Cinacalcet Reddi

Leaflet accompanying the packaging: patient information

Cinacalcet Reddy, 30 mg, coated tablets

Cinacalcet Reddy, 60 mg, coated tablets

Cinacalcet Reddy, 90 mg, coated tablets

Cinacalcet

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

The mechanism of action of Cinacalcet Reddy involves controlling the concentrations of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used in diseases caused by disorders of the parathyroid glands (parathyroid glands). The parathyroid glands are four small glands located in the neck near the thyroid gland. They produce a hormone called parathormone (PTH).
Cinacalcet Reddy is used in adult patients:

• for the treatment of secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to cleanse the blood of metabolic products.
• to reduce elevated calcium levels in the blood (hypercalcemia) in adults with parathyroid cancer.
• to reduce elevated calcium levels in the blood (hypercalcemia) in adults with primary hyperparathyroidism, in whom parathyroidectomy is not possible.

Cinacalcet Reddy is used in children and adolescents from 3 to less than 18 years of age:

• for the treatment of secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to cleanse the blood of metabolic products, in whom it is not possible to control the disease with other treatments.

In primary and secondary hyperparathyroidism, the parathyroid glands produce excessive amounts of PTH. "Primary" means that the hyperparathyroidism is not caused by any other factors, while "secondary" means that the hyperparathyroidism is caused by other factors, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to calcium loss in bones, which can cause bone pain and fractures, cardiovascular disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Cinacalcet Reddy

When not to take Cinacalcet Reddy

• -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 the calcium levels in the blood.

Warnings and precautions

Before starting to take Cinacalcet Reddy, the patient should discuss it with their doctor, pharmacist, or nurse.
Before taking cinacalcet, the patient should inform their doctor about any current or previous diseases, including:

• seizures. The risk of seizures is higher in people who have had them before;
• liver function disorders;
• heart failure.

Cinacalcet Reddy reduces calcium levels. In adults and children treated with cinacalcet, life-threatening and fatal events related to low calcium levels (hypocalcemia) have been reported.
The patient should tell their doctor if they experience symptoms of low calcium levels: seizures or muscle cramps or numbness or tingling of the fingers or around the mouth or seizures, confusion, or loss of consciousness while taking Cinacalcet Reddy.
Low calcium levels can affect heart rhythm. The patient should consult their doctor if they experience unusual rapid heartbeat or palpitations, if they have arrhythmias, or if they are taking other medicines that affect heart rhythm while taking Cinacalcet Reddy.
For additional information, see section 4.
While taking Cinacalcet Reddy, the patient should inform their doctor about:

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

Children and adolescents

Cinacalcet Reddy should 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 the calcium levels before starting and during treatment with Cinacalcet Reddy. The patient should inform their doctor if they experience symptoms of low calcium levels as described above.
It is important for the patient to take the dose of Cinacalcet Reddy as prescribed by their doctor.

Cinacalcet Reddy and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, including etelcalcetide or other medicines that lower calcium levels in the blood.
The patient should not take Cinacalcet Reddy at the same time as etelcalcetide.
The patient should inform their doctor if they are taking the following medicines, as they may affect the efficacy of cinacalcet:

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

Cinacalcet may affect the efficacy of:

• medicines used for depression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• medicines used for cough suppression(dextromethorphan);
• medicines used for heart rhythm disorders(flecainide and propafenone);
• medicines used for high blood pressure(metoprolol).

Cinacalcet Reddy with food and drink

Cinacalcet Reddy should be taken during or shortly after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Cinacalcet has not been studied in pregnant women. In case of pregnancy, the doctor may decide to change the treatment, as cinacalcet may pose a risk to the fetus.
It is not known whether cinacalcet passes into human milk. The doctor will discuss with the patient whether to stop breastfeeding or stop taking Cinacalcet Reddy.

Driving and using machines

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

Cinacalcet Reddy contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Cinacalcet Reddy

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will inform the patient about the dose of Cinacalcet Reddy to be taken.
Cinacalcet Reddy should be taken orally, during or shortly after a meal. The tablets should be swallowed whole and not chewed, crushed, or divided.
Cinacalcet is also available as a granule in open capsules. Children who need to take doses less than 30 mg or who cannot swallow tablets should take cinacalcet in granules.
The doctor will regularly take blood samples to check the progress of the treatment and adjust the dose as needed.
Treatment of secondary hyperparathyroidism
The usual initial dose of Cinacalcet Reddy in adults is 30 mg (one tablet) once a day.
The usual initial dose of cinacalcet in children and adolescents from 3 to less than 18 years of age is up to 0.20 mg/kg body weight per day.
Treatment of parathyroid cancer and primary hyperparathyroidism
The usual initial dose of Cinacalcet Reddy in adults is 30 mg (one tablet) twice a day.

Taking a higher dose of Cinacalcet Reddy than recommended

In case of taking a higher dose of Cinacalcet Reddy than recommended, the patient should immediately contact their doctor. Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or cramps, or seizures.

Missing a dose of Cinacalcet Reddy

The patient should not take a double dose to make up for a missed dose.
If a dose of Cinacalcet Reddy is missed, the patient should take the next dose at the usual time.
In case of any doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Cinacalcet Reddy can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor:

• if they start to feel numbness or tingling around the mouth, muscle pain or cramps, or seizures. These may be symptoms of low calcium levels (hypocalcemia).
• if they experience swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema).

Very common: affects more than 1 in 10 people:

• nausea and vomiting; usually mild and do not last long.

Common: affects less than 1 in 10 people

• dizziness
• feeling of numbness or tingling (paresthesia)
• loss of appetite (anorexia) or decreased appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• low testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (convulsions)
• low blood pressure (hypotension)
• upper respiratory tract infection
• breathing difficulties (dyspnea)
• cough
• indigestion
• diarrhea
• abdominal pain, upper abdominal pain
• constipation
• muscle cramps
• back pain
• low calcium levels in the blood (hypocalcemia).

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

• hives
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema)
• unusually rapid heartbeat or palpitations, which may be related to low calcium levels in the blood (prolonged QT interval and ventricular arrhythmias due to hypocalcemia).

In a small number of patients with heart failure taking cinacalcet, worsening of heart failure and/or low blood pressure (hypotension) have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cinacalcet Reddy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP) and on the blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cinacalcet Reddy contains

• The active substance is cinacalcet. Each coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as hydrochloride).
• The other ingredients are:
• Starch 1500
• Microcrystalline cellulose
• Povidone (K-12)
• Crospovidone (Type A)
• Colloidal anhydrous silica
• Magnesium stearate
• Coating ingredients:
• Lactose monohydrate
• Hypromellose (HPMC 2910)
• Titanium dioxide (E171)
• Triacetin
• Indigo carmine (E132)
• Yellow iron oxide (E172)

What Cinacalcet Reddy looks like and contents of the pack

Cinacalcet Reddy is a light green, coated tablet. It is oval and marked with "30", "60", or "90" on one side and "C" on the other.
Cinacalcet Reddy is available in blisters containing 30 mg, 60 mg, or 90 mg coated tablets. Each pack (carton) contains 14, 28, 42, 84, or 98 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Manufacturer/Importer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:
Cinacalcet beta Filmtabletten
Spain:
Cinacalcet Dr. Reddys comprimidos recubiertos con película EFG
Italy:
Cinacalcet Dr. Reddy´s
Austria:
Cinacalcet Reddy Filmtabletten
Netherlands:
Cinacalcet Reddy filmomhulde tabletten
France:
CINACALCET REDDY PHARMA, comprimé pelliculé
Poland:
Cinacalcet Reddy
Czech Republic:
Cinacalcet Reddy
Slovakia:
Cinacalcet Reddy filmom obalené tablety
Portugal:
Cinacalcet Reddy comprimidos revestidos por película
United Kingdom (Northern Ireland):
Cinacalcet Dr. Reddy's Film-Coated Tablets

Date of last revision of the leaflet: 09/2023