CINACALCET 30 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Cinacalcet Aristo, 30 mg, coated tablets
3. Cinacalcet Aristo, 60 mg, coated tablets
4. Cinacalcet Aristo, 90 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Cinacalcet Aristo and what is it used for
6. Important information before taking Cinacalcet Aristo
   1. When not to take Cinacalcet Aristo
   2. Warnings and precautions
   3. Children and adolescents
   4. Cinacalcet Aristo and other medicines
   5. Cinacalcet Aristo with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Cinacalcet Aristo contains lactose
   9. Cinacalcet Aristo contains sodium
7. How to take Cinacalcet Aristo
   1. Taking a higher dose of Cinacalcet Aristo than recommended
   2. Missing a dose of Cinacalcet Aristo
8. Possible side effects
   1. Reporting side effects
9. How to store Cinacalcet Aristo
10. Contents of the packaging and other information
    1. What Cinacalcet Aristo contains
    2. What Cinacalcet Aristo looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Cinacalcet Aristo, 30 mg, coated tablets

Cinacalcet Aristo, 60 mg, coated tablets

Cinacalcet Aristo, 90 mg, coated tablets

Cinacalcet

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 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 Aristo 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 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 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 patient's calcium levels.

Warnings and precautions

Before starting treatment with Cinacalcet Aristo, the patient should consult a doctor or pharmacist. Before starting treatment with Cinacalcet Aristo, the patient should inform their doctor about their 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. 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 Aristo. Low calcium levels can affect the heart rhythm. The patient should consult their doctor if they experience an abnormally fast or pounding heartbeat, or if they have arrhythmias or are taking other medicines that can cause arrhythmias while taking Cinacalcet Aristo. For more information, see section 4. During treatment with Cinacalcet Aristo, the patient should inform their 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 the patient is being treated for secondary hyperparathyroidism, the doctor will closely monitor the patient's calcium levels before starting and during treatment with Cinacalcet Aristo. 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 Aristo prescribed by their doctor.

Cinacalcet Aristo 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. Medicines known to reduce calcium levels in the bloodThe patient should not take Cinacalcet Aristo at the same time as etelcalcetide, as the risk of hypocalcemia increases if Cinacalcet Aristo is taken with medicines that are known to reduce calcium levels in the blood. The patient should inform their doctor if they 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 efficacy 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Cinacalcet Aristo has not been studied in pregnant women. In case of pregnancy, the 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 milk. The doctor will discuss with the patient whether to stop breastfeeding or stop taking Cinacalcet Aristo.

Driving and using machines

Patients taking Cinacalcet Aristo have reported dizziness and seizures. If the patient experiences these symptoms, they should not drive or operate machinery.

Cinacalcet Aristo contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Cinacalcet Aristo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Cinacalcet Aristo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The doctor will determine the dose of Cinacalcet Aristo that the patient 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. The doctor will regularly take blood samples to check how the treatment is progressing and adjust the dose as needed. If the patient is being treated for secondary hyperparathyroidism, the usual initial dose of Cinacalcet Aristo for adults is 30 mg (one tablet) once a day. If the patient is being treated for parathyroid cancer and primary hyperparathyroidism, the usual initial dose of Cinacalcet Aristo for adults is 30 mg (one tablet) twice a day.

Taking a higher dose of Cinacalcet Aristo than recommended

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

Missing a dose of Cinacalcet Aristo

The patient should not take a double dose of the medicine to make up for a missed dose. If a dose of Cinacalcet Aristo is missed, the patient should take the next dose at the usual time. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• if they 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 they experience swelling of the face, lips, tongue, and throat, which can cause difficulty swallowing and 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 less than 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, and throat, which can cause difficulty swallowing and breathing (angioedema)
• abnormally fast or pounding heartbeat, 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, more information can be gathered on the safety of the medicine.

5. How to store Cinacalcet Aristo

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 or blister after: EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storage. 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 Aristo contains

• -The active substance of the medicine is cinacalcet. Each coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet.
• -The other ingredients are: Core:cornstarch, 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 long and 6.3 mm wide.
Cinacalcet Aristo, 60 mg, coated tablets
White to almost white, oval, coated tablet with the imprint ‘60’ on one side, approximately 12.5 mm long and 7.9 mm wide.
Cinacalcet Aristo, 90 mg, coated tablets
White to almost white, oval, coated tablet with the imprint ‘90’ on one side, approximately 14.3 mm long and 9 mm wide.
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 leaflet: