Gaviscon with mint flavor tab

Gaviscon o smaku mięty TAB, 250 mg + 133.5 mg + 80 mg, chewable tablets
(Natrii alginas + Natrii hydrogenocarbonas + Calcii carbonas)
Please read this entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription. However, to achieve the best treatment outcome,
Gaviscon o smaku mięty TAB should be used with caution.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or additional information.
• If symptoms worsen or do not improve after 7 days, consult a doctor.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Leaflet contents:

1. What Gaviscon o smaku mięty TAB is and what it is used for
2. Important information before taking Gaviscon o smaku mięty TAB
3. How to take Gaviscon o smaku mięty TAB
4. Possible side effects
5. How to store Gaviscon o smaku mięty TAB
6. Further information

1. WHAT GAVISCON O SMAKU MIĘTY TAB IS AND WHAT IT IS USED FOR

Gaviscon o smaku mięty TAB forms a protective layer that floats on the surface of stomach contents. This layer prevents the backflow of acidic stomach contents from the stomach, thereby reducing pain and discomfort in the throat and oral cavity. Heartburn may occur after meals (especially fatty or spicy foods), during pregnancy, or in patients with symptoms of oesophagitis (e.g. difficulty and/or painful swallowing, oral pain, vomiting).

Gaviscon o smaku mięty TAB 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 TAB

MINT TAB
When not to take Gaviscon Mint Flavour TAB

• If the patient is allergic (hypersensitive) to any component of the medicine, manifested by breathing difficulties or skin rash (see further information in the full list of adverse reactions).

When to exercise special caution when using Gaviscon Mint Flavour TAB
This medicine contains sodium (5.3 mmol per dose of two tablets) and calcium (1.6 mmol per dose of two tablets). The maximum recommended daily dose contains 1012 mg of sodium (a component of table salt). This corresponds to 50.6% of the recommended maximum daily sodium intake for an adult.
Gaviscon Mint Flavour TAB is intended for short-term treatment unless otherwise directed by a physician. Consult your doctor or pharmacist if it is necessary to take Gaviscon Mint Flavour TAB daily for a prolonged period or on a regular basis, especially if the patient needs to control salt intake in their diet.
Consult your doctor if you have kidney or heart disease, as increased salt intake may increase the risk of these conditions.
If symptoms persist for more than 7 days, consult your doctor.
This medicine contains 3.75 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Use of 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 available without a prescription.

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

Important information about certain ingredients of Gaviscon Mint Flavour TAB
The medicine contains a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. HOW TO TAKE GAVISCON MINT FLAVOUR TAB

Take the medicine orally. Chew the tablet thoroughly before swallowing.

Dosage for adults, including elderly patients, and children aged 12 years and above:
When symptoms occur, take 2 to 4 tablets after meals and at bedtime, up to four times daily.

Dosage for children under 12 years of age:
Only administer after consultation with a doctor.

Overdose of Gaviscon Mint Flavour TAB
Taking too high a dose may cause abdominal bloating and discomfort in the abdominal cavity. If this does not resolve, contact your doctor.

Missed dose of Gaviscon Mint Flavour TAB
Do not take a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Gaviscon o smaku mięty TAB may cause adverse reactions, although not
everyone will experience them.
Very rarely (in less than 1 in 10,000 patients), allergic reactions to the ingredients of the medicine may occur. Symptoms may include skin rash, itching, breathing difficulties, dizziness, swelling of the face, lips, tongue or throat.
Reporting of adverse reactions
If any adverse reactions occur, including any unlisted adverse reactions not mentioned in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE GAVISCON MINT FLAVOUR TAB

Keep out of the sight and reach of children.
Do not use Gaviscon Mint Flavour Tab after the expiry date stated on the blister and carton: EXP: month/year. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Gaviscon Mint Flavour TAB contains

• The active substances are 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate, and 80 mg of calcium carbonate.
• The other ingredients are mannitol (E421), macrogol 20 000, copovidone, aspartame (E951), peppermint flavour, magnesium stearate, and acesulfame potassium.

What Gaviscon Mint Flavour TAB looks like and contents of the pack
Gaviscon Mint Flavour TAB is a round tablet ranging in colour from white to creamy white, slightly mottled.
Gaviscon Mint Flavour TAB is available in the following pack sizes:
blister packs: 8, 16, 24, 32, 48 tablets
PP container in a cardboard box: 8, 12, 16, 18, 20, 22, 24 tablets
PP container in a cardboard box: 2x16, 2x18, 2x20, 2x22, 2x24 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane, Hull, HU8 7DS
United Kingdom

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. 801 88 88 07