Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Alfacalcidol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Alfacalcidol contains the active substance alfacalcidol. Alfacalcidol belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth. Alfacalcidol works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. Alfacalcidol is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat:
e Alfacalcidol Do not take Alfacalcidol:
Your doctor may prescribe another medicine called a phosphate binding agent to take as well as Alfacalcidol. This will help to keep the right amount of phosphate in your blood. Your doctor may also prescribe a calcium supplement to take as well as Alfacalcidol. This is to maintain the right amount of calcium in your blood. Other medicines and Alfacalcidol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription. In particular, you must tell your doctor or pharmacist if you are taking any of the following medicines:
Alfacalcidol Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many capsules to take, or to give your child. At first you will have weekly blood tests to check the levels of some substances in your blood. These tests are to check the levels of calcium, an enzyme called alkaline phosphatase or the parathyroid hormone. This is so your doctor knows that you are taking the dose that is right for you. When you are getting the correct dose you will
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not need blood tests so often. You may also have other tests such as X-rays. This is also so your doctor knows that the dose is right for you. Your doctor may adjust your dose. Your doctor may ask you to take more or less capsules depending on your test results. You may get too much calcium or phosphate in your blood when you take this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor will tell you not to take any more medicine. You will need to have some blood tests. When the blood tests are normal you can start your medicine again. It is important that you only take half the dose you had before. Adults and adolescents The usual starting dose is 1 microgram each day. People usually take between 1 and 3 micrograms each day. Most people take between 0.25 and 1 microgram each day once the blood test results show the medicine is working. If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 microgram each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as Alfacalcidol. This will help to keep the right amount of calcium level in your blood. Elderly The usual starting dose is 0.5 microgram each day. Use in children The dose depends on the weight of the child for children less than 20kg (called bodyweight).
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
alfacalcidol
What Alfacalcidol contains The active substance is alfacalcidol. Each Alfacalcidol 0.25 microgram soft capsule contains 0.25 microgram of alfacalcidol. Each Alfacalcidol 0.5 microgram soft capsule contains 0.5 microgram of alfacalcidol. Each Alfacalcidol 1.0 microgram soft capsules contains 1 microgram of alfacalcidol. The other ingredients are:
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Other possible side effects: Common (may affect up to 1 in 10 people):
Dimension – 135 x 420 mm
Back Side
ALFACALCIDOL CAPSULES – 0.25/0.5/1 mcg SPUK
PACK INSERT
135 x 420 1048844
—-1038087
BLACK
1
PC-TSG/2023/020 – Record # 373751
6.0
Front & Back side printing. To be supplied in the unfolded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
Alfacalcidol 1.0 microgram soft capsules comes as capsule containing 1mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Alfacalcidol 1.0 microgram soft capsules is alfacalcidol.
Medicines with the same active substance, strength and form include: AlfaD 1 microgram Capsule, One-Alpha 1 microgram soft capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Alfacalcidol 1.0 microgram soft capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Alfacalcidol is indicated in conditions where there is a disturbance of calcium metabolism due to impaired 1-α hydroxylation such as when there is reduced renal function.
The main indications are:
a) Renal osteodystrophy
b) Hyperparathyroidism (with bone disease)
c) Hypoparathyroidism
d) Nutritional and malabsorptive rickets and osteomalacia
e) Pseudo-deficiency (D-dependent) rickets and osteomalacia
f) Hypophosphataemic vitamin D resistant rickets and osteomalacia
Posology
Initial dose for all indications:
Adults, adolescents and children > 20 kg bodyweight:
1 microgram/day
Elderly:
0.5 microgram/day
Children from 6 year of age and under 20 kg bodyweight:
0.05 microgram/kg/day
The dose of Alfacalcidol should be adjusted thereafter to avoid hypercalcaemia according to the biochemical response. Indices of response include plasma levels of calcium (ideally corrected for protein binding), alkaline phosphatase, parathyroid hormone, as well as radiographic and histological investigations.
Plasma levels should initially be measured at weekly intervals. The daily dose of Alfacalcidol may be increased by increments of 0.25-0.5 microgram. When the dose is established, measurements of calcium, phosphorous and creatinine may be taken every 2-4 weeks.
Most adult patients respond to doses between 1and 3 micrograms per day. When there is biochemical or radiographic evidence of bone healing, (and in hypoparathyroid patients when normal plasma calcium levels have been attained), the dose generally decreases. Maintenance doses are generally in the range of 0.25 to 1 microgram per day. If hypercalcaemia occurs, Alfacalcidol should be stopped until plasma calcium returns to normal (approximately 1 week) then restarted at half the previous dose.
a) Renal bone disease:
Patients with relatively high initial plasma calcium levels may have autonomous hyperparathyroidism, often unresponsive to Alfacalcidol. Other therapeutic measures may be indicated.
Before and during treatment with Alfacalcidol, phosphate binding agents should be considered to prevent hyperphosphataemia. It is particularly important to make frequent plasma calcium measurements in patients with chronic renal failure because prolonged hypercalcaemia may aggravate the decline of renal function.
b) Hyperparathyroidism:
In patients with primary or tertiary hyperparathyroidism about to undergo parathyroidectomy, pre-operative treatment with Alfacalcidol for 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, Alfacalcidol should be continued until plasma alkaline phosphatase levels fall to normal or hypercalcaemia occurs.
c) Hypoparathyroidism:
In contrast to the response to parent vitamin D, low plasma calcium levels are restored to normal relatively quickly with Alfacalcidol. Severe hypocalcaemia is corrected more rapidly with higher doses of Alfacalcidol (e.g., 3-5 micrograms) together with calcium supplements.
d) Nutritional and malabsorptive rickets and osteomalacia:
Nutritional rickets and osteomalacia can be cured rapidly with Alfacalcidol. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of Alfacalcidol.
e) Pseudo-deficiency (D-dependent) rickets and osteomalacia:
Although large doses of parent vitamin D would be required, effective doses of Alfacalcidol are similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia.
f) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:
Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory.
Treatment with Alfacalcidol at normal dosage rapidly relieves myopathy when present and increases calcium and phosphate retention. Phosphate supplements may also be required in some patients.
Method of administration
Oral use
The soft capsules should be swallowed whole with sufficient amount of fluid.
Hypersensitivity to the active substance, arachis oil (peanut oil), soya or to any of the excipients listed in section 6.1.
Hypercalcaemia, metastatic calcification.
Monitoring
During treatment with Alfacalcidol, serum calcium and serum phosphate and creatinine levels should be monitored regularly especially in children, patients with renal impairment and patients receiving high doses. PTH, alkaline phosphatase and calcium phosphates should be monitored as clinically indicated.
Hypercalcaemia
Hypercalcaemia may appear in patients treated with Alfacalcidol. For this reason, patients should be informed about the clinical symptoms connected with hypercalcaemia. Refer section 4.8 (Undesirable effects)
In case of hypercalcaemia, Alfacalcidol treatment should be stopped until serum calcium concentrations return to normal, usually in about 1 week. Alfacalcidol may then be restarted at half the last dose used with monitoring of calcium.
Prolonged hypercalcaemia may aggravate arteriosclerosis, cardiac valve sclerosis or nephrolithiasis and therefore prolonged hypercalcaemia should be avoided when Alfacalcidol is used in these patients. Transient or even long-lasting deterioration of kidney function has been observed. Alfacalcidol should also be used with caution in patients with calcification of pulmonary tissue as this may result in cardiac disease.
Renal
In patients with renal bone disease or severely reduced renal function, a phosphate binding agent could be used simultaneously with alfacalcidol to prevent increased serum phosphate and potential metastatic calcification.
Granulomatous diseases
Alfacalcidol should be used with caution in patients with granulomatous diseases such as sarcoidosis where the sensitivity to vitamin D is increased due to increased hydroxylation activity.
Fructose intolerance
This medicinal product contains sorbitol as an excipient and patients with rare hereditary problems of fructose intolerance (HFI) should not take this medicinal product.
This medicinal product contains 1 mg of alcohol (ethanol) per soft capsule, corresponding to 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.
Digitalis glycosides
Concurrent use of digitalis glycosides in the presence of hypercalcaemia due to vitamin D administration increases the potential for cardiac arrhythmias and is therefore contraindicated. Patients taking digitalis and alfacalcidol concomitantly should be frequently monitored with ECG and measurements of plasma levels of digitalis glycosides and calcium.
Thiazide diuretics and calcium containing preparations
Use with caution in patients being treated with thiazide diuretics or calcium containing preparations as they may have an increased risk of developing hypercalcaemia. Calcium levels should be monitored.
Other vitamin D containing preparations
Vitamin D or its analogous should not be given concurrently with alfacalcidol as may enhance the risk of hypercalcaemia.
Anticonvulsants
Patients taking barbiturates or anticonvulsants may require larger doses of Alfacalcidol to produce the desired effect due to the induction of hepatic detoxification enzymes.
Magnesium-containing antacids
Magnesium based antacids and laxatives should not be used during treatment with alfacalcidol due to increased risk of hypermagnesaemia.
Aluminium-containing preparations
Alfacalcidol may increase the serum concentration of aluminium. Patients taking aluminium- containing preparations (e.g. aluminium hydroxide, sucralfate) should be monitored for signs of aluminium related toxicities.
Bile acid sequestrants
Concomitant oral administration of bile acid sequestrants such as cholestyramine may impair the intestinal absorption of oral Alfacalcidol formulations. Alfacalcidol 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.
Pregnancy
There is alimited amount of data from the use of alfacalcidol in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Therefore, Alfacalcidol is not recommended during pregnancy and in women of child- bearing potential not using contraception.
Breast-feeding
Although it has not been established, it is likely that increased amounts of 1,25- dihydroxyvitamin D will be found in the milk of lactating mothers treated with Alfacalcidol. This may influence calcium metabolism in the infant.
Breast-fed infants of alfacalcidol-using mothers should be monitored closely for hypercalcaemia.
Fertility
There are no clinical studies on the effect of alfacalcidol on fertility. A pre-clinical study did not show an effect on fertility in rats.
Alfacalcidol has no or negligible direct influence on the ability to drive and use machines. However, the patient suffering from “dizziness” or “confusional states” due to Alfacalcidol should not drive or use machines.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported undesirable effects are skin reactions such as pruritus and rash, hypercalcaemia, gastrointestinal pain/discomfort and hyperphosphataemia. Symptoms of hypercalcaemia are headache, weakness, anorexia, weight loss, nausea, vomiting, diarrhoea, constipation, polyuria, polydepsia, and muscle and bone pain, and metallic taste. Renal failure has been reported post-marketing.
Undesirable effects are listed by MedDRA system organ class (SOC) and the individual undesirable effects are listed starting with the most frequently reported one.
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
Psychiatric disorders
Uncommon
Confusional state
Nervous system disorders
Uncommon
Headache
Rare
Dizziness
Gastrointestinal disorders
Common
Abdominal pain and discomfort
Uncommon
Diarrhoea
Vomiting
Constipation
Nausea
Skin and subcutaneous tissue disorders
Common
Rash*
Pruritus
*Various types of rash such as erythematous, maculo-papular and pustular have been reported.
Musculoskeletal and connective tissue disorders
Uncommon
Myalgia
Renal and urinary disorders
Common
Hypercalciuria
Uncommon
Nephrolithiasis/Nephrocalcinosis
Renal impairment (including acute renal failure)
General disorders and administration site conditions
Uncommon
Fatigue/asthenia/malaise
Calcinosis
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Excessive intake of Alfacalcidol may lead to the development of hypercalcaemia, however, the effect is reversed rapidly on withdrawal.
Symptoms of overdosage of Alfacalcidol strides are anorexia, lassitude, nausea and vomiting, diarrhoea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised concentrations of calcium and phosphate in plasma and urine.
In severe cases of hypercalcaemia, general supportive measures should be undertaken. Keep the patient well hydrated by i.v. infusion of saline (force diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.
Ask anything about Alfacalcidol 1.0 microgram soft capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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