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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your 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 clean the blood of waste products.
• 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 for whom other treatments are not possible.

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 you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of calcium in the blood. Your doctor may recommend monitoring your blood calcium levels.

Warnings and Precautions

Before taking Cinacalcet Aurovitas, discuss with your doctor, pharmacist, or nurse.

Before taking Cinacalcet Aurovitas, inform your doctor about any current or past 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.

Inform your doctor if you 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. If you experience unusual rapid or pounding heartbeat, or if you have irregular heartbeats or are taking other medications that can affect heart rhythm while taking Cinacalcet Aurovitas, consult your doctor.

Additional information, see section 4.

While taking Cinacalcet Aurovitas, inform your 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 you are being treated for secondary hyperparathyroidism, your doctor may recommend monitoring your calcium levels before and during treatment with Cinacalcet Aurovitas.

Inform your doctor if you experience any symptoms of low calcium levels, as described above.

It is essential to take the prescribed dose of Cinacalcet Aurovitas as recommended by your 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, especially etelcalcetide or any other medications that lower calcium levels in the blood.

Do not take Cinacalcet Aurovitas with etelcalcetide.

Inform your doctor if you are taking any of the following medications.

Medications that may affect the action of Cinacalcet Aurovitas:

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

Cinacalcet Aurovitas may affect the action of:

• medications used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• medications used to treat cough (dextromethorphan);
• medications used to treat heart rhythm disorders (flecainide and propafenone);
• medications 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 you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cinacalcet has not been studied in pregnant women. If you are pregnant, your doctor may decide to change your treatment, as Cinacalcet Aurovitas may pose a risk to the fetus.

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

Driving and Using Machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these side effects, do not drive or operate machinery.

Cinacalcet Aurovitas Contains Lactose

Cinacalcet Aurovitas contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Cinacalcet Aurovitas Contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is considered to be essentially sodium-free.

3. How to Take Cinacalcet Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will determine the dose of Cinacalcet Aurovitas that you should take.

Cinacalcet Aurovitas should be taken orally, during or shortly after a meal. Swallow the tablets whole, do not divide them.

Your 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 up to 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

If you take more Cinacalcet Aurovitas than you should, contact your doctor immediately. Symptoms of overdose may include numbness or tingling around the mouth, muscle cramps or spasms, or seizures.

Missed Dose of Cinacalcet Aurovitas

Do not take a double dose to make up for a forgotten dose.

If you miss a dose of Cinacalcet Aurovitas, take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Tell Your Doctor Immediately:

• if you start to feel 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 you 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 testosterone levels;
• high potassium levels in the blood (hyperkalemia);
• allergic reactions (hypersensitivity);
• headache;
• seizures (convulsions);
• low blood pressure (hypotension);
• upper respiratory tract infection;
• difficulty breathing (dyspnea);
• cough;
• indigestion;
• diarrhea;
• abdominal pain, upper abdominal pain;
• constipation;
• muscle spasms;
• back pain;
• low calcium levels 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 heart rhythm, which may be related to low calcium levels in the blood (prolonged QT interval and ventricular arrhythmia due to hypocalcemia).

In a small number of patients with heart failure, worsening of the condition and/or low blood pressure (hypotension) have been reported after taking cinacalcet.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to Store Cinacalcet Aurovitas

Keep this medicine out of the 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 required.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.

• The 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: