Cinacalcet Sandoz

Leaflet attached to the packaging: patient information

Cinacalcet Sandoz, 30 mg, coated tablets

Cinacalcet Sandoz, 60 mg, coated tablets

Cinacalcet Sandoz, 90 mg, coated tablets

Cinacalcet

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Sandoz and what is it used for
• 2. Important information before taking 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 is Cinacalcet Sandoz and what is it used for
The mechanism of action of Cinacalcet Sandoz involves controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by parathyroid gland disorders. 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 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, in whom surgery to remove the parathyroid glands is not possible.

Cinacalcet Sandoz is used in children and adolescents from 3 to less than 18 years of age:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clean the blood of metabolic 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 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 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 calcium levels in your blood.
Your doctor will regularly check your blood calcium levels.

Warnings and precautions

Before starting treatment with Cinacalcet Sandoz, discuss it with your doctor, pharmacist, or nurse.
Before taking Cinacalcet Sandoz, tell your doctor about any current or past illnesses, 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 toes, 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 are taking other medicines that can cause irregular heartbeats while taking Cinacalcet Sandoz.
For more information, see section 4.
While taking Cinacalcet Sandoz, tell your doctor:

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

Children and adolescents

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

Cinacalcet Sandoz and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially etelcalcetide or other medicines that lower calcium levels in the blood.
Do not take Cinacalcet Sandoz with etelcalcetide.
Tell your doctor about taking the following medicines.
The action of Cinacalcet Sandoz may be affected by:

• medicines used to treat skin infections and 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 a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Cinacalcet has not been studied in pregnant women. In case of pregnancy, your doctor may decide to change the treatment, as Cinacalcet Sandoz may pose a risk to the fetus.
It is not known whether Cinacalcet Sandoz passes into human milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Cinacalcet Sandoz.

Driving and using machines

Patient 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 diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Cinacalcet Sandoz

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the dose of Cinacalcet Sandoz that you should take.
Cinacalcet Sandoz should be taken orally, during or shortly after a meal. The tablets should be taken whole to ensure that you receive the correct dose, and should not be chewed, crushed, or divided.
Cinacalcet is also available as a granule in open capsules. Children who require doses less than 30 mg or who cannot swallow tablets should use cinacalcet granules.
Your doctor will regularly take blood samples to check how the treatment is progressing and adjust the dose as needed. This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Sandoz in adults is 30 mg (one tablet) once a day.
The usual starting dose of Cinacalcet Sandoz in children and adolescents from 3 to less than 18 years of age 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 in adults is 30 mg (one tablet) twice a day.

Taking a higher dose of Cinacalcet Sandoz than recommended

If you take more Cinacalcet Sandoz than recommended, 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 Sandoz

Do not take a double dose of the medicine to make up for a missed dose.
If you miss a dose of Cinacalcet Sandoz, take the next dose at the usual time. If you have any further doubts about taking the medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Cinacalcet Sandoz can cause side effects, although not everybody gets them.

Seek medical attention 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 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 up to 1 in 10 people

• dizziness
• feeling of 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: frequency cannot be estimated from the available data

• hives
• swelling of the face, lips, tongue, and throat, which may cause difficulty swallowing and 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 side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cinacalcet Sandoz

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
The medicinal product does not require 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. This 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 coated tablet contains 30 mg of cinacalcet (as cinacalcet hydrochloride).
Cinacalcet Sandoz, 60 mg
Each coated tablet contains 60 mg of cinacalcet (as cinacalcet hydrochloride).
Cinacalcet Sandoz, 90 mg
Each 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 coated tablet with "L83" embossed on one side and smooth on the other (approximate dimensions 9.8 x 6.2 mm).
Cinacalcet Sandoz, 60 mg: Light green, oval, biconvex coated tablet with "L84" embossed on one side and smooth on the other (approximate dimensions 12.4 x 7.8 mm).
Cinacalcet Sandoz, 90 mg: Light green, oval, biconvex coated tablet with "L85" embossed on one side and smooth on the other (approximate dimensions 14.1 x 8.9 mm).
Cinacalcet Sandoz is packaged in blisters.
Pack sizes: 28 coated tablets, 28x1 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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

To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00

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

Spain
Cinacalcet Sandoz Farmacéutica 30 mg film-coated tablets EFG
Cinacalcet Sandoz Farmacéutica 60 mg film-coated tablets EFG
Cinacalcet Sandoz Farmacéutica 30 mg film-coated tablets EFG
Belgium
Cinacalcet Sandoz 30 mg film-coated tablets
Cinacalcet Sandoz 60 mg film-coated tablets
Cinacalcet Sandoz 90 mg film-coated tablets
Bulgaria
Цинакалцет Сандоз 30 mg филмирани таблетки
Czech Republic
Cinacalcet Sandoz
Germany
Cinacalcet HEXAL 30 mg film-coated tablets
Cinacalcet HEXAL 60 mg film-coated tablets
Cinacalcet HEXAL 90 mg film-coated tablets
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 film-coated tablet
CINACALCET SANDOZ 60mg film-coated tablet
CINACALCET SANDOZ 90mg film-coated tablet
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, film-coated tablets
Cinacalcet Sandoz 60 mg, film-coated tablets
Cinacalcet Sandoz 90 mg, film-coated tablets
Poland
Cinacalcet Sandoz
Sweden
Cinacalcet Sandoz 30 mg film-coated tablets
Cinacalcet Sandoz 60 mg film-coated tablets
Cinacalcet Sandoz 90 mg film-coated tablets

Date of last revision of the leaflet:

(Logo of the marketing authorization holder)