CINACALCET ZENTIVA 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cinacalcet Zentiva 30 mg film-coated tablets EFG

cinacalcet

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cinacalcet Zentiva and what is it used for
2. What you need to know before you take Cinacalcet Zentiva
3. How to take Cinacalcet Zentiva
4. Possible side effects
5. Storage of Cinacalcet Zentiva
6. Contents of the pack and other information

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

Cinacalcet works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body. It is used to treat disorders of the 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.

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 calcium to be lost from the bones, which can lead to bone pain and fractures, blood vessel and heart problems, kidney stones, mental illness, and coma.

2. What you need to know before you take Cinacalcet Zentiva

Do not take Cinacalcet Zentiva

• 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 blood calcium levels.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Cinacalcet Zentiva.

Before you start taking cinacalcet, tell your doctor if you have or have had:

• seizures (fits or convulsions). The risk of having seizures is higher in people who have already had them;
• liver problems;
• heart failure.

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

Tell 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, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking cinacalcet.

Low calcium levels can affect your heart rhythm. Tell your doctor if you experience unusually strong or fast heartbeats, if you have heart rhythm problems, or if you take medicines that can cause heart rhythm problems while taking cinacalcet.

For more information, see section 4.

During treatment with cinacalcet, tell your doctor:

• if you start or stop smoking, as this may affect the action of cinacalcet.

Children and adolescents

Children under 18 years 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. You should tell 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 as directed by your doctor.

Using Cinacalcet Zentiva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines known to reduce serum calcium.

You should not receive 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 your blood. Tell your doctor if you are taking the following medicines.

Medicines that may alter the action of cinacalcet:

• medicines used to treat skinand fungal infections(ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat HIVand AIDS(ritonavir);
• a medicine used to treat depression(fluvoxamine).

Cinacalcet may alter the action of medicines such as:

• 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 Zentiva with food and drinks

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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. In case of 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 to stop breastfeeding or stop taking cinacalcet.

Driving and using machines

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

Cinacalcet Zentiva contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Cinacalcet Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Your doctor will tell you how much cinacalcet to take.

Cinacalcet should be taken by mouth, with food or shortly after eating. The tablets should be swallowed whole and not chewed, crushed, or divided.

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

If you are being treated for secondary hyperparathyroidism

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

If you are being treated for parathyroid cancer or primary hyperparathyroidism

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

If you take more Cinacalcet Zentiva than you should

If you have taken more cinacalcet than 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cinacalcet Zentiva

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately:

• If you notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These can be symptoms of low calcium levels (hypocalcemia).
• If you notice swelling of the face, lips, mouth, tongue, or throat that can 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 (anorexia) or decreased appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• decreased testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (fits or convulsions)
• low blood pressure (hypotension)
• upper respiratory tract infections
• difficulty breathing (dyspnea)
• cough
• stomach upset (dyspepsia)
• diarrhea
• abdominal pain, upper abdominal pain
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcemia).

Not known: frequency cannot be estimated from the available data

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use https://www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Zentiva

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 packaging and blister after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cinacalcet

The active substance is cinacalcet. Each film-coated tablet contains 30 mg of cinacalcet.

The other ingredients are:

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

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

Appearance and packaging

Cinacalcet is a white to off-white film-coated tablet. They are oval in shape and marked "30" on one side and measure approximately 10 mm in length and 6.3 mm in width.

Cinacalcet is available in blister packs of 30 mg film-coated tablets. Each carton contains 28, 30, or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

For more information about this medicine, 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 under the following names:

Netherlands Cinacalcet Aristo 30 mg, film-coated tablets

Austria Cinacalcet Aristo 30 mg film-coated tablets

Czech Republic Cinacalcet Aristo

Germany Cinacalcet Aristo 30 mg film-coated tablets

Denmark Cinacalcet Aristo

Spain Cinacalcet Zentiva 30 mg film-coated tablets EFG

Finland Cinacalcet Aristo 30 mg film-coated tablets

Italy Cinacalcet Aristo

Norway Cinacalcet Aristo

Poland Cinacalcet Aristo

Portugal Cinacalcet Aristo

Romania Cinacalcet Aristo 30 mg film-coated tablets

Sweden Cinacalcet Aristo 30 mg film-coated tablets

Slovakia Cinacalcet Aristo 30 mg film-coated tablets

United Kingdom Cinacalcet Aristo 30 mg film-coated tablets

Date of last revision of this leaflet:March 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/