Active ingredients: Sodium alginate, potassium bicarbonate
Gaviscon Advance oral suspension
Gaviscon advance package inserts are available for pack sizes:- Gaviscon Advance oral suspension
- Gaviscon Advance oral suspension mint flavor in sachets
- GAVISCON ADVANCE chewable tablets
Why is Gaviscon advance used? What is it for?
Gaviscon Advance belongs to a group of medicines called 'anti-reflux'.
This medicine forms a protective layer that floats over the contents of the stomach. This layer prevents reflux and keeps stomach contents away from the inner wall of the esophagus relieving the symptoms of heartburn and indigestion.
Gaviscon Advance is used to treat symptoms related to gastroesophageal reflux, such as acid regurgitation, heartburn and indigestion (due to reflux), for example after meals or during pregnancy or in patients with symptoms related to oesophagitis due to reflux.
Contraindications When Gaviscon advance should not be used
Do not take Gaviscon Advance:
- if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine
Precautions for use What you need to know before taking Gaviscon advance
This medicine contains sodium (4.6 mmol per 10 ml), potassium (2.0 mmol per 10 ml) and calcium.
- If you have been recommended to follow a diet that is particularly low in any of these salts, talk to your doctor before taking this medicine.
- Consult your doctor regarding the content of these salts if you have or have suffered from kidney or heart disease, as some salts can interfere with these diseases.
Interactions Which drugs or foods may change the effect of Gaviscon advance
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Gaviscon Advance:
This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (including delayed).
Driving and using machines:
This medicine has no influence on the ability to drive and use machines.
Dose, Method and Time of Administration How to use Gaviscon advance: Posology
Check that the closure is intact before taking this medicine.
Shake well before use.
Adults including the elderly and children aged 12 years and over: 5-10ml (1-2 5ml teaspoons) after meals and in the evening before going to bed, or as directed by your doctor.
Children under 12 years: should only be given on medical advice.
Overdose What to do if you have taken an overdose of Gaviscon advance
If you forget to take Gaviscon Advance do not take a double dose to make up for a forgotten dose, just continue taking it as before.
If you take more Gaviscon Advance than you need, you may feel bloated. This is unlikely to harm you, but consult your doctor or pharmacist if this does not go away.
If symptoms persist after 7 days, consult your doctor.
Side Effects What are the side effects of Gaviscon advance
Very rarely (less than 1 in 10,000 patients) there is a chance 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 these or any other side effects, stop taking the medicine and consult your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not use Gaviscon Advance after the expiry date which is stated on the pack.
Use the product within 6 months of first opening.
Keep this medicine out of the sight and reach of children.
Do not refrigerate.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What does Gaviscon Advance contain:
The active ingredients in 10 ml of oral suspension are: 1000 mg of sodium alginate and 200 mg of potassium bicarbonate.
The other ingredients are calcium carbonate, carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, sodium hydroxide, anise flavoring derived from fennel and purified water.
What Gaviscon Advance looks like and contents of the pack
Gaviscon advance is available in bottles of 80ml, 100ml, 125ml, 140ml, 150ml, 180ml, 200ml, 250ml, 300ml, 400ml, 500ml, 560ml, 600ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
GAVISCON ADVANCE ORAL SUSPESION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains sodium alginate 100 mg and potassium bicarbonate 20 mg
Excipients with known effects: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Oral suspension.
Viscous, whitish suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of symptoms related to gastroesophageal reflux, such as acid regurgitation, heartburn and indigestion (due to reflux), for example after meals or during pregnancy or in patients with symptoms related to reflux oesophagitis.
04.2 Posology and method of administration
Dosage
Adults and children 12 years and older: 5-10 ml after meals and in the evening before going to bed.
Children under 12 years: should only be given on medical advice.
Duration of treatment
If symptoms do not improve after seven days, the clinical picture should be reassessed.
Special populations
Elderly: it is not necessary to change the doses for this age group.
Patients with hepatic insufficiency: it is not necessary to modify the doses.
Patients with renal insufficiency: use caution if a low-salt diet is required (see section 4.4).
Method of administration
Oral use.
Shake well before use. Check that the seal is intact before taking the product for the first time.
