- Approval Id
- 8607ef46b3359588
- Drug Approval Emc Name
- Gaviscon Peppermint Liquid Relief
- Drug Name
- Gaviscon Peppermint Liquid Relief
- 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
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
- Authorisation Number
- PL 00063/0127
- Authorisation Date
- 03/02/2003 / 27/02/2009
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
- Instruction Authorisation Number
- PL 00063/0127
- Instruction Authorisation Date
- 03/02/2003 / 27/02/2009
- Instruction Composition
- Gaviscon Peppermint Liquid Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For excipients, see Section 6.1.
- Instruction Dosage Form
- Oral suspension.
An opaque, off-white to cream suspension with the odour and flavour of peppermint.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.4.2 Posology and method of administration
For oral administration.
Adults and children over 12 years: 10-20ml after meals and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dosage modification is required in 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 listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).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 285.2 mg (12.4 mmol) sodium per 20 ml dose, equivalent to 14.26 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 57 % 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).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 and 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:\*\*
Pre-clinical investigations have revealed alginate has no negative effect 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
None.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
On ingestion the 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 mode of action of the product is physical and does not depend on absorption into the systemic circulation.5.3 Preclinical safety data
No preclinical findings relevant to the prescriber have been reported.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Carbomer
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Saccharin sodium
Peppermint oil
Sodium hydroxide
Water6.2 Incompatibilities
Not applicable.6.3 Shelf life
Three years for 600 ml pack size.
Two years for 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, and 500 ml pack sizes.6.4 Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.6.5 Nature and contents of container
Amber glass Winchester bottle with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad containing 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 500ml and 600ml.6.6 Special precautions for disposal and other handling
No special instructions.
- Instruction Content
- ## Composition
Gaviscon Peppermint Liquid Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For excipients, see Section 6.1.
## Pharmaceutical Form
Oral suspension.
An opaque, off-white to cream suspension with the odour and flavour of peppermint.
## Clinical Particulars
4.1 Therapeutic indications
Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.4.2 Posology and method of administration
For oral administration.
Adults and children over 12 years: 10-20ml after meals and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dosage modification is required in 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 listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).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 285.2 mg (12.4 mmol) sodium per 20 ml dose, equivalent to 14.26 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 57 % 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).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 and 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:\*\*
Pre-clinical investigations have revealed alginate has no negative effect 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
None.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
On ingestion the 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 mode of action of the product is physical and does not depend on absorption into the systemic circulation.5.3 Preclinical safety data
No preclinical findings relevant to the prescriber have been reported.
## Pharmaceutical Particulars
6.1 List of excipients
Carbomer
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Saccharin sodium
Peppermint oil
Sodium hydroxide
Water6.2 Incompatibilities
Not applicable.6.3 Shelf life
Three years for 600 ml pack size.
Two years for 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, and 500 ml pack sizes.6.4 Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.6.5 Nature and contents of container
Amber glass Winchester bottle with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad containing 100 ml, 150 ml, 200 ml, 250 ml, 300 ml, 500ml and 600ml.6.6 Special precautions for disposal and other handling
No special instructions.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
