CINACALCET TARBIS 30 mg FILM-COATED TABLETS

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

Do nottake Cinacalcet Tarbisif you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).

Do not take Cinacalcet Tarbisif 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 starting cinacalcet.

Before starting cinacalcet, tell your doctor if you have or have ever had:

• seizures(attacks or fits). 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 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:

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

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 to take your dose of cinacalcet as directed by your doctor.

Children who require doses lower than 30 mg or who cannot swallow tablets should receive cinacalcet granules.

Other medicines and cinacalcet

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

Do not take 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 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 change the effect of some 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 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. If you become pregnant, your doctor may decide to change your treatment, as cinacalcet may harm 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 Tarbis contains lactose

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

3. How to take Cinacalcet Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again. Your doctor will tell you how much cinacalcet to take.

Cinacalcet should be taken orally, 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 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 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 than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medicine and the amount used. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

If you forget to take cinacalcet

Do not take a double dose to make up for forgotten 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 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 may be symptoms of low calcium levels (hypocalcemia).
• If you notice swelling of 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 (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 attacks)
• 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 may 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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Cinacalcet Tarbis

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.

Do not use this medicine after the expiry date which is stated on the carton and bottle. 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 Tarbis

The active substance is cinacalcet. Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).

The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, crospovidone, talc, magnesium stearate.

The tablets are coated with: hypromellose, lactose monohydrate, titanium dioxide (E171), aluminum lake blue FD&C #2 (E132), yellow iron oxide (E172), macrogol.

Appearance and packaging

Cinacalcet Tarbis is a light green film-coated tablet. They are oval, biconvex, and marked "C6" on one side and "H" on the other.

The tablets are approximately 9.9 mm long and 6.2 mm wide.

Cinacalcet Tarbis is available in blisters of 7, 14, 28, 56, and 84 tablets. There are blisters with a perforated format of 28 x 1, 30 x 1, 84 x 1, 90 x 1, and 100 x 1 tablets.

Cinacalcet Tarbis is available in bottles of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Cinacalcet Amarox 30 mg film-coated tablets

Germany: Cinacalcet Amarox 30 mg film-coated tablets

Netherlands: Cinacalcet Amarox 30 mg film-coated tablets

Spain: Cinacalcet Tarbis 30 mg film-coated tablets EFG

Sweden: Cinacalcet Amarox 30 mg film-coated tablets

United Kingdom: Cinacalcet Amarox 30 mg film-coated tablets

Date of last revision of this leaflet: April 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.