CINACALCET 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Cinacalcet Accord, 30 mg, film-coated tablets
3. Cinacalcet Accord, 60 mg, film-coated tablets
4. Cinacalcet Accord, 90 mg, film-coated tablets
   1. Read the package 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. Inform your doctor immediately:
   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 pack and other information
    1. What Cinacalcet Accord contains
    2. What Cinacalcet Accord looks like and contents of the pack
    3. Marketing Authorization Holder:
    4. Manufacturer/Importer:
    5. Date of last revision of the leaflet: 04/2020

Package Leaflet: Information for the Patient

Cinacalcet Accord, 30 mg, film-coated tablets

Cinacalcet Accord, 60 mg, film-coated tablets

Cinacalcet Accord, 90 mg, film-coated tablets

Cinacalcet

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack and other information

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

The mechanism of action of Cinacalcet Accord is to control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by parathyroid gland disorders (hyperparathyroidism). 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 waste products.
• to reduce high levels of calcium in the blood (hypercalcemia) in adults with parathyroid cancer.
• to reduce high levels of calcium 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 waste 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 loss of calcium from bones, which can cause bone pain and fractures, cardiovascular disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Cinacalcet Accord

When not to take Cinacalcet Accord:

• 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 the blood. Your doctor will closely monitor your blood calcium levels.

Warnings and precautions

Before starting treatment with Cinacalcet Accord, you should discuss it with your doctor, pharmacist, or nurse. Before taking Cinacalcet Accord, you should inform your 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 and fatal events related to low calcium levels (hypocalcemia). You should tell your doctor if you 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. You should inform your doctor if you experience unusual rapid or pounding heartbeat, or if you have heart rhythm disorders, or if you are taking other medicines that can cause heart rhythm disorders while taking cinacalcet. For additional information, see section 4. While taking Cinacalcet Accord, you should inform your 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 calcium levels before starting and during treatment with Cinacalcet Accord. You should inform your doctor if you experience symptoms of low calcium levels as described above. It is important that the patient takes the dose of Cinacalcet Accord prescribed by the doctor.

Cinacalcet Accord and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, especially etelcalcetide or other medicines that lower calcium levels in the blood. You should not take Cinacalcet Accord with etelcalcetide. You should inform your doctor if you 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

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Cinacalcet has not been studied in pregnant women. In case of pregnancy, your 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 breast milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Cinacalcet Accord. This is important to avoid passing the medicine to the baby through breast milk.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these symptoms, you should not drive or operate machinery.

Cinacalcet Accord contains lactose

If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Cinacalcet Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the dose of cinacalcet that you should take. 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 openable capsules. Children who need to take doses less than 30 mg or who cannot swallow tablets should take Cinacalcet Accord as a granule. Your 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 starting dose of Cinacalcet Accord in adults is 30 mg (one tablet) once a day. The usual starting dose of Cinacalcet Accord in children and adolescents from 3 to less than 18 years of age is up to 0.20 mg/kg body weight per day.

Treatment of parathyroid cancer and primary hyperparathyroidism

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

Taking a higher dose of Cinacalcet Accord than recommended

If you take more Cinacalcet Accord than you should, contact your doctor immediately. Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or cramps, or seizures.

Missing a dose of Cinacalcet Accord

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose of Cinacalcet Accord, take the next dose at the usual time. If you have any questions about taking Cinacalcet Accord, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Inform your doctor immediately:

• if you start to feel numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low calcium levels (hypocalcemia).
• if you experience swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or 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
• feeling of numbness or tingling (paresthesia)
• loss of appetite (anorexia) or decreased appetite
• muscle pain
• weakness
• rash
• low testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (convulsions)
• low blood pressure (hypotension)
• upper respiratory tract infections
• breathing difficulties (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, or throat, which may cause difficulty in swallowing or breathing (angioedema)
• abnormal heart rhythm, 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Accord

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 after EXP and on the blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicinal product. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Accord contains

• The active substance is cinacalcet. Each film-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), pregelatinized corn 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), lake.

What Cinacalcet Accord looks like and contents of the pack

Cinacalcet Accord is a light green, film-coated tablet. The tablets are oval and have the marking "30", "60", or "90" on one side and "C" on the other. Packs: 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.

Marketing Authorization Holder:

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