ROCALTROL 0,25 MCG Софт капсула

Содержание инструкции

1. Rocaltrol 0.25 mcg soft capsules, 0.50 mcg soft capsules
   1. What is Rocaltrol and what is it used for
   2. What you need to know before taking Rocaltrol
   3. How to take Rocaltrol
   4. Possible side effects
   5. How to store Rocaltrol
   6. Contents of the pack and other information

Rocaltrol 0.25 mcg soft capsules, 0.50 mcg soft capsules

Calcitriol

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

1. What is Rocaltrol and what is it used for

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

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

In addition, Rocaltrol is indicated in postmenopausal women:

• to treat a disease that weakens bones and increases the risk of developing bone fractures (postmenopausal osteoporosis).

2. What you need to know before taking Rocaltrol

Do not take Rocaltrol:

• if you are allergic to calcitriol or similar medicines or to any of the other components of this medicine (listed in section 6);
• if you suffer from a disease caused by increased 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 Rocaltrol.
In particular, tell your doctor:

• if you have 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 Rocaltrol”).

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. Therefore:

• during treatment with Rocaltrol, follow the diet prescribed by your doctor to avoid an increase in calcium and phosphate values in the blood (see section “Rocaltrol with food and drinks”)
• before and during therapy, your doctor will ask you to undergo 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 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 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 your blood before starting
therapy and at regular intervals during treatment.

Dehydration
If you do not suffer from kidney disorders, your doctor will advise you to drink plenty of water during therapy with
this medicine to avoid dehydration (excessive fluid loss from the body).
Elderly
No dosage adjustments are necessary in elderly patients.

Children and adolescents
Rocaltrol must notbe administered 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 Rocaltrol
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 Rocaltrol (see also “Rocaltrol with food and drinks”)
• ergocalciferol(vitamin D) as this may cause an excessive increase in calcium levels in the blood. In this case, your doctor will prescribe Rocaltrol 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 Rocaltrol if you are on dialysis
• medicinesused to reducethe absorption of phosphates; in case of rickets with vitamin D-resistant hypophosphatemia or reduced kidney function (renal insufficiency), your doctor will continue oral phosphate therapy
• medicinesthat increaseliver 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

Rocaltrol with food and drinks
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 or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe Rocaltrol only if the benefits for you outweigh the potential risk
to the fetus.
Breastfeeding
Rocaltrol will be prescribed during breastfeeding provided that calcium levels in you and your baby
are monitored and are within the normal range.

Driving and using machines
It is unlikely that Rocaltrol will affect your ability to drive and operate machinery.

Rocaltrol contains sorbitol
Rocaltrol 0.25 mcg soft capsules
This medicine contains 2.87 – 4.37 mg of sorbitol per 0.25 mcg capsule
Rocaltrol 0.50 mcg soft capsules
This medicine contains 2.87 – 4.36 mg of sorbitol per 0.50 mcg capsule

3. How to take Rocaltrol

Take this medicine following exactly the instructions of your doctor or pharmacist. 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 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 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

If you suffer from a disease related to increased parathyroid function (Hyperparathyroidism

secondary)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 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.

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 initial dose 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.

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 period of interruption/suspension of treatment, the values of
calcium and phosphate in the blood must be monitored daily.

If you take more Rocaltrol than you should
In case of accidental ingestion/intake of an excessive dose of Rocaltrol, immediately inform
your doctor or go to the nearest hospital.
Symptoms
Taking high doses of calcium and phosphate together with Rocaltrol can cause side effects
such as:
Acute symptoms:

• anorexia (lack or loss of appetite)
• headache
• vomiting
• constipation
• chronic symptoms:
• weakness, weight loss (dystrophy)
• sensory disturbances
• fever with a need to drink
• frequent need to urinate (polyuria)
• fluid loss (dehydration)
• state of indifference (apathy)
• growth arrest
• urinary tract infections
• hypercalcemia with calcium deposits in healthy tissues (kidneys, heart, lungs and pancreas)

Treatment
The doctor will stop the therapy with Rocaltrol and establish adequate supportive measures to your
clinical condition (e.g. he/she may proceed with immediate gastric lavage or induce vomiting
to prevent further absorption of the medicine or he/she may administer liquid paraffin
to promote elimination with the stool).
The doctor will advise you to perform repeated measurements of calcemia. If high values of
calcium in the blood (hypercalcemia) persist, phosphates and corticosteroids may be administered to induce a
adequate diuresis.

If you forget to take Rocaltrol
Do not take a double dose to make up for a missed dose.

If you stop taking Rocaltrol
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

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

• an increase in calcium or creatinine levels in the blood, treatment with Rocaltrol will be stopped immediatelyuntil normal calcium concentrations in the blood are restored;
• abnormal calcium and phosphorus values ​​present in the blood, treatment will be interrupted. 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 available data)
• allergic reactions (hypersensitivity)
• urticaria
• frequent need to drink (polydipsia)
• dehydration
• weight loss
• state of indifference (apathy)
• muscle weakness
• sensory disturbances
• constipation
• stomach pain
• itching
• skin redness (erythema)
• growth delay
• frequent need to urinate (polyuria)
• fever
• thirst
• deposition of calcium salts in the skin, in the tissues under the skin and, more rarely, in the tendons, in the tissues around the joints and in the muscles (calcinosis)

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

5. How to store Rocaltrol

Do not store at a temperature above 30°C.
Store in the original container to protect the medicine from light.
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 package after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Rocaltrol contains
Rocaltrol 0.25 mcg soft capsules
One capsule contains:

• The active ingredient is calcitriol 0.25 mcg.
• The other ingredients are medium chain saturated triglycerides, butylated hydroxyanisole, butylated hydroxytoluene. The capsule shell contains gelatin, glycerol 85%, Karion 83 [ sorbitol(see section 2. Rocaltrol contains sorbitol), mannitol, hydrolysed hydrogenated starch], titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).

Rocaltrol 0.50 mcg soft capsules
One capsule contains:

• The active ingredient is calcitriol 0.50 mcg.
• The other ingredients are medium chain saturated triglycerides, butylated hydroxyanisole, butylated hydroxytoluene. The capsule shell contains gelatin, glycerol 85%, Karion 83 [ sorbitol(see section 2. Rocaltrol contains sorbitol), mannitol, hydrolysed hydrogenated starch], titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).

Description of the appearance of Rocaltrol and contents of the pack
Rocaltrol 0.25 mcg is presented as soft capsules and is available in packs of 30 capsules.
Rocaltrol 0.50 mcg is presented as soft capsules and is available in packs of 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Roche S.p.A. - – Viale G.B. Stucchi, 110 – 20900 Monza (MB)

Manufacturer
Delpharm Milano S.r.l.
Via Carnevale, 1
20090 Segrate (MI)
Roche S.p.A.
Viale G.B. Stucchi, 110
20900 Monza (MI)