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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Alfacalcidol 0.5 microgram soft capsules

⚠ This medicine appears to have been discontinued

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.

Active substance: Alfacalcidol

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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:

  • Changes in bone caused by kidney failure (osteodystrophy).
  • Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. o The glands may make the amount of calcium in your blood too high. (hyperparathyroidism). o The glands may make the amount of calcium in your blood too low (hypoparathyroidism).
  • Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia).

What you need to know before you take it

e Alfacalcidol Do not take Alfacalcidol:

  • If you are allergic to alfacalcidol, arachis oil (peanut oil), soy or any of the other ingredients of this medicine (listed in section 6 ).
  • If you know you have a condition called hypercalcaemia. This means you have high levels of calcium in your blood.
  • If you know that you have a condition called calcification. This means you have high levels of calcium in your body tissues.
  • If you are unsure if any of the above apply to you, talk to your doctor before taking Alfacalcidol. Warnings and precautions Talk to your doctor or pharmacist before taking Alfacalcidol. In particular, tell your doctor:
  • If you are taking any of the medicines in the "Other medicines and Alfacalcidol" section below.
  • If you have any problems with your kidneys. This includes if you have kidney stones.
  • If you have a disease which leads to formation of clumps of inflammatory cells in various organs (granulomas or sarcoidosis). You may be more sensitive to Alfacalcidol. You may get too much calcium or phosphate or creatinine 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 may need to change your dose. While you are taking Alfacalcidol your doctor will take regular blood tests. This is very important in children, patients with kidney problems, or patients on a high dose of medicine. This is to check the level of creatinine, calcium and phosphate in your blood while you take your medicine.

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:

  • Anticonvulsants (for epilepsy or fits). You may need a larger dose of Alfacalcidol.
  • Cardiac glycosides, such as digoxin (for heart problems). You may get too much calcium in your blood. This may cause an abnormal heart beat.
  • Thiazide diuretics, often called "water pills": for increasing the amount of water (urine) that your body makes. You may get too much calcium in your blood.
  • Medicines that contain calcium or other medicines that contain vitamin D. You may get too much calcium in your blood.
  • Barbiturates (for sleeping disorders). You may need a larger dose of Alfacalcidol.
  • Antacids (for heartburn) and laxatives (for relieving constipation) containing magnesium:
  • You may get too much magnesium in your blood.
  • Medicines containing aluminium. Too much aluminium is toxic.
  • Bile acid sequestrants such as colestyramine (for lowering cholesterol levels or stopping some types of diarrhea or itching). Alfacalcidol may not enter your blood as usual. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines (for example dizziness and decrease alertness due to alfacalcidol.) Alfacalcidol contains arachis oil (peanut oil), lecithin (soya lecithin), ethanol and sorbitol: Alfacalcidol capsules contain arachis oil (peanut oil), lecithin (soya lecithin). It you are allergic to peanut or soya, do not use this medicine. This medicine contains 10 mg sorbitol in each capsule. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. 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. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take it

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

Front Side

Dimension – 135 x 420 mm

ALFACALCIDOL CAPSULES – 0.25/0.5/1 mcg SPUK

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135 x 420 1048844

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PC-TSG/2023/020 – Record # 373751

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Front & Back side printing. To be supplied in the unfolded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.

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).

  • Children from 6 years of age and weighing less than 20 kilograms: The usual starting dose is 0.05 microgram per kilogram bodyweight each day.
  • Children weighing 20 kilograms and more: The usual starting dose is 1 microgram each day. If you take more Alfacalcidol than you should Tell your doctor straight away. You may need to stop taking this medicine. You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. If you forget to take Alfacalcidol If you forget to take your medicine, take it as soon as you remember. Then take the next dose at the usual time. Do not take a double dose to make up for the forgotten one. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:
  • You have difficulty breathing
  • Your face or throat swell
  • Your skin develops a severe rash. Tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood. The frequency of these side effects is common (may affect up to 1 in 10 people):
  • You feel weak or have pain in your muscles or bones
  • You have lost weight
  • You need to pass water (urine) more often
  • You feel thirsty
  • You feel fatigue
  • You feel sick, vomit, have constipation or diarrhoea
  • You have lost your appetite
  • You are sweating a lot
  • You are having headaches
  • You feel confused
  • You feel drowsy
  • You have high blood pressure
  • You have a metallic taste in your mouth Tell your doctor as soon as possible if you spot any of the following signs which may be due to problems developing with your kidneys. The frequency of these side effects is not known (cannot be estimated from the available data):
  • Needing to pass water (urine) less often.
  • Swelling of any parts of your body.
  • Fever with a pain in your side. Kidney stones may be forming. Kidney stones may cause a sharp spasm in one side of your lower back.
  • High levels of phosphate in the blood
  • Abdominal/stomach pain or discomfort
  • Rash
  • Itching Uncommon (may affect up to 1 in 100 people):
  • Headache
  • Diarrhoea, vomiting, constipation, nausea
  • Muscle pain
  • Fatigue
  • Deposits of calcium in the body (calcinosis)
  • Feeling weak or unwell
  • Increased calcium levels in the kidneys, kidney stones
  • Confusion
  • Renal impairment (including acute renal failure) Rare (may affect up to 1 in 1,000 people):
  • Dizziness Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any

Possible side effects

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.

How to store it

alfacalcidol

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date on the carton. The expiry date refers to the last day of that month.
  • This medicinal product does not require any special storage conditions Do not throw away any medicine via waste water or household waste. Please ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

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:

  • citric acid, anhydrous;
  • all-rac-α-Tocopherol;
  • propyl gallate;
  • ethanol, anhydrous;
  • arachis oil, hydrogenated. The capsule shell contains
  • gelatin;
  • glycerol;
  • anidrisorb;
  • purified water;
  • medium chain triglyceride
  • soya lecithin. The capsules contain the following colours: 0.25 microgram capsules: titanium dioxide (E171), ferric oxide red (E172) and ferric oxide black (E172) 0.5 microgram capsules: titanium dioxide (E171) and ferric oxide red (E172) 1.0 microgram capsules: titanium dioxide (E171) and ferric oxide yellow (E172) What Alfacalcidol looks like and contents of the pack Alfacalcidol 0.25 mcg capsule: reddish brown colored, oval shaped soft gelatin capsules containing clear oily liquid. Alfacalcidol 0.5 mcg capsule: light pink colored, oval shaped soft gelatin capsules containing clear oily liquid. Alfacalcidol 1.0 mcg capsule: pale yellow colored, oval shaped soft gelatin capsules containing clear oily liquid. Alfacalcidol comes in white opaque HDPE container, with white opaque HDPE screw closure and induction sealing in a pack of 30 capsules, 50 capsules and 100 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre, Dwight Road, Watford, WD18 9SS United Kingdom This leaflet was last revised in 09/2023.

1048844

Other possible side effects: Common (may affect up to 1 in 10 people):

  • High levels of calcium in the urine or blood

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.

Frequently asked questions about Alfacalcidol 0.5 microgram soft capsules

How do I take Alfacalcidol 0.5 microgram soft capsules?

Alfacalcidol 0.5 microgram soft capsules comes as capsule containing 0.5mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Alfacalcidol 0.5 microgram soft capsules?

The active substance in Alfacalcidol 0.5 microgram soft capsules is alfacalcidol.

Are there equivalent medicines to Alfacalcidol 0.5 microgram soft capsules?

Medicines with the same active substance, strength and form include: AlfaD 0.5 microgram Capsule, One-Alpha 0.5 microgram soft capsules. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Alfacalcidol 0.5 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.

Can I get Alfacalcidol 0.5 microgram soft capsules without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Alfacalcidol (11 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

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

4.2. Posology and method of administration

Posology

Initial dose for all indications:

Adults, adolescents and children > 20 kg bodyweight:

1 microgram/day

Elderly:

0.5 microgram/day

Children from 6 years 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.

4.3. Contraindications

Hypersensitivity to the active substance, arachis oil (peanut oil), soya or to any of the excipients listed in section 6.1.

Hypercalcaemia, metastatic calcification.

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

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.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is a limited 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.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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.

4.9. Overdose

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 about this leaflet

Ask anything about Alfacalcidol 0.5 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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