Alfacalcidol Capsule 0.25mcg Taj Pharma

  1. Name of the medicinal product

Alfacalcidol 1 microgram soft capsules Taj Pharma
Alfacalcidol 0.25 microgram soft capsules Taj Pharma
Alfacalcidol 0.5 microgram soft capsules Taj Pharma

  1. Qualitative and quantitative composition

Each capsule contains 1 microgram of alfacalcidol
Each capsule contains 0.25 micrograms of alfacalcidol
Each capsule contains 0.5 micrograms of alfacalcidol

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Alfacalcidol1 microgram soft capsules: brown, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

Alfacalcidol0.25 microgram soft capsules: Cream-coloured, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

Alfacalcidol0.5 microgram soft capsules: Reddish, egg-shaped soft gelatin capsules, holding 0.1 g oily solution.

  1. Clinical particulars

4.1 Therapeutic indications

Alfacalcidolis indicated in all 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:

  1. a) Renal osteodystrophy
  2. b) Hyperparathyroidism (with bone disease)
  3. c) Hypoparathyroidism
  4. d) Neonatal hypocalcaemia
  5. e) Nutritional and malabsorptive rickets and osteomalacia
  6. f) Pseudo-deficiency (D-dependent) rickets and osteomalacia
  7. g) Hypophosphataemic vitamin D resistant rickets and osteomalacia

4.2 Posology and method of administration

Posology

Initial dose for all indications:

Adults and children over 20 kg bodyweight:

Elderly:

Neonates and premature infants:

Children under 20 kg bodyweight:

1 microgram/day

0.5 microgram/day

0.05 – 0.1 microgram/kg/day

0.05 microgram/kg/day

The dose of Alfacalcidolshould 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 Alfacalcidolmay be increased by increments of 0.25 – 0.5 microgram. When the dose is stabilised, measurements may be taken every 2 – 4 weeks.

Most adult patients respond to doses between 1 and 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, Alfacalcidolshould 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 One-Alpha. Other therapeutic measures may be indicated.

Before and during treatment with One-Alpha, 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 Alfacalcidolfor 2-3 weeks alleviates bone pain and myopathy without aggravating pre-operative hypercalcaemia. In order to decrease post-operative hypocalcaemia, Alfacalcidolshould 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 One-Alpha. Severe hypocalcaemia is corrected more rapidly with higher doses of Alfacalcidol(e.g. 3-5 micrograms) together with calcium supplements.

(d) Neonatal hypocalcaemia:

Although the normal starting dose of Alfacalcidolis 0.05-0.1 microgram/kg/day (followed by careful titration) in severe cases doses of up to 2 microgram/kg/day may be required. Whilst ionised serum calcium levels may provide a guide to response, measurement of plasma alkaline phosphatase activity may be more useful. Levels of alkaline phosphatase approximately 7.5 times above the adult range indicates active disease.

A dose of 0.1 microgram/kg/day of Alfacalcidolhas proven effective as prophylaxis against early neonatal hypocalcaemia in premature infants.

(e) Nutritional and malabsorptive rickets and osteomalacia:

Nutritional rickets and osteomalacia can be cured rapidly with One-Alpha. Malabsorptive osteomalacia (responding to large doses of IM or IV parent vitamin D) will respond to small doses of One-Alpha.

(f) Pseudo-deficiency (D-dependent) rickets and osteomalacia:

Although large doses of parent vitamin D would be required, effective doses of Alfacalcidolare similar to those required to heal nutritional vitamin D deficiency rickets and osteomalacia.

(g) Hypophosphataemic vitamin D-resistant rickets and osteomalacia:

Neither large doses of parent vitamin D nor phosphate supplements are entirely satisfactory. Treatment with Alfacalcidolat 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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypercalcaemia, metastatic calcification.

4.4 Special warnings and precautions for use

During treatment with One-Alpha, serum calcium and serum phosphate 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 might appear in patients treated with One-Alpha. For this reason, patients should be informed about the clinical symptoms connected with hypercalcaemia. Signs of hypercalcaemia are muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea and vomiting, constipation, polyuria, sweating, headache, polydipsia, hypertension and somnolence.

Hypercalcaemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (in about one week). Alfacalcidolmay then be restarted at a reduced dose (half the previous dose) with monitoring of calcium.

Prolonged hypercalcaemia may aggravate arteriosclerosis, cardiac valve sclerosis or nephrolithiasis and therefore prolonged hypercalcaemia should be avoided when Alfacalcidolis used in these patients. Transient or even long-lasting deterioration of kidney function has been observed. Alfacalcidolshould also be used with caution in patients with calcification of pulmonary tissue as this may result in cardiac disease.

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.

Alfacalcidolshould 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.

Concurrent use of digitalis glycosides in the presence of hypercalcaemia due to vitamin D administration increases the potential for cardiac arrhythmias.

Alfacalcidolcapsules contain sesame oil as an excipient. Sesame oil may rarely cause severe allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Thiazide diuretics and calcium containing preparations

Concurrent use of thiazide diuretics or calcium containing preparations may enhance the risk of hypercalcaemia. Calcium levels should be monitored.

Other vitamin D containing preparations

Concurrent use of other vitamin D containing preparations may enhance the risk of hypercalcaemia. Use of multiple vitamin D analogues should be avoided.

Anticonvulsants

Anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone) have enzyme-inducing effects resulting in an increased metabolism of alfacalcidol. Patients taking anticonvulsants may require larger doses of One-Alpha.

Magnesium-containing antacids

Absorption of magnesium-containing antacids may be enhanced by One-Alpha, increasing the risk of hypermagnesaemia.

Aluminium-containing preparations

Alfacalcidolmay 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 Alfacalcidolformulations. Alfacalcidolshould 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.

Therefore, Alfacalcidolis 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 One-Alpha. This may influence calcium metabolism in the infant.

Consequently, breast-fed infants of alfacalcidol-using mothers should be monitored closely for hypercalcaemia.

Fertility

There are no clinical studies on the effect of Alfacalcidolon 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 should be informed that dizziness may occur during treatment and take this into account while driving or using 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 various skin reactions such as pruritus and rash, hypercalcaemia, gastrointestinal pain/discomfort and hyperphosphataemia.

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. Within each frequency grouping, adverse reactions are presented in the 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

Psychiatric disorders
Not known: 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

Not known: Urticaria
Musculoskeletal and connective tissue disorders
Uncommon: Myalgia
Renal and urinary disorders
Common: Hypercalciuria
Uncommon: Nephrolithiasis/Nephrocalcinosis
Not known: 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.

4.9 Overdose

Excessive intake of Alfacalcidolmay lead to the development of hypercalcaemia, however, the effect is reversed rapidly on withdrawal.

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 using digitalis. More specifically, treatment with glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content should be considered.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin D and analogues.

Alfacalcidol is converted rapidly in the liver to 1,25-dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of Alfacalcidoland 1,25-dihydroxyvitamin D are very similar.

Impaired 1α-hydroxylation by the kidneys reduces endogenous 1,25-dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of One-Alpha.

The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of Alfacalcidolis the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment.

5.2 Pharmacokinetic properties

In patients with renal failure, 1-5 µg/day of 1α-hydroxyvitamin D (1α-OHD3) increased intestinal calcium and phosphorus absorption in a dose-related manner. This effect was observed within 3 days of starting the drug and conversely, it was reversed within 3 days of its discontinuation.

In patients with nutritional osteomalacia, increases in calcium absorption were noted within 6 hours of giving 1 µg 1α-OHD3 orally and usually peaked at 24 hours. 1α-OHD3 also produced increases in plasma inorganic phosphorus due to increased intestinal absorption and renal tubular re-absorption. This latter effect is a result of PTH suppression by 1α-OHD3. The effect of the drug on calcium was about double its effect on phosphorus absorption.

Patients with chronic renal failure have shown increased serum calcium levels within 5 days of receiving 1α-OHD3 in a dose of 0.5 – 1.0 µg/day. As serum calcium rose, PTH levels and alkaline phosphatase decreased toward normal.

5.3 Preclinical safety data

The non-clinical toxicity of alfacalcidol is attributed to the known vitamin D-effect of calcitriol on calcium homeostasis, which is characterised by hypercalcaemia, hypercalciuria and eventually soft tissue calcification.

Alfacalcidol is not genotoxic.

No specific effects of alfacalcidol on fertility or behaviour of the offspring were noted in rats and rabbits. In terms of embryo-fetal development, fetal toxicity (post-implantation loss, lower litter size and lower pup weight) was observed at doses high enough to cause toxicity in the dams. High doses of vitamin D are known to be teratogenic in experimental animals.

  1. Pharmaceutical particulars

6.1 List of excipients

One-Alpha1 microgram soft capsules: sesame oil, all-rac-α-tocopherol, gelatine, glycerol, potassium sorbate, black iron oxide, red iron oxide.

One-Alpha0.25 microgram soft capsules: sesame oil, all-rac-α-tocopherol, gelatin, glycerol, potassium sorbate, titanium dioxide.

One-Alpha0.5 microgram soft capsules: sesame oil, all-rac-α-tocopherol, gelatin, glycerol, potassium sorbate, red iron oxide, titanium dioxide.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Alfacalcidol1 microgram soft capsules: 3 years

Alfacalcidol0.25 microgram soft capsules: 3 years

Alfacalcidol0.5 microgram soft capsules: 3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.

6.6 Special precautions for disposal and other handling

None.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Alfacalcidol Capsules 1mcg/0.25mcg/0.5mcg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • In this leaflet Alfacalcidol Capsules soft capsules will be called Alfacalcidol Capsules.

What is in this leaflet

  1. What Alfacalcidol Capsules is and what it is used for
  2. What you need to know before you take Alfacalcidol Capsules
  3. How to take Alfacalcidol Capsules
  4. Possible side effects
  5. How to store Alfacalcidol Capsules
  6. Contents of the pack and other information

 

  1. What Alfacalcidol Capsules is and what it is used for

Alfacalcidol Capsules contains the active substance alfacalcidol.

Alfacalcidol Capsules 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 Capsules 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 Capsules 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.

° The glands may make the amount of calcium in your blood too high (hyperparathyroidism).

  • Low levels of calcium in the blood of newborn babies
  • Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia).
  1. What you need to know before you take Alfacalcidol Capsules

Do not take Alfacalcidol Capsules

  • If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients. You can find a list of these ingredients in section 6 of this leaflet.
  • 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 Capsules.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Alfacalcidol Capsules

  • If you are taking any of the medicines in the ‘Taking other medicines” section below.
  • If you have any problems with your kidneys. This includes if you have kidney stones.
  • If you have granulomas or sarcoidosis. You may be more sensitive to Alfacalcidol Capsules.

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 may need to change your dose.

While you are taking Alfacalcidol Capsules 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 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 Capsules. 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 Capsules. This is to maintain the right amount of calcium in your blood.

Other medicines and Alfacalcidol Capsules

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.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • Anticonvulsants (for example, barbiturates, phenytoin, carbamazepine or primidone): for epilepsy or fits. You may need a larger dose of Alfacalcidol Capsules.
  • 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.
  • Calcium-containing medicines. You may get too much calcium in your blood.
  • Other medicines that contain vitamin D. You may get too much calcium in your blood.
  • Antacids containing magnesium: for heartburn or indigestion. You may get too much magnesium in your blood.
  • Medicines containing aluminium. Too much aluminium is toxic.
  • Bile acid sequestrants such as cholestyramine: for lowering your cholesterol level, or to help stop some types of diarrhoea or itching. Your Alfacalcidol Capsules may not enter your blood as usual.

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, for example dizziness, that may stop you from driving or using machines.

Important information about some of the ingredients of Alfacalcidol Capsules

Alfacalcidol Capsules contains:

  • Sesame oil. This may rarely cause severe allergic reactions.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

  1. How to take Alfacalcidol Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How to take the capsule out of the blister

Press on the shiny side of the blister. The capsule will come out through the printed side of the foil. Please see the diagram.

How much Alfacalcidol Capsules to take

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 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 children weighing more than 20 kilograms:

The usual starting dose is 1 microgram each day. This is either 1 brown capsule, 2 red capsules or 4 white capsules.

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. This is usually one white capsule, or one red capsule or one brown capsule.

If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 micrograms each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as Alfacalcidol Capsules. 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. This is either 1 red capsule or 2 white capsules.

Children:

The dose depends on the weight of the child (called bodyweight).

  • Newborn and premature babies:

The usual starting dose is 0.05 to 0.1 microgram per kilogram of bodyweight each day.

If the level of calcium in their blood is very low, up to

2 micrograms per kilogram of bodyweight may be needed each day.

A dose of 0.1 microgram per kilogram bodyweight each day is used to stop low blood calcium levels in premature babies.

  • Children weighing less than 20 kilograms:

The usual starting dose is 0.05 microgram per kilogram bodyweight each day.

If you take more Alfacalcidol Capsules 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 Capsules

If you forget to take your medicine, take it as soon as you remember. Then take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

  1. 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.

You should 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. These side effects may affect up to 1 in 10 people:

  • You feel weak or have pain in your muscles or bones
  • You need to pass water (urine) more often
  • You feel thirsty
  • You feel fatigue
  • You feel sick, vomit, have constipation or have lost your appetite
  • You are sweating a lot
  • You are having headaches
  • You feel confused
  • You feel drowsy.

You should 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):

  • Kidney problems:
    • 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.

Other possible side effects which may affect up to 1 in 10 people are:

  • Abdominal/stomach pain or discomfort
  • Rash

Uncommon possible side effects which may affect up to 1 in 100 people are:

  • Headache
  • Diarrhoea, vomiting, constipation, nausea
  • Muscle pain
  • Fatigue
  • Calcinosis (deposits of calcium in the body)
  • Feeling weak or unwell.

Rare possible side effects which may affect up to 1 in 1,000 people are:

Side effects with unknown frequency (cannot be estimated from the available data):

  • Confusion
  • Hives (urticaria).

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.

By reporting side affects you can help provide more information on the safety of this medicine.

  1. How to store Alfacalcidol Capsules
  • Keep out of the sight and reach of children.
  • Do not take this medicine after the expiry date which is stated on the carton and foil blister (EXP). The expiry date refers to the last day of that month.
  • Do not store above 25°C.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Alfacalcidol Capsules contains

The active ingredient is alfacalcidol.

  • Alfacalcidol Capsules 0.25 microgram soft capsules contain

0.25 microgram of alfacalcidol in each capsule. Alfacalcidol Capsules 0.5 microgram soft capsules contain

0.5 microgram of alfacalcidol in each capsule. Alfacalcidol Capsules 1 microgram soft capsules contain 1 microgram of alfacalcidol in each capsule.

  • The other ingredients are sesame oil, all-rac--tocopherol, gelatin, glycerol, and potassium sorbate.

The 0.25 microgram capsules also contain titanium dioxide.

The 0.5 microgram capsules also contain titanium dioxide and red iron oxide.

The 1 microgram capsules also contain black iron oxide and red iron oxide.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com