Gaviscon duo with mint flavor

Gaviscon Duo with mint flavour
500 mg + 213 mg + 325 mg
Oral suspension
Natrii alginas + Natrii hydrogenocarbonas + Calcii carbonas
Please read the package leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact 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 your doctor.

Contents of the leaflet

1. What Gaviscon Duo with mint flavour is and what it is used for

2. Important information before taking Gaviscon Duo with mint flavour

3. How to take Gaviscon Duo with mint flavour

4. Possible side effects

5. How to store Gaviscon Duo with mint flavour

6. Contents of the pack and other information

7. What is Gaviscon Duo with mint flavour oral suspension and what is it used for?

Gaviscon Duo with mint flavour oral suspension is a combination of alginic acid and two agents that neutralize gastric acid (calcium carbonate and sodium hydrogen carbonate), which work in two ways:

1. They form a protective layer that remains on the surface of stomach contents for up to 4 hours, preventing the backflow of acidic stomach contents from the stomach, which causes a burning sensation in the chest.
2. They neutralize excess hydrochloric acid in the stomach to relieve pain and discomfort.

This medicinal product is used to treat symptoms of gastroesophageal reflux associated with hyperacidity, such as acid 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 with mint flavour

When not to use Gaviscon Duo with mint flavour:

• if the patient has known hypersensitivity (allergic reaction) to any of the ingredients of the medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Gaviscon Duo with mint flavour, consult your doctor or pharmacist if:

• the patient suffers or has suffered from severe kidney or heart disease, because certain salts may affect these conditions (discuss sodium content with your doctor),
• the patient has significant kidney problems,
• the patient has electrolyte disturbances causing low blood phosphate levels (hypophosphatemia),
• the patient knows they have reduced hydrochloric acid secretion in the stomach, which may reduce the effectiveness of the medicine.

Prolonged use should be avoided. As with other agents that neutralize gastric acid, taking this medicine may mask symptoms of other, more serious diseases.
If symptoms do not improve 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 (hypernatremia) in children who have kidney problems or gastroenteritis (inflammation of the stomach and intestines).

Taking Gaviscon Duo with mint flavour with other medicines:
Do not take this medicine within two hours of other oral medicines, as it may affect the efficacy 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 (in iron deficiency disorders), thyroid hormones (in thyroid hormone deficiency), antifungal medicines such as ketoconazole (for fungal infections), digoxin and beta-blockers (for heart conditions), neuroleptics (for psychiatric disorders), thyroxine (for thyroid hormone deficiency), chloroquine (for malaria), bisphosphonates (for osteoporosis), and estramustine (for prostate gland treatment).
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility:
This medicine may be used during pregnancy, breastfeeding, and by 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 with mint flavour
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 5.21 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 taking Gaviscon Duo with mint flavour 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 use if you have kidney stones or high blood calcium levels.

3. How to use Gaviscon duo o smaku mięty

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.
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 of age: Not recommended for children under 12 years of age.
Taking more Gaviscon duo o smaku mięty 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 resolve, contact a doctor.
Missing a dose of Gaviscon duo o smaku mięty: If a dose is missed, do not take a double dose next time. Continue treatment as before.

4. Possible adverse reactions

Like all medicines, Gaviscon Duo o smaku mięty mint-flavoured 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).

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

Reporting of adverse reactions
If any adverse reactions occur in patients, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 improve the safety information available for this medicine.

5. How to store Gaviscon Duo with mint flavour

Keep this medicine out of 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 indicated 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 intact.
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 pack and other information

What Gaviscon Duo mint flavour contains:
The active substances in each 10 ml dose are 500 mg of sodium alginate, 213 mg of sodium hydrogen carbonate, and 325 mg of calcium carbonate.
The other ingredients are carbomer, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), sodium saccharin, mint flavour, sodium hydroxide, and water.
The flavours contain propylene glycol (E1520).

What Gaviscon Duo mint flavour looks like and contents of the pack:
Gaviscon Duo mint flavour oral suspension is an opaque, white to creamy suspension with a mint odour and taste.
Gaviscon Duo mint flavour oral suspension is available in bottles with a capacity of 150, 200, 250, 300, 500 and 600 ml, which may be supplied in an outer cardboard carton. It may be supplied with a measuring spoon (natural polypropylene) marked with graduations at 5 ml, 10 ml, 15 ml and 20 ml. Not all pack types may be marketed. The cardboard box and dosing device or measuring spoon may not be available in all markets / in all pack sizes.

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

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: