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 Calcium carbonate, Sodium alginate, Sodium hydrogen carbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
Gaviscon Peppermint Flavour Tablets: For oral administration. Chew thoroughly before swallowing. Adults, including the elderly and children 12 years and over: When symptoms occur take two to four tablets after meals and at bedtime. Children under 12 years: Should only be taken on medical advice. If you forget a dose, it is not necessary to double the dose next time, just carry on taking as before. If you take too much of this product you may feel bloated and experience some abdominal discomfort. It is unlikely to cause you any harm, but please consult your doctor or pharmacist. After taking Gaviscon Peppermint Flavour Tablets: If symptoms persist after 7 days consult your doctor.
: Very rare (less than 1 in 10,000) chance of an allergic reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience these or any other side-effects stop taking the product and consult your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects, you can help provide more information on the safety of this medicine. Storing your medicine: Do not use this product after the expiry date (EXP: month/year) shown KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Do not store above 30°C. Further information Gaviscon Peppermint Flavour Tablets are circular tablets with an off white to cream, slightly mottled appearance. Each chewable tablet contains 250mg sodium alginate, 133.5mg sodium hydrogen carbonate and 80mg calcium carbonate as the active ingredients. The other ingredients are mannitol (E421), macrogol 20,000, copovidone, aspartame (E951), peppermint flavouring, magnesium stearate and acesulfame potassium. These tablets do not contain sugar or gluten. Gaviscon Peppermint Flavour Tablets are available in pack sizes of 6's, 8's, 12's, 16's, 24's, 32's, & 48's. Not all pack sizes may be marketed. Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. Gaviscon and are trade marks. PL 00063/0627 Date of Preparation: February 2021
CUSTOMER INFO: Minimum Point Size = 9.00pt
250mg Tablets
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Peppermint
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12Tablets UK
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Date:
12/02/21
RBH Contact:
Anoop James
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PATIENT INFORMATION LEAFLET GAVISCON PEPPERMINT FLAVOUR TABLETS Sodium alginate Sodium hydrogen carbonate Calcium carbonate Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor What are Gaviscon Peppermint Flavour Tablets? Gaviscon Peppermint Flavour Tablets belong to a group of medicines called "reflux suppressants", which form a protective layer on top of the stomach contents to prevent stomach acid escaping from the stomach where it works into the food pipe causing pain and discomfort. What are Gaviscon Peppermint Flavour Tablets used for? Gaviscon Peppermint Flavour Tablets are used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux) which may occur, for example, following meals or during pregnancy, and in patients with symptoms related to oesophagitis. Before taking Gaviscon Peppermint Flavour Tablets: Do not take this product if:
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UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.
1.3.1 Package Leaflet – Proposed Gaviscon Peppermint Tablets National 0007239 eCTD
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Muthukumar Rajachithambaram v2.0
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Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100
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Gaviscon Peppermint Flavour Tablets comes as tablet. 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 Peppermint Flavour Tablets is calcium carbonate, sodium alginate, sodium hydrogen carbonate.
Medicines with the same active substance, strength and form include: Gaviscon Double Action Mixed Berries Flavour Chewable Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Gaviscon Peppermint Flavour Tablets, 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.
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.
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).
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
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.
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, biphosphonates (diphosphonates) and estramustine. See also 4.4.
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Fertility:
There is a lack of robust pre-clinical data available regarding the effects of alginate on fertility; limited studies have not reported any negative effects on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.
Not relevant.
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.
Symptoms
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
Management
In the event of overdose symptomatic treatment should be given.
Ask anything about Gaviscon Peppermint Flavour Tablets. 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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