CALCITRIOLO 0,25 MCG Kapsułki

Treść ulotki

1. Calcitriolo Teva 0.25 micrograms capsules, 0.5 micrograms capsules
   1. What is Calcitriolo Teva and what is it used for
   2. What you need to know before taking Calcitriolo Teva
   3. How to take Calcitriolo Teva
   4. Possible side effects
   5. How to store Calcitriolo Teva
   6. Contents of the pack and other information

Calcitriolo Teva 0.25 micrograms capsules, 0.5 micrograms capsules

Generic medicine

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

1. What is Calcitriolo Teva and what is it used for

Calcitriolo Teva is a medicine that contains vitamin D, necessary for the formation of
bones.
Calcitriolo Teva is used for the treatment of:

• a bone disease in patients with kidney problems (renal osteodystrophy), especially if undergoing hemodialysis (a method of blood filtration);
• diseases related to reduced function of the parathyroid glands (hypoparathyroidism, pseudohypoparathyroidism), glands present in the neck that secrete PTH (parathyroid hormone), i.e. the hormone that regulates calcium metabolism;
• rickets: a disease characterized by a defect in the formation and development of bones (vitamin D-resistant hypophosphatemic rickets, vitamin D-dependent rickets);
• a disease related to increased function of the parathyroid glands caused by chronic kidney disease from moderate to severe, not treated with dialysis (secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency in pre-dialysis).

Calcitriolo Teva is also indicated in women with confirmed menopause:

• to treat a condition that weakens the bones and increases the risk of bone fractures (post-menopausal osteoporosis).

Calcitriol works in such a way that the body absorbs more calcium from the diet. This helps to form
healthy bones and reduce damage to the bones.

2. What you need to know before taking Calcitriolo Teva

Do not take Calcitriolo Teva

• if you are allergic to calcitriol or similar medicines or to any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia).
• if you have calcium deposits in your body (metastatic calcification).
• if you suffer from illness due to high levels of vitamin D in your body. Do not take Calcitriolo Teva if you find yourself in any of the above conditions. If you have doubts, ask your doctor or pharmacist before taking Calcitriolo Teva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Calcitriolo Teva

• if you have difficulty with movements (for example after surgery), as this increases the risk of hypercalcemia (increased calcium in the blood).
• if you suffer from reduced kidney function (renal insufficiency), as this increases the risk of calcium build-up in areas of the body where it is not needed (ectopic calcification) (your doctor may need to monitor phosphate levels in the blood and in your diet).
• if you suffer from a bone formation defect (rickets with vitamin D-resistant hypophosphatemia), and are being treated with medicines containing phosphate.
• if you are already being treated with ergocalciferol (see section 2 “Other medicines and Calcitriolo Teva”).

Monitoring 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. For this reason:

• during treatment with Calcitriolo Teva, follow the diet prescribed by your doctor to avoid an increase in calcium and phosphate levels in the blood (see section “Calcitriolo Teva 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 stop treatment immediately until calcium levels return to normal (see section “Possible side effects”);
• your doctor will check phosphate levels in your blood;
• your doctor will instruct you to recognize any symptoms of increased calcium and phosphate levels in the blood. If you are postmenopausal and suffer from osteoporosisIf you are postmenopausal and this medicine has been prescribed for you to treat osteoporosis, your doctor will carefully check your kidney function and calcium levels in your 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).

Children and adolescents
Calcitriolo Teva should not be given to children and adolescents as the safety and
efficacy of the medicine in this patient group has not been sufficiently studied to
allow recommendations on dosage.

Other medicines and Calcitriolo Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines available without a prescription and herbal
medicines as Calcitriolo Teva can interfere with the way some medicines work and other medicines may
interfere with the correct
functioning of Calcitriolo Teva.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines containing vitamin D, including calcium supplements.
• diuretics (used to treat high blood pressure). These include bendroflumethiazide, chlortalidone and indapamide.
• medicines such as digoxin or digitoxin (used to treat heart disease).
• medicines containing magnesium, such as antacids (used to treat heartburn).
• steroid medicines, such as hydrocortisone, prednisolone and dexamethasone.
• cholestyramine or other “ion exchange resins” (used to treat high cholesterol levels in the blood) and sevelamer.
• phosphates (your doctor may need to monitor phosphate levels in the blood).
• medicines that increase liver activity, such as phenytoin (for treating epilepsy) or phenobarbital (a barbiturate). Also, tell your doctor or pharmacist if you have taken a medicine containing vitamin D in recent months that may have long-lasting effects. These medicines include ergocalciferol and cholecalciferol.

Calcitriolo Teva with food and drink

• DO NOT take any vitamins or supplements containing vitamin D if you are taking Calcitriolo Teva.
• DO NOT eat foods fortified with vitamin D (foods enriched with vitamin D) if you are taking Calcitriolo Teva.
• It is very important to follow the diet prescribed by your doctor.
• If you significantly change your calcium or vitamin D intake in your diet, this may increase the risk of side effects (for example, if you consume more dairy products such as milk and cheese or if you take vitamins without your doctor knowing).
• Drink plenty of fluids (such as water) to avoid dehydration. This does not apply if you have kidney problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor before taking Calcitriolo Teva if you are pregnant, suspect you are or
are planning a pregnancy. The doctor will decide whether you can take Calcitriolo Teva.
Breastfeeding
You can take Calcitriolo Teva if you are breastfeeding. However, your doctor will prescribe blood tests
for you and your baby to check that there are no side effects.

Driving and operating machinery
It is unlikely that Calcitriolo Teva will affect your ability to drive and operate tools and
machinery.

Calcitriolo Teva contains sorbitol

Calcitriolo Teva 0.25 micrograms capsules
This medicine contains 10.73 mg of sorbitol per capsule.

Calcitriolo Teva 0.5 micrograms capsules
This medicine contains 10.79 mg of sorbitol per capsule.
If your doctor has told you that you are intolerant to certain sugars, talk to your doctor before taking
this medicine.

Calcitriolo Teva contains sodium(component of Quinoline Yellow)
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Calcitriolo Teva

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 that the calcium levels in the blood do not become too high.

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, it is
necessary to ensure a supplementary intake of 600-1000 mg of calcium per day.

• The recommended initial dose for adults 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 0.5 micrograms and 1 microgram per day.
• Possibly, based on the results of blood tests, the doctor may have to adjust the dose again. They may ask you to take Calcitriolo Teva 2 or 3 times a week instead of once a day. The maximum weekly dose is 12 micrograms.

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 dose for women is 0.25 micrograms 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 supplementary calcium treatment.

If you suffer from a disease related to increased functionality of the parathyroid glands (secondary
hyperparathyroidism) in patients with moderate to severe renal insufficiency in pre-dialysis):

• The recommended initial dose in adults is 0.25 micrograms per day.
• If necessary, the dose may be increased up to 0.5 micrograms per day.

If you suffer from a disease related to reduced functionality of the parathyroid glands (hypoparathyroidism) or if
you suffer from rickets:

• The recommended dose is 0.25 micrograms per day, to be taken in the morning.
• If there is no improvement, the doctor may increase the dose every 2-4 weeks.

Control of calcium levels
Once the doctor has established the optimal dose, they 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 4 “Possible
side effects”). During the period of interruption/suspension of treatment, calcium and
phosphate levels in the blood must be monitored daily.

Elderly
Elderly patients do not need a different dosage.

Use in children and adolescents
The use of Calcitriolo Teva is not recommended in children.
Swallow the entire capsule with a little water.

If you take more Calcitriolo Teva than you should
If you take more Calcitriolo Teva than you should, inform your doctor or go to the nearest hospital.
Bring the medicine packaging with you.
If you take too many capsules, too much calcium can accumulate in the blood (hypercalcemia). Symptoms
include loss of appetite, weight loss, feeling unwell, malaise, constipation, headache and
feeling tired, sleepy or weak.

If you forget to take Calcitriolo Teva
If you forget to take the dose, skip the missed dose. Then take the next dose
normally.
Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Calcitriolo Teva
Do not stop treatment with Calcitriolo Teva without asking your doctor. This is because
bone weakness requires long-term treatment.
If someone else takes Calcitriolo Teva capsules by mistake, they should inform a doctor or
go to the nearest hospital.
If you have any doubts about the use of 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.
Very common (may affect more than 1 in 10 people).
Common (may affect up to 1 in 10 people).
Uncommon (may affect up to 1 in 100 people).
Rare (may affect up to 1 in 1,000 people).
Very rare (may affect up to 1 in 10,000 people).
Not known (frequency cannot be estimated from the available data).
If you experience:

• an increase in calcium or creatinine levels in the blood, treatment with Calcitriolo Teva will be stopped immediatelyuntil normal calcium concentrations in the blood are restored;
• abnormal calcium and phosphate 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 levels of calcium 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 the available data)

• allergic reactions (hypersensitivity)
• urticaria
• frequent need to drink (polydipsia)
• dehydration
• weight loss
• state of indifference (apathy)
• mental disorders
• muscle weakness
• sensory disturbances
• drowsiness
• irregular heartbeat
• constipation
• stomach pain
• intestinal obstruction
• itching
• skin redness (erythema)
• growth retardation
• frequent need to urinate (polyuria)
• bedwetting (nocturia)
• fever
• thirst
• deposition of calcium salts in the skin, in the tissues under the skin and, more rarely, in the tendons, around the joints and in the muscles (calcinosis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Calcitriolo Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in the original container. Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Calcitriolo Teva contains

• The active ingredient is calcitriol. Calcitriolo Teva 0.25 micrograms capsulesEach capsule contains 0.25 micrograms of calcitriol. Calcitriolo Teva 0.5 micrograms capsulesEach capsule contains 0.5 micrograms of calcitriol.
• The other ingredients are fractionated coconut oil, butylated hydroxyanisole (E320), butylated hydroxytoluene (E321), gelatin, glycerol (E422), sorbitol (E420), titanium dioxide (E171), quinoline yellow (E104) (contains sodium). The 0.5 microgram capsules also contain patent blue (E131).

Both capsule strengths have a print with black ink that contains
shellac (E904) and black iron oxide (E172).

Description of the appearance of Calcitriolo Teva and contents of the pack
Calcitriolo Teva 0.25 micrograms capsules are opaque, yellow, oval soft gelatin capsules with
“0.25” imprinted on them.
Calcitriolo Teva 0.5 micrograms capsules are opaque, green, oblong soft gelatin capsules with
“0.5” imprinted on them.
The product is available in packs of 20, 30 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
Pharmachemie B.V. Swensweg, 5, P.O. Box 552, RN 2003 Haarlem (Netherlands)
Teva Pharmaceuticals Europe B.V. Swensweg 5, 2031 GA Haarlem (Netherlands)
Balkanpharma Dupnitsa AD Samokovsko Shosse strasse 3, 2600 Dupnitsa (Bulgaria)