Gaviscon Advance

Leaflet included in the packaging: patient information

Gaviscon Advance, (1000 mg + 200 mg)/10 ml, oral suspension

Sodium alginate + Potassium hydrogen carbonate
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• This medicine is available without a prescription, so you can treat certain conditions without a doctor's help. This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor.
• You should keep this leaflet, so you can read it again if you need to.
• You should consult a pharmacist if you need advice or additional information.
• If after 7 days there is no improvement or the patient feels worse, you should contact a doctor. If the patient experiences any side effects, including any possible side effects not listed in the leaflet, you should tell the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Gaviscon Advance and what is it used for
• 2. Important information before using Gaviscon Advance
• 3. How to use Gaviscon Advance
• 4. Possible side effects
• 5. How to store Gaviscon Advance
• 6. Contents of the packaging and other information

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

Gaviscon Advance belongs to a group of medicines called "gastroesophageal reflux inhibitors".
This medicine creates a protective layer that stays on the surface of the stomach contents. This layer
prevents the stomach contents from flowing back into the esophagus, relieving symptoms of heartburn and acid reflux.
Gaviscon Advance is used to treat symptoms of gastroesophageal reflux, such as belching, heartburn, and indigestion (associated with reflux), for example after meals or during pregnancy, as well as in patients with symptoms associated with reflux esophagitis.

2. Important information before using Gaviscon Advance

When not to use Gaviscon Advance:

Warnings and precautions

The medicine contains small amounts of sodium - 106 mg of sodium (the main component of common salt) in each 10 ml dose.
This is equivalent to 5% of the recommended maximum daily sodium intake for an adult.
This medicine also contains 78 mg of potassium in a 10 ml dose. This should be taken into account in patients with kidney function disorders or patients controlling potassium intake in their diet.
This medicine contains 80 mg of calcium in a 10 ml dose.
Patients who require significant restriction of these ingredients in their diet should consult a doctor before using the medicine.
You should also talk to a doctor or pharmacist if the patient needs four or more doses per day for a long time, especially if they have been advised to follow a low-sodium diet or if the patient has or has had severe kidney or heart disease, as some salts may affect these diseases.

Other medicines and Gaviscon Advance

You should tell the doctor or pharmacist about all medicines currently being used or recently used,
as well as medicines that the patient plans to use. You should wait at least 2 hours between taking this medicine and other medicines, such as tetracyclines, fluoroquinolones (types of antibiotics), iron salts, thyroid hormones, chloroquine (a medicine used to prevent malaria),
bisphosphonates (medicines used to treat osteoporosis), and estramustine (a medicine used to treat prostate cancer).

Pregnancy and breastfeeding

Before using any medicine, you should consult a doctor or pharmacist. This medicine can be used during pregnancy and breastfeeding.
The medicine contains methyl (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (also delayed).

Driving and operating machinery

This product does not affect the ability to drive vehicles and operate machinery in motion.

3. How to use Gaviscon Advance

Before using the medicine for the first time, check the security on the cap.
The medicine should be shaken before use.
Adults, including the elderly, and children over 12 years of age: 5-10 ml (one to two teaspoons) after meals and before bedtime or as directed by a doctor.
Children under 12 years of age: should only be given after consulting a doctor.

Missing a dose of Gaviscon Advance

You should not take a double dose of the medicine to make up for a missed dose. The next dose should be taken at the usual time.

Taking a higher dose of Gaviscon Advance than recommended

Taking too much of the medicine may cause stomach bloating and discomfort in the abdominal cavity. It is unlikely to be harmful, but if it does not go away, you should contact a doctor or pharmacist.
If the symptoms do not go away after 7 days of treatment, you should consult a doctor.

4. Possible side effects

Very rarely (less than 1 in 10,000 patients), allergic reactions to the ingredients of the medicine may occur.
Symptoms may occur, such as skin rashes, itching, difficulty breathing, dizziness,
swelling of the face, lips, tongue, or throat.
If any side effects occur, including any possible side effects not listed in the leaflet, you should consult a doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, you should tell the doctor or pharmacist. 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Thanks to reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gaviscon Advance

Do not use this medicine after the expiry date stated on the bottle after: EXP.
Shelf life after opening: 6 months.
The medicine should be stored out of sight and reach of children.
Do not store in the refrigerator.
Before using the product for the first time, check the security on the cap.
Medicines should not be disposed of in the drainage system or household waste containers. You should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gaviscon Advance contains

• The active substances of the medicine are sodium alginate and potassium hydrogen carbonate. A 10 ml dose of the medicine contains 1000 mg of sodium alginate and 200 mg of potassium hydrogen carbonate.
• The other excipients are: calcium carbonate, carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, aniseed flavor containing anethole, benzyl alcohol, and purified water. The product does not contain sugar or gluten.

What Gaviscon Advance looks like and what the packaging contains

Available packaging: bottles of 150, 300, or 500 ml.

Responsible entity

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

Manufacturer

Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane, Hull, East Yorkshire 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, please contact the representative of the responsible entity: tel. 0801 88 88 07
Date of last update of the leaflet:07/2020