Gaviscon Advance
Italy
Table of Contents
www.agenziafarmaco.gov.it/it/responsabili .
www.agenziafarmaco.gov.it/it/responsabili .
( Package leaflet: Information for the patient
Gaviscon Advance oral suspension, peppermint flavour
Sodium alginate and potassium bicarbonate
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- What Gaviscon Advance is and what it is used for
- What you need to know before taking Gaviscon Advance
- How to take Gaviscon Advance
- Possible side effects
- How to store Gaviscon Advance
- Contents of the pack and other information
1. What Gaviscon Advance is and what it is used for
Gaviscon Advance belongs to a group of medicines called "anti-reflux agents".
This medicine forms a protective layer that floats on top of the stomach contents.
This layer prevents reflux and keeps stomach contents away from the inner wall of the oesophagus, thereby relieving symptoms of heartburn and indigestion.
Gaviscon Advance is used to treat symptoms associated with gastro-oesophageal reflux, such as acid regurgitation, heartburn and indigestion (due to reflux), for example after meals, during pregnancy or in patients with symptoms related to reflux oesophagitis.
2. What you need to know before taking Gaviscon Advance
Do not take Gaviscon Advance:
if you are allergic (hypersensitive) to the active substances or to any of the other components of
this medicine (listed in section 6).
Warnings and precautions:
This medicine contains sodium (4.6 mmol per 10 ml), potassium (2.0 mmol per 10 ml), and
calcium.
- If you have been advised to follow a diet particularly low in any of these ingredients, consult your doctor before taking this medicine.
- Consult your doctor regarding the content of these salts if you suffer or have suffered from kidney or heart disease, as certain salts may interfere with these conditions. Other medicines and Gaviscon Advance: Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. Pregnancy and breastfeeding: Ask your doctor or pharmacist for advice before taking any medicine. Important information about some ingredients of Gaviscon Advance: This medicine contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions). Driving and using machines: This medicine has no effect on the ability to drive or operate machinery.
3. How to take Gaviscon Advance
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Check that the seal is intact before taking this medicine.
Shake well before use.
Adults, including elderly and children aged 12 years and over: 5–10 ml (1–2 teaspoonfuls of 5 ml) after meals and at bedtime, or as directed by a doctor.
Children under 12 years: should only be taken on medical advice.
If you forget to take Gaviscon Advance, do not take a double dose to make up for the missed dose. Continue taking it as before.
If you take more Gaviscon Advance than you need, you may feel bloated. This is unlikely to cause harm, but consult your doctor or pharmacist if the discomfort persists.
If symptoms persist after 7 days, consult your doctor.
4. Possible side effects
Very rarely (less than 1 patient in 10,000), there is a possibility of an allergic reaction
to the ingredients. Symptoms may include skin rash, itching, difficulty breathing,
dizziness, swelling of the face, lips, tongue or throat.
If you experience any of these or other side effects, stop taking the medicine and
consult your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system available at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Gaviscon Advance
Do not use this medicine after the expiry date stated on the packaging.
Use the product within 6 months of first opening.
Keep out of the sight and reach of children.
Do not refrigerate.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Gaviscon Advance contains:
10 ml of oral suspension contain 1000 mg of sodium alginate and 200 mg of potassium bicarbonate as active substances. The other ingredients are calcium carbonate, carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, peppermint flavour, and purified water.
This medicine does not contain sugar or gluten.
Description of the appearance of Gaviscon Advance and contents of the pack
This medicine is available in bottles of 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml. It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer:
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano.
This leaflet was last updated on:
GAVISCON ADVANCE chewable tablets
Sodium alginate + potassium bicarbonate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Gaviscon Advance is and what it is used for
- What you need to know before taking Gaviscon Advance
- How to take Gaviscon Advance
- Possible side effects
- How to store Gaviscon Advance
- Package contents and other information
1. What Gaviscon Advance is and what it is used for
Gaviscon Advance chewable tablets belong to a group of medicines called "anti-reflux agents".
This medicine forms a protective layer that floats on top of the stomach contents. This layer prevents reflux and keeps stomach contents away from the inner wall of the oesophagus, thereby relieving symptoms of heartburn and indigestion.
Gaviscon Advance is used to treat symptoms related to gastro-oesophageal reflux, such as acid regurgitation, heartburn (pyrosis), and indigestion (due to reflux), for example after meals, during pregnancy, or in patients with symptoms associated with reflux oesophagitis.
2. What you need to know before taking Gaviscon Advance
Do not take Gaviscon Advance chewable tablets:
if you are allergic (hypersensitive) to the active substances or to any of the other ingredients
of this medicine (listed in section 6).
Consult your doctor if symptoms do not improve within seven days.
Warnings and precautions:
- Each dose of 2 tablets contains 4.5 mmol of sodium, 2.0 mmol of potassium, and 2.0 mmol of calcium. If you have been advised to follow a diet particularly low in any of these ingredients, consult your doctor before taking this medicine.
- When used in the presence of renal insufficiency, the product may cause central nervous system depression; therefore, the product must not be used in patients with renal insufficiency.
Gaviscon Advance chewable tablets contain aspartame (E951):
If you suffer from phenylketonuria, do not take this product as it is a source of
phenylalanine.
Other medicines and Gaviscon Advance:
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding:
Gaviscon Advance may be taken during pregnancy and breastfeeding.
3. How to take Gaviscon Advance
For oral administration. Gaviscon Advance tablets must be
thoroughly chewed before swallowing.
Adults, including elderly, and children from 12 years of age onwards: 1-2 tablets after meals and
at bedtime, or as directed by a doctor.
Children under 12 years: should only be given on medical advice.
If you take more Gaviscon Advance than you should, you may feel bloated. This is
unlikely to cause harm, but consult your doctor or pharmacist if the discomfort persists.
If you forget to take Gaviscon Advance, do not take a double dose to make up for
the missed dose; continue taking it as before.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience these or any other side effects, stop taking the medicine and contact your doctor immediately.
Very rarely (less than 1 patient in 10,000) there is a possibility of an allergic reaction to the ingredients. Symptoms may include skin rash, itching, difficulty breathing, dizziness, swelling of the face, lips, tongue or throat.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Gaviscon Advance
Do not use the product after the expiry date stated on the packaging.
Keep the medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging.
6. Contents of the pack and other information
What Gaviscon Advance contains:
Each tablet contains 500 mg of sodium alginate and 100 mg of potassium bicarbonate as active substances. The other components are mannitol (E421), calcium carbonate, macrogol 20,000, copovidone, magnesium stearate, aspartame (E951), acesulfame potassium and peppermint flavour.
Description of the appearance of Gaviscon Advance and contents of the pack
White to off-white, circular, flat tablet with bevelled edges, with peppermint odour and taste.
Blister pack containing 6 individually sealed tablets. 2 or 4 blisters per carton.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer:
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano
This leaflet was last updated on