Cinacalcet Aurobindo

Package leaflet: Information for the patient

Cinacalcet Aurobindo 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets

Equivalent medicine
Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What is Cinacalcet Aurobindo and what is it used for?

Cinacalcet Aurobindo contains the active substance cinacalcet, which acts on the regulation of parathyroid hormone (PTH), calcium, and phosphorus levels in your body. It is used to treat diseases caused by disorders of organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, and they produce parathyroid hormone (PTH).
Cinacalcet Aurobindo is used in adults:

• to treat secondary hyperparathyroidism in adult patients with severe kidney disease who require dialysis to remove waste products from the blood.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid carcinoma.
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism, when removal of the glands is not possible.

Cinacalcet Aurobindo is used in children aged between 3 and 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from the blood, when their condition is not controlled with other treatments.

In both primary and secondary hyperparathyroidism, excessive amounts of PTH are produced by the parathyroid glands. "Primary" means that hyperparathyroidism is not caused by other conditions, while "secondary" means that hyperparathyroidism is caused by another condition, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to loss of calcium from bones, which may cause bone pain and fractures, blood and cardiovascular problems, kidney stones, mental disturbances, and coma.

2. What you need to know before taking Cinacalcet Aurobindo

Do not take Cinacalcet Aurobindo:

• if you are allergic to cinacalcet or to any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Cinacalcet Aurobindo.
Before taking Cinacalcet Aurobindo, inform your doctor if you have or have ever had:

• seizures (fits or convulsive attacks). The risk of having seizures is higher if you have previously experienced seizures
• liver problems
• heart problems

Cinacalcet Aurobindo reduces calcium levels. In adults and children treated with cinacalcet, life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported.
Inform your doctor if, during treatment with Cinacalcet Aurobindo, you experience any of the following symptoms, which may be signs of low calcium levels: spasms, muscle twitching or cramps, numbness or tingling in the fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness.
Low calcium levels may affect heart rhythm. Inform your doctor if, during treatment with Cinacalcet Aurobindo, you experience an unusually fast or pounding heartbeat, have heart rhythm problems, or are taking medicines known to cause heart rhythm disturbances.
For additional information, see section 4.
During treatment with Cinacalcet Aurobindo, inform your doctor:

• if you have started or stopped smoking, as this may affect the action of Cinacalcet Aurobindo.
  Children and adolescents
  Children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism must not take Cinacalcet Aurobindo. If you are being treated for secondary hyperparathyroidism, your doctor must check your calcium levels before starting treatment with Cinacalcet Aurobindo and during treatment. You must inform your doctor if any of the signs of low calcium levels as described above occur. It is important that you take your dose of Cinacalcet Aurobindo exactly as recommended by your doctor.

For children who require a dose lower than 30 mg, or who are unable to swallow, other dosage forms/strengths of cinacalcet are available.
Other medicines and Cinacalcet Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially etelcalcetide or any other medicine that lowers calcium levels in the blood.
You must not take Cinacalcet Aurobindo together with etelcalcetide.
Inform your doctor if you are taking any of the following medicines.
Medicines that may affect the action of Cinacalcet Aurobindo:

• medicines used to treat skin infections or fungal infections (ketoconazole, itraconazole, and voriconazole)
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin)
• a medicine used to treat HIV and AIDS (ritonavir)
• a medicine used to treat depression (fluvoxamine).

Cinacalcet Aurobindo may affect the action of the following medicines:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine)
• a medicine used to relieve cough (dextromethorphan)
• medicines used to treat heart rhythm disorders (flecainide and propafenone)
• a medicine used to treat high blood pressure (metoprolol).

Cinacalcet Aurobindo with food and drink
Cinacalcet Aurobindo should be taken during or immediately after meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as cinacalcet could harm the unborn baby.
It is not known whether cinacalcet is excreted in breast milk. Your doctor will discuss with you whether you need to stop breastfeeding or stop treatment with Cinacalcet Aurobindo.
Driving and using machines
Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these side effects, do not drive or operate machinery.
Cinacalcet Aurobindo contains lactose monohydrate
Cinacalcet Aurobindo film-coated tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Cinacalcet Aurobindo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Cinacalcet Aurobindo

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you are unsure, consult your doctor or pharmacist. Your doctor will tell you how much Cinacalcet Aurobindo you
should take.
Cinacalcet Aurobindo should be taken orally during or immediately after meals. The tablets
must not be chewed or crushed.
Your doctor will carry out regular blood tests during treatment to assess your response to therapy and adjust the dose if necessary.
If you are being treated for secondary hyperparathyroidism
The initial dose of Cinacalcet Aurobindo in adults is 30 mg (one tablet) once daily.
The usual initial dose of Cinacalcet Aurobindo for children aged 3 to 18 years is no more than
0.20 mg/kg body weight per day.
If you are being treated for parathyroid carcinoma or primary hyperparathyroidism
The usual initial dose of Cinacalcet Aurobindo in adults is 30 mg (one tablet) twice
daily.
If you take more Cinacalcet Aurobindo than you should
If you take more Cinacalcet Aurobindo than prescribed, contact your doctor immediately. Possible
signs of overdose include numbness or tingling around the mouth, muscle pain or
cramps, and seizures.
If you forget to take Cinacalcet Aurobindo
Do not take a double dose to make up for the missed dose.
If you have missed a dose of Cinacalcet Aurobindo, take your next scheduled dose as usual.
If you have any doubts about how to use this medicine, consult 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, and seizures. These symptoms may indicate that calcium levels are too low (hypocalcemia).
• If you experience swelling of 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; these side effects are usually mild and short-lived.

Common: may affect up to 1 in 10 people

• dizziness
• numbness or tingling sensation (paresthesia)
• loss (anorexia) or reduced appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin reaction
• reduced testosterone levels
• elevated potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• epileptic seizures (convulsions or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• difficulty in breathing (dyspnea)
• cough
• indigestion (dyspepsia)
• diarrhea
• abdominal pain, pain in the upper part of the abdomen
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcemia).

Not known: frequency cannot be estimated from the available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema)
• Unusually fast or pounding heartbeat, which may be associated with low calcium levels in the blood (QT prolongation and ventricular arrhythmia secondary to hypocalcemia).

After taking cinacalcet, a very small number of patients with cardiac impairment have experienced worsening of their condition and/or low blood pressure (hypotension).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Aurobindo

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 and blister after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any change in the appearance of the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cinacalcet Aurobindo contains

• The active substance is cinacalcet.

Cinacalcet Aurobindo 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
Cinacalcet Aurobindo 60 mg film-coated tablets
Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).
Cinacalcet Aurobindo 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride).

• The other components are:
  Tablet core: Pregelatinized maize starch, crospovidone (type-A), microcrystalline cellulose (grade - 102), anhydrous colloidal silica, and sodium stearyl fumarate.

Tablet coating:
Lactose monohydrate, hypromellose 2910, titanium dioxide, yellow iron oxide, indigo carmine, macrogol 6000 and macrogol 400.

Description of the appearance of Cinacalcet Aurobindo and pack contents
Cinacalcet Aurobindo 30 mg film-coated tablets
Light green, oval-shaped, biconvex, film-coated tablets, marked with “CN” on one side and “30” on the other.

Cinacalcet Aurobindo 60 mg film-coated tablets
Light green, oval-shaped, biconvex, film-coated tablets, marked with “C” and “N” separated by a breakline on one side and “60” on the other. The tablet can be divided into two equal doses.

Cinacalcet Aurobindo 90 mg film-coated tablets
Light green, oval-shaped, biconvex, film-coated tablets, marked with “C” and “N” separated by a breakline on one side and “90” on the other. The tablet can be divided into two equal doses.

Cinacalcet Aurobindo film-coated tablets are available in blister packs.
Pack sizes
Blister packs: 14, 28, 30, 50, 84 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 – Saronno (VA)
Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Cinacalcet AB 30 mg/ 60 mg/ 90 mg filmomhulde tabletten
Czech Republic: Cinacalcet Aurovitas
France: Cinacalcet Arrow 30 mg/ 60 mg/ 90 mg comprimé pelliculé
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