Cinacalcet polpharma

Patient information leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language.
Cinacalcet Polpharma (Cinacalcet Normon), 90 mg, film-coated tablets
Cinacalcetum
Cinacalcet Polpharma and Cinacalcet Normon are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Cinacalcet Polpharma works by controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck near the thyroid gland. They produce a hormone called parathyroid hormone (PTH). Cinacalcet Polpharma is used in adult patients:

• for the treatment of secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to clear metabolic waste products from the blood,
• to reduce elevated blood calcium levels (hypercalcemia) in adults with parathyroid cancer,
• to reduce elevated blood calcium levels (hypercalcemia) in adults with primary hyperparathyroidism when surgery to remove the parathyroid glands is not possible.

Cinacalcet Polpharma is used in children and adolescents aged from 3 to below 18 years:

• for the treatment of secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clear metabolic waste products from the blood, when the condition cannot be controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means that the overactivity is not caused by any other factors, whereas "secondary" means that the overactivity is caused by other factors, such as kidney disease. Both primary and secondary hyperparathyroidism may lead to loss of calcium from bones, which can result in bone pain and fractures, vascular and heart complications, kidney stones, mental disturbances, and coma.

2. Important information before using Cinacalcet Polpharma

When not to take Cinacalcet Polpharma

• if the patient is allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6),
• if the patient has low blood calcium levels. The doctor will monitor calcium levels in the blood.

Warnings and precautions
Before starting treatment with Cinacalcet Polpharma, discuss this with your doctor,
pharmacist, or nurse.
Before taking cinacalcet, inform your doctor about current and previously existing
medical conditions, including:

• seizures. The risk of seizures is higher in patients who have experienced them previously,
• liver function disorders,
• heart failure.

Cinacalcet Polpharma reduces calcium levels. In adults and children treated with cinacalcet,
life-threatening events and fatal outcomes related to low calcium levels (hypocalcaemia) have been reported.
Inform your doctor if the patient experiences symptoms of low calcium levels while taking Cinacalcet Polpharma:
muscle spasms or cramps, numbness or tingling in the fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness.
Low calcium levels may affect heart rhythm. Contact your doctor if there is unusually rapid heartbeat or palpitations, if heart rhythm disturbances occur, or if the patient is taking other medicines causing heart rhythm disturbances during treatment with Cinacalcet Polpharma.
Additional information, see section 4.
During treatment with Cinacalcet Polpharma, inform your doctor about:

• starting or stopping smoking, as this may affect the effectiveness of cinacalcet.

Children and adolescents
Cinacalcet Polpharma must not be used in children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism.
If the patient is being treated for secondary hyperparathyroidism, the doctor will monitor calcium levels before and during treatment with Cinacalcet Polpharma. Inform the doctor if symptoms of low calcium levels described above occur.
It is important that the patient takes the dose of Cinacalcet Polpharma prescribed by the doctor.
Cinacalcet Polpharma with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, especially etelcalcetide or other medicines that reduce blood calcium levels.
Do not take Cinacalcet Polpharma together with etelcalcetide.
Inform your doctor if the patient is taking any of the following medicines.
The effectiveness of cinacalcet may be affected by:

• medicines used for skin infections and fungal infections (ketoconazole, itraconazole, and voriconazole),
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin),
• a medicine used for HIV infection and AIDS (ritonavir),
• a medicine used for depression (fluvoxamine).

Cinacalcet may affect the effectiveness of:

• medicines used for depression (amitriptyline, desipramine, nortriptyline, and clomipramine),
• a medicine used to reduce cough (dextromethorphan),
• medicines used for heart rhythm disorders (flecainide and propafenone),
• a medicine used for hypertension (metoprolol).

Cinacalcet Polpharma with food and drink
Cinacalcet Polpharma should be taken during or shortly after a meal.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, the doctor may decide to change treatment, as cinacalcet may pose a risk to the fetus.
It is unknown whether cinacalcet passes into human breast milk. The treating doctor will discuss with the patient whether to discontinue breastfeeding or stop taking Cinacalcet Polpharma.
Driving and operating machinery
Patients taking cinacalcet have reported dizziness and seizures. If these symptoms occur, the patient should not drive or operate machinery.

3. How to use Cinacalcet Polpharma

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist. The doctor will inform the patient what dose of
Cinacalcet Polpharma should be taken.
Cinacalcet Polpharma is available in the following strengths: 30 mg, 60 mg, 90 mg.
Cinacalcet Polpharma should be taken orally, during or shortly after a meal. Tablets should be
swallowed whole and must not be chewed, crushed, or divided.
Cinacalcet is also available as granules in opening capsules. Children who require doses lower than
30 mg or who cannot swallow tablets should take cinacalcet as granules.
The doctor will regularly take blood samples to monitor the progress of treatment and adjust the
dose as necessary.

Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Polpharma in adults is 30 mg once daily.
The usual starting dose of Cinacalcet Polpharma in children and adolescents aged 3 to below 18 years
is no more than 0.20 mg/kg body weight per day.

Treatment of parathyroid carcinoma and primary hyperparathyroidism
The usual starting dose of Cinacalcet Polpharma in adults is 30 mg twice daily.

Taking more Cinacalcet Polpharma than prescribed
If more Cinacalcet Polpharma has been taken than prescribed, contact a doctor immediately.
Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or
cramps, or seizures.

If a dose of Cinacalcet Polpharma is missed
Do not take a double dose to make up for a missed dose.
If a dose of Cinacalcet Polpharma is missed, take the next dose at the usual time.
If there are any questions about the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You must contact your doctor immediately:

• if the patient develops numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low calcium levels (hypocalcaemia).
• if the patient develops swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting (usually mild and short-lived).

Common: may affect less than 1 in 10 people

• dizziness
• sensation of numbness or tingling (paraesthesiae)
• loss of appetite (anorexia) or reduced appetite
• muscle pain
• weakness
• rash
• decreased testosterone levels
• high blood potassium levels (hyperkalaemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (seizure attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• breathing difficulties (dyspnoea)
• cough
• indigestion
• diarrhoea
• abdominal pain, upper abdominal pain
• constipation
• muscle cramps
• back pain
• low blood calcium levels (hypocalcaemia).

Frequency unknown: cannot be estimated from the available data

• urticaria
• swelling of the face, lips, oral cavity, tongue and throat, which may cause difficulty in swallowing and breathing (angioedema)
• abnormally rapid heartbeat or palpitations, which may be related to low blood calcium levels (QT interval prolongation and ventricular arrhythmias resulting from hypocalcaemia).

In a small number of patients with heart failure taking cinacalcet, worsening of heart failure and/or reduction in blood pressure (hypotension) has occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49-21-301
Fax: + 48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cinacalcet Polpharma

Keep this medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Polpharma contains

• The active substance is cinacalcet. Each coated tablet contains 90 mg of cinacalcet (as cinacalcet hydrochloride).
• The other ingredients are:
  Tablet core: microcrystalline cellulose, povidone, colloidal anhydrous silica, crospovidone, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, talc, indigo carmine (E 132), yellow iron oxide (E 172).

What Cinacalcet Polpharma looks like and contents of the pack
Cinacalcet Polpharma 90 mg is a light green, elongated, biconvex coated tablet, 15 mm long and 7 mm wide, marked with "C90" on one side and smooth on the other.
Cinacalcet Polpharma is available in blisters containing coated tablets. Each carton package contains 28 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Spain, the country of export, and Manufacturer:
Laboratorios Normon, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Parallel Importer:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław

Spanish Marketing Authorisation Number (country of export): 725025.8
Parallel Import Licence Number: 313/25
[parallel importer's logo]