- Approval Id
- 133dbc3602ce0ba6
- Drug Approval Emc Name
- Gaviscon Peppermint Flavour Tablets
- Drug Name
- Gaviscon Peppermint Flavour Tablets
- Company Address
- RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
- Company Website
- http://www.reckittbenckiser.com
- Company Telephone
- 0333 2005 345
- Company Medical Info Direct Line
- 0333 2005 345
- Company Customer Care Direct Line
- 0333 2005 345
- Atc Code
- A02BX
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom.
- Authorisation Number
- PL 00063/0627
- Authorisation Date
- 21/10/2024
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom.
- Instruction Authorisation Number
- PL 00063/0627
- Instruction Authorisation Date
- 21/10/2024
- Instruction Composition
- Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg and calcium carbonate 80 mg.
Excipient(s) with with known effect:
Aspartame (E951)
For excipients, see Section 6.1.
- Instruction Dosage Form
- Chewable tablet.
An off-white to cream, slightly mottled tablet.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in patients with symptoms related to reflux oesophagitis.4.2 Posology and method of administration
For oral use, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime.
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 Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.4.4 Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 235 mg (11 mmol) of sodium per four-tablet dose, equivalent to 12.65% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 50.6% 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 four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with phenylketonuria.4.5 Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, biphosphonates (diphosphonates) and estramustine. See also 4.4.4.6 Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Fertility:
There is a lack of robust pre-clinical data available regarding the effects of alginate on fertility; limited studies have not reported any negative effects on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Event\*\* |
| Immune System Disorders | Very rare | Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria. |
| Respiratory, Thoracic and Mediastinal Disorders | Very rare | Respiratory effects such as bronchospasm. |
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 Overdose
\*\*Symptoms\*\*
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
\*\*Management\*\*
In the event of overdose symptomatic treatment should be given.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group: Other drugs for peptic ulcer and gastrooesophageal reflux disease (GORD) ATC code: A02BX.\*\*
\*\*On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.\*\*5.2 Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Peppermint flavour
Macrogol 20,000
Mannitol (E421)
Copovidone
Aspartame (E951)
Acesulfame potassium (E950)
Magnesium stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 30°C.6.5 Nature and contents of container
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister pack containing 4, 6 or 8 individually sealed tablets.
Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.
Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets
Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.
Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into cartons.
Pack sizes 8, 12, 16, 18, 20, 22, 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets\*.\*
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg and calcium carbonate 80 mg.
Excipient(s) with with known effect:
Aspartame (E951)
For excipients, see Section 6.1.
## Pharmaceutical Form
Chewable tablet.
An off-white to cream, slightly mottled tablet.
## Clinical Particulars
4.1 Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in patients with symptoms related to reflux oesophagitis.4.2 Posology and method of administration
For oral use, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime.
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 Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.4.4 Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 235 mg (11 mmol) of sodium per four-tablet dose, equivalent to 12.65% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 50.6% 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 four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with phenylketonuria.4.5 Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, biphosphonates (diphosphonates) and estramustine. See also 4.4.4.6 Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Fertility:
There is a lack of robust pre-clinical data available regarding the effects of alginate on fertility; limited studies have not reported any negative effects on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.4.7 Effects on ability to drive and use machines
Not relevant.4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Event\*\* |
| Immune System Disorders | Very rare | Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria. |
| Respiratory, Thoracic and Mediastinal Disorders | Very rare | Respiratory effects such as bronchospasm. |
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 Overdose
\*\*Symptoms\*\*
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
\*\*Management\*\*
In the event of overdose symptomatic treatment should be given.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group: Other drugs for peptic ulcer and gastrooesophageal reflux disease (GORD) ATC code: A02BX.\*\*
\*\*On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.\*\*5.2 Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans.
## Pharmaceutical Particulars
6.1 List of excipients
Peppermint flavour
Macrogol 20,000
Mannitol (E421)
Copovidone
Aspartame (E951)
Acesulfame potassium (E950)
Magnesium stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.6.4 Special precautions for storage
Do not store above 30°C.6.5 Nature and contents of container
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister pack containing 4, 6 or 8 individually sealed tablets.
Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.
Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets
Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.
Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into cartons.
Pack sizes 8, 12, 16, 18, 20, 22, 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets\*.\*
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
