CINACALCET PHARMSOL 60 mg FILM-COATED TABLETS

Introduction

Leaflet:information for theuser

Cinacalcet PharmSol 30mg film-coated tablets EFG

Cinacalcet PharmSol 60mg film-coated tablets EFG

Cinacalcet PharmSol 90mg film-coated tablets EFG

Cinacalcet

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Cinacalcet PharmSol and what is it used for
2. What you need to know before taking Cinacalcet PharmSol
3. How to take Cinacalcet PharmSol
4. Possible side effects
5. Storage of Cinacalcet PharmSol
6. Package contents and additional information

1. What is Cinacalcet PharmSol 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 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 loss from the bones, which can lead to 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 PharmSol

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

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

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 or have ever had:

• seizures(attacks or crises). 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.

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 taking cinacalcet.

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience unusually strong or fast heartbeats, if you have problems with your heart rhythm, or if you take medications that cause problems with your heart rhythm, 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 of age 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 inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is essential that you take your dose of cinacalcet as directed by your doctor.

Other medicines and cinacalcet

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

You should not receive cinacalcet with etelcalcetide.

Inform your doctor if you are taking the following medications.

Medicines such as the following 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 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 plan to become pregnant, consult your doctor or pharmacist before using 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 whether you should interrupt breastfeeding or treatment with 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 PharmSol contains lactose and sodium

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

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

3. How to take Cinacalcet PharmSol

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult 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.

Cinacalcet is also available as a granule in capsules for opening. Children who require doses below 30 mg or who cannot swallow tablets should receive cinacalcet granules.

Your doctor will perform 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 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 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 other questions about the use of this medicine, 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) in your blood.
• If you notice swelling in 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
• feeling of numbness or tingling (paresthesia)
• loss (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 (crises or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infections
• 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 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, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

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

5. Storage of Cinacalcet PharmSol

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 after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Cinacalcet PharmSol

• The active ingredient is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as hydrochloride).

• The other excipients are:

Core of the tablet

Pregelatinized cornstarch

Microcrystalline cellulose (E460)

Sodium croscarmellose (E468)

Colloidal anhydrous silica (E551)

Magnesium stearate (E470b)

Coating

Hypromellose 15cP (E464)

Lactose monohydrate

Titanium dioxide (E171)

Triacetin

FD & C Blue No. 2/Aluminum carmine indigo (E132)

Yellow iron oxide (E172)

Appearance of the product and package contents

Cinacalcet PharmSol 30 mg: green, oblong, biconvex, film-coated tablet, engraved with "30" on one side and smooth on the other.

Cinacalcet PharmSol 60 mg: green, oblong, biconvex, film-coated tablet, engraved with "60" on one side and smooth on the other.

Cinacalcet PharmSol 90 mg: green, oblong, biconvex, film-coated tablet, engraved with "90" on one side and smooth on the other.

Cinacalcet PharmSol is available in transparent blister packs of 30 mg, 60 mg, or 90 mg film-coated tablets.

Package size: 28 tablets per carton.

Marketing authorization holder and manufacturer:

Marketing authorization holder

PharmSol Europe Limited

The Victoria Centre Unit 2,

Lower Ground Floor,

Valletta Road, Mosta MST 9012,

MALTA

Manufacturer

Genepharm S.A.

18 km Marathon Avenue

153 51 Pallini

Greece

Or

Delorbis Pharmaceuticals Ltd

17 Athinon str.,

Ergates Industrial Area,

2643 Ergates,

Nicosia, Cyprus

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

AustriaCinacalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets

CroatiaCinakalcet PharmSol 30 mg, 60 mg, 90 mg film-coated tablets

Czech RepublicCinacalcet PharmSol

HungaryCinacalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets

MaltaCinacalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets

Slovak RepublicCinacalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets

SloveniaCinakalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets

SpainCinacalcet PharmSol 30 mg, 60 mg, and 90 mg film-coated tablets EFG

Date of last revision of this leaflet:November 2020

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