Cinacalcet aurovitas

Package leaflet: Information for the patient

Cinacalcet Aurovitas, 30 mg, film-coated tablets
Cinacalcet Aurovitas, 60 mg, film-coated tablets
Cinacalcet Aurovitas, 90 mg, film-coated tablets
Cinacalcetum
Please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Cinacalcet Aurovitas contains the active substance called cinacalcet, which helps control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck near the thyroid gland, which produce a hormone called parathyroid hormone (PTH).

Cinacalcet Aurovitas is used in adults:

• for the treatment of secondary hyperparathyroidism in adult patients with severe kidney disease who require dialysis to remove waste products from the blood.
• to reduce elevated blood calcium levels (hypercalcemia) in adult patients with parathyroid cancer.
• to reduce elevated blood calcium levels (hypercalcemia) in adult patients with primary hyperparathyroidism when surgery to remove the parathyroid glands is not possible.

Cinacalcet Aurovitas is used in children aged from 3 to below 18 years:

• for the treatment of secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from the blood and in whom the disease cannot be controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means the overactivity is not caused by any other factors, whereas "secondary" means the overactivity is caused by other factors, such as kidney disease. Both primary and secondary hyperparathyroidism may lead to loss of calcium from bones, which can result in bone pain and fractures, vascular and cardiac complications, kidney stones, mental disturbances, and coma.

2. Important information before using Cinacalcet Aurovitas

When not to use Cinacalcet Aurovitas

• 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 treating physician may recommend monitoring blood calcium levels.

Warnings and precautions
Before starting treatment with Cinacalcet Aurovitas, discuss this with your doctor, pharmacist, or nurse.
Before using Cinacalcet Aurovitas, inform your doctor about current and previously existing medical conditions, including:

• Seizures; the risk of seizures is higher in individuals who have experienced them previously;
• Liver problems;
• Heart failure.

Cinacalcet Aurovitas lowers calcium levels. In patients treated with Cinacalcet Aurovitas, life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported.
Inform your doctor if any of the following symptoms occur during treatment with Cinacalcet Aurovitas, as they may indicate low calcium levels: muscle spasms, tremors or cramps, numbness or tingling in the fingers, toes, or around the mouth, or seizures, disorientation, or loss of consciousness.
Low calcium levels may affect heart rhythm. Contact your doctor if you experience abnormally rapid heartbeat or palpitations, if you have heart rhythm disorders, or if you are taking other medications causing heart rhythm disturbances while on Cinacalcet Aurovitas.
Additional information, see section 4.
During treatment with Cinacalcet Aurovitas, inform your doctor about:

• Starting or stopping cigarette smoking, as this may affect the action of Cinacalcet Aurovitas.

Children and adolescents
Cinacalcet Aurovitas must not be used in children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism.
If the patient is being treated for secondary hyperparathyroidism, the doctor may recommend monitoring calcium levels before starting and during treatment with Cinacalcet Aurovitas.
Inform the doctor if any of the symptoms of low calcium levels occur, as described above.
It is important that the patient takes Cinacalcet Aurovitas exactly as prescribed by the doctor.
For children requiring doses lower than 30 mg or who are unable to swallow tablets, cinacalcet in different strengths and/or pharmaceutical forms is available.

Cinacalcet Aurovitas and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use, particularly etelcalcetide or any other medicines that lower blood calcium levels.
Do not take Cinacalcet Aurovitas together with etelcalcetide.
Inform your doctor if you are taking any of the following medicines.
Medicines that may affect the action of Cinacalcet Aurovitas:

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

Cinacalcet Aurovitas may affect the action of:

• Medicines used for depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• A medicine used to suppress cough (dextromethorphan);
• Medicines used for heart rhythm disorders (flecainide and propafenone);
• A medicine used for high blood pressure (metoprolol).

Cinacalcet Aurovitas with food, drink, and alcohol
Cinacalcet Aurovitas should be taken during or shortly after a meal.

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, the doctor may decide to change treatment, as Cinacalcet Aurovitas may pose a risk to the fetus.
It is unknown whether cinacalcet passes into human milk. The treating physician will discuss with the patient either discontinuing breastfeeding or stopping treatment with Cinacalcet Aurovitas.

Driving and operating machinery
Dizziness and seizures have been reported in patients taking cinacalcet. If these adverse effects occur, the patient should not drive or operate machinery.

Cinacalcet Aurovitas contains lactose
Cinacalcet Aurovitas contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Cinacalcet Aurovitas contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Cinacalcet Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist. Your doctor will determine the dose of Cinacalcet Aurovitas
that you should take.
Cinacalcet Aurovitas should be taken orally, during or shortly after a meal. The tablets should be swallowed whole and must not be divided.
Your doctor will regularly take blood samples during treatment to monitor how the treatment is progressing and will adjust the dose as necessary.
Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Aurovitas is 30 mg (one tablet) once daily.
The usual starting dose of Cinacalcet Aurovitas for children aged 3 years to below 18 years is no more than 0.20 mg/kg body weight per day.
Treatment of parathyroid carcinoma and primary hyperparathyroidism
The usual starting dose of Cinacalcet Aurovitas is 30 mg (one tablet) twice daily.
Taking more than the recommended dose of Cinacalcet Aurovitas
If you take more than the recommended dose of Cinacalcet Aurovitas, 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 Aurovitas
Do not take a double dose to make up for a missed dose.
If a dose of Cinacalcet Aurovitas is missed, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must immediately inform your doctor if:

• the patient develops numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low blood calcium levels (hypocalcaemia).
• swelling occurs in the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people.

• nausea and vomiting; usually mild and short-lived.

Common: may affect up to 1 in 10 people.

• dizziness;
• sensation of numbness or tingling (paraesthesiae);
• loss of appetite (anorexia) or reduced appetite;
• muscle pain;
• weakness;
• rash;
• decreased testosterone levels;
• high blood potassium levels (hyperkalaemia);
• allergic reactions (hypersensitivity);
• headache;
• seizures (seizure attacks);
• low blood pressure (hypotension);
• upper respiratory tract infection;
• breathing difficulties (dyspnoea);
• cough;
• indigestion;
• diarrhoea;
• abdominal pain, upper abdominal pain;
• constipation;
• muscle cramps;
• back pain;
• low blood calcium levels (hypocalcaemia).

Frequency unknown (cannot be estimated from available data)

• urticaria;
• swelling of the face, lips, mouth, tongue and throat, which may cause difficulty in swallowing and breathing (angioedema);
• unusually rapid heartbeat or palpitations, which may be related to low blood calcium levels (QT interval prolongation and ventricular arrhythmias resulting from hypocalcaemia).

In a very small number of patients with heart failure, worsening of condition and/or low blood pressure (hypotension) has been observed after taking cinacalcet.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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]
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cinacalcet Aurovitas
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cinacalcet Aurovitas contains

• The active substance is cinacalcet.

Cinacalcet Aurovitas, 30 mg, film-coated tablets:
Each film-coated tablet contains 30 mg of cinacalcet.
Cinacalcet Aurovitas, 60 mg, film-coated tablets:
Each film-coated tablet contains 60 mg of cinacalcet.
Cinacalcet Aurovitas, 90 mg, film-coated tablets:
Each film-coated tablet contains 90 mg of cinacalcet.

• Other ingredients are: pregelatinized starch, maize; crospovidone (type A); microcrystalline cellulose (PH102); colloidal anhydrous silica; and sodium stearyl fumarate.
  Coating ingredients: lactose monohydrate, hypromellose 2910 (15 cPs), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172), indigo carmine, aluminium lake of indigo carmine (E 132), hypromellose 2910 (5 cPs), macrogol 6000, macrogol 400.

What Cinacalcet Aurovitas looks like and contents of the pack
Cinacalcet Aurovitas, 30 mg, film-coated tablets
Light green, oval, biconvex film-coated tablets, embossed with the characters “CN” on one side and “30” on the other.
Cinacalcet Aurovitas, 60 mg, film-coated tablets
Light green, oval, biconvex film-coated tablets, embossed with the characters “C” and “N” on both sides of the division line on one side and “60” on the other. The tablet can be divided into equal doses.
Cinacalcet Aurovitas, 90 mg, film-coated tablets
Light green, oval, biconvex film-coated tablets, embossed with the characters “C” and “N” on both sides of the division line on one side and “90” on the other. The tablet can be divided into equal doses.
Cinacalcet Aurovitas is available in blister packs contained in a cardboard box.
Pack sizes: 14, 28, 30, 50, 84 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland

Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG, 3000, Malta
Generis Farmacêutica, S.A.
Rua João de Deus, n.° 19, Venda Nova
2700-487 Amadora, Portugal
Arrow Génériques-Lyon
26 avenue Tony Garnier
69007 Lyon, France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Cinacalcet AB 30 mg/ 60 mg/ 90 mg film-coated tablets
Czech Republic: Cinacalcet Aurovitas
France: Cinacalcet Arrow 30 mg/ 60 mg/ 90 mg film-coated tablets
Germany: Cinacalcet PUREN 30 mg/ 60 mg/ 90 mg Filmtabletten
Italy: Cinacalcet Aurobindo
Netherlands: Cinacalcet Aurobindo 30 mg/ 60 mg/ 90 mg, filmomhulde tabletten
Poland: Cinacalcet Aurovitas
Portugal: Cinacalcet Generis
Spain: Cinacalcet Aurovitas 30 mg/ 60 mg/ 90 mg comprimidos recubiertos con película EFG