HCL Issue 10 - Page 2

CHOOSE A VITAMIN D TREATMENT THAT MEETS THE NEEDS OF YOUR PATIENTS VEGETARIAN VEGAN * HALAL KOSHER DIET POOR ADHERENCE Licensed 25,000 IU & 1,000 IU vitamin D 3 tablets 1 • Total product Halal 2 / Kosher 3 • Suitable for vegetarians 1* Nut, Soya and Gluten-free formulation 1** • Stable for 28 days in compliance aid 4 • Free text reminder service 5 Not all vitamin D treatments are the same Rx Stexerol-D 3 by brand Stock photography - posed by models. * Vitamin D3 is derived from lanolin contained in sheep wool, therefore may not be suitable for all vegans. ** Cannot guarantee the complete absence of traces of gluten, nuts or soya in Stexerol-D3. REFERENCES: 1. Stexerol-D3 Summary of Product Characteristics. 2. Halal Authority Board. Vitamin D Halal Certificate. 3. Federation of synagogues. Vitamin D3 Film Coated Tablets Kosher Certificate. 4. Data on File, Kyowa Kirin Ltd - DOF-UK-030-Stexerol. 5. Stexerol Patient Information Leaflet. Available at http://www.medicines.org.uk/emc/PIL.31220.latest.pdf (accessed January 2018). PRESCRIBING INFORMATION Please refer to the full Summary of Product Characteristics before prescribing. Name: Stexerol-D3 (colecalciferol) Tablets. Presentation: Film-coated tablets containing 1,000 IU or 25,000 IU colecalciferol (equivalent to 25 or 625 micrograms of vitamin D3). Indications and dosage: Not recommended for children under 12 years. Treatment of vitamin D deficiency (< 25 ng/ml): Adults and the elderly; a loading dose of 50,000 IU/week for 6 weeks or 3,000 – 4,000 IU/day for 10-12 weeks followed by a maintenance dose of 25,000 IU/month or 1,000 IU/day. In certain situations higher doses of up to 50,000 IU/month or up to 4,000 IU/day may be required if patients cannot be maintained at the lower doses. Adolescents 12 years and over; a loading dose of 25,000 IU once every 2 weeks for 6 weeks (i.e. total dose 75,000 IU), or 2,000 IU/day for 6 weeks followed by a maintenance dose of 1,000 IU/day. Prevention of vitamin D deficiency: Adults and the elderly; 25,000 IU/month or 1,000 IU/ day. In certain situations higher doses of up to 50,000 IU/month or up to 4,000 IU/day may be required if patients cannot be maintained at the lower doses. Adolescents 12 years and over; 25,000 IU every 6 weeks. As an adjunct to specific therapy for osteoporosis: Adults and the elderly, 25,000 IU/month or 1,000 IU/day. Certain populations are at higher risk of vitamin D deficiency and may require higher doses. Contraindications: Hypersensitivity to vitamin D or any of the excipients, hypervitaminosis D, nephrolithiasis, nephrocalcinosis, severe renal impairment, or diseases or conditions resulting in hypercalcaemia and/or hypercalciuria. Precautions: Use with caution in patients with impaired renal function, or with sarcoidosis or other granulomatous disease. Monitor serum calcium levels and renal function during long-term treatment. Adjust the total dose of vitamin D when prescribing with other products containing vitamin D, and consider the calcium status and dietary intake of individual patients. Monitor patients with increased sensitivity to vitamin D. Patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take vitamin D. Side effects: Uncommon: Hypercalcaemia, hypercalciuria. Rare: Pruritus, rash, urticaria. Hypersensitivity reactions, nausea and vomiting may also occur. Prescribers should consult the summary of product characteristics for further details of side effects. Marketing Authorisation number and NHS cost: Stexerol-D 3 Tablets 1,000 IU; PL16508/0047; 28 tablet blister pack, £2.95. Stexerol-D3 Tablets 25,000 IU; PL16508/0048; 12 tablet blister pack, £17.00. Marketing Authorisation Holder: Kyowa Kirin Ltd., Galabank Business Park, Galashiels TD1 1QH, UK. Legal classification: POM. Date of Prescribing Information: May 2016. Date of preparation: January 2018 Code: UK/STX/0168 ADVERSE EVENT REPORTING Adverse Events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse Events should also be reported to Kyowa Kirin Ltd. on +44 (0)1896 664000, email: medinfo@kyowakirin.com For more information, visit www.stexerol.com