Alfadiol

Package Leaflet: Information for the Patient

ALFADIOL, 0.25 micrograms, soft capsules

ALFADIOL, 1 microgram, soft capsules

Alfacalcidol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Alfadiol and what is it used for
• 2. Important information before taking Alfadiol
• 3. How to take Alfadiol
• 4. Possible side effects
• 5. How to store Alfadiol
• 6. Contents of the pack and other information

1. What is Alfadiol and what is it used for

Alfadiol contains the active substance alfacalcidol, which is a synthetic derivative of vitamin D.
It facilitates the absorption of calcium from the gastrointestinal tract and its incorporation into bone tissue.
Too little vitamin D in food and insufficient calcium intake can cause rickets in children and softening of the bones (osteomalacia) or increased susceptibility to fractures in adults.
Deficiencies of vitamin D and calcium occur in postmenopausal women, the elderly, and people with certain kidney diseases, leading to the development of osteoporosis.
To achieve full biological activity, vitamin D must undergo chemical transformations in the human body to alfacalcidol in the kidneys and then to calcitriol in the liver.
In some kidney diseases, these transformations are difficult or even impossible, and therefore patients with these diseases suffer from disturbances in calcium and phosphate metabolism.
Alfadiol is intended for use under medical supervision, especially in this group of patients.

Indications for use of Alfadiol:

• postmenopausal osteoporosis and senile osteoporosis with concurrent vitamin D deficiency or its active metabolites,
• low blood calcium levels (hypocalcemia), especially in patients with diseases leading to impaired hydroxylation of vitamin D in the kidneys,
• rickets and softening of the bones (osteomalacia) resistant to vitamin D,
• hypoparathyroidism,
• renal osteodystrophy (renal rickets causing bone disorders),
• calcium metabolism disorders in patients with chronic renal failure,
• nephrotic syndrome in children after long-term treatment with glucocorticoids.

2. Important information before taking Alfadiol

When not to take Alfadiol

Do not take the medicine if you have:

• hypersensitivity to alfacalcidol or any of the other ingredients of this medicine (listed in section 6),
• hypersensitivity to peanuts or soybeans,
• high blood calcium levels (hypercalcemia), metastatic calcification,
• high blood phosphate levels (hyperphosphatemia) - (except in cases of hypoparathyroidism),
• high blood magnesium levels (hypermagnesemia),
• idiopathic hypercalciuria (excretion of calcium in the urine),
• softening of the bones due to aluminum poisoning (osteomalacia),
• vitamin D overdose and poisoning,
• kidney stones (calcium deposits in the urinary system),
• severe liver dysfunction.

Warnings and precautions

Before starting treatment with Alfadiol, discuss it with your doctor or pharmacist.

• During treatment with this medicine, there may be an excessive increase in blood calcium or phosphate levels, especially in patients with kidney function disorders. Therefore, the doctor will prescribe control of calcium levels - initially 1 to 2 times a week, and after establishing the dose of the medicine - 1 time a month.
• Caution should be exercised when using the medicine in patients with renal failure and kidney stones.
• Treatment of renal osteodystrophy with Alfadiol requires systematic control of parathyroid hormone (PTH) levels in the blood - due to the risk of developing adynamic bone disease, which is a disorder of bone metabolism.
• In patients with high blood calcium levels in the course of renal osteodystrophy, autonomous hyperparathyroidism may occur. These patients may not respond to this medicine.
• Patients with renal failure, tertiary hyperparathyroidism, or regular hemodialysis (potential decrease in phosphate levels) are particularly prone to excessive increases in blood calcium levels. Early symptoms of excessive calcium levels include: polyuria, increased thirst, weakness, headaches, nausea, dry mouth, constipation, muscle pain, bone pain, and a metallic taste in the mouth.
• Depending on the patient's condition and risk factors, the doctor may prescribe periodic (every 1-3 months) blood tests (measurement of nitrogen in the blood, creatinine, alkaline phosphatase, phosphate levels in the blood) and urine tests (daily excretion of calcium in the urine and the calcium-creatinine ratio).
• In patients using a low-calcium diet, the response to Alfadiol may be reduced or may not occur at all.
• Caution should be exercised in patients treated with digitalis glycosides, such as foxglove, as hypercalcemia can lead to heart rhythm disorders in these patients.
• In elderly patients, there may be a need to use lower doses of Alfadiol.

Alfadiol and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines with Alfadiol:

• digitalis glycosides(medicines used to treat heart failure) - due to the risk of their overdose,
• thiazide diuretics(medicines that increase urine production, such as hydrochlorothiazide),
• calcium-containing medicinestaken regularly in a daily dose above 1.5 g - due to the risk of increased blood calcium levels,
• antacids- due to the risk of increased blood calcium levels,
• estrogen-containing medicines, as they may enhance the effect of Alfadiol,
• antacids containing magnesium salts, as they may lead to increased blood magnesium levels,
• antacids containing aluminum salts, as they may cause decreased blood magnesium levels,
• hydantoin derivatives(e.g., phenytoin), barbiturates, primidone, and other antiepileptic medicines(used to treat epilepsy), as they may weaken the effect of Alfadiol,
• glucocorticoids(steroids, used to treat, among other things, rheumatic diseases), as they weaken the effect of Alfadiol,
• salicylates, as they may weaken the effect of Alfadiol,
• cholestyramine, colestipol(medicines that lower blood cholesterol levels) and paraffin oil, as they inhibit the absorption of Alfadiol,
• medicines and dietary supplements containing metal ions.

Alfadiol with food and drink

When taking Alfadiol, do not consume large amounts of dairy products (milk and its products), as they may cause an increase in blood calcium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Alfadiol can be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Alfadiol should not be used during breastfeeding. It cannot be excluded that the medicine has an unfavorable effect on the breastfed infant.

Driving and using machines

There are no data indicating that alfacalcidol has an unfavorable effect on the ability to drive vehicles and operate machines.

Alfadiol contains purified arachis oil, cochineal red, ethyl parahydroxybenzoate, and sodium

• The medicine contains arachis oil (from peanuts). Do not use in case of known hypersensitivity to peanuts or soybeans (see section "When not to take Alfadiol").
• The medicine contains cochineal red (E124), a dye that may cause allergic reactions.
• The medicine contains ethyl parahydroxybenzoate (E214), which may cause allergic reactions (possible late reactions).
• The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., the medicine is considered "sodium-free).

3. How to take Alfadiol

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor.
The dosage and duration of treatment are determined by the doctor, depending on the patient's age and condition.

Children with a body weight below 20 kg

Children with a body weight between 20 and 40 kg

Adults (with a body weight above 40 kg)

Dose of the medicine

Indication for use

• postmenopausal osteoporosis
• senile osteoporosis 0.5 micrograms to 1 microgram 1 time a day
• -
• -

0.25 micrograms
1 time a day
0.25 micrograms
to
0.5 micrograms
1 time a day

• nephrotic syndrome in children after long-term treatment with glucocorticoids
• -

0.25 micrograms
1 time a day
0.25 micrograms
to
0.5 micrograms
1 time a day
0.5 micrograms
to 1 microgram
1 time a day

• hypocalcemia
• rickets and softening of the bones (osteomalacia) resistant to vitamin D
• hypoparathyroidism
• calcium metabolism disorders in patients with chronic renal failure and renal osteodystrophy

The doctor may determine the dosage based on the results of blood tests (measurement of calcium levels in the blood) or urine tests (excretion of calcium in the urine) and on the basis of daily calcium intake.

Taking a higher dose of Alfadiol than recommended

If you have taken a dose of the medicine higher than recommended, contact your doctor or pharmacist immediately.
Symptoms of vitamin D overdose are:

• increased blood calcium levels (hypercalcemia),
• loss of appetite, weakness,
• nausea, vomiting, diarrhea,
• excretion of large amounts of urine (polyuria),
• excessive sweating,
• thirst,
• headache, dizziness.

After significant overdose, bordering on poisoning, bone pain, ectopic calcification (calcium deposits in atypical locations), proteinuria (presence of protein in the urine), hypertension, and heart rhythm disorders may occur.
Furthermore, prolonged overdose of vitamin D may cause generalized calcification of blood vessels and kidneys, as well as rapid deterioration of kidney function.

Missing a dose of Alfadiol

If you miss a dose, take the medicine as soon as possible.
If it is almost time for the next dose, skip the missed dose.
Take the next dose as directed by your doctor.
Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• hypersensitivity reactions (e.g., hypersensitivity in patients with asthma, skin irritation, contact dermatitis, itching, rash, urticaria, eye irritation),
• increased blood calcium levels (hypercalcemia),
• increased blood phosphate levels - especially in patients with renal failure,
• excretion of calcium in the urine (hypercalciuria), polyuria,
• kidney calcification, ectopic calcification (calcium deposits in atypical locations),
• kidney function disorders (as a result of hypercalcemia),
• headache, dizziness, confusion,
• diarrhea, constipation, nausea, vomiting, dry mouth, increased thirst, irritation of mucous membranes, including gastric mucosa, metallic taste in the mouth (as a result of hypercalcemia),
• heart rhythm disorders, muscle pain, bone pain, fatigue (related to hypercalcemia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Alfadiol

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not freeze.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Alfadiol contains

The active substance of the medicine is alfacalcidol.
Each soft capsule contains 0.25 micrograms (μg) or 1 microgram (μg) of alfacalcidol.
The other excipients are: all-rac-α-tocopheryl acetate, butylhydroxytoluene (E321),
purified arachis oil.
The composition of the Alfadiol 0.25 μg capsule shell is: gelatin, glycerol, ethyl parahydroxybenzoate (E214), cochineal red (E124), titanium dioxide (E 171), purified water.
The composition of the Alfadiol 1 μg capsule shell is: gelatin, glycerol, ethyl parahydroxybenzoate (E214), cochineal red (E124), purified water.

What Alfadiol looks like and contents of the pack

Alfadiol 0.25 μg is a soft capsule, spherical in shape, with a non-transparent gelatin shell, red in color, with a seam, completely filled with an oily solution.
Alfadiol 1 μg is a soft capsule, spherical in shape, with a transparent gelatin shell, red in color, with a seam, completely filled with an oily solution.
Packaging: 100 soft capsules - 2 blisters of PVC/PVDC/Aluminum foil, each containing 50 capsules, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Łokietka Street 10

• 98-200 Sieradz

Date of last revision of the leaflet: