Nexium Control overview

Product Information

Nexium Control 20 mg gastro resistant tablets and hard capsules.Each gastro resistant hard capsule/tablet contains 20 mg esomeprazole (as magnesium trihydrate)Indications: The short term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.Dosage: The recommended dose is 20 mg esomeprazole (one tablet or capsule) per day. It might be necessary to take the tablets or capsules 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 active substance, substituted benzimidazoles or to any of the excipients. Esomeprazole must not be used concomitantly with nelfinavir.Precautions: Jaundice or severe liver disease. 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. Gastric ulcer or gastrointestinal surgery. Treatment of indigestion or heartburn for 4 or more weeks. Over 55 years old with new or recently changed symptoms. Not suitable for long term use. 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. Consult doctor prior to have an endoscopy or urea breath test. Co administration with atazanavir is not recommended. Interactions with medicinal products metabolised through CYP2C19 should be considered. The use of esomeprazole with clopidogrel should be discouraged. Patients should not take another PPI or H2 antagonist concomitantly. PPI 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.Pregnancy and lactation: Avoid use of Nexium Control during pregnancy and breast feedingSide effects: Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/ vomiting, fundic gland polyps (benign). Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritus, rash urticaria. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, hyponatraemia, agitation, confusion, depression, taste disturbance, blurred vision, bronchospasm, stomatitis, gastrointestinal candidiasis, hepatitis with or without jaundice, alopecia, photosensitivity, arthralgia, myalgia, malaise, increased sweating. Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), muscular weakness, interstitial nephritis, gynaecomastia. Not known: hypomagnesaemia; severe hypomagnesaemia which can correlate with hypocalcaemia; hypomagnesaemia may also result in hypokalaemia, microscopic colitis, subacute cutaneous lupus erythematosus (SCLE).Legal category: Supply through pharmacy only Product licence number: EU/1/13/860/001; EU/1/13/860/002; EU/1/13/860/003; EU/1/13/860/004 and EU/1/13/860/005. MAH: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Full product information is available in the SPC. Additional information is available upon request.Text prepared: July 2021.Contains esomeprazole. Always read the label/leaflet.