CALCITRIOLO 0.25 MICROGRAMS Soft capsule

Зміст інструкції

1. CALCITRIOLO EG 0,25 mcg soft capsules, 0,5 mcg soft capsules
   1. WHAT IS CALCITRIOLO EG AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING CALCITRIOL EG
   3. HOW TO TAKE CALCITRIOL EG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CALCITRIOLO EG
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

CALCITRIOLO EG 0,25 mcg soft capsules, 0,5 mcg soft capsules

Equivalent medicinal product
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 their symptoms are the same as yours, as it could 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 Calcitriolo EG is and what it is used for
• 2. What you need to know before you take Calcitriolo EG
• 3. How to take Calcitriolo EG
• 4. Possible side effects
• 5. How to store Calcitriolo EG
• 6. Contents of the pack and other information

1. WHAT IS CALCITRIOLO EG AND WHAT IS IT USED FOR

Calcitriolo EG contains calcitriol, an active metabolite of vitamin D, necessary for the formation of
bones.
Calcitriolo EG is indicated:

• for treating a bone disease that occurs in the presence of chronic kidney disease (renal osteodystrophy), especially if undergoing hemodialysis (a method of blood filtration)
• for treating 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
• for treating rickets: a disease characterized by a defect in the formation and development of bones (hypophosphatemic vitamin D-resistant rickets, vitamin D-dependent rickets)
• for treating a disease related to increased function of the parathyroid glands caused by moderate to severe chronic kidney disease, not treated with dialysis (Secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency in pre-dialysis).

In addition Calcitriolo EG is indicated in postmenopausal women:

• for treating a disease that weakens the bones and increases the risk of developing bone fractures (postmenopausal osteoporosis).

2. WHAT YOU NEED TO KNOW BEFORE TAKING CALCITRIOL EG

Do not take Calcitriol EG

• If you are allergic to calcitriol or similar medicines or to any of the other components 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
Consult your doctor or pharmacist before taking Calcitriol EG.
In particular, tell your doctor:

• if you suffer from 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 immobilised, 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 hypophosphataemia due to vitamin D resistance), and are being treated with medicines containing phosphate
• if you are already being treated with ergocalciferol (see section “Other medicines and Calcitriol EG”).

Monitoring 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 Calcitriol EG, follow the diet prescribed by your doctor to avoid an increase in calcium and phosphate values in the blood (see section “Calcitriol EG with food and drinks”)
• before and during therapy, your doctor will ask you to undergo blood tests to check the values of calcium and creatinine (a protein used to assess kidney function); if these are too high, your doctor will instruct you to immediately stop treatment until calcium values return to normal (see section “Possible side effects”)
• your doctor will monitor phosphate levels in the blood
• your doctor will instruct you to recognise 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 for 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 problems, 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
Calcitriol EG must notbe administered to children and adolescents as the safety and efficacy of the
medicine in this patient group has not been sufficiently studied to allow dosage recommendations.

Other medicines and Calcitriol EG
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 Calcitriol EG (see also “Calcitriol EG with food and drinks”)
• ergocalciferol(vitamin D) as this may cause an excessive increase in calcium levels in the blood. In this case, your doctor will prescribe Calcitriol EG 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 values
• 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 the occurrence of arrhythmias (irregular heartbeats)
• corticosteroids(medicines to treat inflammation)
• medicines containing magnesium(e.g. antacids). Avoidtaking these medicines during therapy with Calcitriol EG if you are on dialysis
• medicinesused to reducethe absorption of phosphates; in the case of rickets with vitamin D-resistant hypophosphataemia or reduced kidney function (renal insufficiency), your doctor will continue oral phosphate therapy
• medicinesthat increase liver activitysuch as phenytoin (for the treatment of epilepsy) or phenobarbital (a barbiturate)
• medicines to lower blood fat levels, such as bile acid sequestrants, including cholestyramine and sevelamer

Calcitriol EG with food and drinks
Follow the diet prescribed by your doctor carefully.
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 are 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 Calcitriol EG only if the benefits for you outweigh the potential risk
to the foetus.
Breastfeeding
Calcitriol EG will be prescribed during breastfeeding provided that calcium levels in you and the infant
are monitored and are within the normal range.

Driving and operating machinery
It is unlikely that Calcitriol EG will affect your ability to drive and operate machinery.

Calcitriol EG contains sorbitol
This medicine contains 16.668 mg of sorbitol per 0.25 microgram capsule and 22.978 of sorbitol
per 0.5 microgram capsule.

Calcitriol EG contains para-hydroxybenzoates
May cause allergic reactions (including delayed reactions).

Calcitriol EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE CALCITRIOL EG

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 a kidney disease in patients undergoing dialysis (renal osteodystrophy):
The effectiveness of the treatment is conditional on the simultaneous intake of calcium: in adults, an
additional intake of 600-1000 mg of calcium per day must be ensured.

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

If you suffer from a disease related to increased parathyroid function (Secondary Hyperparathyroidism

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

• the recommended initial 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 parathyroid function (hypoparathyroidism) or if you suffer

from rickets:

• the recommended dose is 0.25 mcg 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 initial dose is 0.25 mcg twice a day
• if calcium levels do not show significant changes, the doctor will not change your dose. In this case the doctor, will notprescribe you additional calcium treatment.

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 section “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 Calcitriol EG than you should
In case of accidental ingestion/intake of an excessive dose of Calcitriol EG, immediately
inform your doctor or go to the nearest hospital.

Symptoms
Taking high doses of calcium and phosphate together with Calcitriol EG can cause side effects such as:
Acute symptoms

• Anorexia (loss of appetite)
• headache
• vomiting
• constipation

Chronic symptoms

• weakness, weight loss (dystrophy)
• sensory disturbances
• fever with a need to drink
• frequent need to urinate (polyuria)
• loss of fluids (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 Calcitriol EG 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).

If you forget to take Calcitriol EG
Do not take a double dose to make up for a missed dose.

If you stop taking Calcitriol EG
If you have any doubts about using this medicine, ask 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 EG will be stopped immediatelyuntil normal calcium concentrations in the blood are restored;
• abnormal calcium and phosphorus values in the blood, treatment will be stopped.

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

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

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

Common (may affect up to 1 in 10 people)

• Headache
• Nausea
• Abdominal pain
• Urinary tract infections
• Skin rashes

Uncommon (may affect up to 1 in 100 people)

• Loss of appetite
• Vomiting
• Increased creatinine in the blood

Not known (frequency cannot be estimated from 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
• Itching
• Skin redness (Erythema)
• Growth delay
• Frequent need to urinate (polyuria)
• Fever
• Thirst
• Calcium salt deposits in the skin, in tissues under the skin and, more rarely, in tendons, tissues around joints and muscles (calcinosis)
• Psychiatric disorders
• Drowsiness
• Irregular heartbeat (cardiac arrhythmias)
• Intestinal blockage (paralytic ileus)
• Need to urinate during night rest (nocturia)
• Kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 EG

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 packaging after Exp. The expiry date
refers to the last day of that month.
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 Calcitriolo EG contains

• The active substance is calcitriol. Each soft capsule contains 0.25 or 0.50 mcg of calcitriol.
• The other ingredients are: medium chain triglycerides, butylated hydroxyanisole, palmitoyl ascorbate, gelatin, glycerol 85%, non-crystallizing sorbitol solution 70% (E420), titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, red iron oxide, yellow iron oxide (the latter only for Calcitriolo EG 0.50 mcg).

Description of the appearance of Calcitriolo EG and contents of the pack
Soft oval-shaped capsules in PVC/PVDC/Al blisters. The 0.25 mcg capsules are red-orange in color,
those of 0.50 mcg are orange in color.
Calcitriolo EG is available in packs of 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 - 20136 Milano

Manufacturer
Laboratorio Farmaceutico CT S.r.l., Via Dante Alighieri, 71 – 18038 Sanremo (IM)