Calcitriol EG

Patient Information Leaflet

CALCITRIOLO EG 0.25 mcg Soft Capsules, 0.5 mcg Soft Capsules

Generic Medicine
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 CALCITRIOLO EG IS AND WHAT IT IS USED FOR

Calcitriolo EG contains calcitriol, the active metabolite of vitamin D, which is necessary for bone formation.
Calcitriolo EG 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 disorders 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 (hypophosphataemic rickets, vitamin D-resistant rickets, vitamin D-dependent rickets)
• for the treatment of a condition caused by overactivity of the parathyroid glands due to moderate to severe chronic kidney disease not treated with dialysis (secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency not yet on dialysis).

Furthermore, Calcitriolo EG is indicated in confirmed postmenopausal women:

• 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 CALCITRIOL EG

Do not take Calcitriol EG

• If you are allergic to calcitriol or to similar medicines or to any of the other ingredients of this medicine (listed in section 6).
• If you have a disease caused by high 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 Calcitriol EG.
In particular, inform your doctor:

• if you have reduced kidney function (renal insufficiency), as in this case the risk of calcium accumulation in body tissues where it is not needed (ectopic calcification) increases
• if you are immobilized, for example after surgery, as in this case the risk of hypercalcemia (increased calcium in the blood) increases
• 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 EG").

Monitoring of calcium and phosphate levels in 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 EG, follow the diet prescribed by your doctor to avoid increasing calcium and phosphate levels in the blood (see section "Calcitriol EG with food and drink")
• before and during therapy, your doctor will ask you to have blood tests to monitor 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 possible symptoms of increased calcium and phosphate 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 monitor your kidney function and blood calcium levels before starting therapy and at regular intervals during treatment.
Dehydration
If you do not have kidney problems, your doctor will advise you to drink plenty of water during treatment with this medicine to avoid dehydration (excessive loss of body fluids).
Elderly
Dosage adjustments are not required in elderly patients.
Children and adolescents
Calcitriol EG 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 EG
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 using:

• medicines or other preparations containing vitamin D, including calcium supplements. Do not take any other vitamin D-containing preparations during treatment with Calcitriol EG (see also "Calcitriol EG with food and drink")
• ergocalciferol (vitamin D), as excessive increase in blood calcium levels may occur. In this case, your doctor will prescribe Calcitriol EG 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 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)
• medicines containing magnesium (e.g. antacids). Avoid taking these medicines during treatment with Calcitriol EG if you are on dialysis
• medicines used to reduce the absorption of phosphates; in 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 (used to treat epilepsy) or phenobarbital (a barbiturate)
• medicines to lower blood lipid levels, such as bile acid sequestrants, including cholestyramine and sevelamer

Calcitriol EG with food and drink
Carefully follow the diet prescribed by your doctor.
Take into account the total vitamin D intake when consuming other products already containing vitamin D (e.g. dairy products or calcium-containing preparations).
Always maintain an adequate fluid intake.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe Calcitriol EG only if the benefits to you outweigh the potential risks to the fetus.
Breastfeeding
Calcitriol EG may be prescribed during breastfeeding provided that your calcium levels and those of the nursing infant are monitored and remain within normal limits.
Driving and using machines
It is unlikely that Calcitriol EG will affect your ability to drive or operate machinery.
Calcitriol EG contains sorbitol
This medicine contains 16.668 mg of sorbitol per 0.25 microgram capsule and 22.978 mg of sorbitol per 0.5 microgram capsule.
Calcitriol EG contains parahydroxybenzoates
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 CALCITRIOLO EG

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor based on your body weight and your overall health condition. Your doctor will also perform frequent blood tests at the beginning of treatment to determine 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 supplementary intake of 600–1000 mg of calcium per day should be ensured.

• The recommended initial dose is 0.25 mcg daily.
• If your blood calcium levels are normal or only slightly reduced, the recommended initial dose is 0.25 mcg every two days.
• If no improvement is observed after 2–4 weeks, your doctor may increase the dose by 0.25 mcg daily at intervals of 2–4 weeks.
• During treatment, your doctor will adjust the dose between 0.5 mcg and 1 mcg daily.

If you suffer from a disease related to overactivity of the parathyroid glands (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 function of the parathyroid glands (hypoparathyroidism) or if you have rickets:

• The recommended dose is 0.25 mcg daily, to be taken in the morning.
• If no improvement occurs, your doctor may increase the dose every 2–4 weeks.

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

• The recommended initial dose is 0.25 mcg twice daily.
• If your 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 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.

If you take more Calcitriolo EG than you should
In case of accidental ingestion or overdose of Calcitriolo EG, contact your doctor immediately or go to the nearest hospital.

Symptoms
Taking high doses of calcium and phosphate together with Calcitriolo EG may cause the following adverse effects:

Acute symptoms

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

Chronic symptoms

• weakness, weight loss (dystrophy)
• sensory disturbances
• fever with increased thirst
• frequent need to urinate (polyuria)
• fluid loss (dehydration)
• 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 EG and initiate appropriate supportive measures according 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 calcium levels in the blood (hypercalcemia) persist, phosphates and corticosteroids may be administered to promote adequate diuresis.

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

If you stop taking Calcitriolo EG
If you have any questions 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:

• an increase in blood calcium or creatinine levels, treatment with Calcitriol EG will be immediately discontinued until normal blood calcium concentrations 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 (may affect more than 1 in 10 people)

• increased levels of calcium in the blood (hypercalcemia), which may lead to calcium intoxication

Common (may affect up to 1 in 10 people)

• Headache (cephalalgia)
• Nausea
• Abdominal pain
• Urinary tract infections
• Skin rashes

Uncommon (may affect up to 1 in 100 people)

• Decreased appetite
• Vomiting
• Increased creatinine in the blood

Not known (frequency cannot be estimated from the available data)

• Allergic reactions (hypersensitivity)
• Urticaria
• Frequent need to drink (polydipsia)
• Dehydration
• Weight loss
• Indifference state (apathy)
• Muscle weakness
• Sensory disturbances
• Constipation (stipsis)
• Stomach pain
• Itching (pruritus)
• Skin redness (erythema)
• Growth retardation
• Frequent need to urinate (polyuria)
• Fever
• Thirst
• Deposition of calcium salts in the skin, subcutaneous tissues, and, more rarely, in tendons, tissues around joints, and muscles (calcinosis)
• Psychiatric disorders
• Somnolence
• Changes in heart rhythm (cardiac arrhythmias)
• Intestinal blockage (paralytic ileus)
• Need to urinate during night rest (nocturia)
• Kidney stones (nephrolithiasis) or deposition of calcium in the kidneys (nephrocalcinosis)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at 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 EG

Keep this medicinal product out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicinal product after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicinal product in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Calcitriol 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, butylhydroxyanisole, ascorbyl palmitate, gelatin, glycerol 85%, 70% non-crystallizing sorbitol solution (E420), titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, red iron oxide, yellow iron oxide (the latter only in Calcitriol EG 0.50 mcg).

Description of the appearance of Calcitriol EG and the contents of the pack
Oval-shaped soft capsules in PVC/PVDC/Al blisters. The 0.25 mcg capsules are red-orange in colour, those of 0.50 mcg are orange.
Calcitriol EG is available in packs of 30 capsules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6 - 20136 Milan

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