CINACALCET 60 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Cinacalcet Accord, 30 mg, coated tablets
3. Cinacalcet Accord, 60 mg, coated tablets
4. Cinacalcet Accord, 90 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Cinacalcet Accord and what is it used for
6. Important information before taking Cinacalcet Accord
   1. When not to take Cinacalcet Accord:
   2. Warnings and precautions
   3. Children and adolescents
   4. Cinacalcet Accord and other medicines
   5. Cinacalcet Accord with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Cinacalcet Accord contains lactose
7. How to take Cinacalcet Accord
   1. Treatment of secondary hyperparathyroidism
   2. Treatment of parathyroid cancer and primary hyperparathyroidism
   3. Taking a higher dose of Cinacalcet Accord than recommended
   4. Missing a dose of Cinacalcet Accord
8. Possible side effects
   1. The patient should immediately inform their doctor:
   2. Frequency not known: frequency cannot be estimated from the available data
   3. Reporting side effects
9. How to store Cinacalcet Accord
10. Contents of the packaging and other information
    1. What Cinacalcet Accord contains
    2. What Cinacalcet Accord looks like and contents of the pack
    3. Responsible entity:
    4. Manufacturer/Importer:
    5. Date of last revision of the leaflet: 04/2020

Leaflet accompanying the packaging: patient information

Cinacalcet Accord, 30 mg, coated tablets

Cinacalcet Accord, 60 mg, coated tablets

Cinacalcet Accord, 90 mg, coated tablets

Cinacalcet

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

The mechanism of action of Cinacalcet Accord involves controlling the concentrations of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by disorders of the parathyroid glands (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 Accord is used in adult patients:

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

Cinacalcet Accord is used in children and adolescents from 3 to less than 18 years of age:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clean the blood of metabolic products, in whom it is not possible to control the disease with other treatments.

In primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means that the hyperparathyroidism is not caused by any other factors, while "secondary" means that the hyperparathyroidism is caused by other factors, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to calcium loss in bones, which can cause bone pain and fractures, vascular and cardiac disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Cinacalcet Accord

When not to take Cinacalcet Accord:

• 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 calcium levels in the blood. The doctor will closely monitor the calcium levels in the blood.

Warnings and precautions

Before starting treatment with Cinacalcet Accord, the patient should discuss it with their doctor, pharmacist, or nurse. Before taking Cinacalcet Accord, the patient should inform their doctor about any current or previous illnesses, including:

• seizures; the risk of seizures is higher in people who have had them before;
• liver function disorders;
• heart failure.

Cinacalcet Accord reduces calcium levels. In adults and children treated with cinacalcet, there have been reports of life-threatening hypocalcemia (low calcium levels) and deaths. The patient should tell their doctor if they experience symptoms of low calcium levels: seizures or muscle cramps, or numbness or tingling of the fingers or toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking Cinacalcet Accord. Low calcium levels can affect heart rhythm. The patient should consult their doctor if they experience abnormal heartbeats or palpitations, or if they are taking other medicines that can affect heart rhythm while taking cinacalcet. Additional information, see section 4. While taking Cinacalcet Accord, the patient should inform their doctor about:

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

Children and adolescents

Cinacalcet Accord should 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 closely monitor the calcium levels before starting and during treatment with Cinacalcet Accord. The patient should inform their doctor if they experience symptoms of low calcium levels as described above. It is essential that the patient takes the dose of Cinacalcet Accord prescribed by their doctor.

Cinacalcet Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially etelcalcetide or other medicines that lower calcium levels in the blood. The patient should not take Cinacalcet Accord with etelcalcetide. The patient should inform their doctor if they are taking any of the following medicines. The action of Cinacalcet Accord may be affected by:

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

Cinacalcet Accord may affect the action of:

• medicines used to treat depression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• medicines used to treat cough(dextromethorphan);
• medicines used to treat heart rhythm disorders(flecainide and propafenone);
• medicines used to treat high blood pressure(metoprolol).

Cinacalcet Accord with food and drink

Cinacalcet Accord should be taken during or shortly after a meal.

