Gaviscon duo with forest fruit flavor

Gaviscon Duo o smaku owoców leśnych
500 mg + 213 mg + 325 mg
Sodium alginates + Sodium hydrogen carbonate + Calcium carbonate
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 a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those 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, consult your doctor.

Table of contents

1. What Gaviscon Duo o smaku owoców leśnych is and what it is used for
2. Important information before taking Gaviscon Duo o smaku owoców leśnych
3. How to take Gaviscon Duo o smaku owoców leśnych
4. Possible side effects
5. How to store Gaviscon Duo o smaku owoców leśnych
6. Contents of the pack and other information

1. What Gaviscon Duo o smaku owoców leśnych oral suspension is and what it is used for

Gaviscon Duo o smaku owoców leśnych oral suspension is a combination of alginate and two agents that neutralize gastric acid (calcium carbonate and sodium hydrogen carbonate), which work in two ways:

1. It forms a protective layer that remains on the surface of stomach contents for up to 4 hours, preventing the backflow of acidic stomach contents into the oesophagus, which causes heartburn.
2. It neutralizes excess hydrochloric acid in the stomach to relieve pain and discomfort.

This medicinal product is used to treat symptoms of gastro-oesophageal reflux associated with hyperacidity, such as regurgitation, heartburn, and indigestion, for example after meals or during pregnancy, in adults and children aged 12 years and older.

2. Important information before taking Gaviscon Duo o smaku owoców leśnych

When not to take Gaviscon Duo o smaku owoców leśnych:

• If you are allergic (hypersensitive) to any of the ingredients of the medicine (listed in section 6).

Warnings and precautions

Before taking Gaviscon Duo o smaku owoców leśnych, consult your doctor or pharmacist if:

• You suffer from or have suffered from severe kidney or heart disease, because certain salts may affect these conditions (discuss sodium content with your doctor).
• You have serious kidney problems.
• You have electrolyte disturbances causing low blood phosphate levels (hypophosphataemia).
• You know you have reduced hydrochloric acid secretion in the stomach, which may reduce the effectiveness of the medicine.

Avoid prolonged use. As with other medicines that neutralize gastric acid, taking this medicine may mask symptoms of more serious underlying conditions.
If symptoms persist after seven days, consult your doctor.

Children
Not recommended for children under 12 years of age.
There is a risk of increased blood sodium levels (hypernatraemia) in children with kidney problems or with gastroenteritis (inflammation of the stomach and intestines).

Taking Gaviscon Duo o smaku owoców leśnych with other medicines:
Do not take this medicine within two hours of taking other oral medicines, as it may affect the effectiveness of certain drugs. This is particularly important when taking antihistamines (for allergy symptoms), antibiotics (tetracyclines and quinolones such as norfloxacin, used to treat bacterial infections), iron preparations (for iron deficiency disorders), thyroid hormones (for hypothyroidism), antifungal medicines such as ketoconazole (for fungal infections), digoxin and beta-blockers (for heart conditions), neuroleptics (for psychiatric disorders), thyroxine (for hypothyroidism), chloroquine (for malaria), bisphosphonates (for osteoporosis), and estramustine (for prostate cancer).

Tell your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding, and effects on fertility:
This medicine may be used during pregnancy, breastfeeding, and in women planning to become pregnant.
As with all medicines, treatment duration should be as short as possible.

Important information about certain ingredients of Gaviscon Duo o smaku owoców leśnych
This medicine contains 40 mg of methyl parahydroxybenzoate (E218) and 6 mg of propyl parahydroxybenzoate (E216) per 10 ml dose, which may cause allergic reactions (including delayed-type reactions).
This medicine contains 32 mg of propylene glycol (E1520) per 10 ml dose.
This medicine contains 128 mg (5.6 mmol) of sodium per 10 ml dose. The maximum recommended daily dose of this medicine contains 1023 mg of sodium (present in table salt). This corresponds to 51% of the recommended maximum daily sodium intake in the adult diet.
If you are taking Gaviscon Duo o smaku owoców leśnych daily for a prolonged period, patients—especially those monitoring dietary sodium intake—should consult their doctor or pharmacist.
This medicine also contains 130 mg (3.25 mmol) of calcium per 10 ml dose. Consult your doctor before using this medicine if you have kidney stones or high blood calcium levels.

3. How to use Gaviscon duo o smaku owoców leśnych

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use. Shake well before use.
Adults and children aged 12 years and older: When symptoms occur, take 10–20 ml after meals and at bedtime, up to four times daily.
Children under 12 years: Use in children under 12 years of age is not recommended.
Taking more Gaviscon duo o smaku owoców leśnych than recommended
Adverse effects from an overdose are unlikely. However, the medicine may cause a feeling of bloating and abdominal discomfort. If this does not pass, contact a doctor.
If you forget to take Gaviscon duo o smaku owoców leśnych
If a dose is missed, do not take a double dose at the next administration. Continue treatment as previously directed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Gaviscon duo o smaku owoców leśnych oral suspension may cause adverse reactions, although not everyone experiences them.
If adverse reactions occur, discontinue use of the medicine and consult a doctor immediately.

• Very rarely (less than 1 in 10,000 patients), allergic reactions to the ingredients of the medicine may occur. Symptoms may include swelling of the face, lips, tongue or throat, and breathing difficulties (anaphylactic reaction, anaphylactoid reaction), or itchy skin rash (urticaria).
• Other symptoms may include: abdominal pain, diarrhoea, nausea, vomiting, skin itching or rash, and wheezing (bronchospasm).

Consuming large amounts of calcium carbonate, one of the ingredients of this medicine, may lead to increased blood pH (alkalosis), elevated calcium levels in the blood (hypercalcaemia), increased secretion of hydrochloric acid in the stomach, and constipation. These symptoms usually occur after taking doses higher than recommended.

Reporting of adverse reactions
If any adverse effects occur in patients, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE GAVISCON DUO O SMAKU OWOCÓW LEŚNYCH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after the letters EXP
(month/year). The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze. Use within 6 months after opening. Before first use, check that the tamper-evident seal on the cap is not broken.
Medicines must 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Gaviscon Duo Forest Fruit Flavour contains:
The active substances in each 10 ml dose are: 500 mg of sodium alginate, 213 mg of sodium
hydrogencarbonate, and 325 mg of calcium carbonate.
The other ingredients are carbomer, methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216), sodium saccharin, raspberry flavour, cranberry flavour, fruit flavour
(Aromat Fantasy Fruit Masking Flavour PHL-203715), sodium hydroxide, and water.
The flavours contain propylene glycol (E1520).

What Gaviscon Duo Forest Fruit Flavour looks like and contents of the pack:
Gaviscon Duo Forest Fruit Flavour oral suspension is an opaque, white to creamy suspension with a forest fruit flavour and odour.
Gaviscon Duo Forest Fruit Flavour oral suspension is available in bottles of 150, 200, 250, 300, 500, and 600 ml, packed in a cardboard box. The medicinal product may be supplied with an outer cardboard packaging. It may be supplied with a measuring cup (natural polypropylene) marked with graduations at 5 ml, 10 ml, 15 ml, and 20 ml. Not all pack sizes may be marketed. The cardboard box and dispenser or measuring spoon may not be available in all markets / for all pack sizes.

Marketing Authorisation Holder
Marketing Authorisation 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,
The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
[email protected]

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: