Medicines Q&As Q&A 355.4 Is there a calcium and vitamin D preparation which is suitable for a vegetarian or vegan? Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Date prepared: 28 August 2012 Background Vegetarians do not eat meat, poultry, game, fish, shellfish, crustacean or animal products such as gelatine. There are three main types of vegetarian: Lacto-ovo-vegetarian who eat both dairy products and eggs Lacto-vegetarians who eat dairy but not eggs Vegans who do not eat dairy products, eggs or any other animal products (1). Around 2% of the UK population is vegetarian (1). With a large number of people avoiding some or all animal products for reasons of faith, ethics or allergy, information on the origins of active ingredients and excipients in medicines is often requested. Proprietary calcium and vitamin D preparations contain calcium and colecalciferol or calcium and ergocalciferol. Colecalciferol and ergocalciferol are traditionally considered equal in potency. Pharmacopoeias state that one unit of vitamin D is contained in 25 nanograms of colecalciferol or ergocalciferol (2). The BP 2012 states that when calciferol or vitamin D is prescribed, colecalciferol or ergocalciferol should be dispensed (2). However some authors have suggested that colecalciferol is used as the preferred form of vitamin D as colecalciferol has been reported to raise serum vitamin D concentrations more effectively than ergocalciferol (2). Colecalciferol (vitamin D3) is produced in the skin after sun exposure. Colecalciferol is synthesised commercially from a precursor obtained from an animal source such as wool fat (3). Ergocalciferol (vitamin D2) has a different side chain than colecalciferol and is commercially made by irradiating and then purifying the ergosterol extracted from yeast (3). Wool fat derived products are unacceptable to vegans and would only be approved by the Vegetarian Society if the sheep’s wool had been pressed and not derived from slaughter (4). Yeast derived products are acceptable to vegetarians and vegans (5). For information on suitable calcium tablets for vegetarians and vegans please see Medicines Q&A UKMi Q&A 35.7 What are the excipients in calcium supplements? (6). Answer Calcium and colecalciferol: There are a number of branded calcium and vitamin D preparations listed in the British National Formulary (7). These all contain colecalciferol as the vitamin D component. Licensed products Suitability for vegetarians and vegans: Accrete D3 Unsuitable for vegetarians and vegans: Contains gelatin (8) Adcal D3 Caplets Suitable for vegetarians but not vegans: Gelatin free (9) Adcal D3 Lemon Chewable Tablets Unsuitable for vegetarians and vegans: Contains gelatin (10) Adcal-D3 Dissolve 1500mg/400IU Effervescent Tablets Unsuitable for vegetarians and vegans: Contains gelatin (11) Cacit D3 Effervescent Granules 500mg/440IU Unsuitable for vegetarians and vegans: Contains gelatin (12) Calceos Unsuitable for vegetarians and vegans: Contains gelatin (13) From the NHS Evidence website www.evidence.nhs.uk Ref: 1 Medicines Q&As Calcichew D3 * Suitable for vegetarians: Gelatin free (14) Calcichew D3 Forte * Suitable for vegetarians: Gelatin free (14) Calcichew-D3 500mg/400IU Caplets Unsuitable for vegetarians and vegans: Contains gelatin (15) Calfovit D3 Unsuitable for vegetarians and vegans: Contains gelatin (16) Kalcipos-D 500mg/800IU Chewable Tablets Unsuitable for vegetarians and vegans: Contains gelatin (17) Natecal D3 Chewable Tablets Unsuitable for vegetarians and vegans: Contains gelatin and lactose (18) Sandocal+D 600 Effervescent Tablets Unsuitable for vegetarians and vegans: Contains bovine gelatin (19) Sandocal +D 1200 Effervescent Tablets Unsuitable for vegetarians and vegans: Contains bovine gelatin (20) * Gelatin was removed from these products in 2011. Check the PIL to ensure product has the new formulation and is gelatin free (14). Unlicensed calcium and vitamin D3 (colecalciferol) tablets are available: e.g. Unlicensed Product: Manufacturer: Suitability for vegetarians and vegans: Ref: Calcium and Vitamin D3 Chewable Tablets Zanza Laboratories Ltd Suitable for vegetarians but not vegans: Gelatin free (21) Other preparations may be available. Calcium and ergocalciferol: Calcium and ergocalciferol tablets are available from generic pharmaceutical manufacturers. The list below is not exhaustive. Other calcium and ergocalciferol tablets should be checked on an individual basis with the manufacturer. Table 1: Examples of generic calcium and ergocalciferol tablets Manufacturer: Suitability for vegetarians and vegans: Ref: Almus Pharmaceuticals Unsuitable for vegetarians and vegans. Contains porcine gelatin and lactose (22) Crescent Pharma Unsuitable for vegetarians and vegans. Contains porcine gelatin and lactose (23) Table 2: Examples of unlicensed calcium and ergocalciferol tablets Manufacturer: Suitability for vegetarians and vegans: Ref: Chanelle Medical UK Suitable for vegetarians and vegans (24) Zanza Labs Suitable for vegetarians and vegans (21) Whilst a specific excipient may be listed as “not present” in a particular product, it cannot be guaranteed that the product has not been in contact with the listed excipients (or e.g. milk-derived or animal-derived products) during the manufacturing process. Further information on the manufacturing process should therefore be obtained from the manufacturer if appropriate (6). From the NHS Evidence website www.evidence.nhs.uk 2 Medicines Q&As Limitations Manufacturers may change their formulation or the suppliers of their excipients. Current status of the origins of the tablet ingredients should therefore be obtained from the manufacturer if appropriate. The list of generic manufacturers of calcium and vitamin D tablets is not exhaustive. Disclaimer Medicines Q&As are intended for healthcare professionals and reflect UK practice. Each Q&A relates only to the clinical scenario described. Q&As are believed to accurately reflect the medical literature at the time of writing. The authors of Medicines Q&As are not responsible for the content of external websites and links are made available solely to indicate their potential usefulness to users of NeLM. You must use your judgement to determine the accuracy and relevance of the information they contain. This document is intended for use by NHS healthcare professionals and cannot be used for commercial or marketing purposes. See www.ukmi.nhs.uk/activities/medicinesQAs/default.asp for full disclaimer. References 1. NHS Choices Accessed online via http://www.nhs.uk/Livewell/Vegetarianhealth/Pages/Goingvegetarian.aspx 24/7/2012 2. Sweetman S. Martindale: The Complete Drug Reference Accessed online via:www.Medicinescomplete.com 24/7/2012 3. Holick MF. The influence of vitamin D on bone health across the life cycle. J.Nutr 2005;135:2739S-2748S 4. Personal communication Vegetarian Society 13.07.10 5. Personal communication The Vegan Society 03.08.10 6. UKMi Q&A 35.7 What are the excipients in calcium supplements? http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Medicines-Q--A/What-are-the-excipients-incalcium-supplements2/ 7. Martin J (editor). British National Formulary online. Accessed via: www.medicinescomplete.com on 24/7/2012 8. Summary of Product Characteristics – Accrete D3. Internis Pharmaceuticals Ltd. Accessed via http://www.medicines.org.uk/EMC/medicine/25530/SPC/Accrete+D3/ on 24/07/2012 [date of revision of the text 19/01/2011] 9. Personal Communication with Medicines Information ProStrakan Pharmaceuticals 09/08/2012 10. Summary of Product Characteristics – Adcal D3 lemon Chewable Tablets. ProStrakan. Accessed via http://www.medicines.org.uk/EMC/medicine/20117/SPC/Adcal+D3+Lemon+Chewable+Tablet s/ on 24/07/2012 [date of revision of the text 20/05/2009] 11. Summary of Product Characteristics – Adcal D3 Dissolve 1500mg/400IU Effervescent Tablets. ProStrakan. Accessed via http://www.medicines.org.uk/EMC/medicine/20519/SPC/AdcalD3+Dissolve+1500mg+400IU+Effervescent+Tablets/ on 24/07/2012 [date of revision of the text 20/05/2009] 12. Summary of Product Characteristics – Cacit D3 Effervescent Granules 500mg/440IU. Warner Chilcott UK Ltd Accessed via http://www.medicines.org.uk/EMC/medicine/10717/SPC/Cacit+D3+Effervescent+Granules+5 00+mg+440+IU/ on 24/07/2012 [date of revision of the text 01/05/2010] 13. Summary of Product Characteristics – Calceos.Galen Ltd Accessed via http://www.medicines.org.uk/EMC/medicine/448/SPC/Calceos/ on 17/08/2012 [date of revision of the text 31/07/2012] 14. Personal Communication with Medicines Information, Shire Pharmaceuticals 08/08/2012 15. Summary of Product Characteristics – Calcichew-D3 500mg/400IU Caplets. Shire Pharmaceuticals Ltd Accessed via http://www.medicines.org.uk/EMC/medicine/23703/SPC/CalcichewD3+500+mg+400IU+Caplets/ on 24/07/2012 [date of revision of the text Nov 2011] From the NHS Evidence website www.evidence.nhs.uk 3 Medicines Q&As 16. Summary of Product Characteristics – Calfovit D3. A.Menarini Pharma U.K. S.R.L. Accessed via http://www.medicines.org.uk/EMC/medicine/19326/SPC/Calfovit+D3/ on 24/07/2012 [date of revision of the text 23/09/2009] 17. Summary of Product Characteristics – Kalcipos-D 500mg/800IU Chewable Tablets. Meda Pharmaceuticals. Accessed via http://www.medicines.org.uk/EMC/medicine/24306/SPC/KalciposD+500+mg++800+IU+chewable+tablets/ [date of revision of the text 12/08/2010] 18. Summary of Product Characteristics – Natecal D3 Chewable Tablets. Chiesi Ltd. Accessed via http://www.medicines.org.uk/EMC/medicine/20993/SPC/Natecal+D3+Chewable+Tablets/ [date of revision of the text 22/09/2011] 19. Summary of Product Characteristics – Sandocal+D 600 Effervescent Tablets. Novartis Consumer Health. Accessed via http://www.medicines.org.uk/EMC/medicine/21663/SPC/Sandocal%2bD+600+Effervescent+t ablets/ [date of revision of the text 03/06/2011] 20. Summary of Product Characteristics – Sandocal+D 1200 Effervescent Tablets. Novartis Consumer Health. Accessed via http://www.medicines.org.uk/EMC/medicine/22238/SPC/Sandocal+%2b+D+1200+Effervesce nt+Tablets/ [date of revision of the text 03/06/2011] 21. Personal Communication with Zanza Laboratories 10/08/2012 22. Personal Communication with Almus Pharmaceuticals 16/08/2012 23. Personal Communication with Customer Service Crescent Pharma on 14/08/2012 24. Personal Communication with Chanelle Medical UK – 24/08/2012 Quality Assurance Prepared by Gill Lewis, South West Medicines Information and Training, University Hospitals Bristol NHS Foundation Trust Date Prepared 28 August 2012 Checked by Julia Kuczynska, South West Medicines Information and Training, University Hospitals Bristol NHS Foundation Trust Date of check 31st August 2012 Search strategy In-house database/ resources Manufacturer ProStraken Pharmaceuticals email 09/08/2012 Shire Pharmaceuticals email 09/08/2012 Crescent Pharma email 14/08/2012 Kent Pharmaceuticals email 10/08/2012 Almus Pharmaceuticals email 16/08/2012 Chanelle Medical UK Ltd email 24/08/2012 Zanza Laboratories email 10/08/2012 From the NHS Evidence website www.evidence.nhs.uk 4 Medicines Q&As Internet Search BNF on line “calcium “vitamin D”” Electronic Medicines Compendium “calcium” Dictionary of Medicines and Devices Browser “ergocalciferol”, “colecalciferol” Medicines Complete (Martindale and AHFS) “colecalciferol/cholecalciferol”, “ ergocalciferol Google Scholar “"vitamin D" "wool fat"” Google “vegetarians uk nhs” Societies The Vegan Society email 06.07.2010 The Vegetarian Society email 12.07.2010 From the NHS Evidence website www.evidence.nhs.uk 5