Gaviscon o smaku miemti Tab

PATIENT INFORMATION LEAFLET: USER INFORMATION

Gaviscon Mint Flavor TAB, 250 mg + 133.5 mg + 80 mg, chewable tablets

(Sodium alginate + Sodium hydrogen carbonate + Calcium carbonate)
Read the entire leaflet carefully, as it contains important information for the patient.
This medicinal product is available without a prescription. However, to achieve the best treatment results,
Gaviscon Mint Flavor TAB should be used cautiously.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If symptoms worsen or do not improve after 7 days, a doctor should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Gaviscon Mint Flavor TAB and what is it used for
• 2. Important information before using Gaviscon Mint Flavor TAB
• 3. How to use Gaviscon Mint Flavor TAB
• 4. Possible side effects
• 5. How to store Gaviscon Mint Flavor TAB
• 6. Other information

1. WHAT IS GAVISCON MINT FLAVOR TAB AND WHAT IS IT USED FOR

Gaviscon Mint Flavor TAB creates a protective layer that persists on the surface of stomach contents. This layer prevents the reflux of acidic stomach contents from the stomach, which reduces pain and discomfort in the throat and mouth. Heartburn may occur after meals (mainly fatty and spicy) or during pregnancy, or in patients with symptoms of esophageal inflammation (e.g., difficulty and/or impaired swallowing, pain in the mouth, vomiting).
Gaviscon Mint Flavor TAB 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.

2. IMPORTANT INFORMATION BEFORE USING GAVISCON MINT FLAVOR TAB

When not to take Gaviscon Mint Flavor TAB

• If the patient is allergic (hypersensitive) to any component of the medicinal product, manifested as difficulty breathing or skin rashes (see further information on the full list of side effects).

When to exercise special caution when using Gaviscon Mint Flavor TAB

The medicinal product contains sodium (5.3 mmol per dose consisting of two tablets) and calcium (1.6 mmol per dose consisting of two tablets). The maximum recommended daily dose of the medicinal product contains 1012 mg of sodium (a component of common salt). This corresponds to 50.6% of the recommended maximum daily sodium intake for an adult.
Gaviscon Mint Flavor TAB is intended for short-term treatment, unless otherwise recommended by a doctor. A doctor or pharmacist should be consulted if it is necessary to take Gaviscon Mint Flavor TAB daily for a longer period or regularly, especially if the patient should control their salt intake.
A doctor should be consulted in case of kidney or heart disease, as increased salt content increases the risk of these diseases.
If symptoms persist for more than 7 days, a doctor should be consulted.
The medicinal product contains 3.75 mg of aspartame in one tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicinal product.

Using other medicinal products

This medicinal product should not be used within two hours of taking other oral medicinal products, as it may affect the efficacy of some medicinal products.
The doctor or pharmacist should be informed about all medicinal products currently being taken or recently taken, including those available without a prescription.

Pregnancy and breastfeeding

This medicinal product can be used during pregnancy and breastfeeding.

Important information about some components of Gaviscon Mint Flavor TAB

The medicinal product contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.

3. HOW TO TAKE GAVISCON MINT FLAVOR TAB

The medicinal product should be taken orally. The tablet should be chewed thoroughly before swallowing.

Use in adults, including elderly patients, and in children over 12 years of age

In case of symptoms:2 to 4 tablets after meals and before bedtime, up to four times a day.
Use in children under 12 years of age:should only be given after consulting a doctor.

Overdose of Gaviscon Mint Flavor TAB

Taking too much of the medicinal product may cause abdominal bloating and discomfort in the abdominal cavity. If it does not pass, a doctor should be consulted.

Missed dose of Gaviscon Mint Flavor TAB

A double dose should not be taken to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicinal products, Gaviscon Mint Flavor TAB can cause side effects, although not everybody gets them.
Very rarely (less than 1 in 10,000 patients), allergic reactions to the components of the medicinal product may occur. Symptoms such as skin rash, itching, difficulty breathing, dizziness, facial swelling, lips, tongue, or throat may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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.
By reporting side effects, more information can be gathered on the safety of the medicinal product.

5. HOW TO STORE GAVISCON MINT FLAVOR TAB

Store in a place inaccessible and out of sight of children.
Do not use Gaviscon Mint Flavor TAB after the expiry date stated on the blister pack and carton after: EXP: month/year. The expiry date refers to the last day of the given month.
Do not store above 30°C.
Medicinal products should not be disposed of via wastewater or household waste. A pharmacist should be asked what to do with unused medicinal products. This will help protect the environment.

6. OTHER INFORMATION

What Gaviscon Mint Flavor TAB contains

• The active substances of the medicinal product are 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate, and 80 mg of calcium carbonate.
• The medicinal product also contains mannitol (E421), macrogol 20,000, copolyvidone, aspartame (E951), peppermint flavor, magnesium stearate, and acesulfame potassium.

What Gaviscon Mint Flavor TAB looks like and what the pack contains

Gaviscon Mint Flavor TAB is a white to creamy-white, slightly speckled, round tablet.
Gaviscon Mint Flavor TAB is available in packs of:
blister: 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 authorization holder

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

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
Netherlands
To obtain more detailed information, please contact the representative of the marketing authorization holder: phone 801 88 88 07
Date of last revision of the leaflet:10/2020