PYROCALM CONTROL® 20mg TABLETS PRODUCT INFORMATION

Pharmaceutical Form: Gastro-resistant tablets. Indications: For the short-term treatment of reflux symptoms in adults. Active ingredient: Omeprazole. Posology: Once daily for up to 14 days. Discontinue treatment once complete relief of symptoms has occurred. The majority of patients achieve complete relief of heartburn within 7 days. Method of administration: Take one tablet in the morning, swallowed whole with half a glass of water. Do not chew or crush the tablets. Contraindications: Children under 18 years; Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients; nelfinavir. Special warnings and precautions for use: In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded. It is not recommended to co-administrate with atazanavir. Do not use concomitantly with clopidogrel. The tablets contain lactose therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Treatment may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Consult the doctor in the following conditions: previous gastric ulcer or gastrointestinal surgery; continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks; jaundice or severe liver disease; aged over 55 years with new or recently changed symptoms of indigestion or heartburn. Do not take as a preventative medication. Do not take another PPI or H2 antagonist concomitantly. Seek medical help promptly if lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia. This might associate with very infrequent cases of SCLE (Subacute cutaneous lupus erythematosus). Stop using for at least 5 days before CgA measurements in laboratory test. Increased CgA level may interfere with investigations for neuroendocrine tumours. Consult your doctor before taking this medicinal product if you are due to have an endoscopy or urea breath test. Omeprazole may reduce the absorption of vitamin B12 (cyanocobalamin) in patients with risk factors. Interaction with other medicinal products and other forms of interaction: atazanavir, digoxin, clopidogrel, posaconazole, erlotinib, ketoconazole, itraconazole, saquinavir, ritonavir, tacrolimus, methotrexate. Active substances metabolised by CYP2C19 such as: vitamin K antagonists (R-warfarin, cilostazol, phenytoin and diazepam). Active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole). Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John's wort). Concomitant administration of omeprazole with nelfinavir is contraindicated. Use During Pregnancy and Lactation: can be used during pregnancy and breastfeeding. Effects on ability to drive and use machines: None expected. Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machinery. Side Effects: The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. Another common side effect is fundic gland polyps (benign). Uncommon side effects: Insomnia, dizziness, paraesthesia, somnolence, vertigo, increased liver enzymes, dermatitis, pruritus, rash, urticarial, malaise and peripheral oedema. Rare side effects: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock; leukopenia, thrombocytopenia, hyponatraemia, agitation, confusion, depression, taste disturbance, blurred vision, bronchospasm, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, hepatitis with or without jaundice, alopecia, photosensitivity, arthralgia, myalgia, interstitial nephritis, increased sweating. Very rare side effects: agranulocytosis, pancytopenia, hypomagnesaemia, aggression, hallucinations, hepatic failure, encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), muscular weakness, gynaecomastia. Side effect with 'Not known' frequency: Subacute cutaneous lupus erythematosus. Legal Category: GSL. Price: 7 Tablets £5.83, exc. VAT, 14 Tablets £9.16 exc. VAT Product Licence Number and Holder: PL 14017/0277 Dexcel® Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, UK. Date of Preparation: October 2019. Pyrocalm Control Tablets is a registered trademark.

Adverse events should be recorded using the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.