Cinacalcet Aurovitas 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Cinacalcet Aurovitas 30 mg film-coated tablets EFG

Cinacalcet Aurovitas 60 mg film-coated tablets EFG

Cinacalcet Aurovitas 90 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Cinacalcet Aurovitas is and what it is used for
2. What you need to know 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 Cinacalcet Aurovitas is and what it is used for

Cinacalcet Aurovitas contains the active substance cinacalcet, which works by controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in your body. It is used to treat disorders of certain organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).

Cinacalcet is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to remove waste products from their 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 when removal of the parathyroid glands is not possible.

Cinacalcet is used in children between 3 years and less than 18 years of age:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood, and whose condition is not controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term "primary" means that hyperparathyroidism is not caused by any other disease, while "secondary" means that hyperparathyroidism is caused by another condition, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to loss of calcium from the bones, which may result in bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental illness, and coma.

2. What you need to know before taking Cinacalcet Aurovitas

Do not take Cinacalcet Aurovitas

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take cinacalcet.

Before starting cinacalcet, inform your doctor if you have or have ever had:

• seizures (fits or convulsions). The risk of seizures is higher in people who have previously experienced them.
• liver problems.
• heart failure.

Cinacalcet lowers calcium levels. Life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported in adults and children treated with cinacalcet.

Inform your doctor if you experience any of the following symptoms, which may indicate low calcium levels: muscle spasms, twitching or cramps, numbness or tingling in the fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness while taking cinacalcet.

Low calcium levels may affect your heart rhythm. Inform your doctor if you experience unusually strong or rapid heartbeat, have heart rhythm problems, or are taking medications that may cause heart rhythm disturbances while taking cinacalcet.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

• if you start or stop smoking, as this may alter the effect of cinacalcet.

Children and adolescents

Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism must not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with cinacalcet and during treatment. You must inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is important that you take your dose of cinacalcet exactly as prescribed by your doctor.

For children who require doses lower than 30 mg or who cannot swallow tablets, other doses/formulations of cinacalcet are available.

Taking Cinacalcet Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, particularly etelcalcetide or any other medicine that lowers calcium levels in your blood.

You must not receive cinacalcet together with etelcalcetide.

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

The following medicines may alter the effect of cinacalcet:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole, and voriconazole).
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin).
• a medicine used to treat human immunodeficiency virus (HIV) infection and AIDS (ritonavir).
• a medicine used to treat depression (fluvoxamine).

Cinacalcet may alter the effect of the following medicines:

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

Taking Cinacalcet Aurovitas with food and drink

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Cinacalcet has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as cinacalcet may be harmful to the unborn baby.

It is not known whether cinacalcet passes into breast milk. Your doctor will advise you whether you should stop breast-feeding or stop treatment with cinacalcet.

Driving and using machines

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

Cinacalcet Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Cinacalcet Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Cinacalcet Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much cinacalcet you should take.

Cinacalcet should be taken orally, with food or shortly after eating. The tablets must not be chewed or crushed.

Your doctor will carry out regular blood tests during treatment to monitor your progress and, if necessary, adjust your dose.

If treatment is for secondary hyperparathyroidism

The usual starting dose of cinacalcet in adults is 30 mg (one tablet) once daily.

The usual starting dose of cinacalcet in children aged 3 years to less than 18 years should not exceed 0.20 mg/kg body weight per day.

If treatment is for parathyroid carcinoma or primary hyperparathyroidism

The usual starting dose of cinacalcet in adults is 30 mg (one tablet) twice daily.

If you take more Cinacalcet Aurovitas than you should

If you have taken more cinacalcet than you should, you must contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cinacalcet Aurovitas

Do not take a double dose to make up for missed doses.

If you have forgotten to take a dose of cinacalcet, you should take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately:

• If you notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These may be symptoms of low calcium levels (hypocalcemia).
• If you notice swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• Nausea and vomiting. These adverse effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• Dizziness.
• Sensation of numbness or tingling (paresthesia).
• Loss (anorexia) or reduced appetite.
• Muscle pain (myalgia).
• Weakness (asthenia).
• Skin rash.
• Decreased testosterone levels.
• High potassium levels in the blood (hyperkalemia).
• Allergic reactions (hypersensitivity).
• Headache.
• Seizures (fits or attacks).
• Low blood pressure (hypotension).
• Upper respiratory tract infection.
• Difficulty breathing (dyspnea).
• Cough.
• Stomach discomfort (dyspepsia).
• 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 available data

• Hives (urticaria).
• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).
• Unusually fast or strong heartbeat, which may be associated with low calcium levels in the blood (prolonged QT and ventricular arrhythmia secondary to hypocalcemia).

In a small number of patients with heart failure, their condition and/or low blood pressure (hypotension) worsened after taking cinacalcet.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Aurovitas

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 outer carton and blister, after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinacalcet Aurovitas

• The active substance is cinacalcet.

Cinacalcet Aurovitas 30 mg film-coated tablets EFG:

Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).

Cinacalcet Aurovitas 60 mg film-coated tablets EFG:

Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).

Cinacalcet Aurovitas 90 mg film-coated tablets EFG:

Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride).

• The other components are:

Tablet core: pregelatinized maize starch, crospovidone (Type A), microcrystalline cellulose (Grade 102), colloidal anhydrous silica, and sodium stearyl fumarate.

Tablet coating: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, iron oxide yellow (E172), indigo carmine aluminium lake (E132), macrogol 6000 (E1521), macrogol 400 (E1521).

Appearance of the product and pack contents

Cinacalcet Aurovitas 30 mg film-coated tablets EFG

Light green, oval, biconvex film-coated tablets, marked with “CN” on one side and “30” on the other.

Cinacalcet Aurovitas 60 mg film-coated tablets EFG

Light green, oval, biconvex film-coated tablets, marked with “C” and “N” on either side of the breakline on one side and “60” on the other. The tablet can be divided into equal doses.

Cinacalcet Aurovitas 90 mg film-coated tablets EFG

Light green, oval, biconvex film-coated tablets, marked with “C” and “N” on either side of the breakline on one side and “90” on the other. The tablet can be divided into equal doses.

Cinacalcet Aurovitas film-coated tablets are available in blister packs.

Pack sizes:

Blister packs: 14, 28, 30, 50, 84 and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

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:

Germany: Cinacalcet PUREN 30 mg/60 mg/90 mg Filmtabletten

Belgium: Cinacalcet AB 30 mg/60 mg/90 mg filmomhulde tabletten

Spain: Cinacalcet Aurovitas 30 mg/60 mg/90 mg comprimidos recubiertos con película EFG

France: Cinacalcet Arrow 30 mg/60 mg/90 mg comprimé pelliculé

Italy: Cinacalcet Aurobindo

Netherlands: Cinacalcet Aurobindo 30 mg/60 mg/90 mg, filmomhulde tabletten

Poland: Cinacalcet Aurovitas

Portugal: Cinacalcet Generis

Czech Republic: Cinacalcet Aurovitas

Date of the most recent revision of this leaflet: April 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).