ALFACALCIDOLO 1 MICROGRAM Soft capsules

Зміст інструкції

1. ALFACALCIDOLO DOC 1 microgram soft capsules
   1. What is ALFACALCIDOLO DOC and what is it 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

ALFACALCIDOLO DOC 1 microgram soft capsules

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even 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 you take 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 is ALFACALCIDOLO DOC and what is it used for

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

• Altered function of the parathyroid glands caused by renal insufficiency, with resulting bone alterations.
• Low levels of calcium due to reduced function of the parathyroid glands, located in the neck (hypocalcemia due to hypoparathyroidism, post-operative, idiopathic).
• Weakening of the bones after menopause, as an adjunct to specific treatment, when the formation of active vitamin D in the kidney is compromised.

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

• weakening and deformation of the bones due to calcium deficiency caused by altered vitamin D metabolism (Rickets due to pseudo-deficiency (D-dependent))
• vitamin D-resistant hypophosphatemic rickets and osteomalacia.

2. What you need to know before taking ALFACALCIDOLO DOC

Do not take ALFACALCIDOLO DOC

• if you are allergic to alfacalcidol or 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) the symptoms can be fatigue, nausea, vomiting, frequent need to urinate and headache. This means that you have high levels of calcium in your blood.
• if you suffer from hyperphosphataemia (increased phosphate levels in the blood) and hypermagnesaemia (increased magnesium levels in the blood).

If you are not sure whether any of the above conditions apply to you, talk to your doctor before
taking ALFACALCIDOLO DOC.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALFACALCIDOLO DOC.
Because alfacalcidol is an analogue of vitamin D, during treatment with ALFACALCIDOLO DOC
you should not take vitamin D or its derivatives as excessive doses of vitamin D can cause you
serious harm.
Because excessive doses of ALFACALCIDOLO DOC can cause an increase in calcium levels in
the blood and sometimes in the urine, your doctor will ask you to undergo tests to monitor calcium levels in
the blood and to establish the dose of ALFACALCIDOLO DOC suitable for you.
High concentrations of calcium in the blood can in fact cause serious reactions that in some cases may
require emergency therapies. Furthermore, the presence of high concentrations of calcium in the blood for prolonged
periods of time can lead to calcification.
Other symptoms of increased calcium levels in the blood are muscle and bone pain, muscle weakness, confusion dehydration, anorexia, fatigue, nausea, vomiting, constipation, increased
amount of urine produced, sweating, headache, intense thirst, increased blood pressure,
drowsiness.
If you experience an increase in calcium content in the blood, your doctor will tell you to stop the
treatment with ALFACALCIDOLO DOC until the situation normalizes. Afterwards, they may
decide to lower the dose of ALFACALCIDOLO DOC for your treatment.
If you are being treated with digitalis (a drug extracted from a plant that contains substances that stimulate the
heart muscle), your doctor will be cautious when prescribing ALFACALCIDOLO DOC as
the increase in calcium concentrations in the blood resulting from taking ALFACALCIDOLO DOC
can cause heart rhythm disturbances.
If you are taking phosphate-binding substances, your doctor may decide to adjust their dose as
ALFACALCIDOLO DOC affects the transport of phosphates in the intestine, kidney and bones.
Talk to your doctor or pharmacist before taking ALFACALCIDOLO DOC:

• if you are taking any of the medicines in the following section “Other medicines and ALFACALCIDOLO DOC”.
• if you have kidney problems. This includes if you have 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 ALFACALCIDOLO DOC is not recommended in children aged 6 years or less and/or
weighing 20 kg or less in cases of pseudo-deficiency (D-dependent) rickets and vitamin D-resistant hypophosphatemic rickets and osteomalacia).
The use of ALFACALCIDOLO DOC is not recommended in children and adolescents in cases of
altered function of the parathyroid glands caused by renal insufficiency, with resulting
bone alterations; low levels of calcium due to reduced function of the parathyroid glands, a
due to lack of clinical data.
ALFACALCIDOLO DOC is not indicated in children and adolescents as an adjunct to
specific treatment for bone weakening after menopause.

Other medicines and ALFACALCIDOLO DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
If you take other medicines while taking ALFACALCIDOLO DOC, the therapeutic action may be
affected.
In particular, taking ALFACALCIDOLO DOC together with the following medicines is not recommended:

• Thiazide diuretics (medicines used to increase urine production). These medicines can cause an increase in calcium levels in the blood.
• Medicines and supplements containing vitamin D. They can increase calcium levels in the blood.
• Medicines and supplements containing calcium. They can increase calcium levels in the blood.
• Anticonvulsants such as barbiturates, phenytoin, carbamazepine or primidone (medicines used to treat seizures and epilepsy). These medicines can reduce your body's response to taking ALFACALCIDOLO DOC, resulting in the need to increase your dose.
• Antacids and magnesium-based laxatives. Taking them at the same time with ALFACALCIDOLO DOC can cause an increase in magnesium levels in the blood.
• Preparations containing aluminum as the simultaneous administration of ALFACALCIDOLO DOC can cause an increase in aluminum levels in the blood.
• Cholestyramine (medicine used to lower cholesterol levels in the blood) and orlistat (medicine used to treat obesity) as they can reduce the intestinal absorption of ALFACALCIDOLO DOC.
• Digitalis (medicine used for heart problems). This association should be carefully monitored.
• Rifampicin and isoniazid. This association can reduce the effectiveness of vitamin D.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
ALFACALCIDOLO DOC is not recommended during pregnancy due to lack of clinical data.

Breastfeeding
Alfacalcidol is excreted in human milk. The doctor will decide whether to stop breastfeeding or
stop therapy with ALFACALCIDOLO DOC taking into account the benefit
of breastfeeding for the baby and the benefit of therapy for you.
The doctor will carefully monitor the breastfed baby during your treatment with
ALFACALCIDOLO DOC.

Driving and operating machinery
ALFACALCIDOLO DOC does not alter or negligibly alters the ability to drive vehicles and operate
machinery. However, you may experience dizziness during treatment with ALFACALCIDOLO DOC.

3. How to take ALFACALCIDOLO DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
During the entire treatment period, your doctor will ask you to undergo blood tests and
regular check-ups.

Adults (all indications)
The recommended initial dose is 1 capsule per day (equivalent to 1 microgram) for all indications.
The maintenance dose depends on the results obtained with therapy and the laboratory tests that your
doctor will ask you to undergo during treatment.
In patients with hypoparathyroidism and severe hypocalcemia, the doctor may increase the dose to 3 capsules per day
(equivalent to 3 micrograms per day). In such patients, the doctor may also prescribe other medicines
containing calcium.
In any case, the recommended dose may be modified by the doctor based on your response to the
medicine.
Other pharmaceutical forms and dosages of alfacalcidol are available in cases where a dose
lower than 1 microgram is necessary or for children who cannot swallow the capsules.

Use in children and adolescents:
In case of pseudo-deficiency (D-dependent) rickets and vitamin D-resistant hypophosphatemic rickets, the initial dose is 1 capsule per day, which may be reduced at the doctor's discretion. The maintenance dose depends on the results obtained with therapy and the laboratory tests that the doctor will ask you to undergo
during treatment.
For this indication, the use of ALFACALCIDOLO DOC is not recommended in children aged 6 years or
under and/or weighing 20 Kg or less.
Small children may not be able to swallow the capsule, so 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 the lack of clinical data.

Method of administration
Oral use

If you take more ALFACALCIDOLO DOC than you should
In case of accidental intake/ingestion of an excessive dose of ALFACALCIDOLO DOC, immediately
inform your doctor or go to the nearest hospital.

If you forget to take ALFACALCIDOLO DOC
Do not take a double dose to make up for a missed dose.

If you stop taking ALFACALCIDOLO DOC
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, which may be due to an excessive amount of calcium
(hypercalcemia) or phosphate in the blood (hyperphosphoremia) immediately stopusing
ALFACALCIDOLO DOC and consult your doctor or the nearest hospital where you will undergo
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, are constipated or have lost your appetite
• You are sweating a lot
• You have a headache
• You feel confused
• You feel sleepy
• You have a dry mouth or a metallic taste in your 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 (hyperphosphataemia)
• increased levels of calcium in the urine (hypercalciuria)
• abdominal pain and discomfort
• skin rash (various types of rash have been reported such as erythematous, maculo-papular and pustular)
• 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
• formation of calcium deposits in the tissues (calcinosis) rare (may affect up to 1 in 1,000 people)
• dizziness frequency not known (the frequency cannot be estimated from available data)
• kidney damage (including acute renal failure)
• confusional state
• urticaria

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at 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 ALFACALCIDOLO 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 the 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 any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALFACALCIDOLO DOC contains
The active ingredient is alfacalcidol (1 α-hydroxy vitamin D3). Each soft capsule contains 1 microgram of
alfacalcidol.
The other ingredients (excipients) are: Butylated hydroxyanisole, Butylated hydroxytoluene, Glycerol, Gelatin,
Red iron oxide (E172), Black iron oxide (E172), Medium chain triglycerides.

Description of the appearance of ALFACALCIDOLO DOC and contents of the pack
ALFACALCIDOLO DOC is presented as opaque brown soft gelatin capsules, oval in shape,
containing a colorless 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 ingredient.
Blisters (PVC/PVDC and aluminum). Packs of 30 soft capsules.
Not all pack sizes may be 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