Mimpara 5 mg granulado en capsulas para abrir

Product Information for the Patient

Mimpara 1 mg Granules for Capsules to Open Mimpara 2,5 mg Granules for Capsules to Open Mimpara 5 mg Granules for Capsules to OpenCinacalcet

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body, and is used to treat alterations 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 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 loss of calcium from the bones, which can produce bone pain and fractures, problems in blood vessels and heart vessels, kidney stones, mental disease, and coma.

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Mimpara.

Before starting to take Mimpara, inform your doctor if you have ever suffered from:

• seizures(attacks or crises). The risk of seizures is higher in people who have had them before;
• liver problems;

• heart failure.

Mimpara reduces calcium levels. In adults and children treated with Mimpara, there have been reported events that have put lives at risk and fatal outcomes associated with low calcium levels (hypocalcemia).

Inform your doctor if you experience any of the following symptoms that may be indicative of low calcium levels: muscle spasms, contractions, or cramps, or numbness or tingling in the fingers of the hands, feet, or around the mouth, or seizures, confusion, or loss of consciousness while being treated with Mimpara.

Low calcium levels can affect your heart rhythm. Inform your doctor if you experience abnormally strong or rapid heartbeats, if you have problems with your heart rhythm, or if you take medications that cause heart rhythm problems while taking Mimpara.

For additional information, see section 4.

During treatment with Mimpara, inform your doctor:

• if you start or stop smoking, as it may vary the effect of Mimpara.

Children and adolescents

Children under 18 years old 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 inform your doctor if you experience any of the symptoms related to low calcium levels described above.

It is essential to take your Mimpara dose as directed by your doctor.

Other medications and Mimpara

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly etelcalcetide or any other medication that reduces calcium levels in your blood.

You should not receive Mimpara together with etelcalcetide.

Inform your doctor if you are taking the following medications.

Medications such as the following may modify the action of Mimpara:

• medications used to treatskinand fungal infections (ketoconazole, itraconazole, and voriconazole);
• medications used to treatbacterial infections(telithromycin, rifampicin, and ciprofloxacin);
• a medication used to treat infections caused by the human immunodeficiency virus (HIV) and AIDS (ritonavir);

• a medication used to treatdepression(fluvoxamine).

Mimpara may modify the action of medications such as the following:

• medications used to treatdepression(amitriptyline, desipramine, nortriptyline, and clomipramine);
• a medication used to relievecough(dextromethorphan);

• medications used to treatheart rhythm disorders(flecainide and propafenone);
• a medication used to treathigh 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

It is not known if Mimpara passes into breast milk. Your doctor will tell you if you should stop breastfeeding or the treatment with Mimpara.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how much Mimpara you should take.

Do not ingest the capsules whole. You must open the capsules and administer the entire content in granules. For more information on how to take Mimpara in granules, consult the instructions at the end of this leaflet.

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

Granules should be taken with food or shortly after eating.

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

Your doctor will perform regular 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 initial dose of Mimpara in adults is 30 mg (one tablet) once a day.

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

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial 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 forgot to take Mimpara

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

If you have forgotten to take a dose of Mimpara, take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately:

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

• If you notice swelling in the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• Nausea and vomiting. These side effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• Dizziness

• Feeling of numbness or tingling (paresthesia)

• Loss (anorexia) or decrease in appetite

• Muscle pain (myalgia)

• Weakness (asthenia)

• Skin rash

• Decreased testosterone levels

• High levels of potassium in the blood (hyperkalemia)
• Allergic reactions (hypersensitivity)

• Headache

• Seizures (crisis or attacks)

• Low blood pressure (hypotension)

• Upper respiratory tract infection

• Dyspnea (difficulty breathing)

• Cough

• Indigestion (dispepsia)

• 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 available data

• Hives (urticaria)

• Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)

• Unusually fast or strong heartbeat that may be associated with low calcium levels in the blood (QT prolongation and secondary ventricular arrhythmia due to hypocalcemia).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Do not store Mimpara mixed with food or liquids.

Composition of Mimpara

• 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:

• Maize pregelatinized starch

• Microcrystalline cellulose

• Povidone

• Crospovidone

• Silica, type dental

• The outer coating of the capsule contains:

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

• Iron oxide yellow (E172) (capsules of 1 mg and 2.5 mg)

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

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

Appearance of the product and contents of the package

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 impression “1 mg” (colored cap dark green), “2.5 mg” (colored cap yellow) or “5 mg” (colored cap blue) on one side and “AMG” on the other side.

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

Marketing authorization holder and responsible person for manufacturing

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorization holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Responsible person for manufacturing

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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Instructions for taking Mimpara granules

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

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

To patients who can swallow, you will need:

A small bowl, cup or spoon with soft food (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 medicine a bitter taste. The amount of food you use will depend on how many capsules you need to take each day: