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Gaviscon Advance Aniseed flavour Oral Suspension | Clinical particulars - Fertility, pregnancy and lactation | 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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7 |
Gaviscon Advance Aniseed flavour Oral Suspension | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None
4.8 |
Gaviscon Advance Aniseed flavour Oral Suspension | Clinical particulars - Undesirable effects | 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 |
Gaviscon Advance Aniseed flavour Oral Suspension | Clinical particulars - Overdose | 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.
5. Pharmacological properties
5.1 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mode of action of Gaviscon Advance Aniseed flavour Oral Suspension is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
There are no preclinical findings of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6. |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - List of excipients | List of excipients
Calcium carbonate
Carbomer
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Fennel flavour
Sodium hydroxide
Potassium
Purified water
6.2 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - Shelf life | Shelf life
Two years
6.4 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not refrigerate.
6.5 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250 or 300ml suspension.
6.6 |
Gaviscon Advance Aniseed flavour Oral Suspension | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Not applicable.
7. |
Gaviscon Advance Aniseed flavour Oral Suspension | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
8. Marketing authorisation number(s)
PL 00063/0749
9. |
Gaviscon Advance Aniseed flavour Oral Suspension | Date of first authorisation/renewal of the authorisation | 26/04/2017
10. |
Gaviscon Advance Aniseed flavour Oral Suspension | Date of revision of the text | 05/11/2020 |
Gaviscon Advance Aniseed Oral Suspension | Name of the medicinal product | Gaviscon Advance Aniseed Suspension.
2. |
Gaviscon Advance Aniseed Oral Suspension | Qualitative and quantitative composition | Active Substances
mg/10ml
Sodium alginate
1000.0
Potassium bicarbonate
200.0
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218 (20 mg/ 5 ml)
Propyl parahydroxybenzoate E216 (3 mg/ 5 ml).
Sodium (57.85 mg (2.515 mmol)/ 5 ml)
Potassium (39.06 mg/ 5 ml)
Benzyl alcohol* (0.525 mg/ 5 ml)
*present in the fennel flavour
For full list of excipients, see section 6.1.
3. |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical form | Oral suspension.
An off-white, viscous suspension.
4. |
Gaviscon Advance Aniseed 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, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. 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 Advance Aniseed Oral Suspension | Clinical particulars - Posology and method of administration | Posology and method of administration
Adults and children 12 years and over: 5-10 ml after meals and at bedtime
Children under 12 years: Should be given only on medical advice
Elderly: No dose modification is required 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 Advance Aniseed Oral Suspension | Clinical particulars - Contraindications | Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients, or any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
Warning related to Excipients:
Sodium: This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 23.14 % 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).
Potassium: This medicine contains 1mmol (39.06 mg) potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Calcium: Each 10 ml contains 200 mg (2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Methyl and propyl parahydroxybenzoate: Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).
Benzyl alcohol: This medicine contains 0.525 mg benzyl alcohol in each 5 ml. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
4.5 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Interaction with other medicinal products and other forms of interaction | 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, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Fertility, pregnancy and lactation | 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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None
4.8 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Undesirable effects | 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 |
Gaviscon Advance Aniseed Oral Suspension | Clinical particulars - Overdose | 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.
5. Pharmacological properties
5.1 |
Gaviscon Advance Aniseed Oral Suspension | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mode of action of Gaviscon Advance Aniseed Suspension is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Advance Aniseed Oral Suspension | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6. |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - List of excipients | List of excipients
Calcium carbonate
Carbomer
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Saccharin sodium
Fennel flavour
Sodium hydroxide
Potassium
Purified water
6.2 |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - Shelf life | Shelf life
Two years
6.4 |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not refrigerate.
6.5 |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 500, 560 or 600 ml suspension.
6.6 |
Gaviscon Advance Aniseed Oral Suspension | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Not applicable.
7. |
Gaviscon Advance Aniseed Oral Suspension | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
8. Marketing authorisation number(s)
PL 00063/0108
9. |
Gaviscon Advance Aniseed Oral Suspension | Date of first authorisation/renewal of the authorisation | 29 April 2002
10. |
Gaviscon Advance Aniseed Oral Suspension | Date of revision of the text | 13/12/2022 |
Gaviscon Advance Mint Chewable Tablets | Name of the medicinal product | Gaviscon Advance Mint Chewable Tablets
2. |
Gaviscon Advance Mint Chewable Tablets | Qualitative and quantitative composition | Each tablet contains sodium alginate 500 mg and potassium bicarbonate 100 mg.
Excipient(s) with known effect:
Sodium 53.22 mg (2.314 mmol)/tablet
Aspartame (E 951) 4.5 mg/tablet
Potassium 39.43 mg/tablet
For the full list of excipients, see section 6.1.
3. |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical form | Chewable tablet.
An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint. Each tablet is imprinted with a "Sword and Circle" on one side and "GA500" on the reverse.
4. |
Gaviscon Advance Mint 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, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It 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 Advance Mint 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: One to two tablets after meals and at bedtime.
