Cinacalcet Sandoz

Package Leaflet: Information for the Patient

Cinacalcet Sandoz, 30 mg, film-coated tablets

Cinacalcet Sandoz, 60 mg, film-coated tablets

Cinacalcet Sandoz, 90 mg, film-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 and other information:

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

1 What Cinacalcet Sandoz is and what it is used for
The mechanism of action of Cinacalcet Sandoz 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, which produce a hormone called parathyroid hormone (PTH).
Cinacalcet Sandoz 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 Sandoz is used in children and adolescents from 3 years to less than 18 years:

• 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, while "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, psychiatric disorders, and coma.

2. Before you take Cinacalcet Sandoz

Do not take Cinacalcet Sandozif you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Do not take Cinacalcet Sandozif you have low levels of calcium in the blood.
Your doctor will regularly check your calcium levels in the blood.

Warnings and precautions

Before taking Cinacalcet Sandoz, discuss this with your doctor, pharmacist, or nurse.
Before taking Cinacalcet Sandoz, 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 Sandoz reduces calcium levels. In patients treated with cinacalcet, life-threatening and fatal events related to low calcium levels (hypocalcemia) have been reported.
Tell your doctor if you experience symptoms of low calcium levels: seizures or muscle cramps, or numbness or tingling of the fingers or around the mouth, or seizures, confusion, or loss of consciousness while taking Cinacalcet Sandoz.
Low calcium levels can affect heart rhythm. Tell your doctor if you experience unusual rapid or pounding heartbeat, or if you have irregular heartbeats or if you are taking other medicines that can affect heart rhythm while taking Cinacalcet Sandoz.
For more information, see section 4.
While taking Cinacalcet Sandoz, tell your doctor:

• if you start or stop smoking, as this may affect the action of Cinacalcet Sandoz.

Children and adolescents

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

Cinacalcet Sandoz with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• etelcalcetide or other medicines that reduce calcium levels in the blood.

Do not take Cinacalcet Sandoz with etelcalcetide.
Tell your doctor about taking the following medicines:

• 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 Sandoz 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 Sandoz with food and drink

Cinacalcet Sandoz should be taken during or shortly after meals.

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, your doctor may decide to change your treatment, as Cinacalcet Sandoz may pose a risk to the fetus.
It is not known whether Cinacalcet Sandoz passes into human breast milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Cinacalcet Sandoz.

Driving and using machines

Patients taking cinacalcet have reported dizziness and seizures. If you experience these symptoms, do not drive or operate machinery.

Cinacalcet Sandoz contains lactose

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

3. How to take Cinacalcet Sandoz

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 choose the dose of Cinacalcet Sandoz that you should take.
Cinacalcet Sandoz should be taken orally, during or shortly after meals. Swallow the tablets whole to ensure you receive the correct dose; do not chew, crush, or divide them.
Cinacalcet is also available as a granule in opened capsules. Children who need to take doses less than 30 mg or who cannot swallow tablets should use cinacalcet granules.
Your doctor will regularly take blood samples to check how your treatment is progressing and adjust the dose as necessary. Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Sandoz is 30 mg (one tablet) once a day.
The usual starting dose of Cinacalcet Sandoz in children and adolescents from 3 years to less than 18 years is up to 0.20 mg/kg body weight per day.
Treatment of parathyroid cancer and primary hyperparathyroidism
The usual starting dose of Cinacalcet Sandoz is 30 mg (one tablet) twice a day.

If you take more Cinacalcet Sandoz than you should

If you take more Cinacalcet Sandoz 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 Sandoz

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose of Cinacalcet Sandoz, 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, and 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 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: cannot be estimated from the available data

• hives
• swelling of the face, lips, tongue, and throat, which may cause difficulty in swallowing or breathing (angioedema)
• unusual rapid 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, worsening of heart failure and/or low blood pressure (hypotension) have occurred.

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 via the national reporting system listed in the "Contact" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Sandoz

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 medicinal product does not require any special storage conditions.
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 Sandoz contains

The active substance is cinacalcet.
Cinacalcet Sandoz, 30 mg
Each film-coated tablet contains 30 mg of cinacalcet (as cinacalcet hydrochloride).
Cinacalcet Sandoz, 60 mg
Each film-coated tablet contains 60 mg of cinacalcet (as cinacalcet hydrochloride).
Cinacalcet Sandoz, 90 mg
Each film-coated tablet contains 90 mg of cinacalcet (as cinacalcet hydrochloride).
The other ingredients are:

What Cinacalcet Sandoz looks like and contents of the pack

Cinacalcet Sandoz, 30 mg: Light green, oval, biconvex film-coated tablet with "L83" engraved on one side and plain on the other (approximately 9.8 x 6.2 mm in size).
Cinacalcet Sandoz, 60 mg: Light green, oval, biconvex film-coated tablet with "L84" engraved on one side and plain on the other (approximately 12.4 x 7.8 mm in size).
Cinacalcet Sandoz, 90 mg: Light green, oval, biconvex film-coated tablet with "L85" engraved on one side and plain on the other (approximately 14.1 x 8.9 mm in size).
Cinacalcet Sandoz is packaged in blisters.
Pack sizes: 28 film-coated tablets, 28x1 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Sachsen-Anhalt
Germany
Synoptis Industrial Sp. z.o.o.,
ul. Rabowicka 15
62-020 Swarzędz
Poland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain
Cinacalcet Sandoz Farmacéutica 30 mg comprimidos recubiertos con pelicula EFG
Cinacalcet Sandoz Farmacéutica 60 mg comprimidos recubiertos con pelicula EFG
Cinacalcet Sandoz Farmacéutica 30 mg comprimidos recubiertos con pelicula EFG
Belgium
Cinacalcet Sandoz 30 mg filmomhulde tabletten
Cinacalcet Sandoz 60 mg filmomhulde tabletten
Cinacalcet Sandoz 90 mg filmomhulde tabletten
Bulgaria
Цинакалцет Сандоз 30 mg филмирани таблетки
Czech Republic
Cinacalcet Sandoz
Germany
Cinacalcet HEXAL 30 mg Filmtabletten
Cinacalcet HEXAL 60 mg Filmtabletten
Cinacalcet HEXAL 90 mg Filmtabletten
Denmark
Cinacalcet Sandoz
Greece
CINACALCET/SANDOZ, F.C.TAB 30MG/TAB,
CINACALCET/SANDOZ, F.C.TAB 60MG/TAB
CINACALCET/SANDOZ, F.C.TAB 90MG/TAB
France
CINACALCET SANDOZ 30mg comprimé pelliculé
CINACALCET SANDOZ 60mg comprimé pelliculé
CINACALCET SANDOZ 90mg comprimé pelliculé
Ireland
Cinacalcet hydrochloride Rowex 30 mg film-coated tablets
Cinacalcet hydrochloride Rowex 60 mg film-coated tablets
Cinacalcet hydrochloride Rowex 90 mg film-coated tablets
Italy
Cinacalcet Sandoz GmbH
Netherlands
Cinacalcet Sandoz 30 mg, filmomhulde tabletten
Cinacalcet Sandoz 60 mg, filmomhulde tabletten
Cinacalcet Sandoz 90 mg, filmomhulde tabletten
Poland
Cinacalcet Sandoz
Sweden
Cinacalcet Sandoz 30 mg filmdragerade tabletter
Cinacalcet Sandoz 60 mg filmdragerade tabletter
Cinacalcet Sandoz 90 mg filmdragerade tabletter

Date of last revision of the leaflet:

(Logo of the Marketing Authorisation Holder)