CINACALCET AUROVITAS 30 mg FILM-COATED TABLETS

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

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

Cinacalcet Aurovitas contains the active substance cinacalcet, which 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.

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

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

Do not takeCinacalcet Aurovitas

Warnings and precautions

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

Before starting 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, numbness or tingling in the fingers, toes, or around the mouth, 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 problems with your heart rhythm, or if you take medicines that cause problems with your heart rhythm, while taking cinacalcet.

For more information, see section 4.

During treatment with cinacalcet, tell your doctor:

Children and adolescents

Children under 18 years 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. 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.

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

Taking Cinacalcet Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially etelcalcetide or any other medicine that reduces calcium levels in your blood.

You should not receive cinacalcet with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change 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 HIV and AIDS (ritonavir).
• a medicine used to treat depression (fluvoxamine).

Cinacalcet may change the effect of medicines like 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 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor 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 tell you if you should 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 Aurovitas contains lactose

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Cinacalcet Aurovitas contains sodium

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

3. How to take Cinacalcet Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 not be chewed or crushed.

Your doctor will regularly perform 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 starting dose of cinacalcet in adults is 30 mg (one tablet) once a day.

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

If the treatment is 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 Aurovitas 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 Aurovitas

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

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:

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.
• feeling of 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 infection.
• 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).

Frequency not known: cannot be estimated from the available data

• hives (urticaria).
• swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in 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 Agency's website (www.notificaram.es). By reporting side 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 carton and blister, after "EXP". The expiry date is the last day of the month shown.

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 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 ingredients are:

Core of the tablet:pregelatinized corn 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), carmine indigo 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 with "CN" on one face and "30" on the other.

Cinacalcet Aurovitas 60 mg film-coated tablets EFG

Light green, oval, biconvex film-coated tablets with "C" and "N" on either side of the score line on one face 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 with "C" and "N" on either side of the score line on one face 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:14, 28, 30, 50, 84, and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Phone: 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Cinacalcet PUREN 30 mg/60 mg/90 mg film-coated tablets

Belgium: Cinacalcet AB 30 mg/60 mg/90 mg film-coated tablets

Spain: Cinacalcet Aurovitas 30 mg/60 mg/90 mg film-coated tablets EFG

France: Cinacalcet Arrow 30 mg/60 mg/90 mg film-coated tablets

Italy: Cinacalcet Aurobindo

Netherlands: Cinacalcet Aurobindo 30 mg/60 mg/90 mg film-coated tablets

Poland: Cinacalcet Aurovitas

Portugal: Cinacalcet Generis

Czech Republic: Cinacalcet Aurovitas

Date of last revision of this leaflet:April2019

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