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Plenachol® D Capsules                                                                                     The material is intended for UK healthcare professionals only and has been co-developed by Gedeon Richter and PSUK Prescribing
                                                                                                                                    information can be found on the following page.
                                                                      3

                                        (Colecalciferol)





                                    20 000 IU x 10 pack & 40 000 IU x 7 pack


                     Indicated as prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy

                                                                                                                                    Benilexa  One Handed
                        for osteoporosis in patients with vitamin D deficiency or at risk of Vitamin D insufficiency.                                                         ®





                                                                                                   Gelatin                          New MDS
                                                                                                     FREE


                                                                                                                                    PSUK are delighted to announce a NEW and EXCLUSIVE MDS discount

                                                                                               Gelatin Free                         available to Dispensing Doctors on Benilexa 52MD.

                                                                                                                                    This new MDS ensures that dispensing practices can make a saving on the NHS
                                                                                               Suitable for Vegetarians             cost and a increased profit vs comparable intauterine contraceptive devices.

                                                                                               Kosher and Halal Certified
                                                                                                                                     Product Description                    Benilexa            Gedeon Richter offer product
                                                                                               Licenced Medicine                     Supplier                            Gedeon Richter         demonstrations, demonstration placebo
                                                                                                                                     Pip Code
                                                                                                                                                                            4195178
                                                                                                                                                                                                devices and support materials for both
                                                                                               Manufactured in the UK                                    Reimbursement                          healthcare professionals and patients.
                                                                                                                                     Drug Tariff Price:                      £71.00
                                                                                                                                                                                                In addition to the discounts, Benelexa
                                                        Prescribing Information:                                                     Clawback (at 11.18%)                    -£7.94

