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.
E GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS: Do not take Gaviscon Double Action Mixed Berries Flavour Chewable Tablets: If you know you are allergic to any of the ingredients of this medicine (listed in section 4). Talk to your doctor or pharmacist before using Gaviscon Double Action Mixed Berries Flavour Chewable Tablets if you:
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TR2018393
Action:
A
Gaviscon
Brand:
Adult
Segment Group:
Double Action Tablets
Segment:
Mixed Berries
Pack Size:
12 24 48Pack UK
Date:
07/10/20
RBH Contact:
Anoop James
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Market/Country:
230
Category:
D0064065
Finished Goods Code:
0000000
Supply Point:
RB Hull
3rd Party Code
N/A
Pharmacode No/NE:
N/A
Edgemark Position:
200
Parent Technical Packaging Specification:
190
2nd Component Code (if applicable):
N/A
CAD Cam Ref:
G-Lflt-D0064065-175x200mm
Printer:
Medica Packaging Limited (Crewe, UK)
Substrate:
Paper White
Cutter
Cutter 2 (if applicable)
Guides
Guides 2 (if applicable)
170
Technical & Non Printing Items
Colours (Leaflet)
160
Process Black
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1 LTH
This leaflet was last approved in 09/2020.
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Magnification:
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Full Height:
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Bar Height (Smallest Bar):
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BWR:
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Encoded Data:
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Truncated By:
100
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Barcode Number:
90
Barcode Type:
110
BARCODE INFO
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What Gaviscon Double Action Mixed Berries Flavour Chewable Tablets contain The active substances in each chewable tablet are 250 mg sodium alginate, 106.5 mg sodium hydrogen carbonate and 187.5 mg calcium carbonate. The other ingredients are xylitol, carmellose sodium, magnesium stearate, macrogol 20,000, mannitol (E421), copovidone, acesulfame-K, aspartame (E951), cranberry flavour, raspberry flavour, fantasy fruit flavour, Potassium and carmoisine lake (E122). The flavours contain sucrose. This product does not contain gluten. What Gaviscon Double Action Mixed Berries Flavour Chewable Tablets look like and the contents of the pack Gaviscon Double Action Mixed Berries Flavour Chewable Tablets are flat, circular, bi-layer tablets with the odour and flavour of berry. One layer of the tablet is coloured pink with a slightly mottled appearance, with the other layer being white. Gaviscon Double Action Mixed Berries Flavour Chewable Tablets are available in packs of 4, 6, 8, 12, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Reckitt Benckiser Healthcare (UK) Ltd. Hull, HU8 7DS Marketing Authorisation Number PL 00063/0755
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6. CONTENTS OF THE PACK AND FURTHER INFORMATION
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GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS: Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For oral administration, chew thoroughly before swallowing. Adults including the elderly and children 12 years and over: Take two to four tablets after meals and at bedtime, up to four times a day. Children under 12 years old: Should only be taken on medical advice. If you take more Gaviscon Double Action Mixed Berries Flavour Chewable Tablets than you should If you take too much of this product it is unlikely to cause you any harm. However, you may feel bloated. Consult your doctor if this doesn't go away. If you forget to take Gaviscon Double Action Mixed Berries Flavour Chewable Tablets If you forget a dose it is not necessary to double the dose next time, just carry on taking as before.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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Contains carmoisine lake (E122) which may cause an allergic reaction. They also contain 55.89 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 2.8 % of the recommended maximum daily dietary intake of sodium for an adult. The maximum recommended daily dose of this medicinal product contains 894.24 mg sodium (found in table salt). This is equivalent to 44.71 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet. This medicine also contains 300 mg (7.5 mmol) calcium per 4 table dose. Speak to a doctor before taking this medicine if you have kidney stones or high levels of calcium in your blood. This medicine contains Mannitol which may have a mild laxative effect. They also contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
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Artwork Type: BW Submission
STUDIO USE ONLY
balaji haridass
Sm•Art check results:
G=2; O=0; R=0; – BH – 07/10/20 16:39:34
v2.0
mm 10
PG1
RB443026
ZEN Ref:
180
Trident Reference No:
240 250
RB Artwork and Print Specification
Like all medicines, Gaviscon Double Action Mixed Berries Flavour Chewable Tablets can cause side effects, although not everybody gets them. If you experience these side effects, stop taking the product and consult your doctor immediately. Very rare (less than 1 in 10,000) chance of an allergic reaction to the ingredients. Symptoms of this may include abdominal pain, diarrhoea, nausea, vomiting, skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat.
GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS: Keep this medicine out of the sight and reach of children. Do not use this product after the expiry date which is stated on the carton after EXP (month/year). The expiry date refers to the last day of that month. Do not store above 30°C and store in the original package to protect from moisture. 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.
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Component Code (2D if applicable):
Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.
CUSTOMER INFO: Minimum Point Size = 9.00pt
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Gaviscon Double Action Mixed Berries Flavour Chewable 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 Double Action Mixed Berries Flavour Chewable Tablets is calcium carbonate, sodium alginate, sodium hydrogen carbonate.
Medicines with the same active substance, strength and form include: Gaviscon Peppermint Flavour Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Gaviscon Double Action Mixed Berries Flavour Chewable 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 acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy.
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).
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.
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.
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.
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.
This product has no or negligible influence on the ability to drive and use machines.
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.
Symptoms
Some abdominal distension may be noticed.
Management
In the event of overdosage symptomatic treatment should be given
Ask anything about Gaviscon Double Action Mixed Berries Flavour Chewable 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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