Patient Information Leaflet

Cinacalcet Accordpharma 30 mg Film-Coated Tablets

Cinacalcet Accordpharma 60 mg Film-Coated Tablets

Cinacalcet Accordpharma 90 mg Film-Coated Tablets

cinacalcet

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do 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 leaflet. See section 4.

Cinacalcet Accordpharma contains the active ingredient cinacalcet, which acts by controlling the levels of parathyroid hormone (PTH), calcium, and phosphate 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).

Cinacalcet Accordpharma 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.

Cinacalcet Accordpharma 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, for example, 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 Cinacalcet Accordpharma:

• if you are allergic to cinacalcet or any of the other components of this medication (listed in section 6).
• if you have low levels of calcium in your blood. Your doctor will monitor your calcium levels in the blood.

Warnings and precautions

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

Before starting to take Cinacalcet Accordpharma, 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.

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

Inform 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 of the hands, feet, or around the mouth, or seizures, confusion, or loss of consciousness while taking Cinacalcet Accordpharma.

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 can cause heart rhythm problems while taking Cinacalcet Accordpharma.

For additional information, see section 4.

During treatment with Cinacalcet Accordpharma, inform your doctor:

• if you start or stop smoking, as it may affect the effect of Cinacalcet Accordpharma.

Children and adolescents

Children under 18 years old with parathyroid cancer or primary hyperparathyroidism should not take Cinacalcet Accordpharma.

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

Cinacalcet Accordpharma is only available as a film-coated tablet. Therefore, it is not possible to administer Cinacalcet Accordpharma to pediatric patients who require less than a full dose of 30 mg. If an alternative dose is required, other cinacalcet medication presentations should be used.

It is essential to take your dose of Cinacalcet Accordpharma exactly as your doctor has instructed.

Other medications and Cinacalcet Accordpharma

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 Cinacalcet Accordpharma concurrently with etelcalcetide.

Inform your doctor if you are taking the following medications.

The following medications may modify the action of Cinacalcet Accordpharma:

• 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).

Cinacalcet Accordpharma may modify the action of the following medications:

• 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 Cinacalcet Accordpharma with food and drinks

Cinacalcet Accordpharma 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.

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

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

Driving and operating machinery

In patients taking Cinacalcet Accordpharma, cases of dizziness and seizures have been reported.

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 Cinacalcet Accordpharma you should take.

Cinacalcet Accordpharma should be taken orally, with food or shortly after eating. The tablets should be swallowed whole and not chewed, crushed, or divided.

Your doctor will make 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 Cinacalcet Accordpharma in adults is 30 mg (one tablet) once a day.

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

Cinacalcet Accordpharma is only available as a film-coated tablet. Therefore, it is not possible to administer Cinacalcet Accordpharma to pediatric patients who require doses less than 30 mg, or who are unable to swallow the tablets. If an alternative dose or form is required, other presentations of cinacalcet should be used; consult your doctor or pharmacist.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual initial dose of Cinacalcet Accordpharma in adults is 30 mg (one tablet) twice a day.

If you take more Cinacalcet Accordpharma than you should

If you take more Cinacalcet Accordpharma 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 Cinacalcet Accordpharma

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

If you have forgotten to take a dose of Cinacalcet Accordpharma, 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 temporary.

Common: may affect up to 1 in 10 people

• Dizziness
• Sensation 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
• Difficulty breathing (dyspnea)
• Cough
• Indigestion (dyspepsia)
• Diarrhea
• Abdominal pain, upper abdominal pain
• Constipation
• Muscle spasms
• Back pain
• Low levels of calcium in the blood (hypocalcemia).

Unknown: its 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 Cinacalcet Accordpharma.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational 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 blister pack after CAD. The expiration date is the last day of the month indicated.

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 conditions for conservation.

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

Cinacalcet Accordpharma Composition

• The active ingredient is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet (as hydrochloride).
• The other components are:
• Microcrystalline cellulose
• Crospovidone
• Magnesium stearate
• The tablets are coated with:
• Hypromellose (E464),
• Titanium dioxide (E171),
• Triacetin
• Aluminum lake carmine (E132)
• Yellow iron oxide (E172)

Appearance of Cinacalcet Accordpharma and packaging contents

Cinacalcet Accordpharma 30 mg film-coated tablets (tablets)

Light green color, oval shape, (approximately 9.65 mm in length and 6.00 mm in width), biconvex, with “HB1” engraved on one side and smooth on the other.

Cinacalcet Accordpharma 60 mg film-coated tablets (tablets)

Light green color, oval shape, (approximately 12.20 mm in length and 7.60 mm in width), biconvex, with “HB2” engraved on one side and smooth on the other.

Cinacalcet Accordpharma 90 mg film-coated tablets (tablets)

Light green color, oval shape, (approximately 14.00 mm in length and 8.70 mm in width), biconvex, with “HB3” engraved on one side and smooth on the other.

Cinacalcet Accordpharma is presented in film-coated tablet blisters of 30 mg, 60 mg, or 90 mg. Cinacalcet Accordpharma is presented in PVC/Alu blisters with packaging sizes of 14, 28, or 84 tablets, or in single-dose blisters of 14 x 1, 28 x 1, or 84 x 1 tablets.

Cinacalcet Accordpharma is presented in film-coated tablet bottles of 30 mg, 60 mg, or 90 mg. Each bottle contains 30 film-coated tablets.

It is possible that not all packaging sizes are marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6afloor,

08039 Barcelona, Spain

Responsible for manufacturing

Accord Healthcare Limited

Ground floor, Sage House, 319 Pinner Road

Harrow, HA1 4HF

United Kingdom

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, Pabianice,

95-200, Poland

Last review date of this leaflet: {MM/YYYY}

Other sources of information

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