Nexium Control formulation

Nexium Control 20 mg gastro-resistant tablets and hard capsules (Esomeprazole). Indications: The short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation) in adults.

Dosage: The recommended dose is 20 mg (one tablet or capsule) per day. Tablets or capsules may need to be taken for 2-3 consecutive days to achieve symptom improvement. Maximum treatment duration: up to 2 weeks.

Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients. Esomeprazole must not be used concomitantly with nelfinavir.

Warnings and precautions: Patients should 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 to avoid delay in diagnosis. Also, if they have had previous gastric ulcer or gastrointestinal surgery, been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks, have jaundice or severe liver disease, are aged over 55 years with new or recently changed symptoms. Long-term recurrent symptoms of indigestion or heartburn require regular doctor consultation and those over 55 years taking any non-prescription indigestion or heartburn remedy daily should inform their pharmacist or doctor. Nexium Control should not be taken as a long-term preventive product. Treatment with PPIs may lead to a slightly increased risk of GI infections such as Salmonella and Campylobacter and in hospitalised patients, possibly Clostridium difficile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Co-administration of esomeprazole with atazanavir is not recommended. The potential for interactions with medicinal products metabolised through CYP2C19 should be considered. Concomitant use with clopidogrel is discouraged. Not to be taken with another PPI or H2 antagonist. Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. PPIs are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, medical help should be sought promptly, and discontinuation considered. SCLE after previous treatment with a PPI may increase the risk of SCLE with other PPIs. Contains sugar spheres (sucrose). Not suitable for patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Side effects: Common: headache and GI disorders, including abdominal pain, constipation, diarrhoea, and nausea/vomiting, fundic gland polyps (benign). Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritus, rash and urticaria. Other side effects are rare, very rare or have an unknown frequency – refer to the SPC for full details.

Legal category: GSL (7s and 14s) and P (28s).

Product licence number: GSL: Capsules PLGB 44673/0221 & Tablets PLGB 44673/0222, P: Tablets PLGB 44673/0225.

MAH: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS

RRP (excl VAT): Tablets: 7s £6.24, 14s £10.83, 28s £18.32. Capsules: 14s £11.66.

Text prepared: Jan 2023