Gaviscon duo
Poland
Table of Contents
Package leaflet: Information for the patient
Gaviscon Duo, (500 mg + 213 mg + 325 mg)/10 ml, oral suspension
(Natrii alginas + Natrii hydrogenocarbonas + Calcii carbonas)
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- Speak to your pharmacist if you need advice or further information.
- If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. This also applies to any possible side effects mentioned in section 4.
- If there is no improvement after 7 days, or if you feel worse, consult your doctor.
Contents of the leaflet:
- What Gaviscon Duo is and what it is used for
- Important information before using Gaviscon Duo
- How to use Gaviscon Duo
- Possible side effects
- How to store Gaviscon Duo
- Contents of the pack and other information
1. What Gaviscon Duo is and what it is used for
Gaviscon Duo is a combination of alginates and two agents that neutralize hydrochloric acid (calcium carbonate and sodium hydrogen carbonate), and works through two mechanisms:
- Neutralizes excess hydrochloric acid in the stomach and relieves pain and discomfort;
- Forms a protective barrier above the stomach contents to alleviate heartburn, which lasts up to 4 hours.
This medicine is used to treat symptoms of gastro-oesophageal reflux, such as acid regurgitation, heartburn and indigestion (associated with reflux), for example after meals or during pregnancy.
2. Important information before using Gaviscon Duo
Do not use Gaviscon Duo:
- If you are allergic to any of the ingredients of this medicine (listed in section 6).
Before starting treatment with Gaviscon Duo, discuss with your doctor or pharmacist if:
- You have severe kidney disease.
- You have electrolyte disturbances causing low blood phosphate levels (hypophosphatemia).
- You have or have had in the past kidney or heart disease, as increased salt content may increase the risk of these conditions (discuss the salt content with your doctor).
- You have reduced secretion of hydrochloric acid in the stomach, as the medicine may be less effective in such cases.
- As with other agents that neutralize gastric acid, taking Gaviscon Duo may mask symptoms of other, more serious diseases.
- If symptoms persist after 7 days of treatment, you should consult your doctor.
Children
Do not use this medicine in children under 12 years of age unless otherwise advised by a doctor. In children with gastrointestinal disorders or suspected kidney failure, there is an increased risk of elevated blood sodium levels (hypernatraemia).
Other medicines and Gaviscon Duo
Do not take this medicine within two hours of taking other medicines, as it may affect the effectiveness of some medicines.
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 may be used during pregnancy and breastfeeding, or by women planning to become pregnant. However, as with all medicinal products, it is recommended to limit the duration of treatment as much as possible.
Important information about some of the ingredients of Gaviscon Duo
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions). The medicine contains 127.35 mg (5.53 mmol) of sodium per dose. This should be taken into account in patients who are monitoring sodium intake in their diet. The medicine also contains 130 mg (3.25 mmol) of calcium per dose. Consult your doctor if you have kidney stones or elevated blood calcium levels.
3. How to use Gaviscon Duo
Gaviscon Duo should always be used exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults, including elderly people, and children aged 12 years and above: 10–20 ml (one or two sachets) after meals and at bedtime (up to four times daily).
Children under 12 years of age: Only to be administered after consultation with a doctor.
Taking more Gaviscon Duo than recommended
Adverse effects from an overdose are unlikely. However, the medicine may cause abdominal bloating. If this does not resolve, consult your doctor.
If you forget to take Gaviscon Duo
Do not take a double dose to make up for a missed dose. Continue treatment as previously directed.
4. Possible adverse effects
Like any medicine, this medicinal product may cause adverse effects, although not in everyone.
Very rarely (less than 1 in 10,000 patients), allergic reactions to the components of the medicine may occur.
Symptoms may include abdominal pain, diarrhoea, nausea, vomiting, skin itching, skin rashes, dizziness, swelling of the face, lips, tongue or throat, and breathing difficulties.
Consuming large amounts of calcium carbonate, which is a component of this medicine, may lead to increased blood pH (alkalosis), increased calcium concentration in blood (hypercalcaemia), increased secretion of hydrochloric acid in the stomach, and constipation. These symptoms usually occur after intake of doses higher than recommended.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Gaviscon Duo
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the cardboard box after: "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C. Do not store in the refrigerator or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the packaging and other information
What Gaviscon Duo contains
The active substances 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 parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, peppermint flavour, and purified water.
What Gaviscon Duo looks like and contents of the pack
Gaviscon Duo is a white suspension with a mint flavour and taste.
Available pack sizes: 4, 12, 24 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland
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
For further information, please contact the representative of the Marketing Authorisation Holder: tel. 801 88 88 07
02/2019