Gaviscon duo tab with mint flavor

Package leaflet: Information for the patient

Gaviscon duo tab o smaku mięty
250 mg + 106.5 mg + 187.5 mg, chewable tablets
Sodium alginate + Sodium hydrogen carbonate + Calcium carbonate
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or
as directed by a doctor or pharmacist.

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

Leaflet contents:

1. What Gaviscon duo tab o smaku mięty is and what it is used for
2. Important information before using Gaviscon duo tab o smaku mięty
3. How to use Gaviscon duo tab o smaku mięty
4. Possible side effects
5. How to store Gaviscon duo tab o smaku mięty
6. Contents of the pack and other information

1. What Gaviscon duo tab o smaku mięty is and what it is used for

Gaviscon duo tab o smaku mięty is a combination of alginate and two agents that neutralize gastric acid (calcium carbonate and sodium hydrogen carbonate), which work in two ways:

1. Forming a protective barrier above the stomach contents, helping to relieve heartburn (the soothing effect may last up to 4 hours).
2. Neutralizing excess hydrochloric acid in the stomach to relieve pain and discomfort.

This medicine is used to treat symptoms of acid gastro-oesophageal reflux, such as heartburn, regurgitation of acidic stomach contents, and indigestion, for example after meals or during pregnancy.

2. Important information before using Gaviscon duo tab o smaku mięty

When not to use this medicine

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Gaviscon duo tab o smaku mięty, discuss the following with your
doctor or pharmacist:

• if the patient suffers or has suffered from a serious kidney or heart disease, because certain salts may affect these conditions (discuss the salt content of the medicine with your doctor).
• if the patient has severe kidney impairment.
• if the patient has electrolyte disturbances causing low blood phosphate levels (hypophosphatemia).
• if the patient has reduced stomach acid, the medicine may be less effective.

As with other acid-neutralizing medicines, taking this medicine may mask symptoms of other, more serious conditions.
If symptoms persist for more than 7 days, consult a doctor.
Children
This medicine should not be given to children under 12 years of age. There is a risk of
increased blood sodium levels (hypernatremia) in children with impaired kidney function
or with inflammation of the stomach or intestines.
Gaviscon duo tab o smaku mięty and other medicines
Do not take this medicine within two hours of taking any other oral medicines, as it may interfere with their effectiveness. This is particularly important if the patient is taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparations, thyroid hormones, antifungal medicines (such as ketoconazole), digoxin and beta-blockers (used in heart conditions), neuroleptics (used in psychiatric disorders), thyroxine, chloroquine (used for malaria), bisphosphonates (used in osteoporosis), or estramustine (used in prostate cancer).
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
The patient may take this medicine if she is pregnant, breastfeeding, or planning to have a child. As with all medicines, the duration of treatment should be as short as possible.
Important information about certain ingredients of this medicine
This medicine contains 5.86 mg of aspartame (E951) in each chewable tablet.
Aspartame is a source of phenylalanine. It may be harmful if the patient has phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
The chewable tablets contain azorubine (E122), which may cause an allergic reaction.
The medicine contains 223.7 mg (9.728 mmol) of sodium in a dose of four chewable tablets.
The maximum recommended daily dose of this medicine contains 895 mg of sodium (present in table salt). This corresponds to 44.75% of the recommended maximum daily sodium intake for an adult. If the patient takes this medicine daily for a prolonged period, discuss this with a pharmacist or doctor, especially if the patient has been advised to follow a low-sodium diet.
The medicine contains 300 mg (7.5 mmol) of calcium in a dose of four chewable tablets.
Talk to your doctor before taking this medicine if the patient has kidney stones or high blood calcium levels.

3. How to take Gaviscon duo tab o smaku mięty

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral administration. Chew thoroughly before swallowing.
Adults and adolescents aged 12 years and older: When symptoms occur, take two to four chewable tablets after meals and at bedtime, up to four times daily.
Children under 12 years of age: This medicine is not recommended for children under 12 years of age.
If you take more of this medicine than recommended:
It is unlikely that taking an excessive dose of this medicine will cause harm to the patient. However, bloating and abdominal discomfort may occur. If symptoms persist, consult your doctor.
If you forget to take this medicine: Do not take a double dose to make up for the missed dose. Continue taking the medicine as previously instructed.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If adverse effects occur, you should stop using the medicine and consult a doctor immediately. Very rarely (may affect up to 1 in 10,000 people), an allergic reaction to the ingredients of the medicine may occur. Symptoms may include abdominal pain, diarrhoea, nausea, vomiting, rash, itching, dizziness, swelling of the face, lips, tongue or throat, and difficulty breathing.
Consuming large amounts of calcium carbonate, an ingredient in this medicine, may lead to increased blood pH (alkalosis), elevated levels of calcium in the blood (hypercalcaemia), increased gastric acid secretion, and constipation. These usually occur after doses higher than recommended.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Gaviscon duo tab o smaku mięty

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack
following "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Gaviscon duo tab o smaku mięty contains
The active substances in each chewable tablet are 250 mg of sodium alginate,
106.5 mg of sodium bicarbonate and 187.5 mg of calcium carbonate. The other ingredients are: macrogol
20, mannitol type 100, copovidone, peppermint flavour (containing maltodextrin and arabic gum),
acesulfame potassium, aspartame (E951), azorubine, aluminium lake (E122), magnesium stearate, and xylitol.
What Gaviscon duo tab o smaku mięty looks like and contents of the pack
Flat, round, two-layered chewable tablets with a peppermint odour and taste.
One layer of the chewable tablet is pink-coloured with a slightly mottled appearance and marked with "GDA" on the surface, while the other layer is white with sword and circle symbols.
This medicine is available in packs containing 12, 16, 24, 32, 48 or 60 chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05 – 100 Nowy Dwór Mazowiecki
tel. 0 801 88 88 07
Manufacturer/Importer:
RB NL Brands B.V.,
Schiphol Boulevard 207
1118 BH Schiphol
The Netherlands
This medicinal product is authorised in the European Economic Area countries under the following names: