Cinacalcet Aristo

Package Leaflet: Information for the Patient

Cinacalcet Aristo, 30 mg, coated tablets

Cinacalcet Aristo, 60 mg, coated tablets

Cinacalcet Aristo, 90 mg, 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 Package Leaflet

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

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

The mechanism of action of Cinacalcet Aristo involves controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat diseases caused by parathyroid gland disorders (parathyroid disease). The parathyroid glands are four small glands located in the neck near the thyroid gland. They produce a hormone called parathyroid hormone (PTH). Cinacalcet Aristo 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 parathyroid surgery.

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 the bones, which can cause bone pain and fractures, cardiovascular disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Cinacalcet Aristo

When not to take Cinacalcet Aristo

• 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 taking Cinacalcet Aristo, consult your doctor or pharmacist. Before taking Cinacalcet Aristo, inform your doctor about your current and past medical conditions, including:

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

Cinacalcet Aristo reduces calcium levels. In adults and children treated with Cinacalcet Aristo, life-threatening and fatal events related to low calcium levels (hypocalcemia) have been reported. 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 Aristo. Low calcium levels can affect heart rhythm. You should consult your doctor if you experience unusual rapid or pounding heartbeat, or if you have arrhythmias or if you are taking other medicines that affect heart rhythm while taking Cinacalcet Aristo. For more information, see section 4. During treatment with Cinacalcet Aristo, inform your doctor about:

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

Children and adolescents

Cinacalcet Aristo should not be used in children under 18 years of age. If you are being treated for secondary hyperparathyroidism, your doctor will closely monitor your blood calcium levels before and during treatment with Cinacalcet Aristo. You should inform your doctor if you experience symptoms of low calcium levels as described above. It is important that you take the dose of Cinacalcet Aristo as prescribed by your doctor.

Cinacalcet Aristo and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Medicines known to lower blood calcium levelsYou should not take Cinacalcet Aristo at the same time as etelcalcetide, as the risk of hypocalcemia increases if Cinacalcet Aristo is taken with medicines known to lower blood calcium levels. Inform your doctor if you are taking the following medicines. Medicines that affect how Cinacalcet Aristo works:

• medicines used to treat skin infections, 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 Aristo 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 Aristo with food and drink

Cinacalcet Aristo should be taken during a meal 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 Aristo has not been studied in pregnant women. In case of pregnancy, your doctor may decide to change the treatment, as Cinacalcet Aristo may pose a risk to the fetus. It is not known whether Cinacalcet Aristo passes into human breast milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Cinacalcet Aristo.

Driving and using machines

Patients taking Cinacalcet Aristo have reported dizziness and seizures. If you experience these symptoms, you should not drive or operate machinery.

Cinacalcet Aristo contains lactose

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

Cinacalcet Aristo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Cinacalcet Aristo

This medicine should always be taken 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 Aristo that you should take. Cinacalcet Aristo should be taken orally, during a meal or shortly after a meal. The tablets should be swallowed whole and not chewed, crushed, or divided. Your doctor will regularly take blood samples to check how the treatment is progressing and adjust the dose as needed. If you are being treated for secondary hyperparathyroidism, the usual initial dose of Cinacalcet Aristo is 30 mg (one tablet) once a day. If you are being treated for parathyroid cancer and primary hyperparathyroidism, the usual initial dose of Cinacalcet Aristo is 30 mg (one tablet) twice a day.

Taking a higher dose of Cinacalcet Aristo than recommended

If you take more Cinacalcet Aristo 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 Aristo

Do not take a double dose of Cinacalcet Aristo to make up for a forgotten dose. If you miss a dose of Cinacalcet Aristo, take the next dose at the usual time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cinacalcet Aristo can cause side effects, although not everybody gets them. You should immediately inform your doctor:

• if you experience 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 (asthenia)
• 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 a small number of patients with heart failure taking Cinacalcet Aristo, worsening of heart failure and/or low blood pressure (hypotension) have occurred.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Aristo

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 or blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. 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 Aristo contains

• -The active substance is cinacalcet. Each coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet.
• -The other ingredients are: Core:corn starch, crospovidone (Type A), microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate. Coating:hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, macrogol 6000.
• 6000.

What Cinacalcet Aristo looks like and contents of the pack

Cinacalcet Aristo, 30 mg, coated tablets
White to almost white, oval, coated tablet with the imprint ‘30’ on one side, approximately 10 mm in length and 6.3 mm in width.
Cinacalcet Aristo, 60 mg, coated tablets
White to almost white, oval, coated tablet with the imprint ‘60’ on one side, approximately 12.5 mm in length and 7.9 mm in width.
Cinacalcet Aristo, 90 mg, coated tablets
White to almost white, oval, coated tablet with the imprint ‘90’ on one side, approximately 14.3 mm in length and 9 mm in width.
Cinacalcet Aristo, 30 mg, 60 mg, 90 mg, coated tablets are available in PVC/PVDC/Aluminum blisters. The pack contains 28 or 84 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Cinacalcet Aristo 30 mg Filmtabletten
Cinacalcet Aristo 60 mg Filmtabletten
Cinacalcet Aristo 90 mg Filmtabletten
Czech Republic
Cinacalcet Aristo
Denmark
Cinacalcet Aristo
Finland
Cinacalcet Aristo 30 mg kalvopäällysteiset tabletit
Cinacalcet Aristo 60 mg kalvopäällysteiset tabletit
Cinacalcet Aristo 90 mg kalvopäällysteiset tabletit
Spain
Cinacalcet Aristo 30 mg comprimidos recubiertos con película EFG
Cinacalcet Aristo 60 mg comprimidos recubiertos con película EFG
Cinacalcet Aristo 90 mg comprimidos recubiertos con película EFG
Netherlands
Cinacalcet Aristo 30 mg, filmomhulde tabletten
Cinacalcet Aristo 60 mg, filmomhulde tabletten
Cinacalcet Aristo 90 mg, filmomhulde tabletten
Germany
Cinacalcet Aristo 30 mg Filmtabletten
Cinacalcet Aristo 60 mg Filmtabletten
Cinacalcet Aristo 90 mg Filmtabletten
Norway
Cinacalcet Aristo
Poland
Cinacalcet Aristo
Portugal
Cinacalcet Aristo
Romania
Cinacalcet Aristo 30 mg comprimate filmate
Cinacalcet Aristo 60 mg comprimate filmate
Cinacalcet Aristo 90 mg comprimate filmate
Slovakia
Cinacalcet Aristo 30 mg filmom obalené tablety
Cinacalcet Aristo 60 mg filmom obalené tablety
Cinacalcet Aristo 90 mg filmom obalené tablety
Sweden
Cinacalcet Aristo 30 mg filmdragerade tabletter
Cinacalcet Aristo 60 mg filmdragerade tabletter
Cinacalcet Aristo 90 mg filmdragerade tabletter
United Kingdom
Cinacalcet Aristo 30 mg film-coated tablets
Cinacalcet Aristo 60 mg film-coated tablets
Cinacalcet Aristo 90 mg film-coated tablets
Italy
Cinacalcet Aristo

Date of last revision of the package leaflet: