Gaviscon with mint flavor sachets

Patient Information Leaflet

Gaviscon Mint Flavour Sachets, (500 mg + 267 mg + 160 mg)/10 ml, oral suspension
(Natrii alginas + Natrii hydrogenocarbonas + Calcii carbonas)
Please read this leaflet carefully before taking this medicine, as it contains important information
for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Gaviscon Mint Flavour Sachets is and what it is used for
Gaviscon Mint Flavour Sachets belong to a group of medicines called "agents that control gastro-oesophageal reflux". It forms a protective layer that remains on the surface of stomach contents for up to 4 hours, preventing the backflow of acidic stomach contents from the stomach, which causes pain and discomfort in the oesophagus.
Gaviscon Mint Flavour Sachets are 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 taking Gaviscon Mint Flavour Sachets

When not to use Gaviscon Mint Flavour Sachets:

• if you are allergic to any of the ingredients of Gaviscon Mint Flavour Sachets, as very rarely breathing difficulties or skin rashes have been observed (see further information in the full list of side effects).

Warnings and precautions
This medicine contains sodium (6.2 mmol/10 ml) and calcium (1.6 mmol/10 ml). The maximum recommended daily dose contains 1140.8 mg of sodium (a component of table salt). This corresponds to 57.04% of the recommended maximum daily sodium intake for an adult.
Gaviscon Mint Flavour Sachets are intended for short-term treatment unless otherwise directed by a doctor. You should consult your doctor or pharmacist if you need to take Gaviscon Mint Flavour Sachets daily for a prolonged period or regularly, especially if you are required to monitor salt intake in your diet.

• Consult your doctor if you have kidney or heart disease, as increased salt intake may increase the risk of these conditions.

If symptoms do not improve after seven days of treatment, consult your doctor.
Methyl parahydroxybenzoate (40 mg/10 ml) and propyl parahydroxybenzoate (6 mg/10 ml) may cause allergic reactions (including delayed-type reactions).
Gaviscon Mint Flavour Sachets and other medicines
Do not take this medicine within two hours of taking other medicines, as it may affect the effectiveness of some medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy and breastfeeding
This medicine may be used during pregnancy and breastfeeding.
Gaviscon Mint Flavour Sachets contain methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed-type reactions).
3. How to take Gaviscon Mint Flavour Sachets
For oral use.
Shake the bottle 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).
Use in children under 12 years of age: Only to be given after consultation with a doctor.
Taking more Gaviscon Mint Flavour Sachets than recommended
Taking too high a dose may cause abdominal bloating and discomfort.
If this does not resolve, contact your doctor.
If you miss a dose of Gaviscon Mint Flavour Sachets
Do not take a double dose to make up for a missed dose. Continue treatment as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If side effects occur, discontinue use of the medicine and consult a doctor immediately.
Allergic reactions to the ingredients of the medicine may very rarely occur (less than 1 in 10,000 patients).
Symptoms may include skin rash, itching, difficulty in breathing, dizziness, swelling of the face, lips, tongue or throat.
Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, additional information on the safety of the medicine can be collected.

5. How to store Gaviscon o smaku mięty Saszetki

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the outer cardboard packaging after:
EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°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 must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Gaviscon Mint Flavour Sachets 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 parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, mint flavour no. 4, mint flavour no. 5, and purified water.

This medicine does not contain sugar or colourings.
What Gaviscon Mint Flavour Sachets looks like and contents of the pack
Gaviscon Mint Flavour is a white suspension with a mint odour and taste.
Available pack sizes: 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 or 48 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands
For further information, please contact the representative of the Marketing Authorisation Holder: tel. 0801 88 88 07