Team training
TEAM TRAINING
You can use this training to remind you of some of the key points to discuss with your team when they are recommending products for indigestion or heartburn. It may be helpful to act out scenarios or discuss the different products and when they can recommend them.
IN PRACTICE
Mr Hammond has been getting heartburn a few times a week over the last couple of months, and it's worse when he is trying to get to sleep. He has tried the chewable antacid tablets but wants to know if there is something else he can try. He is in his 3Os and has been finding work quite stressful lately.
What is the most appropriate recommendation?
As he suffers from heartburn often, recommend a PPI to reduce the acid produced. Advise him that they may take a few days to work, so he may want to take something else such as an alginate-antacid. Relaxation may help too, as stress is a trigger, as well as raising the head of the bed.
As he is affected by frequent heartburn, this would be a suitable recommendation to give him effective symptom relief.
He could try an alginate as it lasts longer than an antacid. He can also try avoiding trigger foods and cutting down on alcohol and smoking if he smokes.
Another option may be more suitable due to the frequency of his symptoms, and other lifestyle advice may be more suitable for the night-time symptoms.
He should see his GP and be tested for a stomach ulcer.
He hasn't mentioned any symptoms that would indicate a stomach ulcer. However, if symptoms persist despite OTC treatment, he should be referred to his GP.
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1. https://gutscharity.org.uk/advice-and-information/conditions/non-ulcer-dyspepsia/#section-1
2. NICE CKS Dyspepsia - unidentified cause (last revised Oct 2O18) Available at https://cks.nice.org.uk/dyspepsia-unidentified-cause
3. Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management Clinical guideline [CG184] Last updated: 18 October 2O19. Available at: https://www.nice.org.uk/guidance/CG184/chapter/1-Recommendations#helicobacter-pylori-testing-anderadication
4. https://gutscharity.org.uk/advice-and-information/conditions/barretts-oesophagus/
5. https://www.nhs.uk/conditions/hiatus-hernia/
6. https://www.nhs.uk/conditions/heartburn-and-acid-reflux/
7. Disease Management: A guide to clinical pharmacology 3rd Ed, M Randall and K Neil. Pharmaceutical Press 2O16
8. https://www.nhs.uk/conditions/oesophageal-cancer/symptoms/
9. https://www.nhs.uk/conditions/stomach-cancer/
10. Suspected cancer: recognition and referral NICE guideline [NG12] Last updated: 26 July 2O17. Available at: https://www.nice.org.uk/guidance/ng12/chapter/1-Recommendations-organised-by-site-of-cancer#upper-gastrointestinal-tract-cancers
11. https://www.nhs.uk/conditions/stomach-ulcer/
12. https://bnf.nice.org.uk/treatment-summary/antacids.html
13. Mandel KG, et al. Aliment Pharmacol Ther, 2OOO;14:669-9O
14. P Dettmar et al. A comparative study on the raft chemical properties of various alginate antacid raft-forming products Drug Development and Industrial Pharmacy 44(1):1-32 · August 2O17
15. https://bnf.nice.org.uk/drug-class/proton-pump-inhibitors-2
17. https://www.medicines.org.uk/emc/product/623/smpc
18. https://www.medicines.org.uk/emc/product/56O9/smpc
19. Hampson 2005 Int J Pharm. 2005;294:137-147
20. https://www.medicines.org.uk/emc/product/6715/smpc
21. https://www.medicines.org.uk/emc/product/1O345
Online references last accessed September 2020
GUARDIUM ACID REFLUX CONTROL 20MG GASTRO-RESISTANT TABLETS
PL 36687/0395
Active Ingredients: 20 mg of esomeprazole (as esomeprazole magnesium).
Indications: short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.
Dosage and Administration:
Route of Administration: Oral Dosage: Adults aged 18 years and over: The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Contraindications: Hypersensitivity to the esomeprazole, to substituted benzimidazoles or to any of the excipients listed in section 6.1.
Esomeprazole should not be used concomitantly with nelfinavir (see section 4.5).
Precautions and Warnings:
General
Patients should be instructed to consult a doctor if:
- They have significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as treatment with esomeprazole may alleviate symptoms and delay diagnosis.
- They have had previous gastric ulcer or gastrointestinal surgery.
- They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
- They have jaundice or severe liver disease.
- They are aged over 55 years with new or recently changed symptoms.
Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Patients should not take Esomeprazole 20 mg Gastro-resistant Tablets as a long term preventive medicinal product.
Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile (see section 5.1).
Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.
Combination with other medicinal products
Co-administration of esomeprazole with atazanavir is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.
Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with active substances metabolised through CYP2C19 should be considered.
An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain.
As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged (see section 4.5).
Patients should not take another PPI or H2 antagonist concomitantly.
Sucrose and lactose
This medicinal product contains sucrose and lactose. Patients with rare hereditary problems of fructose and/or galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
To avoid this interference, esomeprazole treatment should be temporarily stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Esomeprazole 20 mg Gastro-resistant Tablets. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Pregnancy and Lactation:
Pregnancy
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foetal/neonatal toxicity of esomeprazole. As a precautionary measure, it is preferable to avoid the use of Esomeprazole 20 mg Gastro-resistant Tablets during pregnancy.
Breast-feeding
There is insufficient information on the effects of esomeprazole in newborns/ infants. Esomeprazole should not be used during breast-feeding.
Side Effects:
The following convention has been utilised for the classification of undesirable effects: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (1/10,000).
Summary of the safety profile
Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified.
Blood and lymphatic system disorders
Rare: Leukopenia, thrombocytopenia
Very rare: Agranulocytosis, pancytopenia
Immune system disorders
Rare: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Metabolism and nutrition disorders
Uncommon: Peripheral oedema
Rare: Hyponatraemia
Not known: Hypomagnesaemia (see section 4.4); severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia.
Psychiatric disorders
Uncommon: Insomnia
Rare: Agitation, confusion, depression
Very rare: Aggression, hallucinations
Nervous system disorders
Common: Headache
Uncommon: Dizziness, paraesthesia, somnolence
Rare: Taste disturbance
Rare: Taste disturbance
Rare: Blurred vision
Ear and labyrinth disorders
Uncommon: Vertigo
Respiratory, thoracic and mediastinal disorders
Rare: Bronchospasm
Gastrointestinal disorders
Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign)
Uncommon: Dry mouth
Rare: Stomatitis, gastrointestinal candidiasis
Not known: Microscopic colitis
Hepatobiliary disorders
Uncommon: Increased liver enzymes
Rare: Hepatitis with or without jaundice
Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease
Skin and subcutaneous tissue disorders
Uncommon: Dermatitis, pruritus, rash, urticaria
Rare: Alopecia, photosensitivity
Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Not known: Subacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and connective tissue disorders
Rare: Arthralgia, myalgia
Very rare: Muscular weakness
Renal and urinary disorders
Very rare: Interstitial nephritis
Reproductive system and breast disorders
Very rare: Gynaecomastia
General disorders and administration site conditions
Rare: Malaise, increased sweating
License Number: PL 36687/0395
Legal Classification: GSL
License Holder: Torrent Pharma (UK) Ltd. Unit 4, Charlwood Court, County Oak Way, Crawley, West Sussex RH11 7XA United Kingdom
MRRP: Guardium; 7 - £6.99, 14 - £11.99
Last Revised: February 2018
GAVISCON DOUBLE ACTION MIXED BERRIES FLAVOUR CHEWABLE TABLETS
PL 00063/0755
Name and active: Gaviscon Double Action Mixed Berries Flavour Chewable Tablets. Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 106.5 mg and calcium carbonate 187.5 mg.
Indications: Treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy.
Dosage and administration: 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
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Precautions and Warnings: This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 44.71% 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 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. Due to its aspartame content this product should not be given to patients with phenylketonuria. 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: o Patients with server/impaired renal function/-insufficiency o Patients with hypophosphatemia. 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.
Pregnancy and Lactation:
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. Breast feeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic reaction, anaphylactoid reaction and hypersensitivity reactions such as urticaria. They may also develop gastrointestinal disorders such as abdominal pain, acid rebound, diarrhoea, nausea, vomiting and skin and subcutaneous tissue disorders such as rash pruritic.
