CINACALCET SANDOZ 30 mg FILM-COATED TABLETS

2. What you need to know before taking Cinacalcet Sandoz

Do not take Cinacalcet Sandozif you are allergic to cinacalcet or any of the other ingredients of this medication (listed in section 6).

Do not take Cinacalcet Sandozif you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Cinacalcet Sandoz.

Before starting to take cinacalcet, inform your doctor if you have or have ever had:

• seizures(attacks or crises). The risk of having seizures is higher in people who have had them before;
• liver problems;
• heart failure.

Cinacalcet reduces calcium levels. In adults and children treated with cinacalcet, life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported.

Inform your doctor if you experience any of the following symptoms that may indicate low calcium levels: muscle spasms, contractions, or cramps, or numbness or tingling in the fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking cinacalcet.

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience unusually strong or fast heartbeats, if you have problems with your heart rhythm, or if you take medications that cause problems with your heart rhythm, while taking cinacalcet.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

• if you start or stop smoking, as it may affect the effect of cinacalcet.

Children and adolescents

Children under 18 years with parathyroid cancer or primary hyperparathyroidism should not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with cinacalcet and during treatment with cinacalcet. You should inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is essential that you take your dose of cinacalcet as directed by your doctor.

Other medications and Cinacalcet Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, particularly etelcalcetide or any other medication that reduces calcium levels in the blood.

You should not receive cinacalcet with etelcalcetide.

Inform your doctor if you are taking the following medications.

Medications such as the following may alter the effect of cinacalcet:

• medications used to treat skinand fungal infections(ketoconazole, itraconazole, and voriconazole);
• medications used to treat bacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medication used to treat HIVand AIDS(ritonavir);
• a medication used to treat depression(fluvoxamine).

Cinacalcet may alter the effect of medications such as:

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

Taking Cinacalcet Sandoz with food and drinks

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Cinacalcet has not been studied in pregnant women. In case of pregnancy, your doctor may decide to change your treatment, as cinacalcet may harm the unborn baby.

It is not known if cinacalcet passes into breast milk. Your doctor will advise you whether to interrupt breastfeeding or treatment with cinacalcet.

Driving and using machines

In patients taking cinacalcet, cases of dizziness and seizures have been reported. If you experience these effects, do not drive or use machines.

Cinacalcet Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Cinacalcet Sandoz

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much cinacalcet to take.

Cinacalcet should be taken orally, with food or shortly after eating. The tablets should be swallowed whole to ensure that you receive the correct dose and should not be chewed, crushed, or broken.

Cinacalcet is also available as a granule in capsules for opening. Children who require doses below 30 mg or who cannot swallow tablets should receive cinacalcet granules.

Your doctor will perform regular blood tests during treatment to monitor your progress and, if necessary, adjust the dose you receive.

If the treatment is for secondary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg (one tablet) once a day.

The usual initial dose of cinacalcet in children between 3 years and less than 18 years should not exceed 0.20 mg/kg body weight per day.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg (one tablet) twice a day.

If you take moreCinacalcet Sandozthan you should

If you have taken more cinacalcet than you should, consult your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeCinacalcet Sandoz

Do not take a double dose to make up for forgotten doses.

If you have forgotten to take a dose of cinacalcet, you should take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Tell your doctor immediately:

• If you start to feel numbness or tingling around the mouth, muscle pain or cramps, and seizures. These may be signs that your calcium levels are too low (hypocalcemia).
• If you experience swelling in the face, lips, mouth, tongue, or throat that can 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 temporary.

Common: may affect up to 1 in 10 people

• dizziness
• feeling of numbness or tingling (paresthesia)
• loss (anorexia) or decreased appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• decreased testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (crises or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infections
• difficulty breathing (dyspnea)
• cough
• stomach upset (dyspepsia)
• diarrhea
• abdominal pain, upper abdominal pain
• 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 that can cause difficulty swallowing or breathing (angioedema)
• unusually fast or strong heartbeat that may be associated with low calcium levels in your blood (prolongation of the QT interval and secondary ventricular arrhythmia due to hypocalcemia).

In a small number of patients with heart failure, their disease and/or low blood pressure (hypotension) worsened after taking cinacalcet.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Cinacalcet Sandoz

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition ofCinacalcet Sandoz

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

• Lactose monohydrate
• Microcrystalline cellulose (E-460)
• Crospovidone
• Colloidal silicon dioxide
• Magnesium stearate (E-572)

• The tablets are coated with:

• Hypromellose 6cPs
• Lactose monohydrate
• Triacetin
• Titanium dioxide (E-171)
• Yellow iron oxide (E-172)
• Aluminum lake blue FD&C No. 2

Appearance of the product and contents of the pack

30 mg: Film-coated tablets, light green in color, oval, biconvex, engraved with 'L83' on one side and smooth on the other side (approximate size 9.8 x 6.2 mm).

60 mg: Film-coated tablets, light green in color, oval, biconvex, engraved with 'L84' on one side and smooth on the other side (approximate size 12.4 x 7.8 mm).

90 mg: Film-coated tablets, light green in color, oval, biconvex, engraved with 'L85' on one side and smooth on the other side (approximate size 14.1 x 8.9 mm).

Cinacalcet Sandoz is available in blisters.

Package size: 28, 30, and 84 film-coated tablets.

Not all package sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

Barleben, Sachsen-Anhalt,

39179, Germany

Synoptis Industrial Sp. z o.o.

Ul. Rabowicka 15, Swarzedz

Poland

Date of the last revision of thisleaflet:January 2020.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)