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
Cinacalcetum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Cinacalcet Sandoz is and what it is used for
2. What you need to know 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 Cinacalcet Sandoz is and what it is used for
The mechanism of action of Cinacalcet Sandoz involves controlling 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 Sandoz is used in adult patients:

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

Cinacalcet Sandoz is used in children and adolescents 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, when 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 may cause bone pain and fractures, cardiovascular and vascular problems, kidney stones, mental disturbances and coma.

2. What you need to know before taking Cinacalcet Sandoz

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before starting treatment with Cinacalcet Sandoz.
Before taking Cinacalcet Sandoz, inform your doctor about any current or previous 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. Life-threatening events and fatal outcomes related to low calcium levels (hypocalcemia) have been reported in patients treated with cinacalcet.
Tell your doctor if you experience symptoms of low calcium levels: muscle spasms or cramps, numbness or tingling in the fingers, toes or around the mouth, seizures, confusion or loss of consciousness while taking Cinacalcet Sandoz.
Low calcium levels may affect heart rhythm. Contact your doctor if you experience abnormally rapid heartbeat, palpitations, heart rhythm disturbances, or if you are taking other medicines that cause heart rhythm disturbances while on Cinacalcet Sandoz.
Additional information, see section 4.
During treatment with Cinacalcet Sandoz, inform your doctor about:

• starting or stopping 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 carcinoma or primary hyperparathyroidism.
If you are being treated for secondary hyperparathyroidism, your doctor will closely monitor calcium levels before and during treatment with Cinacalcet Sandoz. Inform your doctor if you experience symptoms of low calcium levels as described above.
It is important that you take the dose of Cinacalcet Sandoz prescribed by your doctor.

Cinacalcet Sandoz with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially etelcalcetide or other medicines that reduce blood calcium levels.
Do not take Cinacalcet Sandoz together with etelcalcetide.
Inform your doctor if you are taking any of the following medicines.
The following medicines may affect the action of Cinacalcet Sandoz:

• 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 in HIV and AIDS (ritonavir);
• a medicine used for depression (fluvoxamine).

Cinacalcet Sandoz may affect the action of:

• medicines used for depression (amitriptyline, desipramine, nortriptyline and clomipramine);
• a medicine used to relieve cough (dextromethorphan);
• medicines used for heart rhythm disorders (flecainide and propafenone);
• a medicine used for hypertension (metoprolol).

Cinacalcet Sandoz with food and drink
Take Cinacalcet Sandoz during or shortly after a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should 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 Sandoz may pose a risk to the unborn child.
It is not known whether Cinacalcet Sandoz passes into human breast milk. Your doctor will discuss with you either stopping breastfeeding or discontinuing treatment with Cinacalcet Sandoz.

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

Cinacalcet Sandoz contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Cinacalcet Sandoz
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Your doctor will determine the dose of Cinacalcet Sandoz you should take.
Take Cinacalcet Sandoz orally during or shortly after a meal. Swallow the tablets whole to ensure you receive the correct dose. Do not chew, crush or divide the tablets.
Cinacalcet is also available as granules in opening capsules. Children who require doses lower than 30 mg or who cannot swallow tablets should take cinacalcet as granules.
Your doctor will regularly take blood samples to monitor your treatment and adjust the dose as necessary. Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Sandoz in adults is 30 mg (one tablet) once daily.
The usual starting dose of Cinacalcet Sandoz in children and adolescents aged from 3 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 Sandoz in adults is 30 mg (one tablet) twice daily.

If you take more Cinacalcet Sandoz than you should
If you take more than the prescribed dose of Cinacalcet Sandoz, 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 missed dose.
If you miss a dose of Cinacalcet Sandoz, take the next dose at the usual time. If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
You should 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 calcium levels (hypocalcaemia).
• if the patient develops swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing and breathing (angioedema).

Very common: may affect more than 1 in 10 people

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

Common: may affect less than 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: frequency 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 (prolongation of the QT interval and ventricular arrhythmias resulting from hypocalcaemia).

In a small number of patients with heart failure taking cinacalcet, worsening of heart failure and/or reduction in blood pressure (hypotension) has been observed.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cinacalcet Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via the sewage system 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).
Other ingredients are:

• lactose monohydrate
• microcrystalline cellulose
• crospovidone (Type A)
• colloidal anhydrous silica
• magnesium stearate
  Coating:
• hypromellose (6 cPs)
• lactose monohydrate
• triacetin
• titanium dioxide (E 171)
• yellow iron oxide (E 172)
• indigo carmine, aluminium lake (E132)

What Cinacalcet Sandoz looks like and contents of the pack
Cinacalcet Sandoz, 30 mg: Light green, oval, biconvex film-coated tablet with the engraved mark “L83” on one side and smooth on the other (with approximate dimensions of 9.8 x 6.2 mm).
Cinacalcet Sandoz, 60 mg: Light green, oval, biconvex film-coated tablet with the engraved mark “L84” on one side and smooth on the other (with approximate dimensions of 12.4 x 7.8 mm).
Cinacalcet Sandoz, 90 mg: Light green, oval, biconvex film-coated tablet with the engraved mark “L85” on one side and smooth on the other (with approximate dimensions of 14.1 x 8.9 mm).
Cinacalcet Sandoz is packed 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, Saxony-Anhalt
Germany
Synoptis Industrial Sp. z o.o.,
ul. Rabowicka 15
62-020 Swarzędz
Poland

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Tel. 22 209 70 00

This medicinal product is authorised 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 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

(Logo of the Marketing Authorisation Holder)