Frequency Not Known patients may develop metabolism and nutritional disorders such as alkalosis, acid rebound, hypercalcaemia, milk-alkali syndrome. They may also develop respiratory effects such as bronchospasm and gastrointestinal disorders such as constipation.
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Licence Number: PL 00063/0755
MRRP: Gaviscon Double Action Mixed Berries Tablets: 12s = £2.99, 24s = £4.99
Date of Preparation: April 2020
GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION
PL 00063/0749
Active substances: Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg.
Indications: Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Dosage and administration: Adults and children 12 years and over: 5-10 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 106 mg (5.0 mmol) sodium per 10 ml dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 21% 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). Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 10 ml dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed). A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Pregnancy and Lactation:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Licence Number: PL 00063/0749
MRRP: Gaviscon Advance Liquids Aniseed: 150ml = £5.99, 300ml = £9.99
Last Revised: April 2020
GAVISCON LIQUID SACHETS MINT FLAVOUR
PL 00063/0628
Active Ingredients: 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate per 10 ml. Also contains methyl and propyl hydroxybenzoates and sodium.
Indications: 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.
Dosage and Administration: For oral administration. Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a 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
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 285.2 mg (12.4 mmol) sodium per 2 sachet dose, equivalent to 14.26% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 57 % 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 10 ml, one sachet dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). 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.
Pregnancy and Lactation: 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. No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Side Effects: Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
License Number: PL00063/0628
Legal Classification: GSL.
License Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull HU8 7DS.
MRRP: Gaviscon Liquid Sachets 12's - £4.69
Last revised: April 2020
GAVISCON PEPPERMINT FLAVOUR TABLETS
PL 00063/0627
Active substances: Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg, calcium carbonate 80 mg.
Indications: 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.
Dosage and administration: 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
Contraindications: Patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Precautions and Warnings: 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, and bisphosphonates (diphosphonates) and estramustine.
Fertility, Pregnancy and Lactation: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Licence Number: PL 00063/0627
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Tablets Peppermint:8 = £1.62, 24 = £3.90, 48 = £6.70
Last Revised: June 2020
GAVISCON ADVANCE MINT CHEWABLE TABLETS
PL 00063/0613
Active Ingredients: Sodium alginate 500 mg and potassium bicarbonate 100 mg.
Indications: Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Dosage and Administration: For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: One to two tablets after meals and at bedtime. 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
Contraindications: Hypersensitivity to the active substances or to any of the excipients
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 103 mg (4.6 mmol) sodium per two tablet dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 21% 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). Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 2 tablet dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. Each two-tablet dose contains 200 mg (2.0 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. May cause central nervous system depression in the presence of renal insufficiency and should not be used in patients with renal failure. A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Pregnancy and Lactation: 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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. Breast feeding: No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Side effects: Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
License Number: PL 00063/0613
Legal Classification: GSL
License Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS.
MRRP: Gaviscon Advance Tablets Mint: 24s -£6.89
NHS LIST PRICE: Gaviscon Advance Tablets Mint: 60s - £3.07
Last Revised: April 2020
GAVISCON ADVANCE PEPPERMINT FLAVOUR ORAL SUSPENSION
PL 00063/0612
Name and active: Gaviscon Advance Peppermint Flavour Oral Suspension. Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg
Indications: Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Dosage and administration: Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons). Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 106 mg (5.0 mmol) sodium per 10 ml dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 21% 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). Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 10 ml dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Fertility, Pregnancy and Lactation:
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 foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding: No known effect on breastfed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Legal Classification: GSL / P
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Licence Number: PL 00063/0612
NHS List Price: Gaviscon Advance Liquid Peppermint: 250ml - £2.56, 500ml - £5.12,
MMRP: Gaviscon Advance Liquid Peppermint: 300ml (GSL / P) - £9.99
Last Revised: June 2020
GAVISCON DOUBLE ACTION MINT
PL 00063/0552
Active Ingredients: Each 10ml dose contains sodium alginate 500mg, sodium bicarbonate 213mg and calcium carbonate 325mg. Also contains methyl and propyl parahydroxybenzoates and sodium saccharin.
Indications: 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.
Dosage and Administration: For oral administration. Adults and children 12 years and over: 10-20ml 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.
Contraindications: Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients. Should not be used in patients with moderate or severe renal insufficiency.
Precautions and Warnings: This medicinal product contains 255.76 mg (11.12 mmol) sodium per 20 ml dose, equivalent to 12.79 % 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 20 ml 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) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). Due to the presence of calcium and carbonates which act as an antacid, a timeinterval 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.
Pregnancy and Lactation: 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 and lactation, if clinically needed. Clinical data do not suggest that this product has an effect on human fertility.
Side effects: Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions
Not known frequency include: Metabolism and Nutritional Disorders: Alkalosis, acid rebound, Hypercalcaemia, Milk-alkali Syndrome. Gastrointestinal Disorders: Constipation.
License Number: Gaviscon Double Action Mint PL00063/0552
Legal Classifciation: GSL
License Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull HU8 7DS.
MRRP: Gaviscon Double Action Mint: £150ml = £4.99, 300ml = £8.49, 600ml = £13.99
Last Revised: April 2020
GAVISCON DOUBLE ACTION ANISEED
PL 00063/0543
Active ingredients: Each 10ml dose contains sodium alginate 500mg, sodium bicarbonate 213mg and calcium carbonate 325mg. Also contains methyl and propyl parahydroxybenzoates and sodium saccharin.
Indications: 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.
Dosage and administration: For oral administration. Adults and children 12 years and over: 10-20ml 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.
Contraindications: Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients.
Precautions and Warnings: This medicinal product contains 255.76 mg (11.12 mmol) sodium per 20 ml dose, equivalent to 12.79 % 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 20 ml contains 260 mg (6.5mmol) 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) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). This medicine contains 2.1 mg benzyl alcohol (from Fennel flavour) per 20 ml dose. Benzyl alcohol may cause allergic reactions. Due to the presence of calcium and carbonates which act as an antacid, a timeinterval 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.
Pregnancy and Lactation: 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 and lactation, if clinically needed. Clinical data do not suggest that this product has an effect on human fertility.
Side effects: Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions Not known frequency include: Metabolism and Nutritional Disorders: Alkalosis, acid rebound, Hypercalcaemia, Milk-alkali Syndrome. Gastrointestinal Disorders: Constipation
Licence Number: PL 00063/0543
Legal Classification: GSL
License Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull HU8 7DS.
MRRP: Gaviscon Double Action Aniseed: 150ml = £4.99, 300ml = £8.49
Last revised: April, 2020
GAVISCON DOUBLE ACTION MINT FLAVOUR CHEWABLE TABLETS
PL 00063/0525
Active substances: Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.
Indications: 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.
Dosage and administration: 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
Contraindications: Hypersensitivity to any of the ingredients.
Precautions and Warnings: This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 44.71% 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 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. 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. This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. This medicine contains Carmoisine lake (E122). This may cause allergic reactions. 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.
Fertility, Pregnancy and Lactation: 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 and breastfeeding, if clinically needed. Clinical data do not suggest that this product has an effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm. Not known frequency include: Metabolism and Nutritional Disorders: Alkalosis, acid rebound, Hypercalcaemia, Milk-alkali Syndrome. Gastrointestinal Disorders: Constipation.
Licence Number: PL00063/0525
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Double Action Mint Chewable Tablets: 12s = £2.99
Last Revised: June 2020
GAVISCON DOUBLE ACTION LIQUID SACHETS
PL 00063/0524
Active substances: Each 10ml contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.
Indications: 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.
Dosage and administration: For oral administration. Adults and children 12 years and over: one to two sachets (10-20ml) 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 modification is required for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Precautions and Warnings: This medicinal product contains 255.76 mg (11.12 mmol) sodium per 2 sachets (20 ml) dose, equivalent to 12.79 % 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) and propyl parahydroxybenzoate (E216) 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.
Fertility, Pregnancy and Lactation: 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 and breastfeeding, if clinically needed. Clinical data do not suggest that this product has an effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.Not known frequency include: Metabolism and Nutritional Disorders: Alkalosis, acid rebound, Hypercalcaemia, Milk-alkali Syndrome. Gastrointestinal Disorders: Constipation.
Licence Number: PL00063/0524
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Double Action Liquid Sachets: 4s = £2.29, 12s = £5.69, 24s = 9.69
Last Revised: June 2020
GAVISCON STRAWBERRY FLAVOUR TABLETS
PL 00063/0155
Active substances: Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg, calcium carbonate 80 mg.
Indications: Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.
Dosage and administration: For oral administration, after being thoroughly chewed. Adults and children 12 years and over: Two to four tablets after meals and at bedtime. 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.
Contraindications: Patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 254.84 mg (11.08 mmol) of sodium per four tablet dose, equivalent to 12.74% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 50.96 % of the WHO adult 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, and bisphosphonates (diphosphonates) and estramustine.
Fertility, Pregnancy and Lactation: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Licence Number: PL 00063/0155
Legal Classification: GSL
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Tablets Strawberry: 8 = £1.00, 24 = £3.90, 48 = £6.70
Last Revised: June 2020
GAVISCON PEPPERMINT LIQUID RELIEF
PL 00063/0127
Active substances: Contains 250 mg sodium alginate, 133.5 mg sodium bicarbonate and 80 mg calcium carbonate per 5ml.
Indications: Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
Dosage and administration: For oral administration. Adults and children over 12 years: 10-20 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Contraindications: Patients with known or suspected hypersensitivity to the active substances or to any of the excipients including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 285.2 mg (12.4 mmol) sodium per 20 ml dose, equivalent to 14.26 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 57% 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). 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, and biphosphonates (diphosphates) and estramustine.
Fertility, Pregnancy and Lactation: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Licence Number: PL 00063/0127
Legal Classification: GSL.
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Peppermint Relief: 150ml £3.99, 300ml £6.69, 600ml £10.99
Last Revised: June 2020
GAVISCON ORIGINAL ANISEED RELIEF
PL 00063/0126
Active substances: Contains 250 mg sodium alginate, 133.5 mg sodium bicarbonate and 80 mg calcium carbonate per 5ml.
Indications: Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
Dosage and administration: For oral administration. Adults and children over 12 years: 10-20 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Contraindications: Patients with known or suspected hypersensitivity to the active substances or to any of the excipients including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 285.2 mg (12.4 mmol) sodium per 20 ml dose, equivalent to 14.26 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 57% 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). This medicine contains 2.2 mg benzyl alcohol (from Fennel flavour) per 20 ml dose. Benzyl alcohol may cause allergic reactions. 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, and biphosphonates (diphosphates) and estramustine.
Fertility, Pregnancy and Lactation: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Licence Number: PL 00063/0126
Legal Classification: GSL.
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
MRRP: Gaviscon Original Aniseed Relief: 150ml £3.99; 300ml £6.69; 600ml £10.99
Last Revised: June 2020
GAVISCON ADVANCE ANISEED SUSPENSION
PL 00063/0108
Active substances: Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg.
Indications: Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Dosage and administration: Adults and children 12 years and over: 5-10 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary.
Contraindications: This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Precautions and Warnings: If symptoms do not improve after 7 days, the clinical situation should be reviewed. This medicinal product contains 106 mg (5.0 mmol) sodium per 10 ml dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 21% 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). Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 10 ml dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. This medicinal product contains methyl hydroxybenzoate and propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed). A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Fertility, Pregnancy and Lactation: Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed. No known effect on breast fed infants. Gaviscon can be used during breast-feeding. No known effect on human fertility.
Side effects: Very rarely (<1/10,000) patients may develop immune system disorders such as anaphylactic and anaphylactoid reactions and hypersensitivity reactions such as urticaria. They may also develop respiratory effects such as bronchospasm.
Legal Classification: GSL / P
Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Licence Number: PL 00063/0108
NHS List Price: Gaviscon Advance Liquid Aniseed: 250ml - £2.56, 500ml - £5.12
MMRP: Gaviscon Advance Liquid Aniseed: 600ml (P) - £15.99
Last Revised: June 2020
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) ltd on: 0333 200 5345