Patient Information Leaflet: Package Leaflet

Cinacalcet Tarbis 60 mg Film-Coated Tablets

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Cinacalcet Tarbis

4. Possible side effects

5. Storage of Cinacalcet Tarbis

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, 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 take Cinacalcet Tarbisif you are allergic to cinacalcet or any of the other ingredients of this medication (listed in section 6).

Do not take Cinacalcet Tarbisif you have low levels of calcium in your blood. Your doctor will monitor your calcium levels in the blood.

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:

• seizures(attacks or crises). The risk of 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 being treated 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 directed by your doctor.

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

Other medications and cinacalcet

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

You should not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking the following medications.

The following medications may modify the action of cinacalcet:

• medications used to treatskinand fungal infections (ketoconazole, itraconazole, and voriconazole);
• medications used to treatbacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medication used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);
• a medication used to treatdepression(fluvoxamine).

Cinacalcet may modify the action of some medications, such as:

• medications used to treatdepression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medication used to relievecough(dextromethorphan);
• medications used to treatheart rhythm disorders(flecainide and propafenone);
• a medication used to treathigh 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 if 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.

Cinacalcet Tarbis contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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. The 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 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 than you should

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

If you forgot to take cinacalcet

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 medications, this medication may 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).(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 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 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not use this medication after the expiration date that appears on the box and the bottle. 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cinacalcet Tarbis

The active ingredient is cinacalcet. Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).

The other components are: Microcrystalline cellulose, pregelatinized maize starch, crospovidone, talc, magnesium stearate.

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

Appearance of the product and contents of the package

Cinacalcet Tarbis is a film-coated tablet of light green color. They have an oval, biconvex shape and are marked “C7” on one face and “H” on the other.

The 60 mg tablets measure approximately 12.5 mm in length and 7.8 mm in width.

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

Cinacalcet Tarbis is presented in bottles of 30 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

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 with the following names:

Denmark:Cinacalcet Amarox 60 mg filmovertrukne tabletter

Germany:Cinacalcet Amarox 60 mg Filmtabletten

Netherlands:Cinacalcet Amarox 60 mg filmomhulde tabletten

Spain:Cinacalcet Tarbis 60 mg comprimidos recubiertos con película EFG

Sweden:Cinacalcet Amarox 60 mg Filmdragerade tabletter

United Kingdom:Cinacalcet Amarox 60 mg film-coated tablets

Last review date of this leaflet: April 2020.

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