Cinacalcet Reddi

Package Leaflet: Information for the Patient

Cinacalcet Reddy, 30 mg, coated tablets

Cinacalcet Reddy, 60 mg, coated tablets

Cinacalcet Reddy, 90 mg, coated tablets

Cinacalcet

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The mechanism of action of Cinacalcet Reddy is to control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat diseases caused by parathyroid gland disorders (hyperparathyroidism). The parathyroid glands are four small glands located in the neck near the thyroid gland. They produce a hormone called parathyroid hormone (PTH).

Cinacalcet Reddy is used in adult patients:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who require dialysis to clean the blood of waste products.
• to reduce high levels of calcium in the blood (hypercalcemia) in adults with parathyroid cancer.
• to reduce high levels of calcium in the blood (hypercalcemia) in adults with primary hyperparathyroidism who cannot undergo surgery to remove the parathyroid glands.

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

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clean the blood of waste 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 loss of calcium from bones, which can cause bone pain and fractures, vascular and cardiac disorders, kidney stones, mental disorders, and coma.

2. Before you take Cinacalcet Reddy

When not to take Cinacalcet Reddy

• -if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
• -if you have low levels of calcium in the blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions

Before taking Cinacalcet Reddy, you should discuss this with your doctor, pharmacist, or nurse.

Before taking cinacalcet, you should inform your doctor about any current or past medical conditions, 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. Patients treated with cinacalcet have reported life-threatening and fatal events related to low calcium levels (hypocalcemia).

You should tell your doctor if you experience symptoms of low calcium levels: seizures or muscle spasms or numbness or tingling of the fingers or toes or around the mouth or seizures or confusion or loss of consciousness while taking Cinacalcet Reddy.

Low calcium levels can affect heart rhythm. You should consult your doctor if you experience unusual rapid or pounding heartbeat, or if you have arrhythmias or if you are taking other medicines that can affect heart rhythm while taking Cinacalcet Reddy.

Additional information, see section 4.

While taking Cinacalcet Reddy, you should inform your doctor about:

• starting or stopping smoking, as this 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 calcium levels before and during treatment with Cinacalcet Reddy. You should inform your doctor if you experience symptoms of low calcium levels as described above.

It is important that the patient takes the dose of Cinacalcet Reddy as prescribed by the doctor.

Cinacalcet Reddy and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, especially etelcalcetide or other medicines that reduce calcium levels in the blood.

You should not take Cinacalcet Reddy at the same time as etelcalcetide.

You should inform your doctor if you are taking any of the following medicines. The effectiveness of cinacalcet may be affected by:

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

Cinacalcet may affect the effectiveness of:

• medicines used to treat depression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• medicines used to treat cough(dextromethorphan);
• medicines used to treat heart rhythm disorders(flecainide and propafenone);
• medicines used to treat 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cinacalcet has not been studied in pregnant women. In case of pregnancy, your doctor may decide to change your treatment, as cinacalcet may pose a risk to the fetus.

It is not known whether cinacalcet passes into human breast milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Cinacalcet Reddy.

Driving and using machines

Patients taking cinacalcet have reported dizziness and seizures. If you experience these symptoms, you should not drive or operate machinery.

Cinacalcet Reddy contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Cinacalcet Reddy

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will tell you what dose of Cinacalcet Reddy to take.

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 opened capsules. Children who require doses less than 30 mg or who cannot swallow tablets should use cinacalcet granules.

Your doctor will regularly take blood samples to check how your treatment is progressing and adjust the dose as necessary.

Treatment of secondary hyperparathyroidism

The usual starting dose of Cinacalcet Reddy in adults is 30 mg (one tablet) once a day.

The usual starting 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 starting dose of Cinacalcet Reddy in adults is 30 mg (one tablet) twice a day.

If you take more Cinacalcet Reddy than you should

If you have taken more Cinacalcet Reddy than you should, contact your doctor immediately. Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or spasms, or seizures.

If you forget to take Cinacalcet Reddy

Do not take a double dose to make up for a forgotten dose.

If you miss a dose of Cinacalcet Reddy, take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention:

• if you start to feel numbness or tingling around the mouth, muscle pain or spasms, or seizures. These may be symptoms of low calcium levels (hypocalcemia).
• if you experience swelling of the face, lips, tongue, and 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 do not last long.

Common: may affect up to 1 in 10 people

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

Frequency not known: cannot be estimated from the available data

• hives
• swelling of the face, lips, tongue, and throat, which may cause difficulty in swallowing or breathing (angioedema)
• abnormal heart rhythm, which may be related to low calcium levels in the blood (QT interval prolongation 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system via the Medicines Agency website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Reddy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the blister after EXP. The expiry date refers to the last day of that month.

No special storage precautions are required.

Medicines should 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 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:
• 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, oval, coated tablet, 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 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH

Kobelweg 95

86156 Augsburg

Germany

Manufacturer/Importer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Date of last revision of the leaflet: