Cinacalcet Stada 30 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cinacalcet STADA 30 mg film-coated tablets EFG

Cinacalcet STADA 60 mg film-coated tablets EFG

Cinacalcet STADA 90 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Cinacalcet works by controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat disorders of certain organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid, 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 of age:

• 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 both primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term "primary" means that hyperparathyroidism is not caused by any other disease, while "secondary" means that hyperparathyroidism is caused by another disease, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to loss of calcium from the bones, which may result in bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental illness, and coma.

2. What you need to know before taking Cinacalcet Stada

Do not take Cinacalcet Stada

• if you are allergic to cinacalcet or to 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 to take cinacalcet.

Before starting this medicine, inform your doctor if you currently have or have ever had:

• seizures (fits or convulsions). The risk of seizures is higher in people who have previously experienced them.
• liver problems
• heart failure

Cinacalcet lowers calcium levels. Life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported in adults and children treated with cinacalcet.

Inform your doctor if you experience any of the following symptoms, which may indicate low calcium levels: muscle spasms, twitching or cramps, 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 may affect your heart rhythm. Inform your doctor if you experience unusually strong or rapid heartbeats, have problems with your heart rhythm, or are taking medications that may affect heart rhythm while on this medicine.

For additional information, see section 4.

During treatment with cinacalcet, inform your doctor:

• if you start or stop smoking, as this may alter the effect of cinacalcet.

Children and adolescents

Children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism must not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting and during treatment with cinacalcet. You must inform 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 exactly as prescribed by your doctor.

Note:

For children requiring doses lower than 30 mg, or in case of difficulty swallowing tablets, other strengths/formulations are available.

Other medicines and Cinacalcet Stada

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

You must not receive cinacalcet together with etelcalcetide.

Inform your doctor if you are taking any of the following medicines.

Medicines such as the following may affect the action of cinacalcet:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Cinacalcet may affect the action of medicines such as 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 drink

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Cinacalcet has not been studied in pregnant women. During 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 you should stop breastfeeding or stop treatment with this medicine.

Driving and use of machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these effects, do not drive or operate machinery.

Cinacalcet Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Cinacalcet Stada

Follow exactly the instructions for use of this medicine given 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.

Dosage

Your doctor will carry out 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 starting dose of cinacalcet in adults is 30 mg once daily.

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

Note:

For children requiring doses lower than 30 mg, or in case of difficulty swallowing tablets, other dosage strengths/formulations are available.

If treatment is for parathyroid carcinoma or primary hyperparathyroidism

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

Method of administration

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

The tablet score line should not be used to divide the tablet.

If you take more Cinacalcet Stada than you should

If you have taken more cinacalcet than you should, you must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cinacalcet Stada

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Tell 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 of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting. These adverse effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• dizziness
• sensation of numbness or tingling (paresthesia)
• loss (anorexia) or decreased appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin 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 infection
• difficulty breathing (dyspnea)
• cough
• stomach discomfort (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 available data

• hives (urticaria)
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema)
• unusually fast or strong heartbeat, which may be associated with low calcium levels in the blood (prolonged QT and ventricular arrhythmia secondary 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 adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cinacalcet Stada

• The active substance 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).

• Other components are:

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

Tablet coating: hypromellose, titanium dioxide E171, triacetin, iron oxide yellow E172, indigo carmine aluminium lake (E132).

Appearance of the product and contents of the container

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

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

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

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio 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

The 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

or

Stada Nordic ApS

Marielundvej 46a

Herlev, 2730

Denmark

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

Austria	Cinacalcet STADA 30 mg Film-coated tablets Cinacalcet STADA 60 mg Film-coated tablets Cinacalcet STADA 90 mg Film-coated tablets
Czech Republic	Cinacalcet STADA 30 mg coated tablets Cinacalcet STADA 60 mg coated tablets Cinacalcet STADA 90 mg coated tablets
Germany	Cinacalcet AL 30 mg Film-coated tablets Cinacalcet AL 60 mg Film-coated tablets Cinacalcet AL 90 mg Film-coated tablets
Denmark	Cinacalcet STADA 30 mg Cinacalcet STADA 60 mg Cinacalcet STADA 90 mg
Spain	Cinacalcet STADA 30 mg film-coated tablets EFG Cinacalcet STADA 60 mg film-coated tablets EFG Cinacalcet STADA 90 mg film-coated tablets EFG
Finland	Cinacalcet STADA 30 mg film-coated tablets Cinacalcet STADA 60 mg film-coated tablets Cinacalcet STADA 90 mg film-coated tablets
France	Cinacalcet EG 30 mg, film-coated tablet Cinacalcet EG 60 mg, film-coated tablet Cinacalcet EG 90 mg, film-coated tablet
Ireland	Cinacalcet Clonmel 30 mg film-coated tablets Cinacalcet Clonmel 60 mg film-coated tablets Cinacalcet Clonmel 90 mg film-coated tablets
Iceland	Cinacalcet STADA
Italy	Cinacalcet EG
Netherlands	Cinacalcet CF 30 mg, film-coated tablets Cinacalcet CF 60 mg, film-coated tablets Cinacalcet CF 90 mg, film-coated tablets
Norway	Cinacalcet STADA
Sweden	Cinacalcet STADA 30 mg film-coated tablets Cinacalcet STADA 60 mg film-coated tablets Cinacalcet STADA 90 mg film-coated tablets
United Kingdom	Cinacalcet STADA 30/60/90 mg film-coated tablet

Date of the most recent review of this leaflet: January 2020

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