04.3 Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, such as methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
04.4 Special warnings and appropriate precautions for use
If symptoms do not improve after seven days, the clinical picture should be reassessed.
Each 10 ml dose contains 106 mg (4.6 mmol) of sodium and 78 mg (2.0 mmol) of potassium. This should be taken into consideration in cases where a particularly low-salt diet is recommended, for example in some cases of congestive heart failure and renal impairment or in the case of taking medications that can increase plasma potassium levels.
Each 10 ml dose contains 200 mg (2.0 mmol) of calcium carbonate. Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): they can cause allergic reactions (sometimes delayed).
For the treatment of children under 12 years of age see section 4.2.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
Pregnancy
Clinical studies on more than 500 pregnant women and a "large amount of data from post-marketing experience" indicate that the active ingredients do not lead to malformations or fetus / neonatal toxicity.
Gaviscon Advance can be used during pregnancy if clinically needed.
Feeding time
No known effects on nursing infants. Gaviscon Advance can be used while breastfeeding.
Fertility
No known effects on human fertility.
04.7 Effects on ability to drive and use machines
Gaviscon Advance has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
Undesirable effects have been divided by frequency according to the following convention: very common (≥ 1/10), common (≥ 1/100, ≤ 1/10), uncommon (≥ 1 / 1,000, ≤ 1/100 ), rare (≥ 1 / 10,000, ≤ 1 / 1,000), very rare (≤ 1 / 10,000) and not known (cannot be estimated from the available data).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "Street address www.aifa.gov.it/responsabili.
04.9 Overdose
In the event of an overdose, symptomatic treatment should be resorted to. The patient may notice abdominal distension.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-reflux drugs, ATC code: A02E A01
The suspension, when ingested, reacts with gastric acid to form a gel cover of alginic acid with a near neutral pH and which floats on the stomach contents (up to 4 hours) effectively preventing gastroesophageal reflux. severe, the same gel cover can flow back into the esophagus instead of stomach contents and exert an emollient effect.
05.2 Pharmacokinetic properties
The mode of action of the drug is physical and does not depend on absorption into the systemic circulation.
05.3 Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Calcium carbonate, carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, fennel flavoring, sodium hydroxide (to adjust the pH) and purified water.
Fennel flavoring ingredients: fennel, anethole, benzyl alcohol.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Shelf life: 2 years.
Shelf life after first opening: 6 months.
06.4 Special precautions for storage
Do not refrigerate.
06.5 Nature of the immediate packaging and contents of the package
Amber glass bottles with shaped polypropylene cap, equipped with a safety seal for opening covered with a polyethylene foam pad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml of suspension
or
Amber glass bottles with shaped polypropylene cap, fitted with a safety seal for opening covered with a polyethylene foam pad, containing either a measuring cup (natural polypropylene) with 5, 10, 15 and 20 ml notches or a spoon dispenser (transparent polystyrene) with notches of 2.5 ml and 5 ml and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml of suspension.
Not all pack sizes may be marketed.
The carton and measuring cup or measuring spoon may not be available in all markets / packs.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull HU8 7DS, United Kingdom
Representative for Italy: Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Bottle of 80 ml of oral suspension: A.I.C. n. 034248082
Bottle of 100 ml of oral suspension: A.I.C. n. 034248017
Bottle of 125 ml of oral suspension: A.I.C. n. 034248029
Bottle of 140 ml of oral suspension: A.I.C. n. 034248031
Bottle of 150 ml of oral suspension: A.I.C. n. 034248106
Bottle of 180 ml of oral suspension: A.I.C. n. 034248070
Bottle of 200 ml of oral suspension: A.I.C. n. 034248043
Bottle of 250 ml of oral suspension: A.I.C. n. 034248056
Bottle of 300 ml of oral suspension: A.I.C. n. 034248118
400 ml bottle of oral suspension: A.I.C. n. 034248120
Bottle of 500 ml of oral suspension: A.I.C. n. 034248068
Bottle of 560 ml of oral suspension: A.I.C. n. 034248094
Bottle of 600 ml of oral suspension: A.I.C. n. 034248132
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 31.10.1996
10.0 DATE OF REVISION OF THE TEXT
01/04/2015
