Alfacalcidol Doc Generici

Patient information leaflet

ALFACALCIDOLO DOC 1 microgram capsule, soft

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ALFACALCIDOLO DOC is and what it is used for

ALFACALCIDOLO DOC contains alfacalcidol, a vitamin D analogue.
ALFACALCIDOLO DOC works by increasing the amount of vitamin D in your body. This means that
the levels of calcium and phosphate in your body will also increase.
ALFACALCIDOLO DOC is indicated in adults for the treatment of:

• Impaired function of the parathyroid glands caused by kidney failure, leading to bone abnormalities.
• Low calcium levels due to reduced function of the parathyroid glands in the neck (hypocalcaemia due to hypoparathyroidism, postoperative or idiopathic).
• Bone weakening after menopause, as an adjunct to specific treatment, when the production of active vitamin D in the kidney is impaired.

ALFACALCIDOLO DOC is indicated in adults, adolescents and children above 6 years of age and with
a body weight greater than 20 kg:

• Bone weakening and deformities due to calcium deficiency caused by impaired vitamin D metabolism (Pseudo-deficiency rickets (vitamin D-dependent)).
• Vitamin D-resistant hypophosphataemic rickets and osteomalacia.

2. What you need to know before taking ALFACALCIDOL DOC

Do not take ALFACALCIDOL DOC

• if you are allergic to alfacalcidol or to any of the other ingredients of this medicine (listed in section 6).
• if you have signs of vitamin D toxicity.
• if you have high levels of calcium in your blood (hypercalcemia); symptoms may include tiredness, nausea, vomiting, frequent need to urinate, and headache. This means you have high levels of calcium in your blood.
• if you suffer from hyperphosphatemia (increased level of phosphate in the blood) or hypermagnesemia (increased level of magnesium in the blood).

If you are unsure whether any of the above conditions apply to you, talk to your doctor before taking ALFACALCIDOL DOC.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALFACALCIDOL DOC.
Since alfacalcidol is a vitamin D analogue, you must not take vitamin D or its derivatives during treatment with ALFACALCIDOL DOC, as excessive doses of vitamin D may cause serious harm.
Because excessive doses of ALFACALCIDOL DOC may increase calcium levels in the blood and sometimes in the urine, your doctor will request regular tests to monitor your blood calcium levels and determine the appropriate dose of ALFACALCIDOL DOC for you.
Elevated calcium levels in the blood may indeed cause serious reactions, which in some cases may require emergency treatment. Moreover, prolonged high calcium levels in the blood may lead to calcification phenomena.
Other symptoms of increased calcium levels in the blood include muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea, vomiting, constipation, increased urine output, sweating, headache, intense thirst, increased blood pressure, and drowsiness.
If you experience elevated calcium levels in your blood, your doctor will instruct you to stop treatment with ALFACALCIDOL DOC until levels return to normal. Afterwards, your doctor may decide to reduce your dose of ALFACALCIDOL DOC.
If you are being treated with digitalis (a plant-derived drug containing substances that stimulate the heart muscle), your doctor will exercise caution when prescribing ALFACALCIDOL DOC, as increased calcium levels resulting from ALFACALCIDOL DOC intake may cause disturbances in heart rhythm.
If you are taking phosphate binders, your doctor may adjust their dosage, as ALFACALCIDOL DOC affects phosphate transport in the intestine, kidney, and bones.
Talk to your doctor or pharmacist before taking ALFACALCIDOL DOC:

• if you are taking any of the medicines listed in the section below “Other medicines and ALFACALCIDOL DOC”.
• if you have kidney problems, including kidney stones.
• if you have granulomatous diseases such as sarcoidosis. You may be more sensitive to alfacalcidol.
• if you suffer from atherosclerosis (a condition in which the inside of the artery narrows).

Children and adolescents
The use of ALFACALCIDOL DOC is not recommended in children aged 6 years or younger and/or weighing 20 kg or less in cases of pseudovitamin D-deficiency rickets and vitamin D-resistant hypophosphatemic rickets and osteomalacia.
The use of ALFACALCIDOL DOC is not recommended in children and adolescents with impaired parathyroid gland function due to renal insufficiency, resulting in bone abnormalities, or with low calcium levels due to reduced parathyroid gland function, due to lack of clinical data.
ALFACALCIDOL DOC is not indicated in children and adolescents as an adjunct to specific treatment for postmenopausal bone weakening.
Other medicines and ALFACALCIDOL DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take other medicines while taking ALFACALCIDOL DOC, their therapeutic effects may be affected.
In particular, concomitant use of ALFACALCIDOL DOC with the following medicines is not recommended:

• Thiazide diuretics (medicines used to increase urine production). These medicines may increase calcium levels in the blood.
• Medicines and supplements containing vitamin D. These may increase calcium levels in the blood.
• Medicines and supplements containing calcium. These may increase calcium levels in the blood.
• Anticonvulsants such as barbiturates, phenytoin, carbamazepine, or primidone (medicines used to treat seizures and epilepsy). These medicines may reduce your body’s response to ALFACALCIDOL DOC, potentially requiring a higher dose.
• Magnesium-based antacids and laxatives. Concurrent use with ALFACALCIDOL DOC may increase magnesium levels in the blood.
• Aluminum-containing preparations, as concomitant administration with ALFACALCIDOL DOC may increase aluminum levels in the blood.
• Cholestyramine (a medicine used to lower blood cholesterol levels) and orlistat (a medicine used to treat obesity), as they may reduce intestinal absorption of ALFACALCIDOL DOC.
• Digitalis (a medicine used for heart problems). This combination must be closely monitored.
• Rifampicin and isoniazid. This combination may reduce the effectiveness of vitamin D.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
ALFACALCIDOL DOC is not recommended during pregnancy due to lack of clinical data.
Breastfeeding
Alfacalcidol is excreted in human milk. Your doctor will decide whether you should stop breastfeeding or stop treatment with ALFACALCIDOL DOC, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.
Your doctor will closely monitor the breastfed infant during your treatment with ALFACALCIDOL DOC.
Driving and using machines
ALFACALCIDOL DOC does not affect or affects negligibly the ability to drive vehicles and use machinery. However, you may experience dizziness during treatment with ALFACALCIDOL DOC.

3. How to take ALFACALCIDOLO DOC

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Throughout the entire treatment period, your doctor will request that you undergo regular blood tests and
check-ups.
Adults (all indications)
The recommended starting dose is 1 capsule daily (equivalent to 1 microgram) for all indications.
The maintenance dose depends on the results achieved with therapy and on laboratory tests that your
doctor will request during treatment.
In patients with hypoparathyroidism and severe hypocalcemia, your doctor may increase the dose to 3 capsules daily
(equivalent to 3 micrograms per day). In such patients, your doctor may also prescribe other medications
containing calcium.
In any case, the recommended dose may be adjusted by your doctor according to your response to
the medicine.
Other pharmaceutical forms and dosage strengths of alfacalcidol are available for cases requiring a dose
lower than 1 microgram or for children unable to swallow capsules.
Use in children and adolescents:
In cases of vitamin D-dependent rickets (pseudo-deficiency rickets) and vitamin D-resistant hypophosphatemic rickets, the initial dose is 1 capsule daily, which may be reduced at the doctor's discretion. The maintenance dose depends on the results achieved with therapy and on laboratory tests that your doctor will request during treatment.
For this indication, the use of ALFACALCIDOLO DOC is not recommended in children aged 6 years or younger and/or weighing 20 kg or less.
Young children may be unable to swallow the capsule; therefore, other appropriate pharmaceutical forms should be considered.
The use of ALFACALCIDOLO DOC is not recommended in children and adolescents for all other
indications due to lack of clinical data.
Method of administration
Oral use
If you take more ALFACALCIDOLO DOC than you should
In case of accidental overdose or ingestion of an excessive dose of ALFACALCIDOLO DOC, contact your
doctor immediately or go to the nearest hospital.
If you forget to take ALFACALCIDOLO DOC
Do not take a double dose to make up for the missed dose.
If you stop treatment with ALFACALCIDOLO DOC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, which could be due to excessive calcium
(hypercalcemia) or phosphate in the blood (hyperphosphatemia), stop taking ALFACALCIDOL DOC immediately and contact your doctor or go to the nearest hospital, where you will be given appropriate and specific treatment:

• You feel weak or have muscle or bone pain
• You need to urinate more often
• You feel thirsty
• You feel tired (fatigued)
• You feel nauseous, vomit, have constipation or have lost your appetite
• You are sweating heavily
• You have a headache
• You feel confused
• You feel drowsy
• You have a dry mouth or a metallic taste in the mouth

The possible side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• High levels of calcium in the blood (hypercalcemia)
• High levels of phosphate in the blood (hyperphosphatemia)
• Increased levels of calcium in the urine (hypercalciuria)
• Abdominal pain and discomfort
• Skin rash (various types of rash have been reported, such as erythematous, maculopapular and pustular rash)
• Itching

Uncommon (may affect up to 1 in 100 people)

• Headache
• Diarrhoea
• Vomiting
• Constipation
• Nausea
• Muscle pain (myalgia)
• Kidney stones (nephrolithiasis)/nephrocalcinosis (formation of calcium deposits in the kidneys)
• Fatigue/weakness/malaise
• Calcium deposits in tissues (calcification)

Rare (may affect up to 1 in 1,000 people)

• Dizziness

Frequency not known (frequency cannot be estimated from the available data)

• Kidney damage (including acute kidney failure)
• Confusional state
• Hives (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALFACALCIDOL DOC

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and packaging after "EXP". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ALFACALCIDOL DOC contains
The active substance is alfacalcidol (1α-hydroxy vitamin D3). Each soft capsule contains 1 microgram of
alfacalcidol.
The other components (excipients) are: Butylated hydroxyanisole, butylated hydroxytoluene, Glycerol, Gelatin,
Iron oxide red (E172), Iron oxide black (E172), Medium-chain triglycerides.
Description of the appearance of ALFACALCIDOL DOC and contents of the pack
ALFACALCIDOL DOC is presented as opaque brown, oval-shaped soft gelatin capsules containing a colourless transparent liquid. The size is approximately 9.5 ± 1 mm in length x 5.5 ± 1 mm in width.
It is available in packs of 30 capsules containing 1 microgram of active substance.
Blister (PVC/PVDC and aluminium). Packs of 30 soft capsules.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy
Manufacturers
Qualimetrix S.A.
579 Mesogeion Avenue, Agia Paraskevi, 15343 Athens, Greece