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.
for 2, What you need to know before you take this medicine 3. How to take this medicine 4, Possible side effects 5, How to store this medicine
____ 6 Contents ofthe pack and other information Children
Do not give this medicine to a child under 12 years of age except on the advice of a doctor. There is a risk of increased levels of sodium in the blood (hypernatremia) in children who have kidney problems or who have an inflamed stomach or bowel (gastroenteritis).
Other medicines and Gaviscon Double Action Mixed Berries Flavour Oral Suspension: Do not take this product within two hours of taking other medicines by mouth as it can interfere with the action of some other medicines. This is especially important if you are taking antihistamines, antibiotics (tetracycline and quinolones such as norfloxacin), iron preparations, antifungals such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroxine, chloroquines (for malaria) and bisphosphonates (for osteoporosis). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines obtained without prescription.
Pregnancy, breast-feeding and fertility: You can take this medicine if you are pregnant or breast-feeding or planning to have a baby. As with all medicines, the treatment duration should be limited as much as possible.
Important information about some of the ingredients of Gaviscon Double Action Mixed Berries Flavour Oral Suspension This product contains methyl (E218) and propyl (E216) parahydroxybenzoates which may cause allergic reactions (possibly delayed). It also contains 127.88 mg (5.56 mmol) sodium per 10ml dose (main component of cooking/table salt).
If you forget to take Gaviscon Double Action Mixed Berries Flavour Oral Suspension: It is not necessary to double the dose next time, just carry on taking as before. If symptoms persist after 7 days consult your doctor. 4) Possible side-effe Like all medicines, Gaviscon Double Action Mixed Berries Flavour Oral Suspension can cause side effects,
although not everybody gets them. Ifyou experience these side effects stop taking the product and consult your doctor immediately. Very rarely (less than 1 in 10,000) chance of an allergic reaction from the ingredients. Symptoms of this may include abdominal pain, diarrhoea, nausea, vomiting, skin rash, itching, dizziness, swelling of the face, lips, tongue, or throat and difficulty in breathing.
Reporting 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 yellow card scheme at www.nhra.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 medicine Always take this medicine exactly as described in this leaflet ar as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Check that the cap seal is unbroken before first using this product. For oral use. Shake well before use. Adults, including the elderly and children over 12 years: Take 10 – 20ml (two to four Sml spoonfils) 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 Oral Suspension than you should: If you take too much of this product you may feel bloated. It is unlikely to cause you any harm, but please consult your doctor or pharmacist if this doesn't go away.
The expiry date refers to the last day of that month » Use within 6 months of opening » Do not store above 30°C. Do not refrigerate or freeze. * Check the cap seal is unbroken before first using this product. 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.
this medicine ~. * Keep out of the sight and reach of children * Do not use this product after the expiry date (EXP: month/year) shown.
Talk to your doctor or pharmacist before using this medicine if you: ¢ suffer or have suffered from significant kidney or heart disease, as certain salts could interfere with these diseases ¢ have severe kidney problems
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This is equivalent to 6.4% of the recommended maximum daily dietary intake of sodium for an adult. The maximum recommended daily dose of this medicinal product contains 1023mg sodium (found in table salt). This is equivalent to 51.15% of the adult recommended maximum daily dietary intake for sodium. Talk to your pharmacist or doctor if you need this medicine on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet. It also contains 130mg (3.25 mmol) calcium per 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 32.93 mg propylene glycol in each 10 ml.
Driving and using machines This medicine has no influence on the ability to drive and use machines.
What this medicine contains: Each 10ml of oral suspension contains 500mg sodium alginate, 213mg sodium hydrogen carbonate and 325mg calcium carbonate as the active ingredients. The other ingredients are sodium, propylene glycol (present in cranberry, raspberry and fantasy fruit flavours), carbomer, methyl (E218) and propyl (E216) parahydroxybenzoates, sodium saccharin, raspberry flavour, cranberry flavour, fantasy fruit masking flavour, sodium hydroxide and purified water. This product does not contain sugar or gluten. What this medicine looks like and contents of the pack: This medicine is an off-white to cream suspension with the odour and flavour of berry. Gaviscon Double Action Mixed Berries Flavour Oral Suspension is available in bottles of 150ml, 200ml, 250ml, 300ml,
and 600ml bottles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS. Gaviscon is a trade mark of the Reckitt group. PL 00063/0753.
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Gaviscon Double Action Mixed Berries Flavour Oral Suspension comes as oral solution. 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 Oral Suspension is calcium carbonate, sodium alginate, sodium hydrogen carbonate.
This leaflet reproduces the patient information leaflet approved for Gaviscon Double Action Mixed Berries Flavour Oral Suspension, 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.
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.
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 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.
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.
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, 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 Oral Suspension. 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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