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Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Contraindications
|
Contraindications
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1.
4.4
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
This medicinal product contains 127.88 mg sodium per 1 sachet (10ml) dose, equivalent to 6.4% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each 2 sachets (20 ml) dose contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
Contains methyl parahydroxybenzoate (E218) 40 mg/ 10ml and propyl parahydroxybenzoate (E216) 6 mg/10ml which may cause allergic reactions (possibly delayed).
4.5
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding.
Fertility:
Clinical data do not suggest that this product has an effect on human fertility.
4.7
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rarely
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Double Action Liquid Sachets
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Double Action Liquid Sachets
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6.
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Sodium, Carbomer 974P, methyl (E218) and propyl (E216) parahydroxybenzoate, saccharin sodium, peppermint flavour no. 2, sodium hydroxide and purified water.
6.2
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - Shelf life
|
Shelf life
Two years.
6.4
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Do not store above 25°C and store in the original package. Do not refrigerate or freeze.
6.5
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
A cardboard outer carton containing unit dose stick pack style sachets.
Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.
Not all pack sizes may be marketed.
The sachets are composed of polyester, aluminium and polyethylene.
Each sachet contains 10ml of Gaviscon Double Action Liquid.
6.6
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
None required.
7.
|
Gaviscon Double Action Liquid Sachets
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0524.
9.
|
Gaviscon Double Action Liquid Sachets
|
Date of first authorisation/renewal of the authorisation
|
28/07/2008 / 07/08/2019
10.
|
Gaviscon Double Action Liquid Sachets
|
Date of revision of the text
|
22/01/2021
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Name of the medicinal product
|
Gaviscon Double Action Mint Flavour Chewable Tablets
2.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Qualitative and quantitative composition
|
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.
Excipient(s) with known effect:
Aspartame
Carmoisine Lake (E122)
For full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical form
|
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and slightly mottled, and the other white.
4.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Contraindications
|
Contraindications
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate or to any of the excipients listed in section 6.1.
4.4
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 44.71% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each 4 tablet dose contains 300 mg (7.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.
This medicine contains Carmoisine lake (E122). This may cause allergic reactions.
4.5
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically needed.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.
Fertility:
Clinical data do not suggest that this product has an effect on human fertility.
4.7
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rarely
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Mint flavour
Carmoisine Lake (E122)
Magnesium stearate
Xylitol DC
6.2
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - Shelf life
|
Shelf life
Two years.
Polypropylene container: Use within 3 months of opening.
6.4
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Blister trays: Do not store above 30°C. Store in the original package.
Flip-top lid containers: Do not store above 25°C. Store in the original package.
6.5
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
Unprinted, glass, clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister tray containing two, four, six or eight sealed tablets. Pack sizes: 4, 6, 8, 12, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets.
Coloured, opaque, injection-moulded, polypropylene flip-top lid containers containing 8, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.
6.6
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
No special instructions.
7.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom
8. Marketing authorisation number(s)
PL 00063/0525
9.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Date of first authorisation/renewal of the authorisation
|
13/11/2009 / 07/08/2019
10.
|
Gaviscon Double Action Mint Flavour Chewable Tablets
|
Date of revision of the text
|
07/08/2019
|
Gaviscon Double Action Mint Oral Suspension
|
Name of the medicinal product
|
Gaviscon Double Action Mint.
2.
|
Gaviscon Double Action Mint Oral Suspension
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218) 40 mg/ 10ml
Propyl parahydroxybenzoate (E216) 6 mg/10ml
Sodium 127.88 mg / 10ml
For a full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical form
|
Oral suspension.
Opaque, off-white to cream viscous suspension.
4.
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
For oral administration.
Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Contraindications
|
Contraindications
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1.
This product should not be used in patients with moderate or severe renal insufficiency
4.4
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
This medicinal product contains 127.88 mg sodium per 10ml dose, equivalent to 6.4% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
Contains methyl parahydroxybenzoate (E218) 40 mg/ 10ml and propyl parahydroxybenzoate (E216) 6 mg/10ml which may cause allergic reactions (possibly delayed).
4.5
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically needed.
Breastfeeding
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.
Fertility
Clinical data do not suggest that this product has an effect on human fertility.
4.7
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rarely
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Mint Oral Suspension
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6.
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Sodium
Carbomer
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Mint flavour
Sodium hydroxide
Purified water
6.2
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - Shelf life
|
Shelf life
Two years.
Use within six months of opening.
6.4
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.
6.5
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
Amber glass bottles or Pink coated Amber glass bottle
With a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad
Pack sizes: 150, 200, 300, 500 and 600 ml.
Not all pack sizes may be marketed.
6.6
|
Gaviscon Double Action Mint Oral Suspension
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
No special requirements.
7.
|
Gaviscon Double Action Mint Oral Suspension
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0552.
9.
|
Gaviscon Double Action Mint Oral Suspension
|
Date of first authorisation/renewal of the authorisation
|
24/06/2008 / 07/08/2019
10.
|
Gaviscon Double Action Mint Oral Suspension
|
Date of revision of the text
|
08/02/2021
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Name of the medicinal product
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
2.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Qualitative and quantitative composition
|
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 106.5 mg and calcium carbonate 187.5 mg.
