CALCITRIOLO 0.25 MICROGRAMS Soft capsules

Зміст інструкції

1. CALCITRIOLO DOC Generici
2. Calcitriolo
   1. WHAT IS CALCITRIOLO DOC Generici AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOLO DOC Generici
   3. HOW TO TAKE CALCITRIOLO DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CALCITRIOLO DOC Generici
   6. PACKAGE CONTENTS AND OTHER INFORMATION

CALCITRIOLO DOC Generici

0.25 micrograms soft capsules
0.50 micrograms soft capsules

Calcitriolo

Equivalent medicine
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 or pharmacist.
• 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 may 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 CALCITRIOLO DOC Generici is and what it is used for
• 2. What you need to know before you take CALCITRIOLO DOC Generici
• 3. How to take CALCITRIOLO DOC Generici
• 4. Possible side effects
• 5. How to store CALCITRIOLO DOC Generici
• 6. Contents of the pack and other information

1. WHAT IS CALCITRIOLO DOC Generici AND WHAT IT IS USED FOR

CALCITRIOLO DOC Generici contains calcitriol, the active metabolite of vitamin D, necessary for
bone formation.
CALCITRIOLO DOC Generici is indicated:

• to treat a bone disease that occurs in the presence of chronic kidney disease (renal osteodystrophy), especially if undergoing hemodialysis (a blood filtration method)
• to treat diseases related to reduced function of the parathyroid glands, glands located in the neck (hypoparathyroidism, pseudohypoparathyroidism) that secrete PTH (parathyroid hormone) i.e. the hormone that regulates calcium metabolism
• to treat rickets: a disease characterized by a defect in the formation and development of bones (vitamin D-resistant hypophosphatemic rickets, vitamin D-dependent rickets).
• to treat a disease related to increased function of the parathyroid glands caused by chronic kidney disease from moderate to severe, not treated with dialysis (Secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency in pre-dialysis).
• Furthermore CALCITRIOLO DOC Generici is indicated in women with confirmed menopause:
• to treat a disease that weakens the bones and increases the risk of developing bone fractures (post-menopausal osteoporosis).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOLO DOC Generici

Do not take CALCITRIOLO DOC Generici

• if you are allergic to calcitriol or similar medicines or to any of the other ingredients of this medicine (listed in section 6);
• - if you suffer from a disease caused by increased levels of calcium in the blood (hypercalcemia);
• in the presence of signs of vitamin D toxicity.

Warnings and precautions
Talk to your doctor or pharmacist before taking CALCITRIOLO DOC Generici.
In particular, tell your doctor:

• if you have reduced kidney function (renal insufficiency), as in this case the risk of calcium accumulation in areas of the body where it is not needed (ectopic calcification) increases
• if you are immobilized, for example if you have undergone surgery, as in this case the risk of hypercalcemia (increased calcium in the blood) increases
• if you suffer from a bone formation defect (rickets with hypophosphatemia resistant to vitamin D), and are being treated with medicines containing phosphate
• if you are already being treated with ergocalciferol (see section “Other medicines and CALCITRIOLO DOC Generici”).

Control of calcium and phosphate levels in the blood
There is a close relationship between treatment with this medicine and an increase in calcium and phosphate levels
in the blood. Therefore:

• during treatment with CALCITRIOLO DOC Generici, follow the diet prescribed by your doctor to avoid an increase in calcium and phosphate levels in the blood (see section “CALCITRIOLO DOC Generici with food and drinks”)
• before and during therapy, your doctor will ask you to undergo blood tests to check calcium and creatinine levels (a protein used to assess kidney function). If these are too high, your doctor will instruct you to immediately stop treatment until calcium levels return to normal (see section “Possible side effects”)
• the doctor will check phosphate levels in the blood
• the doctor will instruct you to recognize any symptoms of an increase in calcium and phosphate in the blood.

If you are postmenopausal and suffer from osteoporosis
If you are postmenopausal and this medicine has been prescribed to you to treat osteoporosis, your doctor will carefully monitor
your kidney function and calcium levels in the blood before starting therapy and at
regular intervals during treatment.
Dehydration
If you do not suffer from kidney disorders, your doctor will advise you to drink plenty of water during therapy with
this medicine to avoid dehydration (excessive fluid loss from the body).
Elderly
No dosage adjustments are necessary in elderly patients.
Children and adolescents
CALCITRIOLO DOC Generici should not be given to children and adolescents because the safety
and efficacy of the medicine in this patient group has not been sufficiently studied to allow
recommendations on dosage.

Other medicines and CALCITRIOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are using:

• medicines or other preparations based on vitamin D, including calcium supplements. Do not take any other vitamin D preparation during treatment with CALCITRIOLO DOC Generici (see also “CALCITRIOLO DOC Generici with food and drinks”)
• ergocalciferol (vitamin D2) as this may cause an excessive increase in calcium levels in the blood. In this case, your doctor will prescribe CALCITRIOLO DOC Generici only when ergocalciferol levels in the blood are adequate. It may take several months for the amount of ergocalciferol in the blood to return to normal levels
• thiazide diuretics (medicines to treat high blood pressure), as this increases the risk of hypercalcemia (increased calcium in the blood)
• digoxin (medicine to treat heart rhythm disorders), to avoid arrhythmias (irregular heartbeats) - corticosteroids (medicines to treat inflammation)
• medicines containing magnesium (e.g. antacids). Avoid taking these medicines during therapy with CALCITRIOLO DOC Generici if you are on dialysis
• medicines used to reduce phosphate absorption; in the case of vitamin D-resistant hypophosphatemic rickets or reduced kidney function (renal insufficiency), your doctor will continue oral phosphate therapy
• medicines that increase liver activity such as phenytoin (for treating epilepsy) or phenobarbital (a barbiturate)
• medicines to lower blood fat levels, such as bile acid sequestrants, including colestyramine and sevelamer

CALCITRIOLO DOC Generici with food and drinks
Carefully follow the diet prescribed by your doctor.
Consider the total dose of vitamin D when taking other products that already contain vitamin D (for
example dairy products or preparations containing calcium).
Always drink an adequate amount of fluids

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe this medicine only if the benefits for you outweigh the potential risk
to the fetus.
Breastfeeding
CALCITRIOLO DOC Generici will be prescribed during breastfeeding provided that calcium levels
in you and the infant are monitored and are normal

Driving and operating machinery
It is unlikely that CALCITRIOLO DOC Generici will impair the ability to drive vehicles or operate
machinery.

CALCITRIOLO DOC Generici contains sorbitol
This medicine contains up to 12 mg of sorbitol per 0.25 microgram soft capsule.
This medicine contains up to 16.5 mg of sorbitol per 0.50 microgram soft capsule.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to some
sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which
patients cannot metabolize fructose, talk to your doctor before you (or your child) take
this medicine.

CALCITRIOLO DOC Generici contains sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate.
They can cause allergic reactions (including delayed reactions).

3. HOW TO TAKE CALCITRIOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The dose will be established by the doctor based on your weight and your state of health. The doctor will also
subject you to frequent blood tests at the beginning of treatment to establish the most suitable dose for you and
during treatment to check the calcium levels in the blood (calcemia).

Bone disease caused by kidney disease in patients undergoing dialysis (renal osteodystrophy):
The effectiveness of treatment is conditional on the simultaneous intake of calcium: in adults, it is
necessary to ensure a supplementary intake of 600-1000 mg of calcium per day.

• the recommended starting dose is 0.25 micrograms per day
• if you have normal calcium levels in the blood or only slightly reduced, the recommended starting dose is 0.25 micrograms every 2 days
• if no improvements are observed after 2-4 weeks, the doctor may increase the dose by 0.25 micrograms per day at intervals of 2-4 weeks.
• during treatment, the doctor will adjust the dose between 0.5 micrograms and 1 microgram per day

If you suffer from a disease related to increased functionality of the parathyroid glands ( Hyperparathyroidism

secondary) in patients with moderate to severe renal failure in pre-dialysis ):

• The recommended starting dose is 0.25 mcg/day in adults.
• If necessary, the dose may be increased to 0.5 mcg/day.

If you suffer from a disease related to reduced functionality of the parathyroid glands (hypoparathyroidism) or if you suffer

from rickets:

• the recommended dose is 0.25 micrograms per day, to be taken in the morning
• if there are no improvements, the doctor may increase the dose every 2-4 weeks.

Postmenopausal women

If you suffer from a disease that weakens the bones and increases the risk of developing bone fractures

(established postmenopausal osteoporosis):

• the recommended starting dose is 0.25 micrograms twice a day
• if calcium levels do not show significant changes, the doctor will not change your dose. In this case, the doctor will not prescribe you supplementary treatment with calcium.

