Leaflet: information for the user

CinacalcetZentiva60 mg film-coated tablets

cinacalcet

Read 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Cinacalcet Zentiva

3. How to take Cinacalcet Zentiva

4. Possible side effects

5. Storage of Cinacalcet Zentiva

6. Contents of the pack and additional information

Cinacalcet acts by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus 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.

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 illness, and coma.

Do not take CinacalcetZentiva

• 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 CinacalcetZentiva.

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

• seizures (attacks or fits). The risk of having 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, or numbness or tingling in the fingers of the hands, feet or around the mouth, or seizures, 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 this may affect the effect of cinacalcet.

Children and adolescents

Children under 18 years old should not take this medicine.

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.

Use of CinacalcetZentivawith other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Medicines known to reduce serum calcium.

You should not take cinacalcet with etelcalcetide, as there is a higher risk of a condition called hypocalcemia when cinacalcet is taken with medicines that are known to reduce calcium levels in the blood.

Inform your doctor if you are taking the following medicines.

Medicines that may modify the action of cinacalcet:

• medicines used to treat skin infections 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 modify the action 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 CinacalcetZentivawith 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 or pharmacist before using this medicine.

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 whether 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.

CinacalcetZentivacontains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

Follow exactly the administration instructions for this medication as indicated 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. Tablets should be swallowed whole and not chewed, crushed, or divided.

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

If treatment is for secondary hyperparathyroidism

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

If 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 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 Zentiva

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

If you have forgotten to take a dose of cinacalcet, 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 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 (crisis 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).

Not known: its frequency cannot be estimated from available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)
• Unusually rapid or strong heartbeat 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 Pharmacovigilance of Medicines for Human Use https://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 outer packaging and the blister pack 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 the packaging and medications that you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Cinacalcet

The active ingredient is cinacalcet. Each film-coated tablet contains 60 mg of cinacalcet.

The other components are:

Core of the tablet: Maize pregelatinised starch, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate.

Coating:Hydroxypropyl methylcellulose, lactose monohydrate, titanium dioxide (E171), triacetin, macrogol.

Appearance of the product and contents of the package

Cinacalcet is a film-coated tablet of white to off-white color. They are oval in shape and marked “60” on one side and measure approximately 12.5 mm in length and 7.9 mm in width.

Cinacalcet is presented in blisters of film-coated tablets of 60 mg. Each box contains 28, 30 or 84 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Republic of Czech

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3,Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

NetherlandsCinacalcet Aristo 60 mg, filmomhulde tabletten

AustriaCinacalcet Aristo 60 mg Filmtabletten

Czech RepublicCinacalcet Aristo

GermanyCinacalcet Aristo 60 mg Filmtabletten

DenmarkCinacalcet Aristo

SpainCinacalcetZentiva60 mg film-coated tablets EFG

FinlandCinacalcet Aristo 60 mg kalvopäällysteiset tabletit

ItalyCinacalcet Aristo

NorwayCinacalcet Aristo

PolandCinacalcet Aristo

PortugalCinacalcet Aristo

RomaniaCinacalcet Aristo 60 mg comprimate filmate

SwedenCinacalcet Aristo 60 mg film-coated tablets

SlovakiaCinacalcet Aristo 60 mg filmom obalené tablety

United KingdomCinacalcet Aristo 60 mg film-coated tablets

Last review date of this leaflet:March 2020

For detailed and updated information about this medicine, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/