Cinacalcet devatis

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cinacalcet Devatis, 30 mg, film-coated tablets
Cinacalcetum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What is Cinacalcet Devatis and what is it used for
2. What you need to know 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 is Cinacalcet Devatis and what is it used for

The mechanism of action of Cinacalcet Devatis involves controlling levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases 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 from 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, when the condition cannot be controlled with other treatments.

In both primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means that the overactivity is not caused by any other factors, whereas "secondary" means that the overactivity is caused by other conditions, such as kidney disease. Both primary and secondary hyperparathyroidism may lead to loss of calcium from bones, which can 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 calcium levels in the blood. 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 current or previously experienced
medical conditions, including:

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

Cinacalcet Devatis lowers calcium levels. In adults and children treated with cinacalcet,
life-threatening events and deaths related to low calcium levels (hypocalcemia) have been reported.
Inform your doctor if the patient experiences symptoms of low calcium levels:
muscle spasms or cramps, numbness or tingling in fingers, toes, or around the mouth,
seizure attacks, confusion, or loss of consciousness while taking Cinacalcet Devatis.
Low calcium levels may affect heart rhythm. Contact your doctor if you experience
unusually fast heartbeat or palpitations, or if you have heart rhythm disorders, or if the patient
is taking other medicines causing 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 smoking, as this may affect the action of cinacalcet.

Children and adolescents
Cinacalcet Devatis must not be used in children under 18 years of age with parathyroid cancer 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 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used,
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. The effectiveness of
cinacalcet may be affected by:

• 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 for HIV infection 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
Cinacalcet Devatis should be taken 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 become
pregnant, 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
the treatment, as cinacalcet may pose a risk to the fetus.
It is unknown whether cinacalcet passes into human breast milk. The treating doctor will discuss
with the patient whether to discontinue breastfeeding or to stop taking 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 the doctor before taking this medicine.

3. How to use Cinacalcet Devatis

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist. The doctor will inform the patient of the dose of
Cinacalcet Devatis to be taken.
Cinacalcet Devatis is available in the following strengths: 30 mg, 60 mg, 90 mg.
Cinacalcet Devatis should be taken orally, during 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 less than
30 mg or who cannot swallow tablets should take cinacalcet as granules.
The doctor will regularly take blood samples to monitor the treatment 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 no
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 recommended
If more Cinacalcet Devatis than recommended is taken, contact a doctor immediately.
Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or
cramps, or seizures.

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

If there are any questions or uncertainties about the use of this medicine, consult the doctor,
pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
You should immediately inform your doctor 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).
• the patient develops 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; usually mild and short-lived.

Common: may affect up to 1 in 10 people:

• dizziness
• sensation of numbness or tingling (paraesthesia)
• loss of appetite (anorexia) or reduced appetite
• muscle pain (myalgia)
• weakness (asthenia)
• 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: cannot be estimated from the available data

• urticaria
• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema)
• abnormally rapid heartbeat or palpitations, which may be related to low blood calcium levels (QT prolongation and ventricular 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Cinacalcet Devatis

Keep the 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 conditions apply.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B.:/Verwendbar bis: (siehe Prägung) – Batch number:/Expiry date: (see imprint).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 30 mg of cinacalcet (as cinacalcet hydrochloride).
• 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), yellow iron oxide (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 "30" on one side.
Cinacalcet Devatis is available in blister packs containing film-coated tablets. Each carton contains 28 film-coated tablets.
For more detailed information, please contact the responsible party 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, Poland
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
German Marketing Authorisation Number (country of export): 94151.00.00
Parallel Import Licence Number: 93/26