Gaviscon with mint flavor

Gaviscon with mint flavour, (500 mg + 267 mg + 160 mg)/10 ml, oral suspension
(Sodium alginate + Sodium hydrogen carbonate + Calcium carbonate)
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Gaviscon with mint flavour is and what it is used for
2. Important information before taking Gaviscon with mint flavour
3. How to take Gaviscon with mint flavour
4. Possible side effects
5. How to store Gaviscon with mint flavour
6. Contents of the pack and other information

1. WHAT GAVISCON WITH MINT FLAVOUR IS AND WHAT IT IS USED FOR

Gaviscon with mint flavour belongs to a group of medicines known as "agents preventing gastro-oesophageal reflux". It forms a protective layer that remains on the surface of gastric contents for up to 4 hours, preventing the backflow of acidic stomach contents into the oesophagus, which causes pain and discomfort.

Gaviscon with mint flavour is used to treat symptoms of gastro-oesophageal reflux, such as regurgitation, heartburn, and indigestion (related to reflux), for example after meals or during pregnancy, as well as in patients with symptoms associated with reflux oesophagitis.

2. IMPORTANT INFORMATION BEFORE USING GAVISCON MINT FLAVOUR

MINT FLAVOUR
When not to use Gaviscon Mint Flavour

• if the patient has had allergic reactions (hypersensitivity) to any component of the medicine, manifested as breathing difficulties or skin rashes (see further information in the full list of adverse effects).

Warnings and precautions
This medicine contains sodium (143 mg/10 ml) and calcium (64 mg/10 ml). The maximum recommended daily dose of this medicine contains 1144 mg of sodium (a component of table salt) and 512 mg of calcium. This corresponds to 57% of the maximum recommended daily intake of sodium in the adult diet. Each maximum recommended dose contains 320 mg of calcium carbonate. This is a dose of 20 ml taken four times a day.
Gaviscon Mint Flavour is indicated for short-term use unless otherwise directed by a doctor. If Gaviscon Mint Flavour is used regularly or for prolonged periods as part of the daily diet, patients—especially those monitoring sodium intake—should consult their doctor or pharmacist.
Consult your doctor if you have kidney or heart disease, as increased salt intake may increase the risk associated with these conditions.
If symptoms persist after seven days of treatment, consult your doctor.

Gaviscon Mint Flavour and other medicines
Do not take this medicine within two hours of taking any other oral medicines, as it may affect the effectiveness of certain drugs.
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

Pregnancy and breastfeeding
This medicine can be used during pregnancy and breastfeeding.

Important information about certain ingredients of Gaviscon Mint Flavour
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).

3. HOW TO USE GAVISCON MINT FLAVOUR

For oral use.
Shake the medicine well before use.
Adults, including elderly, and children aged 12 years and above: 10–20 ml after meals
and at bedtime (up to four times daily).
Children under 12 years of age: only to be given after consultation with a doctor.
Accidental overdose of Gaviscon Mint Flavour
Adverse effects following overdose are unlikely.
However, the medicine may cause bloating and abdominal discomfort. If these symptoms persist,
consult a doctor.
Missed dose of Gaviscon Mint Flavour
If a dose is missed, do not take a double dose at the next administration. Continue treatment as previously directed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Gaviscon o smaku mięty may cause adverse reactions, although not everyone experiences them.
If adverse reactions occur, discontinue use of the medicine immediately and consult a doctor without delay.

Very rarely (less than 1 in 10,000 patients):
Hypersensitivity and allergic reactions. Symptoms may include: skin rash, itching, breathing difficulties, dizziness, swelling of the face, lips, tongue or throat.

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE GAVISCON MINT FLAVOUR

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Gaviscon Mint Flavour after the expiry date (month/year) stated on the packaging after the word "EXP". The date refers to the last day of the stated month.
Do not store above 30°C. Do not store in the refrigerator or freeze.
Before first use, check the tamper-evident seal on the cap to ensure it is not broken.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Gaviscon Mint Flavour contains
The active substances in each 10 ml dose are 500 mg of sodium alginate, 267 mg of sodium hydrogen carbonate, and 160 mg of calcium carbonate.
Other ingredients are carbomer 974P, methyl (E218) and propyl (E216) parahydroxybenzoate, sodium saccharin, sodium hydroxide, peppermint oil, and purified water.
This medicine does not contain sugar or gluten.

What Gaviscon Mint Flavour looks like and contents of the pack
Gaviscon Mint Flavour is a white suspension with a mint odour and flavour.
Available pack sizes: bottles of 150 ml, 200 ml, 250 ml or 300 ml.

Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland

Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands

For further information, please contact the Marketing Authorisation Holder: tel. (22) 211 26 92

This medicine is authorised in the Member States of the European Economic Area under the following names: