Active ingredients: Sodium alginate + sodium bicarbonate
GAVISCON 250 mg + 133.5.5 mg chewable mint flavored tablets
GAVISCON 250 mg + 133.5.5 mg strawberry flavored chewable tablets
Gaviscon package inserts are available for pack sizes: - GAVISCON 250 mg + 133.5.5 mg chewable tablets mint flavor, GAVISCON 250 mg + 133.5.5 mg chewable tablets strawberry flavor
- GAVISCON 500 mg + 267 mg chewable mint flavor tablets
- GAVISCON 500 mg / 10 ml + 267 mg / 10 ml oral suspension GAVISCON 500 mg / 10 ml + 267 mg / 10 ml oral suspension mint flavor
Why is Gaviscon used? What is it for?
Gaviscon is a medicine belonging to the class of drugs for the treatment of peptic ulcer and gastroesophageal reflux disease.
Gaviscon is used for the symptomatic treatment of occasional heartburn.
Contraindications When Gaviscon should not be used
If you are allergic to sodium alginate or sodium bicarbonate or any of the other ingredients of this medicine, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (parabens).
Precautions for use What you need to know before taking Gaviscon
Do not use the medicine for prolonged treatments. If symptoms persist after 7 days, consult your doctor.
In adolescents (12-18 years) use only if clearly needed and under close medical supervision.
In case of renal insufficiency, the medicinal product should be used with caution as the exogenous saline supplement provided by antacids can affect potentially severe electrolyte imbalances.
It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
Interactions Which drugs or foods can modify the effect of Gaviscon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is advisable to interpose an interval of at least two hours between taking Gaviscon and that of other drugs, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates and estramustine.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnancy and breastfeeding, Gaviscon can be used after consulting your doctor and evaluating the risk / benefit ratio with him. Consult your doctor if you suspect you are pregnant or want to plan a maternity leave.
Driving and using machines
Gaviscon does not affect the ability to drive or use machines.
Gaviscon contains sodium, calcium carbonate. methyl parahydroxybenzoate and propyl parahydroxybenzoate Sodium
This medicinal product contains 6.2 mmol (or 141 mg) sodium per 10 ml of suspension. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
Calcium carbonate
Each 10 ml dose of suspension contains 1.6 mmol (or 160 mg) of calcium carbonate.
Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate The suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which can cause allergic reactions (possibly delayed).
Dose, Method and Time of Administration How to use Gaviscon: Posology
How many
Adults and adolescents (12-18 years):
10-20 ml (second-fourth notch of the measuring cup or 2-4 measuring spoons or 1- 2 single-dose sachets) after meals and at bedtime.
Warning: do not exceed the indicated doses.
Special populations
Elderly: it is not necessary to change the doses for this age group.
Patients with renal insufficiency: The reduced ability to urinate the exogenous salt supplement provided by antacids can affect potentially severe electrolyte imbalances (see Warnings and Precautions).
When and for how long
Only use Gaviscon for short periods of treatment.
Consult your doctor if your symptoms worsen or do not improve after seven days of treatment, if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Like
For oral administration. Shake the suspension before use.
Overdose What to do if you have taken too much Gaviscon
A possible consequence of overdose is abdominal distension: in this case, seek symptomatic treatment by adopting general supportive measures.
In case of accidental ingestion / intake of an excessive dose of Gaviscon, notify your doctor immediately or go to the nearest hospital.
If you forget to take Gaviscon
Do not take a double dose to make up for a forgotten dose.
If you stop taking Gaviscon
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Gaviscon
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare: (may affect up to 1 in 10,000 people)
anaphylactic or anaphylactoid reactions
hypersensitivity reactions, such as hives
respiratory symptoms such as bronchospasm
flatulence, nausea
edema
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Expiry and Retention
Oral suspension and oral suspension mint flavored in bottle
Store in the original packaging. Do not store above 30 ° C. Do not refrigerate.
Mint flavored oral suspension in sachets
Store in the original packaging. Do not store above 25 ° C. Do not refrigerate.
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
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon 500 mg + 267 mg chewable mint flavor tablets
One tablet contains:
Active principles: sodium alginate 500 mg
sodium bicarbonate 267 mg
Excipients: aspartame 7.5 mg
Gaviscon 250 mg + 133.5 mg chewable mint flavor tablets
One tablet contains:
Active principles: sodium alginate 250 mg
sodium bicarbonate 133.5 mg
Excipients: aspartame 3.75 mg
Gaviscon 250 mg + 133.5 mg strawberry flavored chewable tablets
One tablet contains:
Active principles: sodium alginate 250 mg
sodium bicarbonate 133.5 mg
Excipients: aspartame 8.80 mg
Gaviscon 500mg / 10ml + 267mg / 10ml oral suspension
10 ml contain:
Active principles: sodium alginate 500 mg
sodium bicarbonate 267 mg
Excipients: methyl parahydroxybenzoate 40 mg
propyl parahydroxybenzoate 6 mg
Gaviscon 500mg / 10ml + 267mg / 10ml oral suspension mint flavor
10 ml contain:
Active principles: sodium alginate 500 mg
sodium bicarbonate 267 mg
Excipients: methyl parahydroxybenzoate 40 mg
propyl parahydroxybenzoate 6 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Chewable tablets.
Oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of occasional heartburn
04.2 Posology and method of administration
Chewable tablets (strawberry flavor and mint flavor)
Adults and adolescents (12-18 years):
1-2 tablets of 500 mg + 267 mg after meals and at bedtime.
2-4 tablets of 250 mg + 133.5 mg after meals and at bedtime.
For oral administration. The tablets should be chewed well (they can be broken up and chewed a little at a time). Then you can drink some water.
Oral suspension
Adults and adolescents (12-18 years):
10-20 ml (second-fourth notch of the measuring cup or 2-4 measuring spoons or 1- 2 single-dose sachets) after meals and at bedtime.
For oral administration. Shake the suspension before use.
Special populations
Elderly: it is not necessary to change the doses for this age group.
Patients with renal insufficiency: the reduced ability to urinate the exogenous salt supplement provided by antacids can affect potentially severe electrolyte imbalances (see section 4.4).
04.3 Contraindications
Hypersensitivity to the active ingredients or to any of the excipients, including esters of hydroxybenzoates (parabens). Severe renal insufficiency.
04.4 Special warnings and appropriate precautions for use
Do not use for prolonged treatments.
In patients with very low gastric acid levels there is a lower chance of efficacy.
In adolescents (12-18 years) use only if clearly needed and under close medical supervision.
In case of renal insufficiency, the medicinal product should be used with caution as the exogenous saline supplement provided by antacids can affect potentially severe electrolyte imbalances.
Each 500 mg + 267 mg tablet contains 123 mg (5.3 mmol) of sodium.
Each 250 mg +133.5 mg tablet contains 61.5 mg (2.65 mmol) of sodium.
Each 10 ml dose of suspension contains 141 mg (6.2 mmol) of sodium.
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.
Each 500 mg + 267 mg tablet contains 160 mg (1.6 mmol) of calcium carbonate.
Each 250 mg +133.5 mg tablet contains 80 mg (0.8 mmol) of calcium carbonate.
Each 10 ml dose of suspension contains 160 mg (1.6 mmol) of calcium carbonate.
Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones.
The tablets contain aspartame, a source of phenylalanine and should therefore not be taken by patients with phenylketonuria.
The suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions. Delayed-type reactions (contact dermatitis) usually occur, rarely immediate reactions with urticaria and bronchospasm.
04.5 Interactions with other medicinal products and other forms of interaction
It is advisable to interpose an interval of at least two hours between taking Gaviscon and that of other drugs.
04.6 Pregnancy and lactation
Use in case of real need and under strict medical supervision.
04.7 Effects on ability to drive and use machines
Gaviscon does not affect the ability to drive or use machines.
04.8 Undesirable effects
Below are the side effects of Gaviscon, organized according to the MedDRA system organ class. They are divided by frequency (very common (≥ 1/10), common (≥ 1/100 to ≤ 1/10), uncommon (≥ 1 / 1,000 to ≤ 1/100), rare (≥ 1 / 10,000 to 1 /1,000), very rare (≤ 1 / 10,000)).
Gastrointestinal disorders
Very rare: flatulence, nausea
Skin and subcutaneous tissue disorders
Very rare: water retention (edema).
Disorders of the immune system
Very rare: allergic manifestations such as urticaria and bronchospasm, anaphylactic or anaphylactoid reactions.
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
Experience with overdose is very limited. The only possible consequence of overdose is abdominal distension: in this case, seek symptomatic treatment with general supportive measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for the treatment of peptic ulcer and gastroesophageal reflux disease.
ATC code: A02BX 13.
After ingestion, the product reacts rapidly with gastric acid forming a barrier of alginic acid gel, which has an almost neutral pH and which floats on the contents of the stomach (up to 4 hours), effectively preventing gastro-oesophageal reflux. In cases of severe reflux the barrier itself can be pushed back into the esophagus instead of the gastric contents and exerts an emollient effect
05.2 Pharmacokinetic properties
The mode of action of the product is physical and does not depend on absorption into the systemic circulation. Most of the drug is eliminated in the faeces.
05.3 Preclinical safety data
Data from animal studies reveal no risk to humans based on conventional studies of pharmacology, safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Mint-flavored chewable tablets
Mannitol (E421); calcium carbonate; magnesium stearate; copovidone; aspartame (E951); acesulfame potassium (E950); macrogol 20,000; mint flavor.
Strawberry flavored chewable tablets
Xylitol, mannitol, calcium carbonate; macrogol 20,000, strawberry flavor, aspartame, magnesium stearate; red iron oxide.
Oral suspension
Calcium carbonate; carbomers; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium saccharin; fennel flavoring; sodium hydroxide; erythrosine; purified water.
Mint flavored oral suspension
Calcium carbonate; carbomers; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium saccharin; mint flavor; sodium hydroxide; purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Chewable tablets: 2 years.
Oral suspension: 3 years.
Mint aroma oral suspension: 2 years.
Shelf life after first opening:
Strawberry flavored chewable tablets in container: after first opening the container, the medicine must be consumed within 6 months; after this period the residual drug must be discarded.
06.4 Special precautions for storage
Oral suspension and mint flavored oral suspension: do not store above 30 ° C. Store in the original package. Do not refrigerate.
Mint flavored oral suspension in sachets: do not store above 25 ° C. Store in the original package. Do not refrigerate.
Mint-flavored chewable tablets: do not store above 30 ° C. Store in the original package.
Strawberry flavored chewable tablets: do not store above 25 ° C. Store in the original package.
06.5 Nature of the immediate packaging and contents of the package
Chewable tablets 500 mg + 250 mg mint flavor
Container cylindrical in polypropylene, white, rigid, preformed, with snap cap, packed in cardboard boxes. The package contains 40 tablets.
Blister unprinted, transparent, thermoformable in PVC / PE / PVdC laminate, welded on an aluminum support and packed in cardboard boxes. Each blister contains 6 individually sealed tablets. The packs contain 24, 36 and 48 tablets in blisters.
Chewable tablets 250 mg + 133.5 mg mint flavor
Blister unprinted, transparent, thermoformable in PVC / PE / PVdC laminate, welded on an aluminum support and packed in cardboard boxes. Each blister contains 6 individually sealed tablets. The packs contain 16, 24, 32 and 48 tablets in blisters.
Chewable tablets 250 mg + 133.5 mg strawberry flavor
Blister unprinted, transparent, thermoformable in PVC / PE / PVdC laminate, welded on an aluminum support and packed in cardboard boxes. Each blister contains 6 individually sealed tablets. The packs contain 16, 24, 32 and 48 tablets in blisters.
Container in polypropylene, white, rigid, preformed, with snap cap, packed in cardboard boxes.
The packs contain 16 and 20 tablets
Oral suspension
Bottle amber glass with cap fitted with polyethylene undercap, packaged in lithographed cardboard boxes. The package is accompanied by a measuring spoon in natural polypropylene with notches of 5, 10, 15 and 20 ml, or a measuring spoon (transparent polystyrene) of 5 ml.
The pack contains 200 ml of oral suspension.
Mint flavored oral suspension
Bottle amber glass with cap fitted with polyethylene undercap, packaged in lithographed cardboard boxes.
The pack is 200 ml, 300 ml and 500 ml of oral suspension.
Single-dose sachets elongated shape of polyester, aluminum and polyethylene packed in cardboard box. Each sachet contains 10 ml of oral suspension. The packs contain 12, 20 or 24 sachets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Unused medicine should be disposed of in the appropriate bins at pharmacies.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Hull (UK)
Representative for Italy: Reckitt Benckiser Healthcare (Italia) S.p.A. - via Spadolini 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Gaviscon 500 mg + 267 mg chewable mint flavor tablets
- 24 tablets in blister A.I.C. n. 024352054
- 36 tablets in blister packs: A.I.C. n. 024352066
- 40 tablets in container: A.I.C. n. 024352080
- 48 tablets in blister packs: A.I.C. n. 024352078
Gaviscon 250 mg + 133.5 mg chewable mint flavor tablets
- 16 tablets in blister A.I.C. n. 024352155
- 24 tablets in blister A.I.C. n. 024352167
- 32 tablets in blister packs: A.I.C. n. 024352179
- 48 tablets in blister packs: A.I.C. n. 024352181
Gaviscon 250 mg + 133.5 mg strawberry flavored chewable tablets
- 16 tablets in blister A.I.C. n. 024352193
- 16 tablets in A.I.C. n. 024352231
- 20 tablets in A.I.C. n. 024352243
- 24 tablets in blister A.I.C. n. 024352205
- 32 tablets in blister packs: A.I.C. n. 024352217
- 48 tablets in blister packs: A.I.C. n. 024352229
Gaviscon 500 mg / 10 ml + 267 mg / 10 ml oral suspension
- 200 ml bottle: A.I.C. n. 024352039
Gaviscon 500 mg / 10 ml + 267 mg / 10 ml mint flavored oral suspension
- 200 ml bottle: A.I.C. n. 024352092
- 300 ml bottle: A.I.C. n. 024352104
- 500 ml bottle: A.I.C. n. 024352116
Gaviscon 500 mg / 10 ml + 267 mg / 10 ml mint flavored oral suspension in sachets
- 12 single-dose sachets: A.I.C. n. 024352128
- 20 single-dose sachets: A.I.C. n. 024352130
- 24 single-dose sachets: A.I.C. n. 024352142
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Chewable tablets: First authorization: November 2007
Oral suspension: First authorization: March 1987
Renewal: May 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA resolution of 12 September 2013
