Gaviscon duo o smaku miemti

PATIENT INFORMATION LEAFLET: PATIENT INFORMATION

Gaviscon Duo Mint Flavor

500 mg + 213 mg + 325 mg
Sodium Alginate + Sodium Hydrogen Carbonate + Calcium Carbonate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Take this medicine always exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Gaviscon Duo Mint Flavor oral suspension and what is it used for

Gaviscon Duo Mint Flavor oral suspension is a combination of an alginate and two acid-neutralizing medicines (calcium carbonate and sodium hydrogen carbonate), which work in two ways:

• 1. They form a protective layer that lasts for up to 4 hours on the surface of the stomach contents, preventing the reflux of acidic stomach contents into the esophagus, which causes heartburn.
• 2. They neutralize excess stomach acid to relieve pain and discomfort.

This medicinal product is used to treat symptoms of gastroesophageal reflux disease (GERD) associated with hyperacidity, such as heartburn, acid reflux, and indigestion, for example after meals or during pregnancy in adults and children over 12 years of age.

2. Important information before taking Gaviscon Duo Mint Flavor

When not to take Gaviscon Duo Mint Flavor:

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

Warnings and precautions

Before taking Gaviscon Duo Mint Flavor, consult your doctor or pharmacist if:

• you have or have had severe kidney or heart disease, as some salts may affect these diseases (you should discuss the salt content with your doctor),
• you have significant kidney problems,
• you have electrolyte disturbances causing low phosphate levelsin the blood (hypophosphatemia).
• you know you have reduced stomach acid secretion, which may reduce the effectiveness of the medicine.

Avoid long-term use. Like other acid-neutralizing products, taking this medicine may mask the 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 sodium levels in the blood (hypernatremia) in children who have kidney problems or stomach and intestinal inflammation (gastroenteritis).

Taking Gaviscon Duo Mint Flavor with other medicines:

Do not take this medicine within two hours of taking other oral medicines, as it may affect the effectiveness of some medicines. This is especially important when taking antihistamines (for allergy symptoms), antibiotics (such as tetracyclines and quinolones, e.g., norfloxacin, for bacterial infections), iron preparations (for iron deficiency disorders), thyroid hormones (for hypothyroidism), antifungal medicines (such as ketoconazole, for fungal infections), digoxin, and beta-adrenergic blockers (for heart disease), neuroleptics (for psychiatric disorders), thyroxine (for hypothyroidism), chloroquine (for malaria), bisphosphonates (for osteoporosis), and estramustine (for prostate cancer).
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility:

The medicine can be taken during pregnancy, breastfeeding, and by women planning to become pregnant.
As with all medicines, the duration of treatment should be as short as possible.

Important information about some ingredients of Gaviscon Duo Mint Flavor

The medicine contains 40 mg of methyl parahydroxybenzoate (E218) and 6 mg of propyl parahydroxybenzoate (E216) per 10 ml dose, which may cause allergic reactions (possible late reactions).
The medicine contains 5.21 mg of propylene glycol (E1520) per 10 ml dose.
The 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 (found in salt). This corresponds to 51% of the recommended maximum daily intake of sodium in the diet for adults.
If you take Gaviscon Duo Mint Flavor regularly for a long time, especially if you are on a low-sodium diet, you should consult your doctor or pharmacist.
The medicine also contains 130 mg (3.25 mmol) of calcium per 10 ml dose. Before taking this medicine, consult your doctor if you have kidney stones or high calcium levels in the blood.

3. How to take Gaviscon Duo Mint Flavor

Take this medicine always exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
For oral use. Shake well before use.
Adults and children over 12 years:Take 10-20 ml after meals and before bedtime, up to four times a day.
Children under 12 years:Not recommended for children under 12 years of age.

Overdose of Gaviscon Duo Mint Flavor

Unfavorable effects due to excessive doses of the medicine are unlikely. However, the medicine may cause bloating and abdominal discomfort. If it does not go away, consult your doctor.
Missed dose of Gaviscon Duo Mint Flavor:If you miss a dose, do not take a double dose at the next intake. Continue treatment as before.

4. Possible side effects

Like all medicines, Gaviscon Duo Mint Flavor oral suspension can cause side effects, although not everybody gets them.
If you experience side effects, stop taking the medicine and consult your doctor immediately.

• Very rare (less than 1 in 10,000 patients) may be allergic reactions to the ingredients of the medicine. Symptoms may include swelling of the face, lips, tongue, or throat, and difficulty breathing (anaphylactic reaction, anaphylactoid reaction) or itchy skin rash (hives).
• Other symptoms may include stomach pain, diarrhea, nausea, vomiting, itchy skin, or rash and wheezing (bronchospasm).

Consuming large amounts of calcium carbonate, a component of this medicine, may cause increased blood pH (alkalosis), high calcium levels in the blood (hypercalcemia), increased stomach acid secretion, and constipation. These symptoms usually occur after taking higher doses than recommended.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl

• The side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gaviscon Duo Mint Flavor

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 EXP (month/year). The expiry date refers to the last day of the month stated.
Do not store in the refrigerator or freeze. Use within 6 months of opening. Before first use, check that the cap seal is not broken.
Medicines should 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 Mint Flavor contains:

The active substances of the medicine 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, peppermint flavor, sodium hydroxide, and water.
The flavors contain propylene glycol (E1520).

What Gaviscon Duo Mint Flavor looks like and contents of the pack:

Gaviscon Duo Mint Flavor oral suspension is a non-transparent, white to creamy suspension with a peppermint flavor and odor.
Gaviscon Duo Mint Flavor oral suspension is available in bottles of 150, 200, 250, 300, 500, and 600 ml in a cardboard box. The medicinal product may be supplied in an outer cardboard packaging. It may be supplied with a measuring cup (natural polypropylene) with 5 ml, 10 ml, 15 ml, and 20 ml graduations. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization 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,
Netherlands
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
[email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: