MIMPARA 5 mg GRANULES IN CAPSULES TO OPEN

Introduction

Patient Information Leaflet

Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for openingcinacalcet

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, 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 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 further 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. 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).

Mimpara is used in adults:

to treat secondary hyperparathyroidism in adults 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 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 require 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, blood vessel and heart problems, 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

Talk to 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 had them before;
• liver problems;

• heart failure.

Mimpara lowers 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: spasms, contractions, or cramps in the muscles, 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 are taking medicines that can cause heart rhythm problems, while taking Mimpara.

For further 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 exactly as your doctor has told you.

Other medicines and Mimpara

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

You should not receive Mimpara together with cinacalcet.

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 your 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.

3. How to take Mimpara

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, ask your doctor or pharmacist again. Your doctor will tell you how much Mimpara to take.

Do not swallow the capsules whole. You must open the capsules and give all the contents as granules. For more information on how to take Mimpara as granules, see the instructions at the end of this leaflet.

To avoid dosing errors, do not mix granules from different doses.

The granules should be taken with food or shortly after eating.

Mimpara is also available as tablets. Children who require doses of 30 mg or higher and can swallow tablets may receive Mimpara as tablets.

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 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 more 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 a forgotten dose.

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

• feeling of numbness or tingling (paresthesia)

• loss (anorexia) or decreased appetite

• muscle pain (myalgia)

• weakness (asthenia)

• rash

• decreased testosterone levels

• high levels of potassium 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 levels of calcium 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 that 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 the bottle. The expiry date is the last day of the month stated.

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.

Do not store Mimpara mixed with food or liquids.

6. Container Contents and Additional Information

Mimpara Composition

• The active ingredient is cinacalcet. Each capsule contains 1 mg, 2.5 mg, or 5 mg of cinacalcet (as hydrochloride) granules.
• The other components of the granules are:

• Pregelatinized corn starch

• Microcrystalline cellulose

• Povidone

• Crospovidone

• Dental-type silica

• The outer capsule shell contains:

• Printing ink: black iron oxide, shellac, propylene glycol
• Gelatin

• Yellow iron oxide (E172) (1 mg and 2.5 mg capsules)

• Indigo carmine (E132) (1 mg and 5 mg capsules)

• Titanium dioxide (E171) (1 mg, 2.5 mg, and 5 mg capsules)

Product Appearance and Container Contents

The Mimpara granules are white to off-white in appearance and are presented in capsules for opening. The capsules have a white body and a colored cap and are marked with the print “1 mg” (dark green cap), “2.5 mg” (yellow cap), or “5 mg” (blue cap) on one side and “AMG” on the other side.

Mimpara is presented in bottles of 1 mg, 2.5 mg, or 5 mg capsules included in a box. Each bottle contains 30 capsules.

Marketing Authorization Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing Authorization 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 medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

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Instructions for Taking Mimpara Granules

Only the granules should be swallowed. The outer capsule shell is not for ingestion.

You should take the granules with food or liquids. In patients who cannot swallow, the granules can be administered through a tube directly into the stomach (nasogastric or gastrostomy tube) in a small amount of water (at least 5 ml).

For patients who can swallow, you will need:

A small bowl, cup, or spoon with soft foods (such as apple sauce or yogurt) or liquids (such as apple juice or pediatric renal formula). It is not recommended to use water, as it will give the medication a bitter taste. The amount of food you use will depend on how many capsules you need to take each day: