medication_name stringlengths 6 170 | section_title stringclasses 42 values | text stringlengths 0 47.1k |
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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 |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | 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 Oral Suspension | Pharmaceutical particulars - List of excipients | List of excipients
Carbomer
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate, (E216)
Saccharin sodium
Raspberry flavour
Cranberry flavour
Fantasy fruit masking flavour
Sodium hydroxide
Sodium
Propylene glycol*
Purified water
*present in cranberry, raspberry and fantasy fruit flavours
6.2 |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | Pharmaceutical particulars - Shelf life | Shelf life
2 years.
Use within 6 months of opening
6.4 |
Gaviscon Double Action Mixed Berries Flavour 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 Mixed Berries Flavour Oral Suspension | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Amber glass bottles or Pink coated Amber glass bottles
With a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5 ml, 10 ml, 15 ml, and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure.
Pack sizes:150, 200, 300 and 600 ml.
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 Double Action Mixed Berries Flavour Oral Suspension | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements for disposal.
7. |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull, HU8 7DS,
United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0753
9. |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | Date of first authorisation/renewal of the authorisation | 01/03/2018
10. |
Gaviscon Double Action Mixed Berries Flavour Oral Suspension | Date of revision of the text | 23/02/2021 |
Gaviscon Infant Sachets | Name of the medicinal product | Gaviscon Infant.
2. |
Gaviscon Infant Sachets | Qualitative and quantitative composition | Each unit dose sachet of 0.65 g powder contains 225 mg sodium alginate and 87.5 mg magnesium alginate.
For a full list of excipients, see section 6.1.
3. |
Gaviscon Infant Sachets | Pharmaceutical form | Sachet of powder.
4. |
Gaviscon Infant Sachets | Clinical particulars - Therapeutic indications | Therapeutic indications
Gaviscon Infant helps to prevent gastric regurgitation in infants where competence of the cardiac sphincter has not been fully established.
The indications for use are gastric regurgitation, gastro-oesophageal reflux and reflux associated with hiatus hernia in infants and young children.
4.2 |
Gaviscon Infant Sachets | Clinical particulars - Posology and method of administration | Posology and method of administration
If symptoms persist for more than 7 days, or worsen, seek medical advice.
Posology
For infants aged 1 to 2 years. Not to be used in premature infants or infants under one year except under medical supervision.
Mix immediately before use as directed below:
Infants under 4.5 kg (10lb) – one sachet should be used
Infants over 4.5kg (10lb) – two sachets should be used
Bottle fed infants:
• Mix each sachet into 115 ml (4 fl oz) of feed in the bottle.
• Shake well
• Feed as normal
Breast fed infants and other infants up to 2 years:
• Mix each sachet with 5 ml (1 teaspoon) of cooled boiled water until a smooth paste is formed.
• Add another 10 ml (2 teaspoons) of cooled boiled water and mix
• For breast fed infants give Gaviscon Infant part way through each feed or meal using a spoon or feeding bottle.
• For all other infants give Gaviscon Infant at the end of each meal using a spoon, or feeding bottle.
Treatment should not be administered more than six times in any 24 hour period.
Not suitable for children over 2 years of age, adults or the elderly.
Renal Insufficiency: Not to be used when treating infants with known or suspected impairment of renal function (see section 4.3).
Method of administration:
For oral used after mixing with water or milk feed
4.3 |
Gaviscon Infant Sachets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to sodium alginate and magnesium alginate or any of the excipients listed in section 6.1.
Contraindicated in cases of intestinal obstruction and in cases of established diarrhoea.
Not to be used in situations where excessive water loss is likely, e.g. fever, diarrhoea, vomiting or high room temperature. Not to be used in gastroenteritis where the appropriate treatment is rehydration with fluid replacement.
Not to be used when treating infants with known or suspected impairment of renal function as the sodium content (approximately 23.9 mg or 1.04 mmol per dose) may add to the risk of hypernatraemia.
Not to be used except on a doctor or other health professional's recommendation.
4.4 |
Gaviscon Infant Sachets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
A medical review of the patient's condition should be undertaken seven days after initiating treatment or before if symptoms worsen.
Significant or sustained changes in bowel habit or stool consistency e.g. diarrhoea or constipation, should be investigated.
Follow dosage instructions exactly to avoid an excessive amount of product per feed and the possible risk of hypernatraemia.
Not to be used when treating infants with known or suspected impairment of renal function as the sodium content (approximately 23.9 mg or 1.04 mmol per dose) may add to the risk of hypernatraemia.
Hypernatraemia should be treated with oral fluids and monitoring of the infant's electrolytes. Severe cases should be treated by the cautious use of hypo-osmotic solutions.
This medicinal product contains 23.9 mg sodium per sachet, equivalent to 1% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The maximum daily dose of this product is equivalent to 14 % of the WHO recommended maximum daily intake for sodium for an adult. This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
4.5 |
Gaviscon Infant Sachets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Not to be used with thickening agents or infant milk preparations containing a thickening agent as this could lead to over-thickening of the stomach contents.
4.6 |
Gaviscon Infant Sachets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy:
Not relevant.
Breastfeeding:
Not relevant.
Fertility:
Not relevant.
4.7 |
Gaviscon Infant Sachets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Not applicable.
4.8 |
Gaviscon Infant Sachets | Clinical particulars - Undesirable effects | Undesirable effects
Gaviscon Infant's mode of action is physical, resulting in a thickening of the gastric contents. An excessive concentration of Gaviscon Infant may lead to gastric distension.
Adverse events which have been associated with sodium alginate and magnesium alginate 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
Not known
Hypersensitivity
Gastrointestinal Disorders
Very rare
Constipation and diarrhoea.
Not known
Intestinal obstruction, flatulence, abdominal distension and bezoar.
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 Infant Sachets | Clinical particulars - Overdose | Overdose
Symptoms
Overdosage with Gaviscon Infant may lead to the formation of an intragastric mass.
Rare instances have occurred in which an intragastric mass has developed comprising Gaviscon Infant and milk proteins. Overdosage may have contributed to the development of such masses. The majority resolved spontaneously when the child was admitted to hospital, Gaviscon Infant was discontinued and a regime of adequate fluid intake and monitoring of fluid and electrolyte balance was installed. If spontaneous resolution of the mass does not occur, removal by surgical or endoscopic means may be required.
Management
In the event of overdose, symptomatic treatment should be given.
5. Pharmacological properties
5.1 |
Gaviscon Infant Sachets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mode of action of Gaviscon Infant is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Infant Sachets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6. |
Gaviscon Infant Sachets | Pharmaceutical particulars - List of excipients | List of excipients
Mannitol and colloidal silica.
6.2 |
Gaviscon Infant Sachets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
None known.
6.3 |
Gaviscon Infant Sachets | Pharmaceutical particulars - Shelf life | Shelf life
Three years.
6.4 |
Gaviscon Infant Sachets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gaviscon Infant Sachets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
A cardboard outer carton containing 30 unit dose sachets joined in pairs. The sachets are composed of paper (41 gsm), low density polyethylene (12 gsm), aluminium foil (21.6 gsm) with Surlyn 1652 laminate (18 gsm).
6.6 |
Gaviscon Infant Sachets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Gaviscon Infant should be mixed with milk or water before taking. As the powder is sterile the sachet should not be opened until immediately before mixing.
7. |
Gaviscon Infant Sachets | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS.
8. Marketing authorisation number(s)
PL 00063/0099.
9. |
Gaviscon Infant Sachets | Date of first authorisation/renewal of the authorisation | 21st April, 1997.
10. |
Gaviscon Infant Sachets | Date of revision of the text | 14/02/2020 |
Gaviscon Original Aniseed Relief | Name of the medicinal product | Gaviscon Original Aniseed Relief.
2. |
Gaviscon Original Aniseed Relief | Qualitative and quantitative composition | Gaviscon Original Aniseed Relief contains 250 mg sodium alginate, 133.5 mg sodium bicarbonate and 80 mg calcium carbonate per 5 ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218: 40 mg/ 10ml
Propyl parahydroxybenzoate E216: 6 mg/10ml
Benzyl alcohol* (1.1 mg/10ml)
Sodium 142.6 mg (6.2 mmol)/ 10ml
*present in fennel flavour
For excipients, see Section 6.1.
3. |
Gaviscon Original Aniseed Relief | Pharmaceutical form | Oral suspension.
An opaque, pink suspension with the odour and flavour of fennel.
4. |
Gaviscon Original Aniseed Relief | Clinical particulars - Therapeutic indications | 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 |
Gaviscon Original Aniseed Relief | Clinical particulars - Posology and method of administration | 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 |
Gaviscon Original Aniseed Relief | 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, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4 |
Gaviscon Original Aniseed Relief | 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 142.6 mg sodium per 10 ml, equivalent to 7.1 % 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).
This medicine contains 1.1 mg benzyl alcohol (from Fennel flavour) per 10 ml dose. 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 a 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 Original Aniseed Relief | 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, 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 |
Gaviscon Original Aniseed Relief | 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 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 |
Gaviscon Original Aniseed Relief | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None.
4.8 |
Gaviscon Original Aniseed Relief | 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 Original Aniseed Relief | 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 Original Aniseed Relief | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The mode of action of the product is physical and does not depend on absorption into the systemic circulation.
5.3 |
Gaviscon Original Aniseed Relief | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No preclinical findings relevant to the prescriber have been reported.
6. |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - List of excipients | List of excipients
Carbomer
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Saccharin sodium
Fennel flavour
Erythrosine
Sodium hydroxide
Water
6.2 |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - Shelf life | Shelf life
Three years for 600ml pack size.
Two years for 100ml, 150ml, 200ml, 250ml and 300ml pack sizes.
6.4 |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.
6.5 |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - Nature and contents of container | 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, 150, 200, 250ml, 300 and 600 ml.
6.6 |
Gaviscon Original Aniseed Relief | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special instructions.
7. |
Gaviscon Original Aniseed Relief | Marketing authorisation holder | Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom
8. Marketing authorisation number(s)
PL 00063/0126
9. |
Gaviscon Original Aniseed Relief | Date of first authorisation/renewal of the authorisation | 27/02/2009
10. |
Gaviscon Original Aniseed Relief | Date of revision of the text | 04/01/2021 |
Gaviscon Peppermint Flavour Tablets | Name of the medicinal product | Gaviscon Peppermint Flavour Tablets.
2. |
Gaviscon Peppermint Flavour Tablets | Qualitative and quantitative 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.
3. |
Gaviscon Peppermint Flavour Tablets | Pharmaceutical form | Chewable tablet.
An off-white to cream, slightly mottled tablet.
4. |
Gaviscon Peppermint Flavour Tablets | Clinical particulars - Therapeutic indications | 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 |
Gaviscon Peppermint Flavour Tablets | Clinical particulars - Posology and method of administration | 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 |
Gaviscon Peppermint Flavour 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.
4.4 |
Gaviscon Peppermint Flavour 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 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 |
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