Gaviscon Duo

Leaflet included in the packaging: patient information

Gaviscon Duo, (500 mg + 213 mg + 325 mg)/10 ml, oral suspension

(Sodium alginate + Sodium hydrogen carbonate + Calcium carbonate)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. This also applies to any possible side effects listed in section 4.
• If you do not feel better or if you feel worse after 7 days, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Gaviscon Duo and what is it used for
• 2. Important information before taking Gaviscon Duo
• 3. How to take Gaviscon Duo
• 4. Possible side effects
• 5. How to store Gaviscon Duo
• 6. Package contents and other information

1. What is Gaviscon Duo and what is it used for

Gaviscon Duo is a combination of alginate and two acid-neutralizing agents (calcium carbonate and sodium hydrogen carbonate) and works through two mechanisms:

• Neutralizes excess stomach acid and relieves pain and discomfort;
• Creates a protective barrier over the stomach contents to soothe the burning sensation in the chest, which can last up to 4 hours. This medicine is used to treat symptoms of gastroesophageal reflux, such as heartburn, acid reflux, and indigestion (associated with reflux), for example, after meals or during pregnancy.

2. Important information before taking Gaviscon Duo

When not to take Gaviscon Duo

Before starting to take Gaviscon Duo, you should discuss it with your doctor or pharmacist:

• As with other acid-neutralizing agents, taking Gaviscon Duo may mask the symptoms of other, more serious diseases.

Children

This medicine should not be given to children under 12 years of age, unless advised by a doctor. In children with stomach or intestinal disorders or suspected kidney failure, there is an increased risk of elevated sodium levels in the blood (hypernatremia).

Other medicines and Gaviscon Duo

This medicine should not be taken within 2 hours of taking other medicines, as it may affect the efficacy of some medicines.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

This medicine can be taken during pregnancy and breastfeeding or by women planning to become pregnant.
However, as with all medicinal products, it is recommended to limit the treatment time as much as possible.

Important information about some ingredients of Gaviscon Duo

The medicine contains methyl (E218) and propyl (E216) parahydroxybenzoate, which may cause allergic reactions (including hypersensitivity).
The medicine contains 127.35 mg (5.53 mmol) of sodium in each dose.
You should take this into account if you are on a low-sodium diet.
The medicine also contains 130 mg (3.25 mmol) of calcium in each dose.
You should consult your doctor if you have kidney stones or elevated calcium levels in the blood.

3. How to take Gaviscon Duo

Gaviscon Duo should always be taken exactly as described in this leaflet or as advised by your doctor or pharmacist.
In case of any doubts, you should consult your doctor or pharmacist.
Adults, including the elderly, and children over 12 years: 10-20 ml(one or two sachets) after meals and before bedtime (up to four times a day).
Children under 12 years:should only be given after consulting a doctor.

Taking a higher dose of Gaviscon Duo than recommended

Adverse effects due to excessive doses of the medicine are unlikely.
However, the medicine may cause stomach bloating.
If it persists, you should contact your doctor.

Missing a dose of Gaviscon Duo

You should not take a double dose to make up for a missed dose.
You should continue treatment as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (less than 1 in 10,000 patients) allergic reactions to the ingredients of the medicine may occur.
Symptoms may include stomach pain, diarrhea, nausea, vomiting, skin rash, itching, dizziness, facial, lip, tongue, or throat swelling, and difficulty breathing.
Consuming large amounts of calcium carbonate, an ingredient of this medicine, may cause elevated blood pH (alkalosis), increased calcium levels in the blood (hypercalcemia), increased stomach acid secretion, and constipation.
These symptoms usually occur after taking doses higher than recommended.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Gaviscon Duo

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the sachet and carton after: "EXP".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package contents and other information

What Gaviscon Duo contains

The active substances of the medicine in each sachet (10 ml) are 500 mg of sodium alginate, 213 mg of sodium hydrogen carbonate, and 325 mg of calcium carbonate.
Other ingredients of the medicine are carbomer, methyl (E218) and propyl (E216) parahydroxybenzoate, sodium saccharin, sodium hydroxide, peppermint flavor, and purified water.

What Gaviscon Duo looks like and contents of the pack

Gaviscon Duo is a white suspension with a peppermint flavor and odor.
Available pack sizes: 4, 12, 24 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki

Manufacturer

Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane, Hull, HU8 7DS
United Kingdom

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
To obtain more detailed information, you should contact the representative of the marketing authorization holder: tel. 801 88 88 07

Date of last revision of the leaflet:

02/2019