Cinacalcet devatis

Package leaflet: Information for the patient

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Cinacalcet Devatis, 60 mg, film-coated tablets
Cinacalcetum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Cinacalcet Devatis is and what it is 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 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 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 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 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 problems, 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 to 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 existing
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. Life-threatening events and fatal outcomes related to low calcium levels (hypocalcemia) have been reported in patients treated with cinacalcet.
Inform your doctor if the patient experiences symptoms of low calcium levels while taking Cinacalcet Devatis: muscle cramps or spasms, 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, palpitations, or arrhythmias occur, or if the patient is taking other medications 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 it may affect the efficacy 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 with other medicines
Inform your doctor or pharmacist about all medicines currently used 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 following 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 cardiac arrhythmias (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 child, 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 unknown whether cinacalcet passes into human breast milk. The treating physician will discuss with the patient either discontinuation of breastfeeding or discontinuation of Cinacalcet Devatis treatment.

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 previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use the medicine Cinacalcet Devatis

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should 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, 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 lower than 30 mg or
who cannot swallow tablets should take 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 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 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.

Missing 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 how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 less than 1 in 10 people:

• dizziness
• sensation of numbness or tingling (paraesthesia)
• loss of appetite (anorexia) or reduced 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 unknown: frequency cannot be estimated from available data:

• urticaria
• swelling of the face, lips, mouth, tongue and throat, which may cause difficulty in swallowing and breathing (angioedema)
• unusually rapid heartbeat or palpitations, which may be related to low blood calcium levels (prolongation of the 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 low blood pressure (hypotension) has occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows collection of further information on the safety of the medicine.

5. How to store Cinacalcet Devatis

Keep this medicine out of 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 are required.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Cinacalcet Devatis contains

• The active substance is cinacalcet. Each film-coated tablet contains 60 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 Cinacalcet Devatis looks like and contents of the pack
Cinacalcet Devatis is a light green film-coated tablet. The tablets are oval and marked with
"60" on one side.
Cinacalcet Devatis is available in blister packs containing film-coated tablets. Each
package (carton box) contains 28 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Germany, 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: 94152.00.00
Parallel import authorisation number: 94/26