Summary of Product Characteristics Updated 13-Oct-2017 | Auden Mckenzie (Pharma Division) Ltd (a subsidiary of Actavis PLC)
Plenachol 20 000 IU Capsules
Colecalciferol 20000 IU Capsules
Each capsule contains 20 000 IU cholecalciferol (equivalent to 0.5 mg vitamin D3).
For the full list of excipients, see section 6.1.
Hard white capsules containing a clear, slightly yellowish oily liquid.
The prevention and treatment of vitamin D deficiency.
▪ Prevention of vitamin D deficiency 12-18 years: 20 000 IU (1 capsule) every 6 weeks
▪ Treatment of vitamin D deficiency 12-18 years: 20 000 IU (1 capsule) once every 2 weeks for 6 weeks (followed by maintenance therapy equivalent to 400-1000 IU/day, such as 1 capsule per month)
▪ Prevention of vitamin D deficiency: 20 000 IU/month (1 capsule), higher doses may be required in certain situations, see below
▪ Treatment of vitamin D deficiency: 40 000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy (equivalent to 1400-2000 IU/day, such as 2-3 capsules per month, may be required. Follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved)
Certain populations are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D:
Institutionalised or hospitalised individuals
Dark skinned individuals
Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens
Patients being evaluated for osteoporosis
Use of certain concomitant medications (e.g., anticonvulsant medications, glucocorticoids)
Patients with malabsorption, including inflammatory bowel disease and coeliac disease
Those recently treated for vitamin D deficiency, and requiring maintenance therapy.
Plenachol® Capsules should not be given to children under 12 years due to the risk of choking.
Method of administration:
Oral - The capsules should be swallowed whole with water.
Patients should be advised to take Plenachol® capsule(s) preferably with a meal (see section 5.2 Pharmacokinetic properties - “Absorption”).
▪ Hypersensitivity to cholecalciferol or other excipients of Plenachol® Capsules.
▪ Hypercalcaemia and/or hypercalciuria.
▪ Nephrolithiasis, or patients who are susceptible to form calcium-containing renal calculi (kidney stone).
▪ Severe renal impairment.
▪ Plenachol® Capsules must not be used in children (under 12 years) due to their inability to swallow capsules and/or the potential risk of choking.
▪ Hypervitaminosis D.
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.
Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 Interaction with other medicinal products and other forms of interaction - cardiac glycosides including digitalis).
Plenachol® capsules should be prescribed with caution in patients with sarcoidosis, due to a possible increase in the metabolism of vitamin D in its active form. In these patients the serum and urinary calcium levels should be monitored.
Allowances should be made for the total dose of vitamin D in cases associated with treatments already containing vitamin D, foods enriched with vitamin D, cases using milk enriched with vitamin D, and the patient's level of sun exposure.
There is no clear evidence for causation between vitamin D supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.
Oral administration of high-dose vitamin D (500,000 IU by single annual bolus) was reported to result in an increased risk of fractures in elderly subjects, with the greatest increase occurring during the first 3 months after dosing.
Treatment with vitamin D can unmask previously undiagnosed primary hyperparathyroidism. Adjusted serum calcium levels should be checked 1 month after completing the loading regimen or after starting vitamin D supplementation in case primary hyperparathyroidism has been unmasked.
Furthermore, certain groups may be at an increased risk of hypercalaemia with this treatment regimen and they should be monitored by measuring adjusted serum calcium levels.
Plenachol® Capsules must not be used in children (under 12 years) due to their inability to swallow capsules and/or the potential risk of choking.
Concomitant use of anticonvulsants (such as phenytoin) or barbiturates (and possibly other drugs that induce hepatic enzymes) may reduce the effect of vitamin D3 by metabolic inactivation.
In cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium, monitoring of serum calcium concentration is recommended.
Concomitant use of glucocorticoids can decrease the effect of vitamin D.
In cases of treatment with drugs containing digitalis and other cardiac glycosides, the administration of vitamin D may increase the risk of digitalis toxicity (arrhythmia). Strict medical supervision is needed, together with serum calcium concentration and electrocardiographic monitoring if necessary.
Simultaneous treatment with ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
In pregnancy and lactation the high strength formulation is not recommended and a low strength formulation should be used.
There are no or limited amount of data from the use of cholecalciferol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3 Preclinical safety data). The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment vitamin D and its metabolites are excreted in breast milk.
Vitamin D can be prescribed while the patient is breast-feeding if necessary. This supplementation does not replace the administration of vitamin D in the neonate.
Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother
There is no data regarding treatment with vitamin D3 and its effects on fertility.
There are no data on the effects of Plenachol® Capsules on the ability to drive. However, an effect on this ability is unlikely.
The frequency of the undesirable effects listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000).
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria
Skin and subcutaneous disorders
Rare: pruritus, rash, and urticaria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Discontinue Plenachol® Capsules when calcaemia exceeds 10.6 mg/dl (2.65 mmol/l) or if the calciuria exceeds 300 mg/24 hours in adults or 4-6 mg/kg/day in children. An overdose manifests as hypercalcaemia and hypercalciuria, the symptoms of which include the following: nausea, vomiting, thirst, constipation, polyuria, polydipsia and dehydration.
Chronic overdosage may lead to vascular and organ calcification, as a result of hypercalcaemia.
Treatment in cases of overdose
Discontinue administration of Plenachol® Capsules and initiate rehydration.
Pharmacotherapeutic group: Cholecalciferol (vitamin D and analogues)
ATC code: A11C C05
In its biologically active form Vitamin D stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D.
The pharmacokinetics of vitamin D is well known.
Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile, so the administration with the major meal of the day might therefore facilitate the absorption of Vitamin D.
Distribution and biotransformation
It is hydroxylated in the liver to form 25-hydroxy-cholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25-dihydroxy-cholecalciferol (calcitriol).
The metabolites circulate in the blood bound to a specific α – globin, vitamin D and its metabolites are excreted mainly in the bile and faeces.
Characteristics in Specific Groups of Subjects or Patients
A 57% lower metabolic clearance rate is reported in subjects with renal impairment as compared with that of healthy volunteers.
Decreased absorption and increased elimination of vitamin D occurs in subjects with malabsorption.
Obese subjects are less able to maintain vitamin D levels with sun exposure, and are likely to require larger oral doses of vitamin D to replace deficits.
Pre-clinical studies conducted in various animal species have demonstrated that toxic effects occur in animals at doses much higher than those required for therapeutic use in humans.
In toxicity studies at repeated doses, the effects most commonly reported were increased calciuria and decreased phosphaturia and proteinuria.
Hypercalcaemia has been reported in high doses. In a state of prolonged hypercalcaemia, histological alterations (calcification) were more frequently borne by the kidneys, heart, aorta, testes, thymus and intestinal mucosa.
Colecalciferol has been shown to be teratogenic at high doses in animals.
At doses equivalent to those used therapeutically, cholecalciferol has no teratogenic activity.
Cholecalciferol has no potential mutagenic or carcinogenic activity.
Colloidal anhydrous silica
Gellan gum (E418)
Titanium dioxide (E171)
Store this medicinal product in the original package in order to protect from light.
PVC/PVdC foiled aluminium blister.
Pack sizes: 4, 10 & 20
Not all pack sizes may be marketed.
Any unused product should be disposed of in accordance with local requirements.
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