CINACALCET MYLAN 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cinacalcet Mylan 30 mg film-coated tablets EFG

Cinacalcet Mylan 60 mg film-coated tablets EFG

Cinacalcet Mylan 90 mg film-coated tablets EFG

cinacalcet

Read all of this leaflet carefully before you start 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 Cinacalcet Mylan and what is it used for
2. What you need to know before you take Cinacalcet Mylan
3. How to take Cinacalcet Mylan
4. Possible side effects
5. Storage of Cinacalcet Mylan
6. Contents of the pack and other information

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

Cinacalcet Mylan contains the active substance cinacalcet, which controls the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body. It is used to treat disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).

Cinacalcet Mylan is used:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood.
• to reduce high levels of calcium in the blood (hypercalcemia) in patients with parathyroid cancer.
• to reduce high levels of calcium in the blood (hypercalcemia) in patients with

primary hyperparathyroidism when the parathyroid gland cannot be removed.

In primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH.

The term "primary" means that the hyperparathyroidism is not caused by any other disease, and "secondary" means that the hyperparathyroidism is caused by another disease, such as kidney disease. Both primary and secondary hyperparathyroidism can cause calcium to be lost from the bones, which can lead to bone pain and fractures, problems with blood vessels and heart vessels, kidney stones, mental illness, and coma.

2. What you need to know before you take Cinacalcet Mylan

Do not take Cinacalcet Mylanif you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).

Do not take Cinacalcet Mylanif you have low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Cinacalcet Mylan.

Before you start taking Cinacalcet Mylan, tell your doctor if you have or have had:

• seizures (fits or convulsions). The risk of having seizures is higher in people who have already had them;
• liver problems;
• heart failure.

Cinacalcet Mylan lowers calcium levels. Potentially life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported in patients treated with cinacalcet.

Tell your doctor if you have any of the following symptoms that would indicate low calcium levels: muscle spasms, muscle twitching, or cramps, or numbness or tingling in the fingers, or around the mouth, or seizures, confusion, or loss of consciousness, while taking Cinacalcet Mylan.

Low calcium levels can affect your heart rhythm. Tell your doctor if you experience unusually strong or fast heartbeats, if you have problems with your heart rhythm, or if you are taking medicines that cause heart rhythm problems, while taking Cinacalcet Mylan.

For more information, see section 4.

During treatment with Cinacalcet Mylan, tell your doctor:

Children and adolescents

Children under 18 years should not take Cinacalcet Mylan.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Cinacalcet Mylan and during treatment with Cinacalcet Mylan. You should tell your doctor if you have any of the symptoms related to low calcium levels described above.

It is important that you take your dose of Cinacalcet Mylan exactly as your doctor has told you.

Taking Cinacalcet Mylan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular etelcalcetide or any other medicine that lowers calcium levels in your blood.

Do not take Cinacalcet Mylan with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of Cinacalcet Mylan:

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

Cinacalcet Mylan may change the effect of medicines like the following:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medicine used to relieve cough (dextromethorphan);
• medicines used to treat heart rhythm disorders (flecainide and propafenone);
• a medicine used to treat high blood pressure (metoprolol).

Taking Cinacalcet Mylan with food and drinks

Cinacalcet Mylan should be taken with food or shortly after eating.

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 be harmful to the unborn baby.

It is not known whether cinacalcet passes into breast milk. Your doctor will tell you if you should stop breastfeeding or stop Cinacalcet Mylan treatment.

Driving and using machines

In patients taking Cinacalcet Mylan, cases of dizziness and seizures have been reported. If you experience these effects, do not drive or use machines.

3. How to take Cinacalcet Mylan

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 Cinacalcet Mylan to take.

Cinacalcet Mylan should be taken by mouth, with food or shortly after eating. The tablets should be swallowed whole and not chewed, crushed, or broken.

Your doctor will regularly perform blood tests during treatment to monitor your progress and, if necessary, adjust the dose you receive.

If the treatment is for secondary hyperparathyroidism

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

If the treatment is for parathyroid cancer or primary hyperparathyroidism

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

If you take more Cinacalcet Mylan than you should

If you have taken more Cinacalcet Mylan than you should, contact your doctor immediately. Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps, and seizures.

If you forget to take Cinacalcet Mylan

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

If you have forgotten to take a dose of Cinacalcet Mylan, 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, Cinacalcet Mylan can cause side effects, although not everybody gets them.

Tell your doctor immediately:

Other possible side effects:

Very common: may affect more than 1 in 10 people

• nausea and vomiting. These side effects are usually mild and temporary.

Common: may affect up to 1 in 10 people

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

Not known: frequency cannot be estimated from the available data

• Hives (urticaria)
• Swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing (angioedema)
• Unusually fast or strong heartbeat that may be associated with low calcium levels in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcemia).

In a small number of patients with heart failure, their disease and/or low blood pressure (hypotension) worsened after taking Cinacalcet Mylan.

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. You can also report side effects directly via the national reporting system listed in Appendix V.

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

5. Storage of Cinacalcet Mylan

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 and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 Mylan contains

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

The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, povidone, crospovidone, magnesium stearate.

The film coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), and yellow iron oxide (E172).

Appearance and packaging

Cinacalcet Mylan is a film-coated tablet, light green in color. They are oval, biconvex, with beveled edges, and marked with an "M" on one side and "CI30", "CI60", or "CI90" on the other.

Cinacalcet Mylan is available in blister packs of 28 film-coated tablets of 30 mg, 60 mg, or 90 mg and unit dose blister packs of 28 x 1 and 30 x 1 film-coated tablets.

Cinacalcet Mylan is also available in bottles of 30 mg film-coated tablets. Each bottle contains 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Mylan S.A.S.

117 Allee des Parcs

69 800 Saint Priest

France

Manufacturers

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1

Hungary

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Mylan B.V.

Dieselweg 25, 3752 LB Bunschoten

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu