CINACALCET 30 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Cinacalcet Accord, 30 mg, coated tablets
3. Cinacalcet Accord, 60 mg, coated tablets
4. Cinacalcet Accord, 90 mg, coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
5. What is Cinacalcet Accord and what is it used for
6. Before you take 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. If you take more Cinacalcet Accord than you should
   4. If you forget to take Cinacalcet Accord
8. Possible side effects
   1. Tell your doctor immediately:
   2. Frequency not known: frequency cannot be estimated from the available data
   3. Reporting of 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 Authorisation Holder:
    4. Manufacturer/Importer:
    5. Date of last revision of the leaflet: 04/2020

Package Leaflet: Information for the Patient

Cinacalcet Accord, 30 mg, coated tablets

Cinacalcet Accord, 60 mg, coated tablets

Cinacalcet Accord, 90 mg, coated tablets

Cinacalcet

Read all of this leaflet carefully before 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 is Cinacalcet Accord and what is it used for
• 2. Before you take 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 to treat 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 who cannot undergo surgery to remove the parathyroid glands.

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, whereas "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. Before you take 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 calcium levels.

Warnings and precautions

Before taking Cinacalcet Accord, you should discuss it with your doctor, pharmacist, or nurse. Before taking Cinacalcet Accord, you should tell your doctor about any current or past medical conditions, 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 or confusion or loss of consciousness while taking Cinacalcet Accord. Low calcium levels can affect heart rhythm. You should tell 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 tell your doctor:

• if you start or stop 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 and during treatment with Cinacalcet Accord. You should tell the doctor if you experience symptoms of low calcium levels as described above. It is important that the patient takes the dose of Cinacalcet Accord as 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, and about any medicines you plan to take, especially about etelcalcetide or other medicines that lower calcium levels in the blood. You should not take Cinacalcet Accord with etelcalcetide. You should tell 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, 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, 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 breast 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 you experience these symptoms, you should not drive or operate machinery.

Cinacalcet Accord contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 open capsules. Children who require 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.

If you take more Cinacalcet Accord than you should

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.

If you forget to take 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 further questions on the use of this product, 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 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: may affect more than 1 in 10 people:

• nausea and vomiting; usually mild and do not last long.

Common: may affect up to 1 in 10 people

• dizziness
• 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 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, 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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, 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Accord contains

• The active substance is cinacalcet. Each 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), lak.

What Cinacalcet Accord looks like and contents of the pack

Cinacalcet Accord is a light green, oval, coated tablet with "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 Authorisation 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