Gaviscon duo tab with forest fruit flavour

Package leaflet: Information for the patient

Gaviscon duo tab fruit flavour
250 mg + 106.5 mg + 187.5 mg, chewable tablets
Sodium alginates + Sodium hydrogen carbonate + Calcium carbonate
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
Please read the entire leaflet carefully before using this 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 the 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 symptoms do not improve after 7 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet:

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

1. What Gaviscon duo tab fruit flavour is and what it is used for

Gaviscon duo tab fruit flavour is a combination of alginate and two agents that neutralize gastric acid (calcium carbonate and sodium hydrogen carbonate), which works in two ways:

1. By forming a protective barrier over the stomach contents, helping to relieve heartburn (the soothing effect may last up to 4 hours).
2. By 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 owoców leśnych

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 taking Gaviscon duo tab o smaku owoców leśnych, discuss with your doctor or pharmacist:

• if the patient has or has had a serious kidney or heart disease, because certain salts may affect these conditions (discuss with your doctor the salt content of the medicine).
• if the patient has previously been diagnosed with intolerance to certain sugars.
• if the patient has severe kidney impairment.
• if the patient has electrolyte disturbances causing low blood phosphate levels (hypophosphatemia).
• if the patient has reduced gastric acid, the medicine may be less effective.

As with other acid-neutralizing medicines, taking this medicine may mask symptoms of other, more serious disorders.
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 sodium levels in the blood (hypernatremia) in children with impaired kidney function or with gastritis or gastroenteritis.
Gaviscon duo tab o smaku owoców leśnych and other medicines
Do not take this medicine within two hours of taking other oral medicines, as this 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 diseases), neuroleptics (used in psychiatric disorders), thyroxine, chloroquine (used in malaria), bisphosphonates (used in osteoporosis), and 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 kept 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 the 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 it 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 the dose of four chewable tablets.
Talk to your doctor before using this medicine if the patient has kidney stones or high blood calcium levels.
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Gaviscon duo tab o smaku owoców leśnych

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral use. 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: Not recommended for children under 12 years of age.
Taking more than the recommended dose of this medicine
It is unlikely that taking more than the recommended dose of this medicine will cause harm to the patient. However, bloating and abdominal discomfort may occur. If symptoms persist, consult a doctor.
Missed dose of this medicine: Do not take a double dose to make up for a 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, 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 breathing difficulties.

Consuming large amounts of calcium carbonate, an ingredient of this medicine, may lead to increased blood pH (alkalosis), elevated calcium levels 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 a doctor or pharmacist. Adverse effects 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 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gaviscon duo tab o smaku owoców leśnych

Keep this medicine out of 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 specified 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. This will help protect the environment.

6. Contents of the pack and other information

What Gaviscon duo fruit flavour chewable tablets contain
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, cranberry flavour (flavouring substances, gum arabic, potato maltodextrin, sucrose, glyceryl trioctanoate), raspberry flavour (flavouring substances, waxy maize starch maltodextrin, propylene glycol, modified waxy maize starch), fruit flavour (flavouring substances, gum arabic, potato maltodextrin, sucrose, glyceryl trioctanoate, propylene glycol), acesulfame potassium, aspartame (E951), azorubine, aluminium lake (E122), magnesium stearate, xylitol.

What Gaviscon duo fruit flavour chewable tablets look like and contents of the pack
Flat, round, two-layered chewable tablets with a forest fruit flavour and odour. One layer of the chewable tablet is pink-coloured with a slightly mottled appearance and marked with "GDB" 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 medicine is authorised in the European Economic Area countries under the following names: