12 years of age : only on medical advice.
Elderly : No dose adjustment is required for this population.
Patients with hepatic impairment : no dose adjustment required
Patients suffering from kidney failure : a precaution is required in case of strict salt-free diet
Method and route of administration
Oral use.
Mix well before opening.
Frequency of Administration
This medication should be taken after meals.
Duration of treatment
In the absence of symptom improvement after seven days, the clinical situation should be reconsidered.
Symptoms and Instructions for Overdose
If you take more GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in saccharine sweetened with saccharin sodium you should:
You may feel bloated. It is unlikely that this will cause harm to your health, however consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take GAVISCONELL MENTHE WITHOUT SUGAR, drinkable suspension in sachet-dose sweetened with saccharine sodium:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
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
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharised sweetened with saccharin sodium?
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 outer carton after EXP. The expiry date refers to the last day of that month.
Storage conditions
Store at a temperature not exceeding 25 ° 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 is GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension in sachet sweetened with saccharine sodium
· The active substances are:
Sodium alginate ............................................... .................................................. .......................... 500 mg
Sodium bicarbonate ............................................... .................................................. 267 mg
For a sachet.
· The other components are:
Calcium carbonate, 974P carbomer, saccharin sodium, natural mint flavor, sodium hydroxide, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water.
Pharmaceutical form and content
Aspect of GAVISCONELL MENTHE WITHOUT SUGAR, oral suspension saccharate sweetened with saccharin sodium and contents of the pack
This medication is in the form of a drinkable suspension in a sachet.
Box of 1, 2, 10, 12, 20 or 24 sachet (s).
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
INN LANE
HU8 7DS HULL
UK
exploiting
RECKITT BENCKISER HEALTHCARE France
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Maker
GLAXO WELLCOME PRODUCTION
ZI OF THE TERRAS
53100 MAYENNE
or
GLAXO WELLCOME PRODUCTION
440, AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
or
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
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 medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
HEALTH EDUCATION COUNCIL
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.
Antacid of local action
sodium alginate, sodium bicarbonate, calcium carbonate
. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
GAVISCONELL mint without sugar: oral suspension (mint flavoring); box of 12 bags.
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GAVISCONELL mint without sugar: oral suspension (mint flavoring); box of 24 sachets.
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Laboratory Reckitt Benckiser Healthcare France
| p sachet | |
| Sodium alginate | 500 mg |
| Sodium bicarbonate | 267 mg |
| either Sodium | 145 mg |
Usual dosage:
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