8. If hypercalcaemia or hypercalciuria occur, this can be corrected rapidly by stopping treatment with AlfaD and any calcium supplements until plasma calcium levels return to normal, usually in about a week. AlfaD may then be restarted at half the last dose used.
Response to AlfaD may be impaired if the diet is markedly deficient in calcium. Healing of bone lesions often indicates a decreased requirement for AlfaD in which case appropriate dose adjustments should be made (see Posology and Method of Administration).
AlfaD capsules contain arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid AlfaD.
1) and patients with rare hereditary problems of fructose intolerance (HFI) should not take it. This medicinal product contains a small amount of alcohol (ethanol) (less than 2mg per soft capsule, corresponding to less than 1% [w/w]).
The amount of alcohol (ethanol) in one soft capsule of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine has no noticeable effects. 5 Interaction with other medicinal products and other forms of interaction Cardiac glycosides Hypercalcaemia in patients taking digitalis preparations may precipitate cardiac arrhythmias.
4). g. barbiturates, phenytoin, carbamazepine, or primidone) have enzyme-inducing effects resulting in an increased metabolism of alfacalcidol. Patients taking anticonvulsants may therefore require larger doses of AlfaD. , cholestyramine, colestipol) may impair the intestinal absorption of AlphaD.
AlphaD should be administered at least 1 hour before, or 4 to 6 hours after, the intake of the bile acid sequestrant in order to minimise the potential risk of interaction. Aluminium-containing preparations Absorption of aluminium-containing antacids may be enhanced by AlfaD so concomitant use of large amounts of aluminium-containing antacids may result in aluminium-related toxicity.
Mineral oil and sucralfate Absorption of AlfaD may be impaired by concurrent use of mineral oil (prolonged use) and sucralfate. Magnesium-containing preparations Caution should be exercised in the use of magnesium-based antacids or laxatives for patients taking AlfaD who are on chronic renal dialysis.
Hypermagnesaemia may occur. Thiazide-diuretics and calcium-containing preparations The risk of hypercalcaemia is increased in patients taking calcium-containing preparations or thiazide diuretics concurrently with AlfaD. Other Vitamin D-containing preparations AlfaD is a potent derivative of Vitamin D.
Pharmacological doses of Vitamin D, or its analogues, should not be given during AlfaD treatment because of the possibility of additive effects and an increased risk of hypercalcaemia. 6 Fertility, pregnancy and lactation Pregnancy There are no or limited data from the use of AlfaD in pregnancy women.
Animal studies have shown reproductive toxicity at high doses. AlfaD is not recommended during pregnancy and in women of child-bearing potential not using contraception. Breast-feeding Although not definitely established, it is likely that increased levels of 1,25- dihydroxyvitamin D3 will be found in the breast milk of mothers treated with AlfaD.
This might have an influence on calcium metabolism in a breast-fed infant; consequently, breast-fed infants of AlfaD-treated mothers should be closely monitored for hypercalcaemia. Fertility There are no clinical studies on the effect of AlfaD on fertility.
Animal studies showed adverse effects on fertility at high doses. 7 Effects on ability to drive and use machines AlfaD has no or negligible influence on the ability to drive and use machines. 8 Undesirable effects Adverse effects generally relate to abnormally elevated serum calcium levels (hypercalcaemia) leading to signs or symptoms that may include abdominal pain/discomfort, anorexia, asthenia, confusional state, dehydration, dry mouth, fatigue/lassitude, nausea, vomiting, constipation or diarrheoa, weight loss, muscle or bone pain, metallic taste, kidney stones, renal impairment, somnolence, sweating, headache, polyuria and polydipsia, vertigo, and raised plasma and urine concentrations of calcium and phosphate.
Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). AlphaD treatment may then be re-started at half the previous dose. In the case of renal impairment, elevated serum phosphate levels may be induced by AlfaD therapy.
The dosage should be adjusted to the patient’s requirements. Undesirable effects are listed by MedDRA system organ class (SOC) and individual undesirable effects are listed starting with the most frequently reported one. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).
• Metabolism and nutrition disorders Common: Hypercalcaemia; Hyperphosphataemia • Skin and subcutaneous tissue disorders Common: Rash, Pruritus Not known: Urticaria • Renal and urinary disorders Common: Hypercalciuria Uncommon: Nephrocalcinosis • General disorders and administration site conditions Uncommon: Calcinosis (ectopic, or metastatic calcifications) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product […]