Cinacalcet polpharma

Package leaflet: Information for the patient

Warning! Keep this leaflet, information on the outer packaging in a foreign language.
Cinacalcet Polpharma (Cinacalcet Normon), 30 mg, film-coated tablets
Cinacalcetum
Cinacalcet Polpharma and Cinacalcet Normon are different trade names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of the leaflet

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

The mechanism of action of Cinacalcet Polpharma involves 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 renal disease who require dialysis to clear the blood of metabolic waste products,
• to reduce elevated blood calcium levels (hypercalcemia) in adults with parathyroid carcinoma,
• 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 3 to below 18 years:

• for the treatment of secondary hyperparathyroidism in patients with severe renal disease who require dialysis to clear the blood of metabolic waste products, 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 conditions, 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 cardiac 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 blood calcium levels.

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 diagnosed
conditions, including:

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

Cinacalcet Polpharma lowers calcium levels. Life-threatening events and fatal outcomes related
to low calcium levels (hypocalcemia) have been reported in adults and children treated with cinacalcet.
Inform your doctor if the patient experiences symptoms of low calcium levels:
muscle twitching or cramps, numbness or tingling in fingers, toes, or around the mouth,
seizure attacks, confusion, or loss of consciousness during treatment with Cinacalcet Polpharma.
Low calcium levels may affect heart rhythm. Contact your doctor if the patient experiences
abnormally rapid heartbeat or palpitations, develops heart rhythm disturbances, or is taking
other medications causing heart rhythm disorders during treatment with Cinacalcet Polpharma.
Additional information, see section 4.
During treatment with Cinacalcet Polpharma, inform your doctor about:

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

Children and adolescents
Cinacalcet Polpharma must not be used in children under 18 years of age with parathyroid cancer
or primary hyperparathyroidism.
If the patient is being treated for secondary hyperparathyroidism, the doctor will monitor
blood 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 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used,
especially etelcalcetide or other medicines that lower 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 in 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 become
pregnant, 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 either discontinuation of breastfeeding or discontinuation of treatment with Cinacalcet Polpharma.
Driving and operating machinery
Patients taking cinacalcet have reported dizziness and seizures. If the patient experiences these
symptoms, he or she should not drive or operate machinery.

3. How to use Cinacalcet Polpharma

This medicine should always be taken as prescribed by a doctor or pharmacist. If in doubt,
consult a 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, with food or shortly after a meal. Tablets
should be swallowed whole and must not be chewed, crushed, or split.
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 (one tablet) 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 (one tablet) twice daily.

If more Cinacalcet Polpharma has been taken than recommended
If more Cinacalcet Polpharma has been taken than recommended, 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 doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if:

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

Very common: affects more than 1 in 10 people

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

Common: affects less than 1 in 10 people

• dizziness
• sensation of numbness or tingling (paraesthesia)
• 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
• difficulty breathing (dyspnoea)
• cough
• indigestion
• diarrhoea
• abdominal pain, upper abdominal pain
• constipation
• muscle cramps
• back pain
• low blood calcium levels (hypocalcaemia).

Frequency unknown: frequency 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)
• unusually 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 treated with 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, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 to provide more information on the safety of the medicine.

5. How to store the medicine Cinacalcet Polpharma

Keep this medicine out of the sight and reach of children.
No special storage conditions apply.
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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Polpharma contains

• The active substance is cinacalcet. Each film-coated tablet contains 30 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), iron oxide yellow (E 172).

What Cinacalcet Polpharma looks like and contents of the pack
Cinacalcet Polpharma 30 mg are light green, elongated, biconvex film-coated tablets, 10.3 mm in length and 4.8 mm in width, marked with "C30" on one side and smooth on the other.
Cinacalcet Polpharma is available in blisters containing film-coated tablets. Each carton package contains 28 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder 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): 725023.4
Parallel import authorisation number: 311/25
[parallel importer's logo]