Control of calcium levels
Once the doctor has established the optimal dose, he/she will check the calcium levels in the blood once a
month. Based on these checks, the doctor may also decide to modify or temporarily suspend
treatment with this medicine (see paragraph “Possible side effects”).
During the period of interruption/suspension of treatment, the values of calcium and phosphate in the
blood must be monitored daily.

If you take more CALCITRIOLO DOC Generici than you should
In case of ingestion/taking an excessive dose of CALCITRIOLO DOC Generici, immediately inform
your doctor or go to the nearest hospital.
Acute symptoms

• anorexia (lack or loss of appetite)
• headache
• vomiting
• constipation

Chronic symptoms

• sensory disturbances
• fever with a need to drink
• frequent need to urinate (polyuria)
• fluid loss (dehydration)
• state of indifference (apathy)
• growth arrest
• urinary tract infections
• hypercalcemia with calcium deposits in healthy tissues (kidneys, heart, lungs and pancreas)

Treatment
The doctor will stop the therapy with CALCITRIOLO DOC Generici and establish adequate supportive measures
to your clinical condition (e.g. may proceed with immediate gastric lavage or induce vomiting
to prevent further absorption of the medicine or may administer liquid paraffin to
promote elimination with the stool).
The doctor will advise to perform repeated measurements of calcemia. If high calcium values persist
in the blood (hypercalcemia), phosphates and corticosteroids may be administered to induce adequate diuresis.

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

If you stop taking CALCITRIOLO DOC Generici
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:

• an increase in calcium or creatinine levels in the blood, treatment with CALCITRIOLO DOC Generici will be discontinued immediately until normal calcium concentrations in the blood are restored;
• abnormal calcium and phosphorus values ​​present in the blood, treatment will be discontinued.

The possible side effects that may occur with this medicine are listed below
grouped by frequency:

Very common side effects (may affect more than 1 in 10 people)

• increased calcium levels in the blood (hypercalcemia) which can lead to calcium intoxication.

Common side effects (may affect up to 1 in 10 people)

• headache,
• abdominal pain,
• nausea,
• skin rashes,
• urinary tract infections.

Uncommon side effects (may affect up to 1 in 100 people)

• loss of appetite,
• vomiting,
• increased creatinine in the blood.

Side effects of unknown frequency (frequency cannot be estimated based on available data)

• Allergic reactions (hypersensitivity),
• urticaria (hives),
• frequent need to drink (polydipsia),
• dehydration,
• weight loss,
• state of indifference (apathy),
• muscle weakness,
• sensory disturbances,
• constipation,
• stomach pain,
• skin redness (erythema),
• itching,
• growth delay,
• frequent need to urinate (polyuria),
• deposition of calcium salts in the skin, in the tissues under the skin and, more rarely, in the tendons, tissues around the joints and muscles (calcinosis),
• fever,
• thirst.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 CALCITRIOLO DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month. Do not dispose of any medicine in waste water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What CALCITRIOLO DOC Generici contains
CALCITRIOLO DOC Generici 0.25 micrograms soft capsules
Each capsule contains:

• The active ingredient is calcitriol 0.25 micrograms.
• The other ingredients are medium-chain triglycerides, butylated hydroxyanisole, palmitoyl ascorbate, gelatin, glycerol 85%, non-crystallizing sorbitol 70% solution, titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, red iron oxide.

CALCITRIOLO DOC Generici 0.50 micrograms soft capsules
Each capsule contains:
The active ingredient is calcitriol 0.50 micrograms.
The other ingredients are medium-chain triglycerides, butylated hydroxyanisole, palmitoyl ascorbate, gelatin,
glycerol 85%, non-crystallizing sorbitol 70% solution, titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium
propyl p-hydroxybenzoate, red iron oxide, yellow iron oxide.

Description of the appearance of CALCITRIOLO DOC Generici and package contents
CALCITRIOLO DOC Generici 0.25 micrograms soft capsules: oval soft capsules of orange color, in
packs of 30 capsules.
CALCITRIOLO DOC Generici 0.50 micrograms soft capsules: oval soft capsules of reddish-orange color
in packs of 30 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan (MI).
Manufacturer
Dragenopharm Apotheker Püschl GmbH, Gőllstraße 1, 84529 Tittmoning, Germany
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – 18038 Sanremo (IM).