CALCITRIOLO 0.25 MICROGRAMS Софт капсула

Содержание инструкции

1. Calcitriolo Mylan Generics
2. Calcitriolo
   1. WHAT IS CALCITRIOLO MYLAN GENERICS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOL MYLAN GENERICS
   3. HOW TO TAKE CALCITRIOL MYLAN GENERICS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CALCITRIOLO MYLAN GENERICS
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Calcitriolo Mylan Generics

0.25 micrograms soft capsules
0.50 micrograms soft capsules

Calcitriolo

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 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 Mylan Generics is and what it is used for
• 2. What you need to know before you take Calcitriolo Mylan Generics
• 3. How to take Calcitriolo Mylan Generics
• 4. Possible side effects
• 5. How to store Calcitriolo Mylan Generics
• 6. Contents of the pack and other information

1. WHAT IS CALCITRIOLO MYLAN GENERICS AND WHAT IT IS USED FOR

Calcitriolo Mylan Generics contains calcitriol as its active ingredient, which belongs to the class
of vitamin D and analogues.
Calcitriolo Mylan Generics is used for the treatment of the following conditions:

• Renal osteodystrophy (abnormality of bone structure related to long-term renal insufficiency) in patients with chronic renal insufficiency, particularly those undergoing hemodialysis (replacement therapy for kidney function).
• Hypoparathyroidism (reduced production of parathyroid hormone by the parathyroid glands), of both idiopathic (of unknown cause) and surgical type.
• Pseudohypoparathyroidism (genetic disease resulting from the body's lack of response to parathyroid hormone).
• Vitamin D-resistant hypophosphatemic rickets (hereditary form of rickets that causes altered mineralization of cartilage and bones during growth and that does not benefit from vitamin D administration).
• Familial vitamin D-dependent pseudodeficiency rickets (hereditary defect in vitamin D metabolism characterized by severe calcium deficiency in the blood leading to altered bone mineralization and skeletal deformities).
• Post-menopausal osteoporosis (weakening of the bones in women after menopause); in this case, it is necessary to exclude other conditions that may present similar symptoms affecting the skeleton, such as multiple myeloma (bone marrow cancer) and tumor osteolysis (bone tumors), for which treatment with Calcitriolo Mylan Generics is not indicated.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCITRIOL MYLAN GENERICS

Do not take Calcitriol Mylan Generics

• If you are allergic to calcitriol, to drugs belonging to the same class (vitamin D metabolites) or to any of the other ingredients of this medicine (listed in section 6).
• If you have a disease associated with high levels of calcium in the blood (hypercalcemia).
• If there are signs of vitamin D intoxication.

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcitriol Mylan Generics.
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 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 Calcitriol Mylan Generics”).

During treatment with Calcitriol Mylan Generics, you should not take other preparations
containing vitamin D to avoid the development of hypervitaminosis D (excess vitamin D).

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 Calcitriol Mylan Generics, follow the diet prescribed by your doctor to avoid an increase in calcium and phosphate levels in the blood (see section “Calcitriol Mylan Generics with food and drink”)
• before and during therapy, your doctor will ask you to have 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”)
• your doctor will check your phosphate levels in the blood
• your doctor will instruct you to recognize any symptoms of increased calcium and phosphate levels in the blood.

Dehydration
If you have normal kidney function and are taking Calcitriol Mylan Generics, you should avoid
dehydration (lack of water in the body) by maintaining an adequate fluid intake.

If you are postmenopausal and suffer from osteoporosis
If you are postmenopausal and this medicine has been prescribed to treat osteoporosis, your doctor
will carefully check your kidney function and calcium levels in the blood before
starting therapy and at regular intervals during treatment.

Elderly
No dosage adjustments are necessary in elderly patients.

Children and adolescents
Calcitriol Mylan Generics should not be given to children and adolescents as the
safety and efficacy of the medicine in this patient group have not been sufficiently
studied to allow dosage recommendations.

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

Calcitriol Mylan Generics with food and drink
There is a close correlation between treatment with calcitriol and the development of hypercalcemia.
Carefully follow the diet prescribed by your doctor.
Consider the total dose of vitamin D when taking other products that already contain vitamin D
(e.g. 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, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor may prescribe this medicine during pregnancy only after carefully evaluating
the benefits for the mother against the possible risks to the baby.
Breastfeeding
If you wish to breastfeed your baby during treatment with Calcitriol Mylan
Generics, your doctor will monitor calcium levels in your blood and your baby's blood, as
calcitriol is likely to pass into breast milk.

Driving and operating machinery
Calcitriol Mylan Generics does not impair the ability to drive vehicles or operate machinery.

3. HOW TO TAKE CALCITRIOL MYLAN GENERICS

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask 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 the treatment is conditional on the simultaneous intake of calcium; in adults
adequate calcium supplementation of 600-1000 mg per day should be ensured.

• The recommended initial dose of Calcitriol Mylan Generics is 0.25 micrograms per day
• if you have normal calcium levels in the blood or only slightly reduced, the recommended initial 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 0.50 micrograms and 1 microgram per 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 micrograms per day, to be taken in the morning
• if there are no improvements, the doctor may increase the dose every 2-4 weeks. In patients with hypoparathyroidism, a malabsorption syndrome (insufficient absorption of substances taken with the diet, which manifests with diarrhea, weight loss, anemia) can sometimes be observed: in these cases, higher doses of Calcitriol Mylan Generics may be required.

Postmenopausal Women

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

bones (postmenopausal osteoporosis):

• The recommended initial dose is 0.25 micrograms twice a day
• if the calcium levels in the blood 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 paragraph “Possible
side effects”). During the interruption/suspension period of treatment, the values of calcium and phosphate in the blood must be monitored daily.
At the doctor's discretion, association with calcitonin (a hormone that counteracts
the decrease in blood calcium levels) is possible, especially in cases of high-turnover osteoporosis
(rapid loss of calcium from the bones).

If you take more Calcitriol Mylan Generics than you should
In case of ingestion/taking an excessive dose of Calcitriol Mylan Generics, immediately inform
your doctor or go to the nearest hospital.
The symptoms of vitamin D intoxication can be:
Acute symptoms
Anorexia (loss of appetite), headache, vomiting and constipation.
Chronic symptoms (long-lasting)
Dystrophy (weakness, weight loss), sensory disturbances, possible fever with thirst, polyuria
(excessive urine production), dehydration, apathy (lack of will), growth arrest
and urinary tract infections. Hypercalcemia can result in metastatic calcifications
in various organs.
Treatment
The doctor will stop the therapy with Calcitriol Mylan Generics and establish appropriate supportive measures
according to your clinical condition (e.g., may proceed with immediate gastric lavage or
induction of vomiting to prevent further absorption of the medicine or may
administer liquid paraffin to promote elimination with the stool).
The doctor will advise repeated measurements of calcemia. If high values persist
of calcium in the blood (hypercalcemia), phosphates and corticosteroids may be administered to
induce adequate diuresis.

If you forget to take Calcitriol Mylan Generics
Do not take a double dose to make up for a missed dose.
If you stop taking Calcitriol Mylan Generics
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 everyone will experience them.
If you experience:

• an increase in calcium or creatinine levels in the blood, treatment with Calcitriolo Mylan Generics will be immediately interrupteduntil normal calcium concentrations in the blood are restored;
• abnormal calcium and phosphorus values in the blood, treatment will be interrupted.

The following side effects may occur:

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

• increased levels of calcium in the blood (hypercalcemia).

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

• Headache
• Abdominal pain
• Nausea
• Skin rash (skin alteration)
• Urinary tract infection

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

• Decreased appetite
• Vomiting
• Increased creatinine concentration in the blood (creatininemia)

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

• Allergic reactions (hypersensitivity)
• Urticaria (skin disease)
• Intense thirst (polydipsia)
• Dehydration
• Weight loss
• Lack of willingness (apathy)
• Muscle weakness
• Sensory disturbances
• Constipation
• Stomach ache
• Skin redness (erythema)
• Itching
• Growth delay
• Excessive urine production (polyuria)
• Calcium deposition in tissues (calcinosis)
• Fever (pyrexia)
• Thirst

Chronic effects may include: muscle weakness, weight loss, sensory disturbances, pyrexia, thirst, urinary disorders (urine emission), polydipsia (intense thirst), polyuria (excessive urine production), dehydration conjunctivitis (due to calcifications), photophobia (excessive sensitivity to light), pancreatitis (inflammation of the pancreas), nephrocalcinosis (calcium deposition in the kidneys), nephrolithiasis (kidney stone formation), rhinorrhea (excessive mucus production by the nose), itching, hyperthermia (increased body temperature), decreased libido (sexual desire), albuminuria (high albumin concentration in urine), hypercholesterolemia (excess cholesterol in the blood), increased SGOT and SGPT (enzymes mainly present in the liver), ectopic calcifications (in various organs), hypertension (high blood pressure), cardiac arrhythmias and, rarely, psychosis.
Alterations in the values of some substances present in the blood (increased creatinine, increased neutrophils, and decreased lymphocytes) may also occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through
adverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CALCITRIOLO MYLAN GENERICS

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month and the product in intact packaging, correctly stored.
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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcitriolo Mylan Generics contains
Calcitriolo Mylan Generics 0.25 micrograms soft capsules
The active ingredient is calcitriol 0.25 micrograms.
The other ingredients are:
Capsule content: concentrated tocopherols, medium-chain triglycerides.
Outer capsule: gelatin, glycerol, titanium dioxide, red iron oxide.
Calcitriolo Mylan Generics 0.50 micrograms soft capsules
Each capsule contains:
The active ingredient: calcitriol 0.50 micrograms.
The other ingredients are:
Capsule content: concentrated tocopherols, medium-chain triglycerides.
Outer capsule: gelatin, glycerol, titanium dioxide, red iron oxide.

Description of the appearance of Calcitriolo Mylan Generics and contents of the pack
Calcitriolo Mylan Generics 0.25 micrograms soft capsules: 30 capsules in blisters.
Calcitriolo Mylan Generics 0.50 micrograms soft capsules: 30 capsules in blisters.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan.

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