Excipient(s) with known effect:
Aspartame (E951)
Carmoisine Lake (E122)
Sucrose*
Sodium
Mannitol
*present within cranberry and fantasy fruit flavours
For a full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical form
|
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and slightly mottled, and the other white.
4.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy.
4.2
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Contraindications
|
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.
4.4
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
This medicine may cause allergic reactions and may have a mild laxative effect
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
Prolonged use should be avoided.
As with other antacid products, taking Gaviscon Double Action Mixed Berries Flavour Chewable Tablets can mask the symptoms of other more serious, underlying medical conditions.
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets should not be used in the following cases:
• Patients with server/impaired renal function/-insufficiency
• Patients with hypophosphatemia
Excipients Warnings:
This medicinal product contains 55.89 mg sodium per dose, equivalent to 2.8 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 44.7% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet
Each 4 tablet dose contains 300 mg (7.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicine contains 5.86 mg aspartame in each Tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
4.5
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolone, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and diphosphonates. See also section 4.4.
4.6
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy:
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of the active substances.
Based on this and previous experience the medicinal product may be used during pregnancy and lactation, if clinically needed.
Nevertheless, taking into account the presence of calcium carbonate it is recommended to limit the treatment duration as much as possible.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding.
Fertility:
Pre-clinical animal investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that this product has an effect on human fertility.
4.7
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium hydrogen carbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare ≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rare
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Not known
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Very Rare
Abdominal pain, acid rebound, diarrhoea, nausea, vomiting
Not Known
Constipation1
Skin and Subcutaneous Tissue Disorders
Very Rare
Rash Pruritic
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Some abdominal distension may be noticed.
Management
In the event of overdosage symptomatic treatment should be given
5. Pharmacological properties
5.1
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SmPC.
6.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Raspberry flavour
Cranberry flavour (contains sucrose)
Fantasy Fruit flavour (contains sucrose)
Carmoisine Lake (E122)
Magnesium stearate
Xylitol, Carmellose Sodium
Potassium
Sucrose
6.2
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - Shelf life
|
Shelf life
2 years.
6.4
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Blister trays: Do not store above 30°C. Store in the original package to protect from moisture.
6.5
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
Unprinted, glass, clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister tray containing 2, 4, 6 or 8 sealed tablets. Pack sizes: 4, 6, 8, 12, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets.
Not all pack sizes may be marketed.
6.6
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
No special instructions.
7.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull, HU8 7DS,
United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0755
9.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Date of first authorisation/renewal of the authorisation
|
28-03-2020
10.
|
Gaviscon Double Action Mixed Berries Flavour Chewable Tablets
|
Date of revision of the text
|
30/12/2020
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Name of the medicinal product
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
2.
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 500 mg, sodium hydrogen carbonate 213 mg and calcium carbonate 325 mg.
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 40mg/10ml
Propyl parahydroxybenzoate (E216) 6mg/10ml
Sodium 127.88mg/10ml
Propylene glycol* 21.38 mg/ 10 ml
*present in cranberry, raspberry and fantasy fruit flavours
For a full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Pharmaceutical form
|
Oral suspension.
An off-white suspension with the odour and flavour of berry.
4.
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy.
4.2
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
Posology:
Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Method of administration:
For oral administration.
4.3
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Contraindications
|
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.
4.4
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
This medicinal product contains 127.88 mg sodium per dose, equivalent to 6.4 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15 % of the WHO recommended maximum daily intake for sodium.
This medicinal product is considered high in sodium. This should be particularly taken into account for those on a low salt diet
Each 10 ml contains 130 mg (3.25 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Prolonged use should be avoided.
As with other antacid products, taking Gaviscon Double Action Mixed Berries Flavour Oral Suspension can mask the symptoms of other more serious, underlying medical conditions.
Gaviscon Double Action Mixed Berries Flavour Oral Suspension should not be used in the following cases:
• Patients with severe/impaired renal function/-insufficiency
• Patients with hypophosphatemia
There is a possibility of reduced efficacy in patients with very low levels of gastric acid.
There is increased risk for hypernatremia in children with gastroenteritis or suspected renal insufficiency.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
4.5
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which acts as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolone, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and diphosphonates. See also section 4.4.
4.6
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy:
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of the active substances.
Based on this and previous experience, the medicinal product may be used during pregnancy and lactation, if clinically needed.
Nevertheless, taking into account the presence of calcium carbonate it is recommended to limit the treatment duration as much as possible.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding.
Fertility:
Pre-clinical animal investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that this product has an effect on human fertility
4.7
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium hydrogen carbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rare
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Not known
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Very Rare
Abdominal pain, acid rebound, diarrhoea, nausea, vomiting
Not Known
Constipation1
Skin and Subcutaneous Tissue Disorders
Very Rare
Rash Pruritic
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Some abdominal distension may be noticed.
Management
In the event of overdosage symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Double Action Mixed Berries Flavour Oral Suspension
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
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