Guardium contains the PPI esomeprazole and can be recommended first-line for patients with GORD, in line with NICE guidance

Differentiating between patients with heartburn and GORD is simple: if heartburn symptoms are troublesome, then the patient has GORD.⁷ Mild symptoms occurring two or more days per week are often considered troublesome by patients.⁷

Recommending Guardium first-line for GORD not only aligns with NICE guidance, it also contains NICE’s standard recommended esomeprazole dose (20mg), so patients can be reassured that this is a prescription-strength product.¹

 

Recommending Guardium

 

Using WWHAM can help determine appropriate heartburn treatments for patients:

 

• WHO is the patient? If under 18 years of age, PPIs are not appropriate⁶ and an alginate and/or antacid should be considered, such as Gaviscon Double Action
• WHAT are the symptoms? A burning pain in the centre of the chest at the lower end of the breastbone that rises upwards, reflux of stomach contents and pain or discomfort when swallowing⁸
• HOW long have symptoms been present? Heartburn that occurs at least twice a week or more for at least 4 weeks is frequent heartburn² and a PPI, such as Guardium, is appropriate. Less frequent symptoms can be managed with alginates and/or antacids, such as Gaviscon Double Action
• ACTION taken? Have they tried other treatments, such as alginates and/or antacids before and have these been effective? If symptoms persist despite trying other OTC treatments, such as alginates and/or antacids, consider a PPI
• MEDICINES being taken? PPIs interact with a range of different medicines (eg anti-fungals, diazepam, methotrexate, phenytoin and warfarin) while antacids should not be taken at the same time as a number of other medicines, such as antibiotics (eg ciprofloxacin. minocycline), antihistamines (eg fexofenadine), corticosteroids (eg deflazacort), digoxin, food supplements (eg iron) and levothyroxine.^6,9

 

For patients with frequent heartburn,^2* recommend Guardium. It is clinically proven to deliver symptomatic relief for your frequent heartburn patients with just one pill every 24 hours.⁶ Up to 86% of patients said the symptom relief from esomeprazole was important/extremely important in being able to do everyday tasks.⁶

Advise patients that Guardium gets to work in 1 hour and it can take 2–3 days for the full effect to be achieved.⁶

To enhance your knowledge on frequent heartburn visit: https://www.rbforhealth.co.uk/s/mini-module-guardium

*Frequent heartburn sufferers can be defined as those experiencing symptoms two days a week or more in the last 4 weeks.^2
†Full effect may take 2–3 days.
^‡ For verification please write to: PO BOX 4044, Slough, SL1 0NS.

REFERENCES:

ESSENTIAL INFORMATION:

Guardium acid reflux control 20mg gastro-resistant tablets               PL 36687/0395

Active Ingredients: 20mg 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 20mg 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 20mg 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 400mg with 100mg of ritonavir; esomeprazole 20mg 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 20mg 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 20mg 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 Eye disorders 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 Mint        PL 00063 055

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. Doasage 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 255.76mg (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

RB-M-32035 | February 2021