4.1. Therapeutic indications

Prevention and treatment of vitamin D deficiency in adults and adolescents with an identified risk.

As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

4.2. Posology and method of administration

Posology

The dosage of vitamin D depends on severity of the disease, as well as patients response to treatment. Based on patients needs, capabilities and preferences daily, weekly or monthly dosing regimens can be offered. Lower dosage forms (e.g. 400 IU, 500 IU, 800 IU and 1,000 IU) are suitable for daily vitamin D supplementation, while higher dosage forms like 20,000 IU contain amounts for weekly or monthly use, which should be taken into consideration. The dosage and the frequency of administration has to be established individually by a physician.

Not all given recommended doses can be achieved with this product.

Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed.

Adults

Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis:

Recommended dose range is 600 IU- 800 IU per day or equivalent weekly or monthly dose [20,000 IU (1 capsule) per month].

Treatment of vitamin D deficiency:

800 IU per day or equivalent weekly or monthly dose [maximum cumulative dose 20,000 IU (1 capsule) per month]. Higher doses 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 dose should not exceed 4,000 IU per day or equivalent weekly [20,000 IU (1 capsule) per week] or monthly dose.

Adolescents:

The dose for adolescents aged 12 years or more 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 4,000 IU per day or equivalent weekly [20,000 IU (1 capsule) per week] or monthly dose.

Paediatric population

STRIVIT-D3 20,000 IU capsules should not be given to children under 12 years of age due to the risk of choking. Instead, it is advisable to use drops or dissolvable tablets.

Hepatic impairment

No dose adjustment is required.

Renal impairment

Patients with mild or moderate renal impairment: no specific adjustment is required. STRIVIT-D3 must not be used in patients with severe renal impairment.

Pregnancy

The recommended daily intake for pregnant women is 400 IU , however, in women who are considered to be vitamin D3 deficient a higher dose may be required [up to 2,000 IU/day or equivalent weekly or monthly dose (60,000 IU (3 capsules) per month)].

Other conditions

In obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism, higher doses are required for the treatment and prevention of vitamin D3 deficiency.

Method of administration

Oral

The capsules should be swallowed whole (not chewed) with water. The capsules should not be chewed in order to facilitate the swallowing of the capsule content. In order to enhance absorption, it is recommended to take vitamin D with a meal.

4.3. Contraindications

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

• Hypervitaminosis D

• Nephrolithiasis

• Nephrocalcinosis

• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria

• Severe renal impairment

4.4. Special warnings and precautions for use

In the case of therapeutic treatment the dose should established on an individual basis for the patients by regular checking (initially weekly, then once every 2-4 weeks) of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level (see section 4.5) . 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.

Renal impairment

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. 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 (see section 4.3, contraindications).

Sarcoidosis

STRIVIT-D3 should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Use of additional supplements

Allowances should be made for vitamin D supplements from other sources.

The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.

Medical supervision is required whilst on treatment to prevent hypercalcaemia.

Paediatric population

STRIVIT-D3 20,000 IU Capsules should not be given to children under 12 years.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per 20,000 IU, that is to say essentially 'sodium-free'.

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 treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation.

Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Simultaneous treatment with bile-acid binding resins (i.e. cholestyramine, colestipol), orlistat, or laxatives 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.

4.6. Fertility, pregnancy and lactation

Pregnancy

STRIVIT-D3

There are limited data from the use of STRIVIT-D3 in pregnant women. Vitamin D deficiency is harmful for mother and child. High doses of vitamin D have been shown to have teratogenic effects in animal experiments (see section 5.3).

Overdose of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia may lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy of the child.

Where there is a vitamin D deficiency the recommended dose is dependent on national guidelines, however, the maximum recommended dose during pregnancy is 4,000 I.U./day vitamin D3. For treatment during pregnancy at higher doses, STRIVIT-D3 is not recommended during pregnancy.

Breastfeeding

Vitamin D and its metabolites are excreted in breast milk. No adverse events have been observed in infants. STRIVIT-D3 can be used at recommended doses during lactation in case of a vitamin D deficiency. This should be considered when giving additional vitamin D to the child.

Fertility

There are no data on the effect of STRIVIT-D3 on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.

4.7. Effects on ability to drive and use machines

STRIVIT-D3 has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Immune system disorders:

Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angio-oedema 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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and rehydration.