CINACALCET NORMON 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cinacalcet Normon 60 mg Film-Coated Tablets EFG

Cinacalcet

Read all of this leaflet carefully before you start 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

1. What is Cinacalcet Normon and what is it used for
2. What you need to know before you take Cinacalcet Normon
3. How to take Cinacalcet Normon
4. Possible side effects
5. Storage of Cinacalcet Normon
6. Contents of the pack and other information

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

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

Cinacalcet Normon is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who need 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 need dialysis to remove waste products from their blood, and whose disease 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 the loss of calcium from the bones, which can lead to bone pain and fractures, problems in the blood vessels and heart, kidney stones, mental illness, and coma.

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

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking cinacalcet.

Before taking cinacalcet, tell your doctor if you have or have had:

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

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

Tell your doctor if you experience any of the following symptoms that may be indicative of 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 taking cinacalcet.

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

For more information, see section 4.

During treatment with cinacalcet, tell your doctor:

• if you start or stop smoking, as it may change 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 check your calcium levels before starting treatment with cinacalcet and during treatment with cinacalcet. You should tell your doctor if you experience any of the symptoms related to low calcium levels described above.

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

Other medicines and Cinacalcet Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly etelcalcetide or any other medicine that lowers calcium levels in your blood.

You should not take cinacalcet with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of cinacalcet:

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

Cinacalcet may change the effect of medicines like the following:

• medicines used to treat depression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medicine used to relieve cough(dextromethorphan);
• medicines used to treat heart rhythm disorders(flecainide and propafenone);
• a medicine 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, 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 may be harmful to the unborn baby.

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

3. How to take Cinacalcet Normon

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask 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 and not chewed, crushed, or divided.

Your doctor will regularly check your 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 starting dose of cinacalcet in adults is 30 mg (one tablet) once a day.

The usual starting 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 starting 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, contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

If you forget to take Cinacalcet Normon

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

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

If you have any further questions on the use of this medicine, 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 notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These can be symptoms of low calcium levels (hypocalcemia) in your blood.
• If you notice swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in 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 (fits 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 which may cause difficulty in swallowing or breathing (angioedema),
• unusually fast or strong heartbeat that may be associated with low calcium levels in your blood (QT prolongation and ventricular arrhythmia secondary 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 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 Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Normon

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 is the last day of the month stated.

This medicine 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinacalcet Normon

• The active substance is cinacalcet. Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).
• The other ingredients are:

Core of the tablet

Appearance of the product and pack contents

Light green, elongated, and biconvex film-coated tablet, 13.1 mm in length and 6 mm in width, marked with "C60" on one side and smooth on the other.

Cinacalcet Normon is available in blister packs of 60 mg film-coated tablets. Each carton contains 28 tablets.

Marketing authorisation holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of last revision of this leaflet:February 2019