GAVISCON

GAVISCON Dual 250mg/106.5mg/187.5mg chewable tablets

Important notes (mandatory information)

Gaviscon Dual 250 mg /106.5 mg /187.5 mg chewable tablets. Areas of application: for the treatment of acid-related symptoms of gastroesophageal reflux such as heartburn, acid regurgitation, indigestion (dyspepsia), e.g. after meals or during pregnancy.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Gaviscon Dual 250 mg /106.5 mg /187.5 mg chewable tablets
Active ingredients: sodium alginate, sodium hydrogen carbonate and calcium carbonate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS GAVISCON DUAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GAVISCON DUAL?
3. HOW TO TAKE GAVISCON DUAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GAVISCON DUAL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS GAVISCON DUAL AND WHAT IS IT USED FOR?

Gaviscon Dual is a combination of an alginate and two antacids (calcium carbonate and sodium hydrogen carbonate) and works in two ways

1. It forms a protective layer over the stomach contents and relieves the burning pain in the chest.
2. It neutralizes excess stomach acid and thus relieves pain and discomfort.
Gaviscon Dual is used to treat acid-related symptoms of gastroesophageal reflux such as heartburn, acid regurgitation, indigestion (dyspepsia), e.g. after meals or during pregnancy.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GAVISCON DUAL?

Gaviscon Dual must not be taken if you are allergic to sodium alginate, sodium hydrogen carbonate and calcium carbonate, menthol, azorubine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Gaviscon Dual:

• if you have severe kidney dysfunction.
• if you have an electrolyte imbalance that can cause low phosphate levels in the blood (hypophosphatemia).
• if you have or have had a significant kidney or heart disease, as certain salts can affect these diseases (please talk to your doctor about the salt content).
• if you know that you have a low level of stomach acid, as this medicine may then be less effective.

As with other antacids, Gaviscon Dual can also mask serious conditions with similar symptoms. Tell your doctor if your symptoms last longer than 7 days.

Children

Only give Gaviscon Dual to children under 12 years of age after consulting a doctor. There is a risk of increased sodium levels in the blood (hypernatremia) in children with kidney problems and inflammatory stomach or intestinal diseases (gastroenteritis).

Taking Gaviscon Dual with other medicines

Do not take any other medicines within 2 hours of taking Gaviscon Dual, as this may interact with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Pregnancy, breastfeeding and fertility

You can take this medicine if you are pregnant, breastfeeding or planning to become pregnant. As with all medicines, the duration of use should be kept as short as possible.

Driving and using machines

Gaviscon Dual has no or negligible influence on the ability to drive and use machines.

Important information about certain other ingredients of Gaviscon Dual

This medicine contains aspartame. Aspartame is a source of phenylalanine and can be harmful if you have phenylketonuria. A dose of 2 chewable tablets contains 110.75 mg (4.82 mmol) of sodium. If you need to follow a low-salt diet, you should take this into account. A dose of 2 chewable tablets also contains 130 mg (3.25 mmol) of calcium. Talk to your doctor before taking this medicine if you have kidney stones or high levels of calcium in your blood.

3. HOW TO TAKE GAVISCON DUAL?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. For oral use, chew thoroughly before swallowing. Adults (including the elderly) and children aged 12 years and over: If symptoms occur, take 2 to 4 chewable tablets after meals and before bedtime (up to four times a day). Children under 12 years of age: Take only on medical advice.

If you have taken more Gaviscon Dual than you should

If you have taken too much of this medicine, it is unlikely to have any negative effects on you. You may experience a feeling of tension in the abdomen. If you experience these symptoms, please talk to your doctor.

If you forget to take Gaviscon Dual

Do not take a double dose to make up for a forgotten dose. In this case, continue taking as usual.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Gaviscon Dual and contact a doctor immediately if any of these side effects occur.

Very rare (may affect up to 1 in 10,000 people)

Allergic reaction to any of the ingredients with symptoms such as abdominal pain, diarrhea, nausea, vomiting, rash, itching, dizziness, swelling of the face, lips, tongue or throat, and shortness of breath.

Other possible side effects

Azorubine can cause allergic reactions. In appropriately sensitized patients, menthol can trigger hypersensitivity reactions (including shortness of breath).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE GAVISCON DUAL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by:". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Store in the original package to protect the contents from moisture. Polypropylene container: Do not store above 25°C. Store in the original package to protect the contents from moisture. Shelf life after opening: 3 months. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gaviscon Dual contains

The active ingredients are: sodium alginate, sodium hydrogen carbonate and calcium carbonate. One chewable tablet contains 250 mg sodium alginate, 106.5 mg sodium hydrogen carbonate and 187.5 mg calcium carbonate. The other ingredients are: xylitol, carmellose sodium, magnesium stearate (Ph.Eur.), macrogol 20,000, mannitol (Ph.Eur.) (E 421), copovidone, acesulfame potassium, aspartame (E 951), peppermint flavor and azorubine (E122). This medicine is sugar-free and gluten-free.

What Gaviscon Dual looks like and contents of the pack

Gaviscon Dual are flat, round, bilayer chewable tablets with a peppermint smell and taste. One layer of the chewable tablet is pink and slightly speckled, the other layer is white. Gaviscon Dual is available in packs of 4, 6, 8, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets. Polypropylene container: Gaviscon Dual is available in packs of 8, 10, 12 and 16 chewable tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4
69115 Heidelberg
Tel: (06221) 9982-333
Fax:(06221)9982-500
www.gaviscon.de

Manufacturer

Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU87DS
United Kingdom

This leaflet was last revised in March 2016.

Source: Package leaflet information
Status: 10/2017
Areas of application: for the treatment of acid-related symptoms of gastroesophageal reflux such as heartburn, acid regurgitation, indigestion (dyspepsia), e.g. after meals or during pregnancy.