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 Advance Mint 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 Advance Mint Chewable Tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 53.22 mg sodium per tablet, equivalent to 2.7% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 21.28 % 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).
Potassium: This medicine contains potassium 1.01 mmol (39.43 mg) per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Each two-tablet dose contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicine contains 4.5 mg aspartame (E 951) in each tablet. Aspartame (E 951) 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.
May cause central nervous system depression in the presence of renal insufficiency and should not be used in patients with renal failure.
4.5 |
Gaviscon Advance Mint Chewable Tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | 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, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6 |
Gaviscon Advance Mint Chewable Tablets | Clinical particulars - Fertility, pregnancy and lactation | 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 foeto/neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7 |
Gaviscon Advance Mint Chewable Tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None.
4.8 |
Gaviscon Advance Mint Chewable Tablets | Clinical particulars - Undesirable effects | 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 |
Gaviscon Advance Mint Chewable Tablets | Clinical particulars - Overdose | 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.
5. Pharmacological properties
5.1 |
Gaviscon Advance Mint Chewable Tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mode of action of Gaviscon Advance Tablets is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Advance Mint Chewable Tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6. |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - List of excipients | List of excipients
Sodium
Potassium
Mannitol
Calcium carbonate
Macrogol 20,000
Magnesium stearate
Aspartame (E 951)
Mint flavour no. 3
Acesulfame potassium
Copovidone
6.2 |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - Shelf life | Shelf life
Two years.
6.4 |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C. Store in the original package.
6.5 |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
White, rigid, injection-moulded, polypropylene cylinder container with snap-bead neck finish.
Container containing 20 or 60 tablets. Pack sizes are comprised of either three 20-tablet containers packed into a carton or one 60-tablet container. For some markets the 60-tablet container will be packed into a carton.
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister tray containing six individually sealed tablets. Two or four blister trays in a carton.
Not all pack sizes may be marketed.
6.6 |
Gaviscon Advance Mint Chewable Tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gaviscon Advance Mint Chewable Tablets | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0613.
9. |
Gaviscon Advance Mint Chewable Tablets | Date of first authorisation/renewal of the authorisation | 28/09/2010
10. |
Gaviscon Advance Mint Chewable Tablets | Date of revision of the text | 04/02/2021 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Name of the medicinal product | Gaviscon Advance Peppermint Flavour
Oral Suspension.
2. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Qualitative and quantitative composition | Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
For a full list of excipients, see section 6.1.
3. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical form | Oral suspension.
Off-white viscous suspension.
4. |
Gaviscon Advance Peppermint Flavour 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, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It 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 Advance Peppermint Flavour Oral Suspension | Clinical particulars - Posology and method of administration | Posology and method of administration
Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required 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 Advance Peppermint Flavour Oral Suspension | Clinical particulars - Contraindications | Contraindications
The 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 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % 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).
Potassium: This medicine contains 1.0 mmol (39.06 mg) Potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
4.5 |
Gaviscon Advance Peppermint 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
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Clinical particulars - Fertility, pregnancy and lactation | 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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Not relevant.
4.8 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Clinical particulars - Undesirable effects | 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 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Clinical particulars - Overdose | 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.
5. Pharmacological properties
5.1 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - List of excipients | List of excipients
Calcium carbonate
Carbomer 974P
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water
6.2 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Shelf life | Shelf life |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Special precautions for storage | Shelf life: 2 years.
Shelf-life after opening: 6 months.
6.4 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Nature and contents of container | Special precautions for storage
Do not refrigerate.
6.5 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Special precautions for disposal and other handling | Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5 ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension. Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.
6.6 |
Gaviscon Advance Peppermint Flavour Oral Suspension | Pharmaceutical particulars - Subsection 7 | Special precautions for disposal and other handling
No special requirements.
7. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0612.
9. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Date of first authorisation/renewal of the authorisation | 11/10/2010
10. |
Gaviscon Advance Peppermint Flavour Oral Suspension | Date of revision of the text | 15/05/2021 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Name of the medicinal product | Gaviscon Advance Peppermint Flavour Oral Suspension
2. |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Qualitative and quantitative composition | Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
For a full list of excipients, see section 6.1.
3. |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Pharmaceutical form | Oral suspension.
Off-white viscous suspension.
4. |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | 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, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It 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 Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Posology and method of administration | Posology and method of administration
Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required 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 Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Contraindications | Contraindications
The 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 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % 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).
Potassium: This medicine contains 1.0 mmol (39.06 mg) Potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
4.5 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Interaction with other medicinal products and other forms of interaction | 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, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Fertility, pregnancy and lactation | 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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Not relevant.
4.8 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Undesirable effects | 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 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Clinical particulars - Overdose | 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.
5. Pharmacological properties
5.1 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
There are no preclinical findings of relevance to the prescriber which are additional to those already included in other section of the SmPC.
6. |
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL) | Pharmaceutical particulars - List of excipients | List of excipients
Calcium carbonate
Carbomer 974P
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water
6.2 |
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