Pregnancy, breastfeeding, and fertility

In pregnancy and breastfeeding, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine. Cinacalcet has not been studied in pregnant women. In case of pregnancy, the doctor may decide to change the treatment, as cinacalcet may pose a risk to the fetus. It is not known whether cinacalcet passes into human milk. The doctor will discuss with the patient whether to stop breastfeeding or stop taking Cinacalcet Accord.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If the patient experiences these symptoms, they should not drive or operate machinery.

Cinacalcet Accord contains lactose

If the patient does not tolerate some sugars, they should consult their doctor before taking this medicine.

3. How to take Cinacalcet Accord

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine the dose of cinacalcet to be taken. Cinacalcet Accord should be taken orally, during or shortly after a meal. The tablets should be swallowed whole and not chewed, crushed, or divided. Cinacalcet Accord is also available as a granule in open capsules. Children who need to take doses less than 30 mg or who cannot swallow tablets should take Cinacalcet Accord in granules. The doctor will regularly take blood samples during treatment to check how the treatment is progressing and adjust the dose as needed.

Treatment of secondary hyperparathyroidism

The usual initial dose of Cinacalcet Accord in adults is 30 mg (one tablet) once a day. The usual initial dose of Cinacalcet Accord in children and adolescents from 3 to less than 18 years of age is not more than 0.20 mg/kg body weight per day.

Treatment of parathyroid cancer and primary hyperparathyroidism

The usual initial dose of Cinacalcet Accord is 30 mg (one tablet) twice a day.

Taking a higher dose of Cinacalcet Accord than recommended

In case of taking a higher dose of Cinacalcet Accord than recommended, the patient should immediately contact their doctor. Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or cramps, or seizures.

Missing a dose of Cinacalcet Accord

The patient should not take a double dose of the medicine to make up for a missed dose. If a dose of Cinacalcet Accord is missed, the patient should take the next dose at the usual time. In case of doubts about taking the medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Cinacalcet Accord can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor:

• if they experience numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low calcium levels (hypocalcemia).
• if they experience swelling of the face, lips, tongue, and 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 do not last long.

Common: affects less than 1 in 10 people

• dizziness
• numbness or tingling (paresthesia)
• loss of appetite (anorexia) or decreased appetite
• muscle pain
• weakness
• rash
• decreased testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (convulsions)
• low blood pressure (hypotension)
• upper respiratory tract infection
• difficulty breathing (dyspnea)
• cough
• indigestion
• diarrhea
• abdominal pain, upper abdominal pain
• constipation
• muscle cramps
• back pain
• low calcium levels in the blood (hypocalcemia).

Frequency not known: frequency cannot be estimated from the available data

• hives
• swelling of the face, lips, tongue, and throat, which may cause difficulty in swallowing and breathing (angioedema)
• abnormal heartbeats or palpitations, which may be related to low calcium levels in the blood (prolonged QT interval and ventricular arrhythmias due to hypocalcemia).

In very rare cases, patients with heart failure taking cinacalcet have experienced worsening of heart failure and (or) low blood pressure (hypotension).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, e-mail: [email protected]. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cinacalcet Accord

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP) and on the blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage of the medicinal product. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cinacalcet Accord contains

• The active substance of the medicine is cinacalcet. Each coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet, as cinacalcet hydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (type 102), maize starch, crospovidone (type A), magnesium stearate, talc.
• Coating ingredients: (SheffCoat green L1171G23): hypromellose (3cP, 6cP), titanium dioxide (E171), lactose monohydrate, triacetin, yellow iron oxide (E172), indigo carmine (E132), lak.

What Cinacalcet Accord looks like and contents of the pack

Cinacalcet Accord is a light green, coated tablet. It is oval and has the marking "30", "60", or "90" on one side and "C" on the other. Packaging: 14 tablets (1 blister) in a cardboard box, 28 tablets (2 blisters) in a cardboard box, 84 tablets (6 blisters) in a cardboard box. Not all pack sizes may be marketed.

Responsible entity:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw

Manufacturer/Importer:

S.C. Polisano Pharmaceuticals S.R.L., Alba Iulia Street 156, 550052 Sibiu, Sibiu County, Romania; Synoptis Industrial Sp. z.o.o., ul. Rabowicka 15, 62-020 Swarzędz; Meditrial Internationals Ltd., Iztok Distr., 3 Charles Darwin Str., Sofia 1113, Bulgaria

Date of last revision of the leaflet: 04/2020