Calcitriol Doc Generici

Package leaflet: Information for the user

CALCITRIOLO DOC Generici

0.25 micrograms soft capsules
0.50 micrograms soft capsules
Calcitriol
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 CALCITRIOLO DOC Generici IS AND WHAT IT IS USED FOR

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

• for the treatment of a bone disease occurring in chronic kidney disease (renal osteodystrophy), especially in patients undergoing haemodialysis (a method of blood filtration)
• for the treatment of diseases related to reduced parathyroid function, glands located in the neck (hypoparathyroidism, pseudohypoparathyroidism), which secrete PTH (parathyroid hormone), the hormone regulating calcium metabolism
• for the treatment of rickets: a disease characterized by defective bone formation and development (vitamin D-resistant hypophosphataemic rickets, vitamin D-dependent rickets)
• for the treatment of a disease caused by overactivity of the parathyroid glands due to moderate to severe chronic kidney disease, in patients not treated with dialysis (secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency in pre-dialysis)
• Additionally, CALCITRIOLO DOC Generici is indicated in women with established menopause:
• for the treatment of a disease that weakens the bones and increases the risk of bone fractures (postmenopausal osteoporosis).

2. WHAT YOU SHOULD KNOW BEFORE TAKING CALCITRIOLO DOC Generici

Do not take CALCITRIOLO DOC Generici

• if you are allergic to calcitriol or medicines similar to it, 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);
• if you have signs of vitamin D toxicity.

Warnings and precautions
Talk to your doctor or pharmacist before taking CALCITRIOLO DOC Generici.
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 (increased calcium 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 CALCITRIOLO DOC Generici”).

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 CALCITRIOLO DOC Generici, follow the diet prescribed by your doctor to avoid increases in blood calcium and phosphate levels (see section “CALCITRIOLO DOC Generici with food and drink”);
• before and during treatment, your doctor will ask you to have 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 on how to recognize possible symptoms of elevated calcium and phosphate levels in the blood.

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.

Dehydration
If you do not have kidney problems, your doctor will advise you to drink plenty of fluids during treatment with this medicine to avoid dehydration (excessive loss of body fluids).

Elderly
No dosage adjustments are necessary in elderly patients.

Children and adolescents
CALCITRIOLO DOC Generici 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 CALCITRIOLO DOC Generici
Inform 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 CALCITRIOLO DOC Generici (see also “CALCITRIOLO DOC Generici with food and drink”);
• ergocalciferol (vitamin D2), as this may lead to excessive increases in blood calcium levels. In such cases, your doctor will prescribe CALCITRIOLO DOC Generici only once ergocalciferol blood levels have returned to adequate levels. 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 this increases the risk of hypercalcemia (increased calcium in the blood);
• digitalis (a medicine used to treat heart rhythm disorders), to avoid the occurrence of arrhythmias (irregular heartbeats);
• corticosteroids (medicines used to treat inflammation);
• magnesium-containing medicines (e.g. antacids). Avoid taking these medicines during treatment with CALCITRIOLO DOC Generici if you are on dialysis;
• medicines used to reduce phosphate absorption; in cases 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 (used to treat epilepsy) or phenobarbital (a barbiturate);
• medicines used to lower blood lipid levels, such as bile acid sequestrants including cholestyramine and sevelamer.

CALCITRIOLO DOC Generici with food and drink
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 supplements).
Always maintain an adequate fluid intake.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will prescribe this medicine during pregnancy only if the benefits to you outweigh the potential risks to the fetus.

Breastfeeding
CALCITRIOLO DOC Generici may be prescribed during breastfeeding, provided that your calcium levels and those of the breastfed infant are monitored and remain within normal limits.

Driving and using machines
It is unlikely that CALCITRIOLO DOC Generici will affect your ability to drive 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) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.

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

3. HOW TO TAKE CALCITRIOLO DOC Generici

Take this medicine exactly as prescribed 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 your overall health condition. Your doctor will also perform frequent blood tests at the beginning of treatment to establish the most suitable dose for you, and during treatment to monitor your blood calcium levels (calcemia).

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

• The recommended initial dose is 0.25 micrograms per day.
• 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 per day, at intervals of 2–4 weeks.
• During treatment, your doctor will adjust the dose between 0.5 micrograms and 1 microgram per day.

If you suffer from a condition related to overactivity of the parathyroid glands (secondary hyperparathyroidism) in patients with moderate to severe renal insufficiency not yet on 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 condition related to reduced parathyroid function (hypoparathyroidism) or suffer from rickets:

• The recommended dose is 0.25 micrograms per day, taken in the morning.
• If no improvement occurs, your 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 bone fractures (confirmed postmenopausal osteoporosis):

• The recommended initial dose is 0.25 micrograms twice daily.
• If 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 monthly. Based on these tests, your doctor may decide to adjust or temporarily suspend treatment with this medicine (see section “Possible side effects”).
During any interruption or suspension of treatment, blood levels of calcium and phosphate must be monitored daily.

If you take more CALCITRIOLO DOC Generici than you should
If you take or ingest too much CALCITRIOLO DOC Generici, contact your doctor immediately or go to the nearest hospital.

Acute symptoms:

• Anorexia (loss of appetite)
• Headache (cephalaea)
• Vomiting
• Constipation (stipsis)

Chronic symptoms:

• Sensory disturbances
• Fever with increased thirst
• Frequent need to urinate (polyuria)
• Fluid loss (dehydration)
• Indifference (apathy)
• Growth arrest
• Urinary tract infections
• Hypercalcemia with calcium deposits in healthy tissues (kidneys, heart, lungs, and pancreas)

Treatment
Your doctor will discontinue therapy with CALCITRIOLO DOC Generici and initiate 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 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 using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

• increased levels of calcium or creatinine in the blood, treatment with CALCITRIOLO DOC Generici will be stopped immediately until normal calcium concentrations in the blood are restored;
• abnormal levels of calcium and phosphorus in the blood, treatment will be discontinued.

The possible adverse reactions that may occur with this medicine are listed below, grouped by frequency:
Very common adverse reactions (may affect more than 1 in 10 people)

• increased calcium levels in the blood (hypercalcaemia), which may lead to calcium intoxication.

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

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

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

• decreased appetite,
• vomiting,
• increased creatinine in the blood.

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

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

Reporting of adverse reactions
If you get any adverse reactions, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 temperatures above 30°C.
Do not use this medicine after the expiry date stated on the carton after "Exp." The expiry date refers to the last day of that month. 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. PACKAGING CONTENTS AND OTHER INFORMATION

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

• The active substance is calcitriol 0.25 micrograms.
• The other components are medium-chain triglycerides, butyl-hydroxyanisole, palmitoyl ascorbate, gelatin, glycerol 85%, 70% non-crystallizing sorbitol 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 substance is calcitriol 0.50 micrograms.
The other components are medium-chain triglycerides, butyl-hydroxyanisole, palmitoyl ascorbate, gelatin, glycerol 85%, 70% non-crystallizing sorbitol 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 contents of the pack
CALCITRIOLO DOC Generici 0.25 micrograms soft capsules: orange, oval soft capsules, pack containing 30 capsules.
CALCITRIOLO DOC Generici 0.50 micrograms soft capsules: red-orange, oval soft capsules, pack containing 30 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan (MI), Italy.

Manufacturers
Dragenopharm Apotheker Püschl GmbH, Gőllstraße 1, 84529 Tittmoning, Germany
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – 18038 Sanremo (IM), Italy