Package Insert: Information for the Patient

Cinacalcet Normon 60 mg Film-Coated Tablets

Cinacalcet

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

- Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Cinacalcet Normon and what is it used for

2. What you need to know before starting to take Cinacalcet Normon

3. How to take Cinacalcet Normon

4. Possible side effects

5. Storage of Cinacalcet Normon

6. Contents of the pack and additional information

Cinacalcet Normon acts by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat alterations of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).

Cinacalcet Normon is used in adults:

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

Cinacalcet Normon is used in children between 3 years and less than 18 years:

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

In primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term “primary” means that the hyperparathyroidism is not caused by any other disease and “secondary” means that the hyperparathyroidism is caused by another disease, such as kidney disease. Both primary and secondary hyperparathyroidism can cause loss of calcium from the bones, which can produce bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental disease, and coma.

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

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

Warnings and precautions

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

Before starting to take cinacalcet, inform your doctor if you have ever suffered from:

• seizures(attacks or crises). The risk of 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 events and fatal outcomes 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 of the hands, feet, or around the mouth, or seizures, confusion, or loss of consciousness while being treated with cinacalcet.

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience abnormally strong or rapid heartbeats, if you have problems with your heart rhythm, or if you take medications that can cause heart rhythm problems 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 old 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. Inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is essential to take your cinacalcet dose as directed by your doctor.

Other medications and Cinacalcet Normon

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

You should not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking the following medications.

The following medications may modify the action of cinacalcet:

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

Cinacalcet may modify the action of the following medications:

• 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 Normon with food and drinks

Cinacalcet should be taken with food or shortly after eating.

Pregnancy, breastfeeding, and fertility

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

Cinacalcet has not been studied in pregnant women. If you become pregnant, your doctor may decide to modify your treatment, as cinacalcet may be harmful to the unborn baby.

It is not known if cinacalcet passes into breast milk. Your doctor will tell you if you should stop breastfeeding or the treatment with cinacalcet.

Driving and operating machinery

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

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

Cinacalcet should be taken orally, with food or shortly after eating. Tablets should be swallowed whole and not chewed, crushed, or divided.

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

If 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 of body weight per day.

If 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 more Cinacalcet Normon than you should

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

If you forgot to take Cinacalcet Normon

Do not take a double dose to make up for the missed dose.

If you have forgotten to take a dose of cinacalcet, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately:

• If you notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These may be symptoms of low calcium levels (hypocalcemia).
• If you notice swelling in the face, lips, mouth, tongue, or throat that 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 transient.

Common: may affect up to 1 in 10 people

• Dizziness,
• tingling or numbness (paresthesia),
• loss (anorexia) or decrease in appetite,
• Muscle pain (myalgia),
• Weakness (asthenia),
• skin rash,
• Decreased testosterone levels,
• High levels of potassium in the blood (hyperkalemia),
• Allergic reactions (hypersensitivity),
• Headache,
• Seizures (crisis or attacks),
• Low blood pressure (hypotension),
• Upper respiratory tract infection,
• Dyspnea (difficulty breathing),
• Cough,
• Indigestion (dispepsia),
• Diarrhea,
• Abdominal pain, upper abdominal pain,
• Constipation,
• Muscle spasms,

• Back pain,
• Low calcium levels in the blood (hypocalcemia).

Unknown: its frequency cannot be estimated from the available data

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Cinacalcet Normon

- The active ingredient is cinacalcet. Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).

- The other components are:

Tablet core

Appearance of the product and content of the packaging

Film-coated tablet, light green in color, elongated and biconvex, 13.1 mm in length and 6 mm in width, marked with “C60” on one side and smooth on the other.

Cinacalcet Normon is presented in blisters of film-coated tablets of 60 mg. Each box contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:February 2019