Prospect: information for the user

Cinacalcet STADA 30 mg film-coated tablets

Cinacalcet STADA 60 mg film-coated tablets

Cinacalcet STADA 90 mg film-coated tablets

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Cinacalcet Stada

4. Possible adverse effects

5. Storage of Cinacalcet Stada

6. Contents of the package and additional information

Cinacalcet 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 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 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 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 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 Stada

• if you are allergic to cinacalcet or any of the other ingredients of this medication (listed in section 6).
• if 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 this medication, 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 taking this medication.

Low calcium levels may 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 this medication.

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.

Note:

For children who require doses lower than 30 mg, or in case of difficulty swallowing the tablets, other dosages/forms are available.

Other medications and Cinacalcet Stada

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.

Medications such as the following may modify the action of cinacalcet:

• medications used to treatskinand fungal infections (ketoconazole, itraconazole, and voriconazole);
• medications used to treatbacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medication used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);
• a medication used to treatdepression(fluvoxamine).

Cinacalcet may modify the action of medications such as the following:

• medications used to treatdepression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medication used to relievecough(dextromethorphan);
• medications used to treatheart rhythm disorders(flecainide and propafenone);
• a medication used to treathigh blood pressure(metoprolol).

Taking Cinacalcet Stada 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 this medication.

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.

Cinacalcet Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Dose

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 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.

Note :

For children who require doses lower than 30 mg, or in case of difficulty swallowing the tablets, other dosages/formulations are available.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial dose of cinacalcet in adults is 30 mg twice a day.

Administration Form

This medication should be taken orally, with food or shortly after eating. The tablets should be swallowed whole and not chewed, crushed, or divided.

The groove should not be used to split the tablet.

If you take more Cinacalcet Stada than you should

If you have taken more cinacalcet than you should, you should contact 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Cinacalcet Stada

Do not take a double dose to compensate for the missed doses.

If you have forgotten to take a dose of this medication, 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.

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
• decrease in testosterone levels
• high levels of potassium in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (crises or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• difficulty breathing (dyspnea)
• cough
• indigestion (dyspepsia)
• diarrhea
• abdominal pain, upper abdominal pain
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcemia).

Not known: its frequency cannot be estimated from 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,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 any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Cinacalcet Stada

• The active ingredient of Cinacalcet Stada is cinacalcet.
• Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
• Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride)
• Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride)

• The other components are:

Tablet core:microcrystalline cellulose, maltodextrin, anhydrous colloidal silica, crospovidone, sodium carboxymethyl starch (type A) from potato, magnesium stearate.

Tablet coating:hypromellose, dioxide of titanium E171, triacetin, yellow iron oxide E172, aluminum lake of Indigotina (E132).

Appearance of the product and contents of the package

The green, oval, biconvex film-coated tablets of Cinacalcet Stada 30 mg are available in blisters of PVC/PCTFE/PVC//Al.

The green, oval, biconvex film-coated tablets of Cinacalcet Stada 60 mg are available in blisters of PVC/PCTFE/PVC//Al with a notch on one side.

The green, oval, biconvex film-coated tablets of Cinacalcet Stada 90 mg are available in blisters of PVC/PCTFE/PVC//Al.

Cinacalcet Stada 30 mg is available in packages containing blisters of 28, 30, 50, and 84 film-coated tablets or 28x1, 30x1, 50x1, 84x1 film-coated tablets.

Cinacalcet Stada 60 mg is available in packages containing blisters of 28, 30, and 84 film-coated tablets or 28x1, 30x1, 84x1 film-coated tablets.

Cinacalcet Stada 90 mg is available in packages containing blisters of 28, 30, and 84 film-coated tablets or 28x1, 30x1, 84x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastraße 2 -18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.,

Van de?Reijtstraat?31-E?

4814 NE Breda?

Netherlands

or

Clonmel Healthcare Ltd., Ireland

Waterford Road, 3

Clonmel, Co. Tipperary

Ireland

or

Thornton & Ross Ltd.,

Linthwaite, Huddersfield,

West Yorkshire

HD7 5QH

UK

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2020

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).