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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
4195178
Pip Code
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
Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or by emai l to drugsafety.uk@gedeonrichter.eu October 2023
P4260.306-V2
or call us on 01904 558 350 5 5
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