Micalcet

Patient Information Leaflet

Micalcet, 30 mg, coated tablets
Micalcet, 60 mg, coated tablets
Micalcet, 90 mg, coated tablets
Cinacalcetum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, ask 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 someone else, 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

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

1. What Micalcet is and what it is used for

Micalcet works by regulating 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). Micalcet is used in adult patients:

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

Micalcet 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 remove 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 it is triggered 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 cardiac complications, kidney stones, psychiatric disturbances, and coma.

2. Important information before using Micalcet

When not to use Micalcet:

• 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 closely monitor blood calcium levels.

Warnings and precautions
Before starting treatment with Micalcet, discuss this with your doctor, pharmacist, or nurse.
Before using Micalcet, inform your doctor if the patient has or has previously had:

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

Micalcet reduces blood calcium levels. In adults and children treated with cinacalcet, life-threatening and fatal events related to low calcium levels (hypocalcaemia) have been reported.
Inform your doctor if the patient experiences symptoms of low calcium levels: seizures or muscle cramps, numbness or tingling in fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness while taking Micalcet.
Low calcium levels may affect heart rhythm. Contact your doctor if the patient experiences abnormally rapid heartbeat, palpitations, arrhythmias, or if the patient is taking other medicines causing heart rhythm disturbances during treatment with Micalcet.
Additional information, see section 4.
During treatment with Micalcet, inform your doctor about:

• starting or quitting smoking, as this may affect the action of Micalcet.

Children and adolescents
Micalcet 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 closely monitor calcium levels before and during treatment with Micalcet. Inform the doctor if symptoms of low calcium levels described above occur.
It is important that the patient takes the dose of Micalcet as prescribed by the doctor.

Micalcet and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially etelcalcetide or other medicines that lower blood calcium levels. Micalcet must not be taken together with etelcalcetide.
Inform your doctor if the patient is taking any of the following medicines.
Medicines that may affect the action of Micalcet:

• 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).

Micalcet may affect the action of:

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

Micalcet with food and drink
Micalcet 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Micalcet has not been studied in pregnant women. During pregnancy, the doctor may decide to change treatment, as Micalcet may pose a risk to the fetus.
It is unknown whether Micalcet passes into human milk. The treating doctor will discuss with the patient either discontinuation of breastfeeding or discontinuation of Micalcet therapy.

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

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

3. How to use Micalcet

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist. The doctor will inform the patient what dose of Micalcet
should be taken.
Micalcet should be taken orally, during or shortly after a meal. Tablets should be swallowed whole and must not be chewed, crushed, or divided.
Children who require doses lower than 30 mg or who are unable to swallow tablets should receive another suitable medicinal formulation available on the market.
The doctor will regularly take blood samples to monitor the progress of treatment and, if necessary, adjust the dose accordingly.

Treatment of secondary hyperparathyroidism
The usual starting dose of Micalcet in adults is 30 mg (one tablet) once daily.
The usual starting dose of Micalcet 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 Micalcet in adults is 30 mg (one tablet) twice daily.

Taking more Micalcet than recommended
If more Micalcet than recommended is taken, contact the doctor immediately. Symptoms of overdose may include: numbness or tingling around the mouth, muscle pain or cramps, and seizures.

Missing a dose of Micalcet
Do not take a double dose to make up for a missed dose.
If a dose of Micalcet is missed, take the next dose at the usual time.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform the 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 patients)

• Nausea and vomiting; usually mild and short-lived

Common (may affect less than 1 in 10 patients)

• Dizziness
• Sensation of numbness or tingling (paraesthesiae)
• 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 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, possibly related to low blood calcium levels (QT interval prolongation and ventricular arrhythmias secondary to hypocalcaemia)

In very rare cases in patients with heart failure taking Micalcet, 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 this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can 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 181 C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
E-mail: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Micalcet

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
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 Micalcet contains

• The active substance is cinacalcet. Each coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as cinacalcet hydrochloride).

• The other ingredients are:
  Tablet core: pregelatinised starch, maize; colloidal anhydrous silica; crospovidone (type A); copovidone (K-28); microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate.

  Tablet coating:
  Opadry II 32K210001 Green: lactose monohydrate, hypromellose 15 cP, titanium dioxide (E171), triacetin, indigo carmine (E132), yellow iron oxide (E172);
  Opadry II 85F19250 Clear: polyvinyl alcohol, talc, macrogol 3350, polysorbate 80.

What Micalcet looks like and contents of the pack
Micalcet 30 mg is a light green, oval, film-coated tablet measuring 6.24 x 9.93 mm,
marked with "30" on one side and smooth on the other.
Micalcet 60 mg is a light green, oval, film-coated tablet measuring 7.97 x 12.80 mm,
marked with "60" on one side and smooth on the other.
Micalcet 90 mg is a light green, oval, film-coated tablet measuring 9.16 x 14.48 mm,
marked with "90" on one side and smooth on the other.

Pack sizes: 14, 28, 84 tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer:
S.C. Zentiva S.A.
Bd. Theodor Pallady no. 50, sector 3
Bucharest 03 2266
Romania

For further information about this medicinal product and its brand names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00