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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 postmarketing 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