Gaviscon o smaku miemti Sashetki

PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: information for the patient

Gaviscon Mint Flavor Sachets, (500 mg + 267 mg + 160 mg)/10 ml, oral suspension

(Sodium alginate + Sodium hydrogen carbonate + Calcium carbonate)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient information leaflet or as advised by the doctor.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If after 7 days there is no improvement or the patient feels worse, consult a doctor.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Gaviscon Mint Flavor Sachets and what is it used for
• 2. Important information before taking Gaviscon Mint Flavor Sachets
• 3. How to take Gaviscon Mint Flavor Sachets
• 4. Possible side effects
• 5. How to store Gaviscon Mint Flavor Sachets
• 6. Package contents and other information

1. What is Gaviscon Mint Flavor Sachets and what is it used for

Gaviscon Mint Flavor Sachets belongs to a group of medicines called "anti-reflux agents", which creates a protective layer that lasts on the surface of the stomach contents for up to 4 hours, preventing the reflux of acidic stomach contents from the stomach, which causes pain and discomfort in the esophagus.
Gaviscon Mint Flavor Sachets is used to treat symptoms of gastroesophageal reflux, such as belching, heartburn, and indigestion (associated with reflux), for example after meals or during pregnancy, as well as in patients with symptoms associated with reflux esophagitis.

• with gastroesophageal reflux, such as belching, heartburn, and indigestion (associated with reflux), for example after meals or during pregnancy, as well as in patients with symptoms associated with reflux esophagitis.

2. Important information before taking Gaviscon Mint Flavor Sachets

When not to take Gaviscon Mint Flavor Sachets:

Warnings and precautions

The medicine contains sodium (6.2 mmol/10 ml) and calcium (1.6 mmol/10 ml). The maximum recommended daily dose of the medicine 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 Flavor Sachets is intended for short-term treatment, unless otherwise prescribed by a doctor. Consult a doctor or pharmacist if it is necessary to take Gaviscon Mint Flavor Sachets every day for a longer period or regularly, especially if the patient should control their salt intake.

• Consult a doctor in case of kidney or heart disease, as increased salt content increases the risk of these diseases.

If symptoms do not improve after seven days of treatment, consult a doctor.
Methyl parahydroxybenzoate (40 mg/10ml) and propyl parahydroxybenzoate (6 mg/10ml) may cause allergic reactions (also of the late type).

Gaviscon Mint Flavor 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 the doctor or pharmacist about all medicines currently being taken by the patient or recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

This medicine can be used during pregnancy and breastfeeding.
Gaviscon Mint Flavor Sachets contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (also of the late type).

3. How to take Gaviscon Mint Flavor Sachets

For oral use.
Shake the medicine before use.
Adults, including the elderly and children over 12 years of age:10–20 ml after meals and before bedtime (up to four times a day).
Use in children under 12 years of age:administer only after consulting a doctor.

Taking a higher dose of Gaviscon Mint Flavor Sachets than recommended

Taking too much of the medicine may cause abdominal bloating and discomfort in the abdominal cavity.
If it does not pass, consult a doctor.

Missing a dose of Gaviscon Mint Flavor 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 gets them.
If side effects occur, stop taking the medicine and consult a doctor immediately.
Very rare (less than 1 in 10,000 patients) allergic reactions to the components of the medicine may occur. Symptoms such as skin rashes, itching, breathing difficulties, dizziness, swelling of the face, lips, tongue, or throat may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gaviscon Mint Flavor Sachets

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after: EXP. The expiry date refers to the last day of the given month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Before first use, check the seal on the cap for damage.
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. Package contents and other information

What Gaviscon Mint Flavor Sachets contains

• The active substances of the medicine 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 of the medicine are carbomer 974P, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, peppermint flavor 4, peppermint flavor 5, and purified water.

This medicine does not contain sugar or dyes.

What Gaviscon Mint Flavor Sachets looks like and what the package contains

Gaviscon Mint Flavor is a white suspension with a minty smell and taste.
Available packages: 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 or 48 sachets.
Not all pack sizes may be marketed.

Marketing authorization 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,
Netherlands
To obtain more detailed information, please contact the representative of the marketing authorization holder: tel. 0801 88 88 07
Date of last revision of the leaflet:08/2022