MIMPARA 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Mimpara 30 mg Film-Coated Tablets

Mimpara 60 mg Film-Coated Tablets

Mimpara 90 mg Film-Coated Tablets

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 Package Leaflet

1. What is Mimpara and what is it used for
2. What you need to know before you take Mimpara
3. How to take Mimpara
4. Possible side effects
5. Storage of Mimpara
6. Contents of the pack and other information

1. What is Mimpara and what is it used for

Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat disorders of the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).

Mimpara is used in adults:

• to treat secondary hyperparathyroidism in adults with severe kidney disease who need dialysis to remove waste products from 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 when removal of the parathyroid glands is not possible.

Mimpara is used in children between 3 years and less than 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to remove waste products from their blood, and whose disease is not controlled with other treatments.

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 Mimpara

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

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking Mimpara.

Before you start taking Mimpara, 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.

Mimpara reduces calcium levels. In adults and children treated with Mimpara, life-threatening and fatal events associated with low calcium levels (hypocalcemia) have been reported.

Tell your doctor if you experience any of the following symptoms that may indicate low calcium levels: muscle spasms, contractions, or cramps, or numbness or tingling in the fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking Mimpara.

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 take medicines that cause problems with your heart rhythm while taking Mimpara.

For more information, see section 4.

During treatment with Mimpara, tell your doctor:

• if you start or stop smoking, as this may affect the effect of Mimpara.

Children and adolescents

Children under 18 years with parathyroid cancer or primary hyperparathyroidism should not take Mimpara.

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

It is important that you take your dose of Mimpara as directed by your doctor.

Other medicines and Mimpara

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

You should not receive Mimpara together with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of Mimpara:

• medicines used to treat skinand fungal infections(ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat HIVand AIDS(ritonavir);

• a medicine used to treat depression(fluvoxamine).

Mimpara 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 Mimpara with food and drinks

Mimpara 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.

Mimpara has not been studied in pregnant women. If you become pregnant, your doctor may decide to change your treatment, as Mimpara may harm the unborn baby.

It is not known whether Mimpara passes into breast milk. Your doctor will advise you whether to stop breastfeeding or stop taking Mimpara.

Driving and using machines

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

Mimpara contains lactose

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

3. How to take Mimpara

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Your doctor will tell you how much Mimpara to take.

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

Mimpara is also available as a granule in capsules for opening. Children who require doses below 30 mg or who cannot swallow tablets should receive Mimpara granules.

Your doctor will regularly take blood samples 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 Mimpara in adults is 30 mg (one tablet) once a day.

The usual starting dose of Mimpara in children between 3 years and less than 18 years should not be higher than 0.20 mg/kg body weight per day.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

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

If you take more Mimpara than you should

If you have taken more Mimpara 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 Mimpara

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

If you have forgotten to take a dose of Mimpara, 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.

Tell your doctor immediately:

• If you notice numbness or tingling around the mouth, muscle pain or cramps, and seizures. These can be symptoms of low calcium levels (hypocalcemia) in your blood.
• If you notice 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 people

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

Common: may affect up to 1 in 10 people

• dizziness

• numbness or tingling (paresthesia)

• loss of appetite (anorexia) or decreased appetite

• muscle pain (myalgia)

• weakness (asthenia)

• rash

• low testosterone levels

• high potassium levels in the blood (hyperkalemia)

• allergic reactions (hypersensitivity)

• headache

• seizures (fits or convulsions)

• low blood pressure (hypotension)

• upper respiratory tract infections

• 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 Mimpara.

Reporting of side effects

If you experience 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 Mimpara

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 is the last day of the month shown.

Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date is 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

Composition of Mimpara

• 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:

• Pregelatinized maize starch

• Microcrystalline cellulose

• Povidone

• Crospovidone

• Magnesium stearate

• Colloidal anhydrous silica

• The tablets are coated with:

• Carnauba wax
• Opadry green (which contains lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), yellow iron oxide (E172))
• Opadry transparent (which contains hypromellose, macrogol)

Appearance and packaging of the product

Mimpara is a light green film-coated tablet. They are oval in shape and marked "30", "60", or "90" on one side and "AMG" on the other.

The 30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.

The 60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.

The 90 mg tablets are approximately 13.9 mm long and 8.7 mm wide.

Mimpara is available in blister packs of 30 mg, 60 mg, or 90 mg film-coated tablets.

Each carton contains 14, 28, or 84 tablets.

Mimpara is available in bottles of 30 mg, 60 mg, or 90 mg film-coated tablets contained in a carton. Each bottle contains 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorisation holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

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