MICALCET 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Micalcet, 30 mg, coated tablets
3. Micalcet, 60 mg, coated tablets
4. Micalcet, 90 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
5. What is Micalcet and what is it used for
6. Important information before taking Micalcet
   1. When not to take Micalcet:
   2. Warnings and precautions
   3. Children and adolescents
   4. Micalcet and other medicines
   5. Micalcet with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Micalcet contains lactose monohydrate
7. How to take Micalcet
   1. If you take more Micalcet than you should
   2. If you forget to take Micalcet
8. Possible side effects
   1. Tell your doctor immediately:
   2. Very common (may affect more than 1 in 10 people)
   3. Common (may affect up to 1 in 10 people)
   4. Frequency not known (cannot be estimated from the available data)
   5. Reporting of side effects
9. How to store Micalcet
10. Contents of the pack and other information
    1. What Micalcet contains
    2. What Micalcet looks like and contents of the pack
    3. Marketing Authorization Holder
    4. Importer:
    5. For more information about this medicine and its authorized names in the European Economic Area, please contact the representative of the Marketing Authorization Holder in Poland:
    6. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Micalcet, 30 mg, coated tablets

Micalcet, 60 mg, coated tablets

Micalcet, 90 mg, coated tablets

Cinacalcet

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Micalcet and what is it 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 is Micalcet and what is it used for

Micalcet works by controlling 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). Micalcet 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 adult patients with parathyroid cancer,
• to reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism who cannot undergo parathyroid gland removal surgery.

Micalcet is used in children and adolescents from 3 years to less than 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to clean the blood of waste products, and for whom other treatments are not possible.

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, cardiovascular disorders, kidney stones, mental disorders, and coma.

2. Important information before taking Micalcet

When not to take Micalcet:

• 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 closely monitor your blood calcium levels.

Warnings and precautions

Before taking Micalcet, discuss it with your doctor, pharmacist, or nurse. Before taking Micalcet, tell your doctor if you:

• have a history of seizures, as the risk of seizures is higher in people who have had them before,
• have liver function disorders,
• have heart failure.

Micalcet reduces calcium levels in the blood. In adults and children taking cinacalcet, life-threatening and fatal cases of low calcium levels (hypocalcemia) have been reported. Tell your doctor if you experience symptoms of low calcium levels: muscle cramps, tingling, or numbness of the fingers or around the mouth, or seizures. Low calcium levels can affect heart rhythm. Tell your doctor if you experience abnormal heartbeats or palpitations, or if you are taking other medicines that can affect heart rhythm while taking Micalcet. For more information, see section 4.

• tell your doctor if you start or stop smoking, as it may affect the way Micalcet works.

Children and adolescents

Micalcet should not be used in children under 18 years of age with parathyroid cancer or primary hyperparathyroidism. If you are being treated for secondary hyperparathyroidism, your doctor will closely monitor your calcium levels before and during treatment with Micalcet. Tell your doctor if you experience symptoms of low calcium levels as described above. It is important to take the dose of Micalcet as prescribed by your doctor.

Micalcet and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially etelcalcetide or other medicines that lower calcium levels in the blood. Do not take Micalcet with etelcalcetide. Tell your doctor if you are taking:

• medicines used to treat fungal skin 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).

Micalcet may affect the way other medicines work:

• 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).

Micalcet with food and drink

Take Micalcet 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. Micalcet has not been studied in pregnant women. If you become pregnant, your doctor may decide to change your treatment, as Micalcet may pose a risk to the fetus. It is not known whether Micalcet passes into breast milk. Your doctor will discuss with you whether to stop breastfeeding or stop taking Micalcet.

Driving and using machines

Dizziness and seizures have been reported in patients taking cinacalcet. If you experience these symptoms, do not drive or operate machinery.

Micalcet 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 Micalcet

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 how much Micalcet to take. Take Micalcet orally, during or shortly after a meal. Swallow the tablets whole, do not chew, crush, or divide them. Children who require doses less than 30 mg or who cannot swallow tablets should receive another suitable formulation available on the market. Your doctor will regularly take blood samples to check how your treatment is progressing and adjust the dose as needed.

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 from 3 years to less than 18 years is up to 0.20 mg/kg body weight per day.

Treatment of parathyroid cancer and primary hyperparathyroidism: The usual starting dose of Micalcet in adults is 30 mg (one tablet) twice daily.

If you take more Micalcet than you should

If you take more Micalcet than you should, contact your doctor immediately. Symptoms of overdose may include: numbness or tingling around the mouth, muscle cramps, or seizures.

If you forget to take Micalcet

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose of Micalcet, take the next dose at the usual time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately:

• If you experience numbness or tingling around the mouth, muscle cramps, or seizures. These may be symptoms of low calcium levels (hypocalcemia).
• If you experience swelling of the face, lips, 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 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
• Difficulty breathing (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, or throat, which may cause difficulty in swallowing or breathing (angioedema).
• Abnormal heartbeats or palpitations, which may be related to low calcium levels in the blood (prolonged QT interval and ventricular arrhythmias due to hypocalcemia).

In very rare cases, patients with heart failure taking Micalcet have experienced worsening of heart failure and/or low blood pressure (hypotension).

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of 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]. You can also report side effects to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micalcet

Keep this medicine out of the sight and reach of children. There are no special storage instructions for this medicine. Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Micalcet contains

• The active substance is cinacalcet. Each tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as cinacalcet hydrochloride).
• The other ingredients are: Tablet core: maize starch, cornstarch; silicon dioxide, anhydrous; 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, 6.24 x 9.93 mm in size, with "30" engraved on one side and a smooth surface on the other. Micalcet 60 mg is a light green, oval, film-coated tablet, 7.97 x 12.80 mm in size, with "60" engraved on one side and a smooth surface on the other. Micalcet 90 mg is a light green, oval, film-coated tablet, 9.16 x 14.48 mm in size, with "90" engraved on one side and a smooth surface on the other. The pack sizes are 14, 28, 84 tablets in blisters, packed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorization Holder

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

Importer:

S.C. Zentiva S.A., Blvd Theodor Pallady nr.50, sector 3, 032266 Bucharest, Romania

For more information about this medicine and its authorized names in the European Economic Area, please contact the representative of the Marketing Authorization Holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00

Date of last revision of the package leaflet: