Calcitriol Mylan Generics: detailed information

Patient Information Leaflet: Information for the User

Calcitriol Mylan Generics

0.25 microgram capsules (soft gelatin)
0.50 microgram capsules (soft gelatin)
Calcitriol
Generic Medicine
Please 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 give it to others, even if they have the same symptoms as you, because 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:

What Calcitriol Mylan Generics is and what it is used for
What you need to know before taking Calcitriol Mylan Generics
How to take Calcitriol Mylan Generics
Possible side effects
How to store Calcitriol Mylan Generics
Contents of the pack and other information

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

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

Renal osteodystrophy (bone structural abnormalities related to long-term kidney failure) in patients with chronic renal failure, particularly those undergoing haemodialysis (a physical therapy replacing kidney function).
Hypoparathyroidism (reduced production of parathyroid hormone by the parathyroid glands), either idiopathic (without known cause) or post-surgical.
Pseudohypoparathyroidism (a genetic disorder resulting from the body's lack of response to parathyroid hormone).
Vitamin D-resistant hypophosphataemic rickets (an inherited form of rickets causing impaired cartilage and bone mineralization during growth, which does not benefit from vitamin D administration).
Familial vitamin D-dependent rickets type II (an inherited defect in vitamin D metabolism characterized by severe calcium deficiency in the blood, leading to impaired bone mineralization and skeletal deformities).
Postmenopausal osteoporosis (weakening of bones in women after menopause); in such cases, other conditions with similar skeletal symptoms must be ruled out, such as multiple myeloma (a tumour of the bone marrow) and tumoral osteolysis (bone tumours), for which treatment with Calcitriolo Mylan Generics is not indicated.

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

Do not take Calcitriol Mylan Generics

If you are allergic to calcitriol, to other medicines in 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, inform your doctor:

if you have reduced kidney function (renal insufficiency), as this increases the risk of calcium accumulation in areas of the body where it is not needed (ectopic calcification)
if you are immobilized, for example after surgery, as this increases the risk of hypercalcemia (elevated calcium levels in the blood)
if you have a bone formation disorder (vitamin D-resistant rickets with hypophosphatemia) and are being treated with phosphate-containing medicines
if you are already being treated with ergocalciferol (see section “Other medicines and Calcitriol Mylan Generics”).

During treatment with Calcitriol Mylan Generics, you must not take other preparations
containing vitamin D to avoid the development of hypervitaminosis D (excess vitamin D).
Monitoring of calcium and phosphate levels in the blood
There is a close relationship between treatment with this medicine and increased levels of calcium
and phosphate in the blood. Therefore:

during treatment with Calcitriol Mylan Generics, follow the diet prescribed by your doctor to prevent elevated calcium and phosphate levels in the blood (see section “Calcitriol Mylan Generics with food and drink”)
before and during therapy, your doctor will request blood tests to monitor your calcium and creatinine levels (a protein used to assess kidney function); if these levels are too high, your doctor will instruct you to stop treatment immediately until calcium levels return to normal (see section “Possible side effects”)
your doctor will monitor your blood phosphate levels
your doctor will instruct you to recognize any symptoms of elevated calcium and phosphate levels in the blood.

Dehydration
If you have normal kidney function and are taking Calcitriol Mylan Generics, avoid dehydration (lack of water in the body) by maintaining adequate fluid intake.
If you are postmenopausal and have osteoporosis
If you are postmenopausal and this medicine has been prescribed for the treatment of osteoporosis, your doctor will carefully assess your kidney function and blood calcium levels before starting treatment and at regular intervals during therapy.
Elderly
No dosage adjustments are required in elderly patients.
Children and adolescents
Calcitriol Mylan Generics must not be administered 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, inform your doctor if you are taking:

medicines or other preparations containing vitamin D, including calcium supplements. Do not take any other vitamin D-containing preparations during treatment with Calcitriol Mylan Generics (see also “Calcitriol Mylan Generics with food and drink”)
ergocalciferol (vitamin D_), as this may lead to excessive increases in blood calcium levels. In this case, your doctor will prescribe Calcitriol Mylan Generics only when ergocalciferol blood levels are adequate. It may take several months for ergocalciferol levels in the blood to return to normal
thiazide diuretics (medicines used to treat high blood pressure), as they increase the risk of hypercalcemia (elevated blood calcium)
digitalis (a medicine used to treat heart rhythm disorders), to prevent the occurrence of arrhythmias (irregular heartbeats)
corticosteroids (medicines used to treat inflammation)
medicines containing magnesium (e.g. antacids). Avoid taking these medicines during treatment with Calcitriol Mylan Generics if you are on dialysis
medicines used to reduce phosphate absorption; in cases of vitamin D-resistant rickets with hypophosphatemia or reduced kidney function (renal insufficiency), your doctor will continue oral phosphate therapy
medicines that increase liver activity, such as phenytoin (used to treat epilepsy) or phenobarbital (a barbiturate)
lipid-lowering medicines such as bile acid sequestrants, including cholestyramine and sevelamer.

Calcitriol Mylan Generics with food and drink
There is a close correlation between calcitriol treatment and the development of hypercalcemia.
Follow carefully the diet prescribed by your doctor.
Take into account the total vitamin D intake when consuming other products containing vitamin D (e.g. dairy products or calcium-containing supplements).
Always maintain an adequate fluid intake.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor may prescribe this medicine during pregnancy only after carefully weighing the benefits to the mother against the potential risks to the fetus.
Breastfeeding
If you wish to breastfeed during treatment with Calcitriol Mylan Generics, your doctor will monitor calcium levels in your blood and in your baby’s blood, as calcitriol is likely to pass into breast milk.
Driving and using machines
Calcitriol Mylan Generics does not affect the ability to drive or operate machinery.

3. HOW TO TAKE CALCITRIOLO MYLAN GENERICS

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose based on your body weight and general health. At the beginning of treatment, your doctor will perform frequent blood tests to establish the most appropriate dose for you and to monitor your blood calcium levels (calcemia) during treatment.

Bone disease caused by kidney disease in dialysis patients (renal osteodystrophy):
The effectiveness of treatment depends on concomitant calcium intake; in adult patients, a supplementary calcium intake of 600–1000 mg per day should be ensured.

The recommended initial dose of Calcitriolo Mylan Generics is 0.25 micrograms daily.
If your blood calcium levels are normal or only slightly reduced, the recommended initial dose is 0.25 micrograms every two days.
If no improvement is observed after 2–4 weeks, your doctor may increase the dose by 0.25 micrograms daily, at intervals of 2–4 weeks.
During treatment, your doctor will adjust the dose between 0.50 micrograms and 1 microgram per day.

If you have a disease related to reduced parathyroid function (hypoparathyroidism)
or if you have rickets:

The recommended dose is 0.25 micrograms daily, taken in the morning.
If no improvement occurs, your doctor may increase the dose every 2–4 weeks. In patients with hypoparathyroidism, malabsorption syndrome (inadequate absorption of dietary nutrients, manifested by diarrhea, weight loss, and anemia) may sometimes occur; in such cases, higher doses of Calcitriolo Mylan Generics may be required.

Postmenopausal women
If you have a disease that weakens the bones and increases the risk of bone fractures (postmenopausal osteoporosis):

The recommended initial dose is 0.25 micrograms twice daily.
If your blood calcium levels do not show significant changes, your doctor will not change your dose. In this case, your doctor will not prescribe additional calcium supplementation.

Monitoring of calcium levels
Once your doctor has established the optimal dose, your blood calcium levels will be monitored once a month. Based on these tests, your doctor may decide to adjust or temporarily interrupt treatment with this medicine (see section “Possible side effects”). During any treatment interruption or suspension, blood calcium and phosphate levels must be monitored daily.
At the doctor’s discretion, combination therapy with calcitonin (a hormone that counteracts decreased blood calcium levels) may be considered, especially in cases of high-turnover osteoporosis (rapid loss of calcium from bones).

If you take more Calcitriolo Mylan Generics than you should
If you take or ingest too much Calcitriolo Mylan Generics, contact your doctor immediately or go to the nearest hospital.
Symptoms of vitamin D intoxication may include:

Acute symptoms
Anorexia (loss of appetite), headache, nausea, vomiting, and constipation.

Chronic symptoms (long-term)
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 may lead to metastatic calcifications in various organs.

Treatment
Your doctor will discontinue therapy with Calcitriolo Mylan Generics and implement supportive measures appropriate to your clinical condition (e.g., immediate gastric lavage or induction of vomiting to prevent further absorption of the medicine, or administration of liquid paraffin to promote fecal elimination).
Your doctor will recommend repeated measurements of serum calcium. If elevated blood calcium levels (hypercalcemia) persist, phosphates and corticosteroids may be administered to promote adequate diuresis.

If you forget to take Calcitriolo Mylan Generics
Do not take a double dose to make up for the missed dose.

If you stop taking Calcitriolo Mylan Generics
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience:

an increase in calcium or creatinine levels in the blood, treatment with Calcitriol Mylan Generics will be immediately discontinued until normal blood calcium levels are restored;
abnormal levels of calcium and phosphorus in the blood, treatment will be discontinued.

The following adverse reactions may occur:
Very common adverse reactions (may affect more than 1 in 10 people)

Increased levels of calcium in the blood (hypercalcemia).

Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

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

Adverse reactions of unknown frequency (frequency cannot be estimated from available data)

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

Chronic effects may include: muscle weakness, decreased body weight, sensory disturbances, pyrexia, thirst, urinary disorders (urination), polydipsia (intense thirst sensation), polyuria (excessive urine production), dehydration, conjunctivitis (due to calcification), photophobia (excessive sensitivity to light), pancreatitis (inflammation of the pancreas), nephrocalcinosis (calcium deposition in the kidneys), nephrolithiasis (formation of kidney stones), rhinorrhea (excessive mucus production from the nose), pruritus, hyperthermia (increased body temperature), decreased libido (sexual desire), albuminuria (high concentration of albumin 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.
Changes in blood test values may also occur (increased creatinine, increased neutrophils, and decreased lymphocytes).
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the relevant authority.
By reporting adverse reactions, you 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 above 25°C.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month and applies to the product in its original intact packaging, properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Calcitriol Mylan Generics contains
Calcitriol Mylan Generics 0.25 microgram soft capsules
The active substance is calcitriol 0.25 micrograms.
The other components are:
Capsule contents: concentrated tocoferols, medium-chain triglycerides.
Capsule shell: gelatin, glycerol, titanium dioxide, red iron oxide.

Calcitriol Mylan Generics 0.50 microgram soft capsules
Each capsule contains:
The active substance: calcitriol 0.50 micrograms.
The other components are:
Capsule contents: concentrated tocoferols, medium-chain triglycerides.
Capsule shell: gelatin, glycerol, titanium dioxide, red iron oxide.

Description of the appearance of Calcitriol Mylan Generics and pack contents
Calcitriol Mylan Generics 0.25 microgram soft capsules: 30 capsules in blister packs.
Calcitriol Mylan Generics 0.50 microgram soft capsules: 30 capsules in blister packs.

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

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