Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Magnesium alginate, Sodium alginate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for? Gaviscon Infant contains sodium alginate and magnesium alginate which belong to a group of medicines called "reflux suppressants". Reflux is the process by which the stomach contents flow back up the tube that leads from the mouth to the stomach (known as the gullet or oesophagus). This can cause an infant to be sick, spit up more than normal and become distressed. Gaviscon Infant prevents reflux by stabilising the stomach contents, so reducing the incidence of reflux and bringing up of feeds (posseting).
2. Before using Gaviscon Infant Do not use Gavsicon Infant:
Gaviscon Infant For infants aged 1 to 2 years. Not to be used in premature infants or infants under one year except under medical supervision. Not suitable for children over 2 years, adults or the elderly. Always use Gaviscon Infant exactly as described below. You should check with your doctor or pharmacist if you are not sure.
The dosage and mixing instructions depend on the weight of your child and the feeding method you use: Infants under 4.5kg (10lb) – one sachet should be used Infants over 4.5kg (10lb) – two sachets should be used Open the sachet(s) and mix the contents immediately before use as directed below: Bottle fed infants:
Like all medicines, Gaviscon Infant can cause side effects, although not everybody gets them. Very rarely (less than 1 in 10,000) patients may experience constipation & diarrhoea. Side effects for which the frequency cannot be estimated from available data include hypersensitivity, bloating, discomfort of the stomach (gastric distension) and intestinal obstruction. If the child has any side effects, stop giving Gaviscon Infant and tell your doctor or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Gaviscon Infant Keep this medicine out of the sight and reach of children. Do not use after the expiry date shown on the pack (EXP month/year). Do not store above 30oC. Do not use if the sachet is damaged or the security seal is broken. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information Each single dose sachet of Gaviscon Infant contains 225 mg sodium alginate and 87.5 mg magnesium alginate as the active ingredients. The other ingredients are mannitol (E421) and colloidal silica. What Gaviscon Infant looks like and the contents of the pack Gaviscon Infant is a powder. Each carton contains 30 single dose sachets of powder, joined in pairs. Marketing Authorisation Holder and Manufacturer Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS. PL 00063/0099 Gaviscon and
RB0000
are trademarks
Leaflet last revised: April 2019
RB0000
Gaviscon Infant Sachets comes as sachet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Gaviscon Infant Sachets is magnesium alginate, sodium alginate.
This leaflet reproduces the patient information leaflet approved for Gaviscon Infant Sachets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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
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.
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.
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.
Pregnancy:
Not relevant.
Breastfeeding:
Not relevant.
Fertility:
Not relevant.
Not applicable.
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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Magnesium alginate, Sodium alginate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Magnesium alginate, Sodium alginate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Gaviscon Infant Sachets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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