Cinacalcet Tarbis 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cinacalcet Tarbis 30 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 symptoms 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 leaflet

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

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

Cinacalcet works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat disorders of certain glands called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid, 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 of age:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood, and whose condition is not controlled with other treatments.

In both 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 lead to loss of calcium from the bones, which may result in bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental illness, and coma.

2. What you need to know before taking Cinacalcet Tarbis

Do not take Cinacalcet Tarbis if you are allergic to cinacalcet or to any of the other ingredients of this medicine (listed in section 6).

Do not take Cinacalcet Tarbis 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 starting treatment with cinacalcet.

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

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

Cinacalcet lowers calcium levels. Life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported in adults and children treated with cinacalcet.

Inform your doctor if you experience any of the following symptoms, which may indicate low calcium levels: muscle spasms, twitching or cramps, or numbness and tingling in the fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking cinacalcet.

Low calcium levels may affect your heart rhythm. Inform your doctor if you experience unusually strong or rapid heartbeat, have heart rhythm problems, or are taking medications that may cause heart rhythm disturbances 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 alter the effect of cinacalcet.

Children and adolescents

Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism must not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting and during treatment with cinacalcet. You must inform 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 exactly as prescribed by your doctor.

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

Other medicines and cinacalcet

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

You must not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking any of the following medicines.

The following medicines may affect the action of cinacalcet:

• medicines used to treat skin conditions and fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Cinacalcet may affect the action of certain 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 drink

Cinacalcet should be taken with food or shortly after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Cinacalcet has not been studied in pregnant women. During 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 you should stop breastfeeding or discontinue treatment with cinacalcet.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these effects, do not drive or operate machinery.

Cinacalcet Tarbis contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Cinacalcet Tarbis

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 must be swallowed whole and must not be chewed, crushed, or split.

Your doctor will perform regular blood tests during treatment to monitor your progress and, if necessary, adjust your dose.

If treatment is for secondary hyperparathyroidism

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

The usual initial dose of cinacalcet in children aged 3 years and under 18 years should not exceed 0.20 mg/kg body weight per day.

If treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg (one tablet) twice daily.

If you take more cinacalcet than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and amount taken. 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 missed doses.

If you forget to take a dose of cinacalcet, take the next dose at your usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• Nausea and vomiting. These adverse effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• Dizziness
• Sensation of numbness or tingling (paresthesia)
• Loss (anorexia) or reduced appetite
• Muscle pain (myalgia)
• Weakness (asthenia)
• Skin rash
• Decreased testosterone levels
• High potassium levels in the blood (hyperkalemia)
• Allergic reactions (hypersensitivity)
• Headache
• Seizures (crises or attacks)
• Low blood pressure (hypotension)
• Upper respiratory tract infection
• Difficulty breathing (dyspnea)
• Cough
• Stomach discomfort (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 available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema)
• Unusually fast or strong heartbeat, which may be associated with low calcium levels in the blood (prolonged QT and ventricular arrhythmia secondary 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 adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse 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 stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This way, you 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 components are: microcrystalline cellulose, pregelatinized corn starch, crospovidone, talc, magnesium stearate.

The tablets are coated with: hypromellose, lactose monohydrate, titanium dioxide (E171) triacetate, FD&C Blue No. 2 aluminium lake (E132), yellow iron oxide (E172), macrogol.

Appearance of the product and contents of the pack

Cinacalcet Tarbis is a light green film-coated tablet. It is oval-shaped, biconvex, and marked with “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 containing 7, 14, 28, 56 and 84 tablets. There are also perforated blister formats containing 28 x 1, 30 x 1, 84 x 1, 90 x 1 and 100 x 1 tablets.

Cinacalcet Tarbis is also available in bottles containing 30 tablets.

Only certain 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

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Cinacalcet Amarox 30 mg filmovertrukne tabletter

Germany: Cinacalcet Amarox 30 mg Filmtabletten

The Netherlands: Cinacalcet Amarox 30 mg filmomhulde tabletten

Spain: Cinacalcet Tarbis 30 mg comprimidos recubiertos con película EFG

Sweden: Cinacalcet Amarox 30 mg Filmdragerade tabletter

United Kingdom: Cinacalcet Amarox 30 mg film-coated tablets

Date of the most recent revision of this leaflet: April 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es