                                           Plenachol D 3 (Colecalciferol) 20 000 IU and 40 000 IU Capsules                           Price after Clawback:                   £63.06             will attract a 20% PA fee meaning
                                             Please refer to the Summary of Product Characteristics (SmPC) before prescribing.                                                                  dispensing this product will generate
                                                                                                                                     +Dispensing Fee                         £2.26              a profit for the practice of £17.48
             Presentation: Each Plenachol D3 20 000  IU capsule contains  patients who are susceptible to form calcium-containing renal calculi  formulation should be used. There are no or limited amount of data   +PA Admin Fee  £12.61  once clawback has been taken into
             equivalent to 0.5 mg vitamin D3. Each Plenachol D3 40 000 IU capsule  (kidney stone); severe renal impairment; children under 12 years  from the use of colecalciferol in pregnant women. The recommended   consideration.
             contains equivalent to 1.0 mg vitamin D3.   due to their inability to swallow capsules and/or the potential risk of  daily intake for pregnant women is 400 IU, however, in women who   Total Reimbursed:  £77.93
             Indications: Prevention and treatment of vitamin D deficiency. As an  choking; hypervitaminosis D.   are considered to be vitamin D deficient a higher dose may be required.   Cost to Surgery
             adjunct to specific therapy for osteoporosis in patients with vitamin D  Warnings and Precautions: Use with caution in patients with  Vitamin D and its metabolites are excreted in breast milk. Vitamin   Please contact:
             deficiency or at risk of Vitamin D insufficiency.  impairment of renal function. The effect on calcium and phosphate   D can be prescribed while the patient is breast-feeding if necessary,   PSUK Member MDS Rebate  20.00%  devicesupport@gedeonrichter.com to
             Dosage and Administration:  Adults: Prevention:  20 000 IU  levels should be monitored, and the risk of soft tissue calcification   though this supplementation does not replace the administration of   order any of these items/services.
             a  month. Higher  doses may be  required  in certain  situations, as  should be taken into account. Caution is required in patients receiving   vitamin D to the neonate. There is no data regarding treatment with   Nett Price (Incl. discount)  £56.80
             detailed  below.  Treatment:  40  000  IU/week  for 7  weeks,  followed  treatment for cardiovascular disease. Use with caution in patients   vitamin D3 and its effects on fertility.
             by maintenance therapy (equivalent to 1400-2000 IU/day, such as  with sarcoidosis, due to a possible increase in the metabolism of   Adverse Events include: See SmPC for details of adverse events.   +VAT (@5%)  £3.55
             one 40 000 IU capsule or two to three 20 000 IU capsules per month,  vitamin D in its active form. In these patients the serum and urinary   Presentation and Price: 20 000 IU capsules x 10 £9.00; 40 000 IU
             may be required. Follow-up 25(OH)D measurements should be made  calcium levels should be monitored.  Allowances should be made   Total Cost to Practice:        £60.35
             approximately three to four months after initiating maintenance  for the total dose of vitamin D in cases associated with treatments   capsules x 7 £10.50   Profit to Surgery
             therapy to confirm that the target level has been achieved).  already containing vitamin D, foods enriched with vitamin D, cases   Legal Category: POM
             Adolescents 12-18 years old: Prevention:  20 000 IU every 6 weeks.  using milk enriched with vitamin D, and the patient’s level of sun   Further information is available from:   Total Reimbursement:  £77.93
             Treatment: 20 000 IU once every 2 weeks for 6 weeks (followed by  exposure. There is no clear evidence for causation between vitamin D   Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS.
             maintenance therapy equivalent to 400-1000 IU/day, such as one 20  supplementation and renal stones, but the risk is plausible, especially   Marketing Authorisation Numbers:   Cost to Practice:  (£60.35)
             000 IU capsule per month). Children under 12 years old: Should not be  in the context of concomitant calcium supplementation. The need  PL 20075/0672 and PL 20075/0673
             given due to the risk of choking. Certain populations are at high risk  for additional calcium supplementation should be considered for  Date of PI Preparation: November 2022  Profit per dose:  £17.58
             of vitamin D deficiency and may require monitoring of serum 25 (OH) individual patients. Calcium supplements should be given under close  Document number: UK-01695
             D and higher doses. These include patients who are institutionalised,  medical supervision. Oral high-dose vitamin D (500 000 IU by single
             hospitalised, obese, dark skinned, being evaluated for osteoporosis;  annual bolus)  was reported  to result in increased risk  of fractures
             using certain concomitant medications (e.g., anticonvulsant  in the elderly.  Treatment with vitamin D can unmask previously   Adverse events should be reported.
             medications, glucocorticoids); patients with limited sun exposure due  undiagnosed primary hyperparathyroidism. Adjusted serum calcium   Reporting forms and information can be
             to protective clothing or consistent use of sun screens, malabsorption  levels  should  be  checked  1  month  after  completing  the  loading
             (including inflammatory bowel disease and coeliac disease); patients  regimen or after starting vitamin D supplementation in case primary   found at www.mhra.gov.uk/yellowcard
             recently treated for vitamin D deficiency, and requiring maintenance  hyperparathyroidism has been unmasked. Certain groups may be at an   Adverse events should also be reported to
             therapy. Method of administration:  Swallow capsules whole with  increased risk of hypercalaemia with this treatment regimen and they   Accord-UK LTD on 01271 385257 or email
             water, preferably with food.       should be monitored by measuring adjusted serum calcium levels.                                                                                          or call:
             Contraindications: Hypersensitivity to colecalciferol or any of the  Fertility, Pregnancy & Lactation: In pregnancy and lactation the   medinfo@accord-healthcare.com  Order now
             excipients, hypercalcaemia and/or hypercalciuria; nephrolithiasis, or  high strength formulation is not recommended and a low strength                                                     01904 558 360
                                                                                                                                    online at:
                                                     UK-05795  |  Date of Preparation: February 2024
                                                                                                                                     Adverse events shou ld be reported. Reporting forms and information can be fo und at
                                                                                                                                     https:ljyellowcard.mhra.gov.uk/, or you can report via t he Yellow Card app which is available to
                                                                                                                                     download from the Apple App Store or Google Play St ore. Adverse events should also be reported to   UK--2300181
                                                                                                                                                                                                                                         October 2023
                                                                                                                                     Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by emai l to drugsafety.uk@gedeonrichter.eu     P4260.306-V2
              4      PS Magazine | MDS Terms Information                                   Buy direct online at PSUK.co.uk


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