Prospect: Information for the Patient

Cinacalcet Aurovitas 30 mg Film-Coated Tablets

Cinacalcet Aurovitas 60 mg Film-Coated Tablets

Cinacalcet Aurovitas 90 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Cinacalcet Aurovitas

3.How to take Cinacalcet Aurovitas

4.Possible adverse effects

5.Storage of Cinacalcet Aurovitas

6.Contents of the pack and additional information

Cinacalcet Aurovitas contains the active ingredient cinacalcet, which acts by controlling levels of parathyroid hormone (PTH), calcium, and phosphate in the body, and is used to treat alterations of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, that 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:

•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 primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term “primary” means that the hyperparathyroidism is not caused by any other disease and “secondary” means that the hyperparathyroidism is caused by another disease, such as kidney disease. Both primary and secondary hyperparathyroidism can cause loss of calcium from the bones, which can produce bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental disease, and coma.

Do not takeCinacalcet Aurovitas

•If you are allergic to cinacalcet or any of the other components of this medication (listed in section 6).

•If you have low levels of calcium in your blood. Your doctor will monitor your calcium blood levels.

Warnings and precautions

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

Before starting to take cinacalcet, inform your doctor if you have ever suffered from:

•seizures (attacks or crises). The risk of seizures is higher in people who have had them before.

•liver problems.

•heart failure.

Cinacalcet reduces calcium levels. In adults and children treated with cinacalcet, life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported.

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

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience abnormally strong or rapid heartbeats, if you have heart rhythm problems, or if you take medications that can cause heart rhythm problems while taking cinacalcet.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

•If you start or stop smoking, as it may affect the effect of cinacalcet.

Children and adolescents

Children under 18 years old with parathyroid cancer or primary hyperparathyroidism should 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 with cinacalcet. Inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is essential to take your cinacalcet dose as directed by your doctor.

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

TakingCinacalcet Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly etelcalcetide or any other medication that reduces calcium levels in your blood.

You should not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking the following medications.

Medications such as the following may modify the action of cinacalcet:

•Medications used to treat skin and fungal infections (ketoconazole, itraconazole, and voriconazole).

•Medications used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin).

•A medication used to treat HIV and AIDS (ritonavir).

•A medication used to treat depression (fluvoxamine).

Cinacalcet may modify the action of medications such as the following:

•Medications used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine).

•A medication used to relieve cough (dextromethorphan).

•Medications used to treat heart rhythm disorders (flecainide and propafenone).

•A medication used to treat high blood pressure (metoprolol).

TakingCinacalcet Aurovitas with food and drinks

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Cinacalcet has not been studied in pregnant women. If you become pregnant, your doctor may decide to modify your treatment, as cinacalcet may be harmful to the unborn baby.

It is not known if cinacalcet passes into breast milk. Your doctor will tell you if you should stop breastfeeding or the treatment with cinacalcet.

Driving and operating machinery

In patients taking cinacalcet, cases of dizziness and seizures have been reported. If you experience these effects, do not drive or operate machinery.

Cinacalcet Aurovitas contains lactose

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

Cinacalcet Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 should not be chewed or crushed.

Your doctor will make regular blood tests during treatment to monitor your progress and, if necessary, adjust the dose you receive.

If the treatment is for secondary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg (one tablet) once a day.

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

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg (one tablet) twice a day.

If you take more Cinacalcet Aurovitas than you should

If you have taken more cinacalcet than you should have, you should 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Cinacalcet Aurovitas

Do not take a double dose to make up for the 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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform 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 in the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

•Dizziness.

•Numbness or tingling (paresthesia).

•Loss of appetite (anorexia) or decreased appetite.

•Muscle pain (myalgia).

•Weakness (asthenia).

•Skin rash.

•Decreased testosterone levels.

•High levels of potassium in the blood (hyperkalemia).

•Allergic reactions (hypersensitivity).

•Headache.

•Seizures (crises or attacks).

•Low blood pressure (hypotension).

•Upper respiratory tract infection.

•Dyspnea (difficulty breathing).

•Cough.

•Indigestion (dyspepsia).

•Diarrhea.

•Abdominal pain, upper abdominal pain.

•Constipation.

•Muscle spasms.

•Back pain.

•Low calcium levels in the blood (hypocalcemia).

Unknown frequency: cannot be estimated from available data

•Hives (urticaria).

•Swelling in the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).

•Unusual heart rhythm or palpitations that may be associated with low calcium levels in the blood (QT prolongation and secondary ventricular arrhythmia due 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofCinacalcet Aurovitas

-The active ingredient is cinacalcet.

Cinacalcet Aurovitas 30 mg film-coated tablets:

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

Cinacalcet Aurovitas 60 mg film-coated tablets:

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

Cinacalcet Aurovitas 90 mg film-coated tablets:

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

-The other components are:

Core of the tablet:pregelatinized maize starch, crospovidone (Type A), microcrystalline cellulose (Grade 102), anhydrous colloidal silica, and sodium stearyl fumarate.

Coating of the tablet:lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172), indigo carmine lake (E132), macrogol 6000 (E1521), and macrogol 400 (E1521).

Appearance of the product and contents of the package

Cinacalcet Aurovitas 30 mg film-coated tablets

Film-coated tablets of a light green color, oval, biconvex, with the marks “CN” on one face and “30” on the other.

Cinacalcet Aurovitas 60 mg film-coated tablets

Film-coated tablets of a light green color, oval, biconvex, with the marks “C” and “N” on either side of the groove on one face and “60” on the other. The tablet can be divided into equal doses.

Cinacalcet Aurovitas 90 mg film-coated tablets

Film-coated tablets of a light green color, oval, biconvex, with the marks “C” and “N” on either side of the groove on one face and “90” on the other. The tablet can be divided into equal doses.

CinacalcetAurovitas film-coated tablets are available in blister packs.

Pack sizes:

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the member states of the European Economic Area with 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 last review of this leaflet:April2019

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).