CINACALCET QILU 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cinacalcet Qilu 30 mg film-coated tablets EFG

Cinacalcet Qilu 60 mg film-coated tablets EFG

Cinacalcet Qilu 90 mg film-coated tablets EFG

Cinacalcet

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

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

Cinacalcet acts 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 need 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 need 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 the loss of calcium 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 Qilu

Do nottake Cinacalcet Qilu:

• if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• 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 you start taking Cinacalcet Qilu.

Before you start taking 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

Low calcium levels

Cinacalcet Qilu lowers calcium levels. In adults and children treated with Cinacalcet Qilu, 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 be signs of low calcium levels: muscle spasms, muscle contractions, or cramps, or numbness or tingling in your fingers, toes, or around your mouth, or seizures, confusion, or loss of consciousness while taking Cinacalcet Qilu.

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 can cause heart rhythm problems, while taking cinacalcet.

For more information, see section 4 "Possible side effects".

During treatment with cinacalcet, tell your doctor:

• if you start or stop smoking, as this may change the effect of Cinacalcet Qilu.

Children and adolescents

Children under 18 years with parathyroid cancer or primary hyperparathyroidism should not take Cinacalcet Qilu.

If you (or your child) are being treated for secondary hyperparathyroidism, your doctor (or your child's doctor) should monitor your calcium levels before starting treatment with Cinacalcet Qilu and during treatment with Cinacalcet Qilu. You should tell your doctor if you (or your child) experience any of the symptoms related to low calcium levels described above.

It is important that you take your dose of Cinacalcet Qilu as instructed by your doctor.

Other medicines and Cinacalcet Qilu

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 lowers calcium levels in your blood.

Do not take Cinacalcet Qilu with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of Cinacalcet Qilu:

• 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 Qilu 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).

Cinacalcet Qilu with food and drinks

Cinacalcet Qilu 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 Qilu has not been studied in pregnant women. In case of pregnancy, your doctor may decide to change your treatment, as Cinacalcet Qilu may be harmful to the unborn baby.

It is not known whether Cinacalcet Qilu passes into breast milk. Your doctor will advise you whether to stop breastfeeding or stop Cinacalcet Qilu treatment.

Driving and using machines

In patients taking Cinacalcet Qilu, cases of dizziness and seizures have been reported. If you experience these effects, do not drive or use machines.

3. How to take Cinacalcet Qilu

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with 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 be swallowed whole and not chewed, crushed, or divided.

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

Your doctor will regularly perform blood tests during treatment to monitor your progress and, if necessary, adjust the dose you receive.

Recommended doses are:

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 Qilu than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or call the Toxicology Information Service. Telephone 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 Qilu

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 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 can be symptoms of low calcium levels (hypocalcemia) in your blood.
• If you notice swelling of 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)
• 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 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 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, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es.

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

5. Storage of Cinacalcet Qilu

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 refers to 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 Qilu:

• The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as hydrochloride).
• The other ingredients are: pregelatinized corn starch, microcrystalline cellulose PH102, povidone K 30, magnesium stearate.

The tablets are coated with: opadry green 03K110016 (which contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), yellow iron oxide (E172)).

Appearance of the product and pack contents

Cinacalcet Qilu is a film-coated tablet of light green or light yellowish-green color. They are oval tablets with "55", "57", or "71" printed on one side.

The 30 mg tablets are approximately 10.4 mm long and 6.6 mm wide.

The 60 mg tablets are approximately 12.9 mm long and 8.2 mm wide.

The 90 mg tablets are approximately 14.4 mm long and 9.1 mm wide.

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

Each blister pack contains 7 tablets. It is available in pack sizes of 2 blister packs (14 tablets), 4 blister packs (28 tablets), and 12 blister packs (84 tablets) per carton.

Not all pack sizes may be marketed.

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40

8th floor, 28046 - Madrid

Spain

Manufacturer

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral,

22 Alcobendas,

Madrid

28108 Spain

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

Date of last revision of this leaflet:June 2024.

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/