Cinacalcet Aurovitas

Package Leaflet: Information for the Patient

Cinacalcet Aurovitas, 30 mg, Coated Tablets

Cinacalcet Aurovitas, 60 mg, Coated Tablets

Cinacalcet Aurovitas, 90 mg, Coated Tablets

Cinacalcet

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Cinacalcet Aurovitas and what is it used for
• 2. Important information before taking Cinacalcet Aurovitas
• 3. How to take Cinacalcet Aurovitas
• 4. Possible side effects
• 5. How to store Cinacalcet Aurovitas
• 6. Contents of the pack and other information

1. What is Cinacalcet Aurovitas and what is it used for

Cinacalcet Aurovitas contains the active substance cinacalcet, which helps control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat diseases caused by parathyroid gland disorders (hyperparathyroidism). The parathyroid glands are four small glands located in the neck near the thyroid gland, which produce a hormone called parathyroid hormone (PTH).

Cinacalcet Aurovitas is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to remove waste products from the blood.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid cancer.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism who cannot undergo surgery to remove the parathyroid glands.

Cinacalcet Aurovitas is used in children aged 3 to less than 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from the blood, and who cannot be controlled by other treatments.

In primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means that the hyperparathyroidism is not caused by any other factors, while "secondary" means that the hyperparathyroidism is caused by other factors, such as kidney disease.

Both primary and secondary hyperparathyroidism can lead to calcium loss in the bones, which can cause bone pain and fractures, cardiovascular disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Cinacalcet Aurovitas

When not to take Cinacalcet Aurovitas

• If the patient is allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• if the patient has low levels of calcium in the blood. The doctor may recommend monitoring calcium levels in the blood.

Warnings and precautions

Before taking Cinacalcet Aurovitas, the patient should discuss it with their doctor, pharmacist, or nurse.

Before taking Cinacalcet Aurovitas, the patient should inform their doctor about any current or previous medical conditions, including:

• seizures; the risk of seizures is higher in people who have had them before;
• liver problems;
• heart failure.

Cinacalcet Aurovitas reduces calcium levels. In patients treated with Cinacalcet Aurovitas, life-threatening and fatal events related to low calcium levels (hypocalcemia) have been reported.

The patient should inform their doctor if they experience any of the following symptoms, which may indicate low calcium levels: muscle cramps, spasms, or twitching, numbness or tingling in the fingers or around the mouth, or seizures, confusion, or loss of consciousness.

Low calcium levels can affect heart rhythm. The patient should consult their doctor if they experience abnormal heartbeats or palpitations, or if they are taking other medicines that can affect heart rhythm while taking Cinacalcet Aurovitas.

Additional information, see section 4.

While taking Cinacalcet Aurovitas, the patient should inform their doctor about:

• starting or stopping smoking, as it may affect the action of Cinacalcet Aurovitas.

Children and adolescents

Cinacalcet Aurovitas should not be used in children under 18 years of age who have been diagnosed with parathyroid cancer or primary hyperparathyroidism.

If the patient is being treated for secondary hyperparathyroidism, the doctor may recommend monitoring calcium levels before and during treatment with Cinacalcet Aurovitas.

The patient should inform their doctor if they experience any symptoms of low calcium levels, as described above.

It is essential for the patient to take the dose of Cinacalcet Aurovitas as recommended by their doctor.

For children who require doses less than 30 mg or who are unable to swallow tablets, cinacalcet is available in other strengths and/or pharmaceutical forms.

Cinacalcet Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, especially etelcalcetide or any other medicines that reduce calcium levels in the blood.

Cinacalcet Aurovitas should not be taken at the same time as etelcalcetide.

The patient should inform their doctor if they are taking any of the following medicines.

Medicines that may affect the action of Cinacalcet Aurovitas:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• medicines used to treat HIV and AIDS (ritonavir);
• medicines used to treat depression (fluvoxamine).

Cinacalcet Aurovitas may affect the action of:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• medicines used to treat cough (dextromethorphan);
• medicines used to treat heart rhythm disorders (flecainide and propafenone);
• medicines used to treat high blood pressure (metoprolol).

Cinacalcet Aurovitas with food, drink, and alcohol

Cinacalcet Aurovitas should be taken during or shortly after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.

Cinacalcet has not been studied in pregnant women. In case of pregnancy, the doctor may decide to change the treatment, as Cinacalcet Aurovitas may pose a risk to the fetus.

It is not known whether cinacalcet passes into breast milk. The doctor will discuss with the patient whether to stop breastfeeding or stop taking Cinacalcet Aurovitas.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If these side effects occur, the patient should not drive or operate machinery.

Cinacalcet Aurovitas contains lactose

Cinacalcet Aurovitas contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Cinacalcet Aurovitas contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Cinacalcet Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine the dose of Cinacalcet Aurovitas to be taken.

Cinacalcet Aurovitas should be taken orally, during or shortly after a meal. The tablets should be swallowed whole and not divided.

The doctor will regularly take blood samples during treatment to check how the treatment is progressing and adjust the dose as needed.

