Document: Colecalciferol Meda tablet ENG SmPC change

• Colecalciferol Meda tablet SmPC
• Colecalciferol Meda tablet ENG SmPC

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summary of product characteristics

1 Name of the Medicinal Product

Colecalciferol Meda 800 IU tablet

2 Qualitative and Quantitative Composition

Each tablet contains colecalciferol (vitamin D₃) 800 IU (equivalent to 20 microgram vitamin D₃).

Excipients with known effect:

Each tablet contains isomalt 91.0 mg and sucrose 1.68 mg.

For the full list of excipients, see section 6.1.

3 Pharmaceutical Form

Tablet

White to light yellow, biconvex, 7 mm in diameter.

4 Clinical Particulars

4.1 Therapeutic indications

Prevention and treatment of vitamin D deficiency in adults and adolescents. Vitamin D deficiency is defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l.

In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency, preferably in combination with calcium.

4.2 Posology and method of administration

Posology

Recommended dose: One tablet per day.

Higher doses can be necessary in treatment of vitamin D deficiency, where the dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment.

The daily dose should not exceed 4000 IU (five tablets per day).

Pediatric population

The safety and efficacy of Colecalciferol Meda in children under 12 years have not been established.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in renal impairment

Colecalciferol Meda should not be used in patients with severe renal impairment (see section 4.3).

Method of administration

The tablets can be swallowed whole or crushed. The tablets can be taken with food.

4.3 Contraindications

• Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria.

• Nephrolithiasis.

• Nephrocalcinosis

• Hypervitaminosis D.

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Colecalciferol Meda should be prescribed with caution to patients suffering from sarcoidosis due to risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Colecalciferol Meda 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. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used.

The content of vitamin D (800 IU) in Colecalciferol Meda should be considered when prescribing other medicinal products containing vitamin D. Additional doses of vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

Colecalciferol Meda contains sucrose and isomalt. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since the metabolism increases.

Excessive dosing of vitamin D can induce hypercalcaemia, which may increase the risk of digitalis toxicity and serious arrhythmias due to the additive inotropic effects. The electrocardiogram (ECG) and serum calcium levels of patients should be closely monitored.

Glucocorticoid steroids may increase vitamin D metabolism and elimination. During concomitant use, it may be necessary to increase the dose of Colecalciferol Meda tablets.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

4.6 Fertility, pregnancy and lactation

Fertility

There are no data on the effect of Colecalciferol Meda on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.

Pregnancy

Colecalciferol Meda should be used during pregnancy, only in the case of a vitamin D deficiency. Colecalciferol Meda is not recommended during pregnancy in patients without a vitamin D deficiency as the daily intake should not exceed 600 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). There are no indications that vitamin D at therapeutic doses is teratogenic in humans.

Breast-feeding

Vitamin D can be used during breast-feeding. Vitamin D₃passes into breast milk. This should be considered when giving additional vitamin D to the child.

4.7 Effects on ability to drive and use machines

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

4.8 Undesirable effects

Adverse reactions frequencies are defined as: uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or not known (cannot be estimated from the available data).

Immune system disorders

Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angiooedema or laryngeal oedema.

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 national reporting system listed in Appendix V*.

4.9 Overdose

Overdose can lead to hypervitaminosis D. An excess of vitamin D causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable Upper Intake Level for vitamin D₃(colecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D₃should not be confused with its active metabolites.

Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Treatment of hypercalcaemia: The treatment with vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5 Pharmacological Properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin supplements

ATC-code: A11C C05

Vitamin D increases the intestinal absorption of calcium and phosphate.

Administration of vitamin D₃counteracts development of rickets in children and osteomalacia in adults. It also counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency and which causes increased bone resorption.

In addition to bone and intestinal mucosa many other tissues have vitamin D receptors, to which the active hormonal form of vitamin D, calcitriol, binds.

5.2 Pharmacokinetic properties

Vitamin D

Absorption:

Vitamin D is easily absorbed in the small intestine.

Distribution and metabolism:

Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then further converted in the kidneys to 1,25- dihydroxycolecalciferol. 1,25-dihydroxycolecalciferol is the active metabolite responsible for increasing calcium absorption. Vitamin D, which is not metabolised, is stored in adipose and muscle tissues.

Elimination:

Vitamin D is excreted in faeces and urine.

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is no further information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.

6 Pharmaceutical Particulars

6.1 List of excipients

Pregelatinized maize starch

Isomalt (E 953)

Magnesium stearate

Sucrose

Sodium ascorbate

Triglycerides, medium chain

Silica, colloidal anhydrous

Modified food (maize) starch

All-rac-alpha-tocopherol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30^oC.

Store the tablets in the original container, in order to protect from light. Keep the container tightly closed in order to protect from moisture.

6.5 Nature and contents of container

30, 60, 90 in white opaque PVC/PVDC/aluminium blister in outer paper carton.

250 tablets in plastic containers of HDPE with LDPE snap on cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 Marketing Authorisation Holder

<To be completed nationally>

8 Marketing Authorisation Number

<To be completed nationally>

9 Date of First Authorisation/ Renewal of the Authorisation

<To be completed nationally>

10 Date of Revision of the Text

2016-06-30