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 bicarbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
Gaviscon Double Action Liquid Sachets
What are Gaviscon Double Action Liquid Sachets?
RB451093
ZEN Ref:
170
Please read this leaflet carefully before you take this medicine. If you are not sure about anything, ask your pharmacist or doctor
Trident Reference No:
180
interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron preparation, thyroid hormones, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquine (for malaria), bisphosphonates (for osteoporosis) and estramustine (for prostate cancer).
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PATIENT INFORMATION LEAFLET
GAVISCON DOUBLE ACTION LIQUID SACHETS Sodium alginate, Sodium bicarbonate, Calcium carbonate
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RB Artwork and Print Specification
5 mm
N/A
Pregnancy and breast-feeding
12 mm
Double Action Liquid
Segment:
STUDIO USE ONLY
Muthukumar Rajachithambaram
Sm•Art check results:
G=2; O=0; R=0; – MR – 17/12/20 12:35:58
v2.0
mm 10
175 mm
Adult
Segment Group:
200
Gaviscon Double Action Liquid Sachets are used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion which may occur, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity).
Gaviscon
Category:
190
What are Gaviscon Double Action Liquid Sachets used for?
B
220
For oral administration. Adults including the elderly and children 12 years and over: one to two 10ml sachets after meals and before bedtime, up to four times a day. Children under 12 years old: Should only be taken on medical advice. 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 a dose it is not necessary to double the dose next time, just carry on taking as before. Taking large doses of calcium carbonate every day for prolonged periods can lead to high levels of calcium in the blood. After taking Gaviscon Double Action Liquid Sachets: If symptoms persist, or treatment is required for more than seven days continuously, seek medical advice.
Gaviscon Double Action Liquid Sachets are a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and work in two ways. 1) Neutralising excess stomach acid to relieve the pain and discomfort. 2) Forming a protective barrier over the stomach contents to soothe the burning pain in your chest.
TR2063278
Action: Brand:
150
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 25°C. Store in the original package. Do not refrigerate or freeze.
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25 mm
DataMatrix
Barcode Number:
0000000
Magnification:
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Full Height:
6.0 mm
Bar Height (Smallest Bar):
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0 microns
Encoded Data:
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6 mm
Barcode Type:
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Do not take this product within two hours of taking other medicines by mouth, as it can
BARCODE INFO
90
Taking other medicines
140
Further information
You can take this product if you are pregnant or breast-feeding. As with all medicines, the treatment duration should be limited as much as possible.
12 mm
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.
1.3.2 Mock-up label clean Gaviscon Double Action peppermint oral suspension sachet National eCTD 0001785
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Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100
CUSTOMER INFO: Minimum Point Size = 9.00pt
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Component Code (2D if applicable):
Very rarely (less than 1 in 10,000 patients treated) there is a 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. Other side effects of unknown frequency may include constipation, irritability, muscle twitching or muscle cramps, indigestion that comes back when you stop taking the tablets and high levels of calcium in the blood. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at 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.
This product is an off-white to cream suspension with the odour and flavour of peppermint. Each 10ml contains 500 mg sodium alginate, 213 mg sodium bicarbonate and 325 mg calcium carbonate. The other ingredients are sodium, carbomer, methyl (E218) and propyl (E216) parahydroxybenzoates, sodium saccharin, peppermint flavour, sodium hydroxide, and water. This product does not contain sugar or gluten. Gaviscon Double Action Liquid Sachets available in packs of 2,4,12 and 24 sachets. Not all pack sizes may be marketed. Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. PL 00063/0524 Gaviscon is a trade mark of the RB group of companies Text Revised: October 2020
2D Code (6 mm2)
Peppermint
Pack Size:
Artwork Type: BW Submission
Gaviscon Double Action Liquid 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 Double Action Liquid Sachets is calcium carbonate, sodium alginate, sodium bicarbonate.
Medicines with the same active substance, strength and form include: Gaviscon Liquid Sachets Mint Flavour. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Gaviscon Double Action Liquid 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.
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
For oral administration.
Adults and children 12 years and over: One to two sachets (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.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1.
This medicinal product contains 127.88 mg sodium per 1 sachet (10ml) 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 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 2 sachets (20 ml) dose contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
Contains methyl parahydroxybenzoate (E218) 40 mg/ 10ml and propyl parahydroxybenzoate (E216) 6 mg/10ml which may cause allergic reactions (possibly delayed).
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically.
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:
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 bicarbonate 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 Rarely
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
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
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: http://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 in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
Ask anything about Gaviscon Double Action Liquid 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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