Treatment of secondary hyperparathyroidism

The usual starting dose of Cinacalcet Aurovitas is 30 mg (one tablet) once a day.

The usual starting dose of Cinacalcet Aurovitas for children aged 3 to less than 18 years is not more than 0.20 mg/kg body weight per day.

Treatment of parathyroid cancer and primary hyperparathyroidism

The usual starting dose of Cinacalcet Aurovitas is 30 mg (one tablet) twice a day.

Overdose of Cinacalcet Aurovitas

In case of overdose, the patient should immediately consult their doctor. Symptoms of overdose may include: numbness or tingling around the mouth, muscle cramps or spasms, or seizures.

Missed dose of Cinacalcet Aurovitas

The patient should not take a double dose of the medicine to make up for a missed dose.

If a dose of Cinacalcet Aurovitas is missed, the patient should take the next dose at the usual time.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cinacalcet Aurovitas can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor:

• if they experience numbness or tingling around the mouth, muscle cramps or spasms, or seizures. These may be symptoms of low calcium levels in the blood (hypocalcemia).
• if they experience swelling: of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people.

• nausea and vomiting; usually mild and do not last long.

Common: may affect up to 1 in 10 people.

• dizziness;
• numbness or tingling (paresthesia);
• loss of appetite (anorexia) or decreased appetite;
• muscle pain;
• weakness;
• rash;
• low levels of testosterone;
• high levels of potassium in the blood (hyperkalemia);
• allergic reactions (hypersensitivity);
• headache;
• seizures (convulsions);
• low blood pressure (hypotension);
• upper respiratory tract infections;
• breathing difficulties (dyspnea);
• cough;
• indigestion;
• diarrhea;
• abdominal pain, upper abdominal pain;
• constipation;
• muscle spasms;
• back pain;
• low levels of calcium in the blood (hypocalcemia).

Frequency not known (cannot be estimated from the available data)

• hives;
• swelling of the face, lips, tongue, and throat, which may cause difficulty in swallowing or breathing (angioedema);
• abnormal heartbeats or palpitations, which may be related to low calcium levels in the blood (prolonged QT interval and ventricular arrhythmias due to hypocalcemia).

In a small number of patients with heart failure, cinacalcet has been associated with worsening of heart failure and/or low blood pressure (hypotension).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Cinacalcet Aurovitas

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Do not use this medicine if the patient notices any changes in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Aurovitas contains

• The active substance is cinacalcet.

Cinacalcet Aurovitas, 30 mg, coated tablets:
Each coated tablet contains 30 mg of cinacalcet.
Cinacalcet Aurovitas, 60 mg, coated tablets:
Each coated tablet contains 60 mg of cinacalcet.
Cinacalcet Aurovitas, 90 mg, coated tablets:
Each coated tablet contains 90 mg of cinacalcet.

• Other ingredients are: cornstarch, crospovidone (type A), microcrystalline cellulose (PH102), colloidal anhydrous silica, and sodium stearyl fumarate. The coating ingredients are: lactose monohydrate, hypromellose 2910 (15cPs), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172), indigo carmine, aluminum lake (E 132), hypromellose 2910 (5 cPs), macrogol 6000, and macrogol 400.

What Cinacalcet Aurovitas looks like and contents of the pack

Cinacalcet Aurovitas, 30 mg, coated tablets
Light green, oval, biconvex coated tablets with "CN" engraved on one side and "30" on the other side.
Cinacalcet Aurovitas, 60 mg, coated tablets
Light green, oval, biconvex coated tablets with "C" and "N" engraved on either side of the break line on one side and "60" on the other side. The tablet can be divided into equal doses.
Cinacalcet Aurovitas, 90 mg, coated tablets
Light green, oval, biconvex coated tablets with "C" and "N" engraved on either side of the break line on one side and "90" on the other side. The tablet can be divided into equal doses.
Cinacalcet Aurovitas is available in blisters, in a cardboard box.
Pack sizes: 14, 28, 30, 50, 84, and 90 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG, 3000, Malta

Generis Farmacêutica, S.A.

Rua João de Deus, n.º 19, Venda Nova
2700-487 Amadora, Portugal

Arrow Génériques-Lyon

26 avenue Tony Garnier
69007 Lyon, France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:

Cinacalcet AB 30 mg/ 60 mg/ 90 mg film-coated tablets

Czech Republic:

Cinacalcet Aurovitas

France:

Cinacalcet Arrow 30 mg/ 60 mg/ 90 mg film-coated tablets

Germany:

Cinacalcet PUREN 30 mg/ 60 mg/ 90 mg film-coated tablets

Italy:

Cinacalcet Aurobindo

Netherlands:

Cinacalcet Aurobindo 30 mg/ 60 mg/ 90 mg film-coated tablets

Poland:

Cinacalcet Aurovitas

Portugal:

Cinacalcet Generis

Spain:

Cinacalcet Aurovitas 30 mg/ 60 mg/ 90 mg film-coated tablets EFG

Date of last revision of the leaflet: