Phytoceutics Phytomist Vitamin D3 Spray

Contraindications • Hypersensitivity to vitamin D3 (cholecalciferol), or any of the other components of the formulation (see also Section 6.1 List of excipients). • Hypercalcaemia Special warnings and precautions for use Health supplements should not be used as a substitute for a healthy diet. High doses of vitamin D can cause, worsen, or precipitate hypercalcaemia (see Section 4.3 Contraindications). Hypercalcaemia can contribute to arteriosclerosis, particularly in patients with kidney disease. Avoid use in this patient population. Due to the potential of vitamin D to increase calcium levels, caution is required in patients with atherosclerosis, hyperparathyroidism, lymphoma, previous hypercalcaemia, sarcoidosis, tuberculosis, or histoplasmosis. These patients should have regular blood tests to monitor blood calcium levels while taking PHYTOMIST VITAMIN D3. Interaction with other medicines and other forms of interaction ALUMINIUM The vitamin D in PHYTOMIST VITAMIN D3 stimulates the protein that transports calcium and aluminium across the intestinal wall. This might increase aluminium absorption and toxicity in patients with renal failure. Patients with renal failure who chronically take aluminium-containing phosphate binders should avoid taking PHYTOMIST VITAMIN D3. ANTIDYSRHYTHMICS High doses of PHYTOMIST VITAMIN D3 may cause hypercalcaemia (see Section 4.4 Special warnings and precautions for use) which in turn increases the risk of fatal cardiac dysrhythmias with digoxin. Patients taking digoxin should strictly adhere to dosage instructions and should not exceed the maximum recommended daily dosage of PHYTOMIST VITAMIN D3 (see Section 4.2 Posology and method of administration). Patients taking PHYTOMIST VITAMIN D3 and digoxin concurrently should periodically have their blood calcium concentrations monitored. In addition, hypercalcaemia may also reduce the antidysrhythmic efficacy of verapamil and diltiazem. The same warnings and precautions as for digoxin are applicable. CALCIPOTRIENE Patients who require calcipotriene for psoriasis should use PHYTOMIST VITAMIN D3 with caution. Calcipotriene can be absorbed in sufficient amounts to cause systemic effects, including hypercalcaemia. Advise patients to strictly adhere to dosage instructions. Periodic monitoring of calcium levels may be warranted. THIAZIDE DIURETICS Thiazide diuretics decrease urinary calcium excretion and thus may increase the risk for hypercalcemia when taken in combination with PHYTOMIST VITAMIN D3. Monitoring of serum calcium levels may be required. GENERAL Vitamin D may induce CYP3A4 enzymes and therefore may reduce bioavailability of CYP3A4 substrates such as atorvastatin. Until more is known, patients taking CYP3A4 substrates should use PHYTOMIST VITAMIN D3 with caution. It is advised that they are monitored regularly to ensure continued clinical efficacy of their treatment. Fertility, pregnancy, and lactation Pregnancy PHYTOMIST VITAMIN D3 at the recommended dosage of 4 sprays daily is safe to use during pregnancy. Advise users to exercise caution when combining health supplements during pregnancy and to ensure that they do not exceed the tolerable upper intake level (UL) of 4 000 I.U. of vitamin D daily.