Pharmacy Guide

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

Pharmacy Guide

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

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AlfaD 0.25 microgram Capsule

⚠ 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

AlfaD is the brand name of your medicine. The name of the active ingredient in AlfaD is alfacalcidol. This medicine will be referred to as AlfaD throughout this leaflet. AlfaD is a vitamin D analogue (a type of vitamin D) which helps to control the levels of two substances in your body. These two substances are calcium and phosphate, which your body needs for healthy bones and teeth. AlfaD 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. AlfaD is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat: • • • •

2.

post-menopausal osteoporosis and osteoporosis caused by treatment with glucocorticoids (used to treat inflammation, and problems with the immune system), in patients who are unable to take medicines known as bisphosphonates e.g. etidronate disodium bone disease related to kidney problems rickets/osteomalacia (which is a disease causing the bones to soften and weaken) patients with low or high activity of the parathyroid glands which may make the amount of calcium in your blood too low or too high.

What you need to know before you take it

e AlfaD

DO NOT take AlfaD if you: • • • •

are allergic (hypersensitive) to alfacalcidol or any other vitamin D products, or to any of the other ingredients of this medicine (listed in section 6) have a peanut or soya allergy. These capsules contain small amounts of peanut oil (arachis oil), which can cause a severe allergic reaction in sensitive people have a condition called hypercalcaemia, which means you have high levels of calcium in your blood have a condition called calcification, which 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 AlfaD. Warnings and precautions: Talk to your doctor, pharmacist, or nurse, before you start to take AlfaD if you: 1

• • • • •

are taking any of the medicines in the "Other medicines and AlfaD" section below have kidney problems (including kidney stones) have a disease which leads to the formation of clumps of inflammatory cells in various organs (granulomas or sarcoidosis). You may be more sensitive to AlfaD. have an intolerance to some sugars as this medicine contains a small amount of sorbitol have a diet deficient in calcium, as AlfaD may not work as well.

You may get too much calcium or phosphate in your blood when you take this medicine. Please read Section 4 – Possible side effects – to enable you to spot any of the signs that this may be happening to you. You should notify your doctor, who may need to change your dose. While you are taking AlfaD, your doctor will take regular blood tests. This is very important in children, patients with kidney problems, and patients on a high dose of AlfaD. This is to check the level of calcium and phosphate in your blood while you take your medicine. Depending on the results of these blood tests, your doctor may: –

prescribe another medicine called a phosphate binding agent to take as well as AlfaD. This will help to keep the right amount of phosphate in your blood.

–

prescribe a calcium supplement, to take in addition to AlfaD, to ensure you have the correct amount of calcium in your blood.

Other medicines and AlfaD: Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any of the following medicines: • • • • • • • • • • •

cardiac glycosides (for heart problems) e.g. digoxin, as you may get too much calcium in your blood and this could result in an abnormal heart beat. barbiturates (to treat anxiety and insomnia) e.g. phenobarbital, as you may need a larger dose of AlfaD anticonvulsants (to control epilepsy or fits) e.g. phenytoin, carbamazepine, or primidone, as you may need a larger dose of AlfaD. mineral oil (to relieve constipation), as AlfaD may not enter your blood as usual. colestyramine or colestipol (used to lower cholesterol levels), as AlfaD may not enter your blood as usual. sucralfate (to treat and prevent ulcers), as AlfaD may not enter your blood as usual. large amounts of aluminium-containing antacids (to relieve heartburn and indigestion) e.g. aluminium hydroxide, as too much aluminium is toxic. magnesium-containing antacids (to relieve heartburn or indigestion) or laxatives (to treat constipation) e.g. magnesium hydroxide, as you may get too much magnesium in your blood. preparations containing calcium (for calcium deficiency) e.g. calcium gluconate, as you may get too much calcium in your blood. thiazide diuretics, often called "water tablets", (for increasing the amount of urine you produce) e.g. bendroflumethiazide, as you may get too much calcium in your blood. any other preparations containing vitamin D (to treat bone disease), e.g. ergocalciferol, as you may get too much calcium in your blood.

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines, including medicines obtained without a prescription. 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, pharmacist, or nurse for advice before taking this medicine.

Driving and using machines: •

AlfaD is not expected to affect your ability to drive or operate machinery. Check with your doctor if you experience any side effect from AlfaD that you feel may affect your ability to drive and/or use machinery (e.g., dizziness or decreased alertness).

Important information about some of the ingredients of AlfaD: •

AlfaD capsules contain arachis oil (peanut oil). If you are allergic to peanut or soya, DO NOT take 2

AlfaD. •

This medicinal product contains small amounts of ethanol (alcohol) (less than 2 mg per capsule). 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.

•

AlfaD capsules contain a small amount (up to 3.16 mg per capsule) of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take it

AlfaD

Always take AlfaD exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. During your treatment with AlfaD, the calcium and phosphate levels in your blood will be monitored regularly (especially if you suffer from kidney problems) and, depending on the results, your dosage may be adjusted to achieve the correct response. The capsules should be swallowed preferably with a drink of water. The usual dose is: Bone disease related to kidney problems, rickets, osteomalacia, and parathyroid problems: •

Adults and children over 20 kg 1.0 microgram a day

•

The elderly 0.5 microgram a day

•

Children under 20 kg AlfaD is not recommended for use in children under 20 kg.

Osteoporosis: •

Adults (including the elderly) 1.0 microgram a day.

If you take more AlfaD than you should If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause loss of appetite, general weakness, feeling sick, being sick, weakness, sweating, diarrhoea, headache, weight loss, vertigo, thirst, and excessive urination. Please take this leaflet, any remaining capsules, and the container with you to the hospital or doctor so that they know which capsules were consumed. If you forget to take AlfaD If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. If you stop taking AlfaD DO NOT stop taking your medicine without first talking to your doctor, pharmacist, or nurse , even if you feel better. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

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4.

Possible side effects

Like all medicines, AlfaD can cause side effects, although not everybody gets them.

Possible side effects

are generally caused by having too much calcium in the blood. Important side effect to look out for: If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital as you may be having a severe allergic reaction: • • • •

swelling of the lips, face, or neck/throat severe difficulty in breathing due to swelling of the neck/throat a severe skin rash or hives.

This is a very rare, but very serious, side effect. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you notice any of the following as this could mean you have too much calcium or phosphate in your blood. These side effects may happen in up to 1 in 10 people: • • • • • • • • • • • •

feeling or being sick general weakness and lack of energy loss of appetite feeling thirsty a lot Unexpected weight loss Sweating a lot experience vertigo (feel that you, or things around you, are moving when they are not) experience headaches needing to pass water (urine) a lot experience a dry mouth or a metallic taste in your mouth experience pain in your muscles or bones experience constipation or diarrhoea

Tell your doctor as soon as possible if you notice any of the following as this could mean you are developing problems with your kidneys, such as kidney stones forming. Kidney stones may cause a sharp spasm in one side of your lower back. The frequency of this side effect is unknown (it cannot be estimated from the data available): • • •

needing to pass water (urine) less often swelling of any parts of your body (oedema) fever with a pain in your side.

Other possible side effects for which the number of people affected in unknown (can not be estimated from available data): •

Urticaria (hives on your skin)

Other possible side effects, which may affect up to 1 in 10 people, include skin problems, such as: • •

itching skin rash

Other possible side effects which may affect up to 1 in a 100 people include: •

Develop deposits of calcium in your kidneys (nephrocalcinosis) or other part of your body (ectopic calcification)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. 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. 4

5.

How to store it

AlfaD

Keep out of the sight and reach of children. Do not store above 25°C. Do not transfer AlfaD to another container. Do not use after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What AlfaD capsules contain: The active ingredient in AlfaD is alfacalcidol (1 α-hydroxyvitamin D3) 0.25, 0.5 or 1 microgram. The other ingredients are: • • • • •

citric acid, anhydrous (E330) propyl gallate (E310) α-tocopherol (vitamin E) (E307) ethanol, anhydrous arachis oil (peanut oil)

The capsule shell contains: • • •

gelatin glycerol 85% (E422) Anidrisorb 85/70 (sorbitol, sorbitans, superior polyols and mannitol)

The printing ink contains: shellac 54% (E904) black iron oxide (E172)

• •

The capsules contain the following colours: • • •

0.25 microgram capsules: red iron oxide (E172) 0.5 microgram capsules: titanium dioxide (E171) and red iron oxide (E172) 1.0 microgram capsules: titanium dioxide (E171) and yellow iron oxide (E172).

What AlfaD capsules look like and contents of the pack: •

The 0.25 microgram capsules are oval, opaque, reddish-brown, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed '0.25' on one side in black ink.

•

The 0.5 microgram capsules are oval, opaque, pale pink, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed '0.5' on one side in black ink.

•

The 1 microgram capsules are oval, opaque, cream-to-ivory, elastic soft gelatin capsules containing a clear, pale-yellow, oily solution. They are printed '1.0' on one side in black ink.

The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, or 168 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, DO1YE64, Ireland 5

Company responsible for manufacture: AENOVA ROMANIA S.R.L Str. Carol, I nr.20, Comuna Cornu, Județ Prahova, cod poștal 107180, Romania. Catalent Germany Eberbach GmbH, Gammelsbacher Straße 2, D-69412 Eberbach, Germany AlfaD is a registered trademark of Theramex HQ UK Limited. This leaflet was last revised: 03/2025 PL 49876/0001-0003

6

Frequently asked questions about AlfaD 0.25 microgram Capsule

How do I take AlfaD 0.25 microgram Capsule?

AlfaD 0.25 microgram Capsule comes as capsule containing 0.25mcg. 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 AlfaD 0.25 microgram Capsule?

The active substance in AlfaD 0.25 microgram Capsule is alfacalcidol.

Are there equivalent medicines to AlfaD 0.25 microgram Capsule?

Medicines with the same active substance, strength and form include: One-Alpha 0.25 microgram soft capsules, Alfacalcidol 0.25 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 AlfaD 0.25 microgram Capsule, 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 AlfaD 0.25 microgram Capsule 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

AlfaD is used for treating conditions in which calcium metabolism is disturbed due to impaired 1α‑hydroxylation and other disorders associated with Vitamin D resistance.

The main indications are:

- Renal osteodystrophy

- Hypoparathyroidism

- Hyperparathyroidism (with bone disease)

- Nutritional and malabsorptive rickets and osteomalacia

- Hypophosphataemic Vitamin-D resistant rickets and osteomalacia

- Pseudo-deficiency (D-dependent Type I) rickets and osteomalacia

- Post-menopausal osteoporosis in patients who are unsuitable for/intolerant to treatment with a bisphosphonate

- Osteoporosis secondary to treatment with glucocorticoids in patients who are unsuitable for/intolerant to treatment with a bisphosphonate

4.2. Posology and method of administration

Posology

Starting dose:

Children 20kg and over:

1 microgram/day

Adults:

1 microgram/day

Elderly patients:

0.5 microgram/day

The dose of AlfaD should subsequently be carefully adjusted to avoid hypercalcaemia according to the biochemical response of each individual patient. Plasma calcium levels (preferably corrected for protein binding) should initially be measured weekly. The dose of AlfaD can be increased by increments of 0.25 to 0.5 micrograms/day. Most adults respond to doses of 1 to 3 micrograms/day. Once the dose of AlfaD is stabilised, calcium levels may be measured every 2-4 weeks.

Indices of response, in addition to plasma calcium, may include alkaline phosphatase, parathyroid hormone levels, bone radiography and histological investigations. When there is biochemical or radiographic evidence of bone healing (or in hypoparathyroidism when calcium levels have normalised) the dose required for maintenance generally decreases to around 0.25 to 1 microgram/day. Should hypercalcaemia occur, AlfaD should be stopped until plasma calcium returns to normal (usually about a week) then restarted at one half of the previous dose.

Renal Osteodystrophy - Patients with already high plasma calcium levels may have autonomous hyperparathyroidism. In this situation, they may not respond to alfacalcidol, and other therapeutic measures may be indicated.

• In patients with chronic renal disease, it is particularly important to check the plasma calcium frequently because prolonged hypercalcaemia may further impair renal function.

• Before and during AlfaD treatment, the use of phosphate binding agents to prevent hyperphosphataemia may also be considered.

Hypoparathyroidism - Low plasma calcium levels may be restored to normal more quickly with AlfaD than with parent Vitamin D. Severe hypocalcaemia is corrected more rapidly with higher doses of AlfaD (e.g., 3-5 micrograms) together with calcium supplements.

Hyperparathyroidism - In patients needing surgery for primary or tertiary hyperparathyroidism, pre- operative treatment with AlfaD for 2-3 weeks can reduce bone pain and myopathy without aggravating hypercalcaemia. To decrease the risk of post-operative hypocalcaemia, AlfaD should be continued until the plasma alkaline phosphatase falls to normal or hypercalcaemia occurs.

Nutritional and Malabsorptive Rickets and Osteomalacia - Malabsorptive osteomalacia, which responds to large doses of IM or IV parent Vitamin D, will respond to small oral doses of AlfaD. Nutritional rickets and osteomalacia can also be rapidly cured with AlfaD.

Hypophosphataemic Vitamin D-Resistant Rickets and Osteomalacia - Normal doses of AlfaD rapidly relieves myopathy, when present, and increase calcium and phosphate retention. Phosphate supplements may also be required in some patients. Neither large doses of parent Vitamin D nor phosphate supplements are entirely satisfactory in these conditions.

Pseudo-Deficiency (D-Dependent Type I) Rickets and Osteomalacia - As with the nutritional conditions, similar oral doses of AlfaD are effective in circumstance which would require high doses of parent Vitamin D.

Post-menopausal or Glucocorticoid-induced Osteoporosis

Adults, including the elderly:

Treatment dose: 1 microgram/day

Serum calcium and creatinine levels should be determined at 1, 3 and 6 months, and at 6 monthly intervals thereafter.

Use in Children

AlfaD capsules are not indicated in children under 20kg as the dosage cannot be titrated adequately.

Use in Elderly

The clinical manifestations of hypo- or hypercalcaemia should be considered, especially in elderly patients with pre-existing renal or heart conditions.

Method of administration: oral

4.3. Contraindications

Hypercalaemia; metastatic calcification.

AlfaD should not be used in patients with evidence of Vitamin D toxicity or known hypersensitivity to the effects of Vitamin D or any of its analogues.

AlfaD capsules should not be used in patients with a peanut allergy or hypersensitivity to alfacalcidol or any of the other excipients listed in section 6.1.

4.4. Special warnings and precautions for use

AlfaD should be used with caution for:

• patients being treated with cardioactive glycosides or digitalis as hypercalcaemia may lead to arrhythmia in such patients

• patients with nephrolithiasis

• patients with granulomatous diseases, such as sarcoidosis, where sensitivity to vitamin D may be increased due to increased hydroxylation activity and vitamin D toxicity can occur.

AlfaD increases the intestinal absorption of calcium and phosphate, serum levels of which should be monitored, particularly in children, patients with renal failure, and patients receiving high doses. Parathyroid hormone, alkaline phosphatase, and calcium x phosphate should be monitored as clinically indicated.

To maintain serum phosphate at an acceptable level in patients with renal bone disease a phosphate binding agent may be used.

Hypercalcaemia may appear in patients treated with AlfaD, the signs/symptoms of which are listed in section 4.8.

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.

This medicinal product contains up to 3.16 mg of sorbitol as an excipient (see Anidrisorb 85/70 in list of excipients in section 6.1) 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.

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

Cardiac glycosides

Hypercalcaemia in patients taking digitalis preparations may precipitate cardiac arrhythmias. Patients taking digitalis concurrently with AlfaD must therefore be closely monitored (see warnings and precautions in section 4.4).

Anticonvulsants

Anticonvulsants (e.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.

Bile acid sequestrants

Concomitant oral administration of bile acid sequestrants (e.g., 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 concomitant 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.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited data from the use of AlfaD in pregnant 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.

4.7. Effects on ability to drive and use machines

AlfaD has no or negligible influence on the ability to drive and use machines.

4.8. 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). AlfaD 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 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 Google Play or Apple App Store.

4.9. Overdose

Excessive intake of Vitamin D leads to the development of hypercalcaemia (see section 4.8).

Severe hypercalcaemia may require treatment with general supportive measures.

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.

In acute overdosage, early treatment with gastric lavage and/or the administration of mineral oil may reduce absorption and promote faecal elimination.

💬 Ask about this leaflet

Ask anything about AlfaD 0.25 microgram Capsule. 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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