CINACALCET STADA 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cinacalcet STADA 30 mg film-coated tablets EFG

Cinacalcet STADA 60 mg film-coated tablets EFG

Cinacalcet STADA 90 mg film-coated tablets EFG

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 Stada and what is it used for
2. What you need to know before you take Cinacalcet Stada
3. How to take Cinacalcet Stada
4. Possible side effects
5. Storage of Cinacalcet Stada
6. Pack contents and further information

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

Cinacalcet 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 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 the loss of calcium from the bones, which can lead to bone pain and fractures, problems with blood vessels and heart vessels, kidney stones, mental illness, and coma.

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

Do not take Cinacalcet Stada

• if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions

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

Before starting this medicine, tell your doctor if you have or have had:

• seizures(attacks or fits). The risk of having seizures is higher in people who have already had them
• 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.

Tell 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 this medicine.

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 can cause heart rhythm problems while taking this medicine.

For additional information, see section 4.

During treatment with cinacalcet, tell your doctor:

• if you start or stop smoking, as this 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 tell your doctor if you experience any of the symptoms related to low calcium levels described above.

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

Note:

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

Other medicines and Cinacalcet Stada

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 reduces calcium levels in your blood.

You should not receive 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 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, 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 whether cinacalcet passes into breast milk. Your doctor will advise you whether to stop breastfeeding or stop taking this medicine.

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 Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Cinacalcet Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will tell you how much cinacalcet to take.

Dose

Your doctor will regularly perform 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 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.

Note:

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

If the treatment is for parathyroid cancer or primary hyperparathyroidism

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

Method of administration

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

The score line is not intended to break the tablet.

If you take more Cinacalcet Stada 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.

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 medicine and the amount taken.

If you forget to take Cinacalcet Stada

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

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

If you have any further questions on the use of this product, 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 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 (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 that can cause difficulty 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Stada

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. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

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, colloidal anhydrous silica, crospovidone, sodium carboxymethyl starch (type A) potato, magnesium stearate.

Tablet coating:hypromellose, titanium dioxide E171, triacetin, yellow iron oxide E172, Aluminum Lake of Indigo (E132).

Appearance of the Product and Package Contents

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

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

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

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 Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:January 2020

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