MICALCET 60 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 all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
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
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 Authorisation Holder
    4. Importer:
    5. For more information about this medicine, contact the representative of the Marketing Authorisation Holder in Poland:
    6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Micalcet, 30 mg, coated tablets

Micalcet, 60 mg, coated tablets

Micalcet, 90 mg, coated tablets

Cinacalcet

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

• 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 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 need dialysis to clean their blood,
• 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 surgery to remove the parathyroid glands.

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

• to treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to clean their blood, and who cannot be controlled by other treatments.

In primary and secondary hyperparathyroidism, the parathyroid glands produce too much 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 problems, kidney stones, mental problems, 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 your blood. Your doctor will monitor your calcium levels closely.

Warnings and precautions

Before taking Micalcet, discuss with your doctor, pharmacist, or nurse:

Before taking Micalcet, tell your doctor if you have or have had:

• seizures, the risk of seizures is higher in people who have had them before,
• liver problems,
• heart failure.

Micalcet lowers the levels of calcium in your blood. In adults and children taking cinacalcet, there have been reports of life-threatening and fatal events associated with low levels of calcium in the blood (hypocalcemia).

Tell your doctor if you experience symptoms of low calcium levels: seizures or muscle cramps, or numbness or tingling in your fingers or around your mouth, or seizures, confusion, or loss of consciousness while taking Micalcet.

Low calcium levels can affect your heart rhythm. Tell your doctor if you experience an abnormally fast or pounding heartbeat, or if you have heart rhythm problems, or if you are taking other medicines that can affect your heart rhythm while taking Micalcet.

Additional information, see section 4.

While taking Micalcet, tell your doctor:

• if you start or stop smoking, as this 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 monitor your calcium levels closely before and during treatment with Micalcet. Tell your doctor if you experience symptoms of low calcium levels as described above.

It is important that you 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 your blood.

Do not take Micalcet with etelcalcetide.

Tell your doctor if you are taking any of the following medicines:

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

Micalcet may affect the way the following medicines work:

• medicines used to treat depression(amitriptyline, desipramine, nortriptyline, and clomipramine),
• medicines used to treat cough(dextromethorphan),
• medicines used to treat heart rhythm problems(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

If you have been told by your doctor 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. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much Micalcet to take.

Take Micalcet by mouth, 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 of the medicine 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 a day.

The usual starting dose of Micalcet in children and adolescents aged 3 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 a day.

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 miss 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, this medicine 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
• 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 (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).
• Abnormally fast or pounding heartbeat, 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 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 regulatory authority via the national reporting system listed in the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products([email protected]).

• Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309. Side effects can also be reported to the marketing authorization holder or its representative in Poland.

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. These measures 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; silica, colloidal anhydrous; crospovidone (Type A); copovidone (K-28); microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate.

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, 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, 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, coated tablet, 9.16 x 14.48 mm in size, with "90" engraved on one side and a smooth surface 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.

Blvd Theodor Pallady nr.50, sector 3

Bucharest 03 2266

Romania

For more information about this medicine, 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

Date of last revision of the leaflet: