Cinacalcet devatis

Patient Information Leaflet

Keep this leaflet. The packaging information is in a foreign language.
Cinacalcet Devatis, 90 mg, film-coated tablets
Cinacalcetum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Cinacalcet Devatis is and what it is used for
2. Important information before taking Cinacalcet Devatis
3. How to take Cinacalcet Devatis
4. Possible side effects
5. How to store Cinacalcet Devatis
6. Contents of the pack and other information

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

Cinacalcet Devatis works by controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in conditions caused by disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck near the thyroid gland. They produce a hormone called parathyroid hormone (PTH).

Cinacalcet Devatis is used in adult patients:

• for the treatment of secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to clear waste products from the blood.
• to reduce elevated blood calcium levels (hypercalcemia) in adults with parathyroid cancer.
• to reduce elevated blood calcium levels (hypercalcemia) in adults with primary hyperparathyroidism when surgery to remove the parathyroid glands is not possible.

Cinacalcet Devatis is used in children and adolescents aged 3 to below 18 years:

• for the treatment of secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clear waste products from the blood and in whom the condition cannot be controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means the overactivity is not caused by other factors, whereas "secondary" means the overactivity is due to other conditions, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to calcium loss from bones, which may result in bone pain and fractures, vascular and heart complications, kidney stones, mental disturbances, and coma.

2. Important information before using Cinacalcet Devatis

When not to take Cinacalcet Devatis

• if the patient is allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6);
• if the patient has low blood calcium levels. The doctor will monitor blood calcium levels.

Warnings and precautions
Before starting treatment with Cinacalcet Devatis, discuss this with your doctor, pharmacist,
or nurse.
Before taking cinacalcet, inform your doctor about any current or previous medical conditions, including:

• seizures – the risk of seizures is higher in patients who have experienced them previously;
• liver function disorders;
• heart failure.

Cinacalcet Devatis lowers calcium levels. In patients treated with cinacalcet, life-threatening and fatal events related to low calcium levels (hypocalcemia) have been reported.
Inform your doctor if the patient experiences symptoms of low calcium levels while taking Cinacalcet Devatis: muscle spasms or cramps, numbness or tingling in fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness.
Low calcium levels may affect heart rhythm. Contact your doctor if unusually rapid heartbeat or palpitations occur, or if arrhythmias develop, or if the patient is taking other medications that may cause heart rhythm disturbances during treatment with Cinacalcet Devatis.
Additional information, see section 4.
During treatment with Cinacalcet Devatis, inform your doctor about:

• starting or stopping tobacco smoking, as it may affect the action of cinacalcet.

Children and adolescents
Cinacalcet Devatis must not be used in children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism.
If the patient is being treated for secondary hyperparathyroidism, the doctor will monitor calcium levels before and during treatment with Cinacalcet Devatis. Inform the doctor if symptoms of low calcium levels described above occur.
It is important that the patient takes the dose of Cinacalcet Devatis prescribed by the doctor.

Cinacalcet Devatis with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, especially etelcalcetide or other medicines that lower blood calcium levels.
Do not take Cinacalcet Devatis together with etelcalcetide.
Inform your doctor if the patient is taking any of the following medicines, as they may affect the effectiveness of cinacalcet:

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

Cinacalcet may affect the effectiveness of:

• medicines used for depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medicine used to reduce cough (dextromethorphan);
• medicines used for heart rhythm disorders (flecainide and propafenone);
• a medicine used for hypertension (metoprolol).

Cinacalcet Devatis with food and drink
Take Cinacalcet Devatis during or shortly after a meal.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Cinacalcet has not been studied in pregnant women. During pregnancy, the doctor may decide to change treatment, as cinacalcet may pose a risk to the fetus.
It is not known whether cinacalcet passes into human milk. The treating doctor will discuss with the patient whether to discontinue breastfeeding or stop treatment with Cinacalcet Devatis.

Driving and operating machinery
Patients taking cinacalcet have reported dizziness and seizures. If the patient experiences these symptoms, he or she should not drive or operate machinery.

Cinacalcet Devatis contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Cinacalcet Devatis

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. Your doctor will inform you of the dose of Cinacalcet Devatis you
should take.
Cinacalcet Devatis is available in the following strengths: 30 mg, 60 mg, 90 mg.
Cinacalcet Devatis should be taken orally, with food or shortly after a meal. Tablets should be
swallowed whole and must not be chewed, crushed, or split.
Cinacalcet is also available as granules in opening capsules. Children who require doses lower than
30 mg or who cannot swallow tablets should be given cinacalcet as granules.
Your doctor will regularly take blood samples to monitor your treatment progress and adjust the
dose as necessary.

Treatment of secondary hyperparathyroidism
The usual starting dose of Cinacalcet Devatis in adults is 30 mg (one tablet) once daily.
The usual starting dose of cinacalcet in children and adolescents aged 3 to below 18 years is not
more than 0.20 mg/kg body weight per day.

Treatment of parathyroid carcinoma and primary hyperparathyroidism
The usual starting dose of Cinacalcet Devatis in adults is 30 mg (one tablet) twice daily.

Taking more Cinacalcet Devatis than prescribed
If you take more Cinacalcet Devatis than prescribed, contact your doctor immediately. Symptoms of
overdose may include numbness or tingling around the mouth, muscle pain or cramps, or seizures.

If you miss a dose of Cinacalcet Devatis
Do not take a double dose to make up for a missed dose.
If you miss a dose of Cinacalcet Devatis, take the next dose at your usual time.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You must inform your doctor immediately:

• if the patient develops numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low calcium levels (hypocalcaemia).
• if the patient develops swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing and breathing (angioedema).

Very common: affects more than 1 in 10 people:

• nausea and vomiting; usually mild and short-lived.

Common: affects less than 1 in 10 people

• dizziness
• sensation of numbness or tingling (paraesthesiae)
• loss of appetite (anorexia) or decreased appetite
• muscle pain
• weakness
• rash
• decreased testosterone levels
• high blood potassium levels (hyperkalaemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (seizure attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• breathing difficulties (dyspnoea)
• cough
• indigestion
• diarrhoea
• abdominal pain, upper abdominal pain
• constipation
• muscle cramps
• back pain
• low blood calcium levels (hypocalcaemia).

Frequency not known: frequency cannot be estimated from the available data

• urticaria
• swelling of the face, lips, mouth, tongue and throat, which may cause difficulty in swallowing and breathing (angioedema)
• unusually fast heartbeat or palpitations, which may be related to low blood calcium levels (prolongation of QT interval and ventricular cardiac arrhythmias resulting from hypocalcaemia).

In a small number of patients with heart failure taking cinacalcet, worsening of heart failure and/or reduction in blood pressure (hypotension) has occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Cinacalcet Devatis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B.:/Verwendbar bis: (siehe Prägung) – Batch number:/Expiry date: (see embossing).
Medicines must 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. Contents of the packaging and other information

What Cinacalcet Devatis contains

• The active substance is cinacalcet. Each film-coated tablet contains 90 mg of cinacalcet (as cinacalcet hydrochloride).
• The other ingredients are: pregelatinized starch, corn starch, microcrystalline cellulose (E 460), crospovidone (type A) (E 1202), colloidal anhydrous silica (E 551), magnesium stearate.
• Coating ingredients: SteffCoat Green L TN 1264G49 (lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), triacetin, indigo carmine, aluminium lake (E 132), iron oxide yellow (E 172)), Opadry Clear OY29020 (hypromellose (E 464), polyethylene glycol 400 (E 1520)).

What the medicine looks like and contents of the pack
Cinacalcet Devatis is a light green film-coated tablet. The tablets are oval and marked with
"90" on one side.
Cinacalcet Devatis is available in blister packs containing film-coated tablets. Each
package (cardboard box) contains 28 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, the country of export:
Devatis GmbH
Spitalstr. 22
79539 Lörrach, Germany
Manufacturer:
Devatis GmbH
Spitalstr. 22
79539 Lörrach, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorisation number, country of export: 94153.00.00
Parallel import authorisation number: 95/26