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 package and additional information

Cinacalcet Aurovitas contains the active ingredient cinacalcet, which acts by controlling the levels of parathyroid hormone (PTH), calcium, and phosphate in your 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 disease 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 ingredients of this medicine (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:

•convulsions (seizures or fits). The risk of having convulsions is higher in people who have had them before.

•liver problems.

•heart failure.

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

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

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience abnormally strong or rapid heartbeats, if you have problems with your heart rhythm 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 instructed by your doctor.

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

TakingCinacalcet Aurovitas with other medicines

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

You should not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking the following medicines.

Medicines such as the following may affect the action 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 HIV and AIDS (ritonavir).

•a medicine used to treat depression (fluvoxamine).

Cinacalcet may affect the action of medicines such as the following:

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

•a medicine used to relieve cough (dextromethorphan).

•medicines used to treat heart rhythm problems (flecainide and propafenone).

•a medicine 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 think you may be pregnant, consult your doctor before using this medicine.

Cinacalcet has not been studied in pregnant women. If you become pregnant, your doctor may decide to change 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 machines

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

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 them before taking this medicine.

Cinacalcet Aurovitas contains sodium

This medicine 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 can 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 temporary.

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 (crisis or attacks).

•Low blood pressure (hypotension).

•Upper respiratory tract infection.

•Difficulty breathing (dyspnea).

•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).

•Unusually fast or strong heartbeat that may be associated with low calcium levels in the blood (prolonged QT 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 Vigilance 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 storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging 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 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:

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

Tablet coating: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 EFG

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 EFG

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 EFG

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.

Marketing authorization holder and responsible 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

Responsible manufacturer

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

Further 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/).