Cinacalcet AccordPharma 90 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cinacalcet Accordpharma 30 mg film-coated tablets EFG

Cinacalcet Accordpharma 60 mg film-coated tablets EFG

Cinacalcet Accordpharma 90 mg film-coated tablets EFG

cinacalcet

Read the 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What is Cinacalcet Accordpharma and what is it used for?

Cinacalcet Accordpharma contains the active substance cinacalcet, which works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in your body. It is used to treat disorders of certain organs called the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid, which 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 of age:

• 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 both primary and secondary hyperparathyroidism, the parathyroid glands produce too much PTH. The term "primary" means that hyperparathyroidism is not caused by any other disease, while "secondary" means that hyperparathyroidism is caused by another disease, such as kidney disease. Both primary and secondary hyperparathyroidism can cause loss of calcium from the bones, leading to bone pain and fractures, blood vessel and heart vessel problems, kidney stones, mental illness, and coma.

2. What you need to know before starting to take Cinacalcet Accordpharma

Do not take Cinacalcet Accordpharma:

• if you are allergic to cinacalcet or to any of the other ingredients of this medicine (listed in section 6);
• if 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 starting to take Cinacalcet Accordpharma.

Before starting Cinacalcet Accordpharma, inform your doctor if you have or have ever had:

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

Cinacalcet Accordpharma lowers calcium levels. Life-threatening events and fatal outcomes associated with low calcium levels (hypocalcemia) have been reported in adults and children treated with Cinacalcet Accordpharma.

Inform your doctor if you experience any of the following symptoms, which may indicate low calcium levels: muscle spasms, twitching or cramps, numbness or tingling in the fingers, toes, or around the mouth, or seizures, confusion, or loss of consciousness while taking Cinacalcet Accordpharma.

Low calcium levels may affect your heart rhythm. Inform your doctor if you experience unusually strong or rapid heartbeat, have heart rhythm problems, or are taking medications that may cause heart rhythm disturbances 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 this may alter the effect of Cinacalcet Accordpharma.

Children and adolescents

Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism must not take Cinacalcet Accordpharma.

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

Cinacalcet Accordpharma is only available as film-coated tablets. Therefore, Cinacalcet Accordpharma cannot be administered to pediatric patients who require less than a full 30 mg dose. If an alternative dosage is required, other cinacalcet-containing medicinal product presentations should be used.

It is important that you take your dose of Cinacalcet Accordpharma exactly as prescribed by your doctor.

Other medicines and Cinacalcet Accordpharma

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

You must not receive Cinacalcet Accordpharma together with etelcalcetide.

Inform your doctor if you are taking any of the following medicines.

The following medicines may affect the action of Cinacalcet Accordpharma:

• 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 human immunodeficiency virus (HIV) infection and AIDS (ritonavir);
• a medicine used to treat depression (fluvoxamine).

Cinacalcet Accordpharma may affect the action of the following medicines:

• 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 Accordpharma with food and drink

Cinacalcet Accordpharma should be taken with food or shortly after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Cinacalcet Accordpharma has not been studied in pregnant women. During pregnancy, your doctor may decide to change 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 advise you whether you should stop breastfeeding or discontinue treatment with Cinacalcet Accordpharma.

Driving and using machines

Dizziness and seizures have been reported in patients taking Cinacalcet Accordpharma.

If you experience these effects, do not drive or operate machinery.

3. How to take Cinacalcet Accordpharma

Follow exactly the instructions for administering this medicine as given 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 must not be chewed, crushed, or split.

Your doctor will carry out regular blood tests during treatment to monitor your progress and, if necessary, adjust the dose you are receiving.

If treatment is for secondary hyperparathyroidism

The usual starting dose of Cinacalcet Accordpharma in adults is 30 mg (one tablet) once daily.

The usual starting dose of Cinacalcet Accordpharma in children aged 3 years up to but less than 18 years should not exceed 0.20 mg/kg body weight per day.

Cinacalcet Accordpharma is only available as film-coated tablets. Therefore, Cinacalcet Accordpharma cannot be administered to pediatric patients who require doses lower than 30 mg or who are unable to swallow the tablets. If an alternative dose or formulation is required, other cinacalcet presentations should be used; consult your doctor or pharmacist.

If treatment is for parathyroid carcinoma or primary hyperparathyroidism

The usual starting dose of Cinacalcet Accordpharma in adults is 30 mg (one tablet) twice daily.

If you take more Cinacalcet Accordpharma than you should

If you take more Cinacalcet Accordpharma than you should, you must 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 Accordpharma

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

If you have missed a dose of Cinacalcet Accordpharma, take the next dose at your usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell 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 of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting. These adverse effects are usually mild and transient.

Common: may affect up to 1 in 10 people

• dizziness
• sensation of numbness or tingling (paresthesia)
• loss (anorexia) or reduced appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin rash
• decreased testosterone levels
• high levels of potassium in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (crises or attacks)
• low blood pressure (hypotension)
• upper respiratory tract infection
• difficulty breathing (dyspnea)
• cough
• stomach discomfort (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 swallowing or breathing (angioedema)
• Unusually fast or strong heartbeat, which may be associated with low calcium levels in the blood (prolonged QT and ventricular arrhythmia secondary 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 adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinacalcet Accordpharma

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

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinacalcet Accordpharma

• The active substance 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
• Indigo carmine aluminium lake (E132)
• Yellow iron oxide (E172)

Appearance of Cinacalcet Accordpharma and contents of the pack

Cinacalcet Accordpharma 30 mg film-coated tablets (tablets)

Light green, oval-shaped (approximately 9.65 mm long and 6.00 mm wide), biconvex, film-coated tablets, marked with “HB1” on one side and plain on the other.

Cinacalcet Accordpharma 60 mg film-coated tablets (tablets)

Light green, oval-shaped (approximately 12.20 mm long and 7.60 mm wide), biconvex, film-coated tablets, marked with “HB2” on one side and plain on the other.

Cinacalcet Accordpharma 90 mg film-coated tablets (tablets)

Light green, oval-shaped (approximately 14.00 mm long and 8.70 mm wide), biconvex, film-coated tablets, marked with “HB3” on one side and plain on the other.

Cinacalcet Accordpharma is available in PVC/Alu blisters containing 30 mg, 60 mg or 90 mg film-coated tablets, in pack sizes of 14, 28 or 84 tablets, or in unit-dose blisters of 14 x 1, 28 x 1 or 84 x 1 tablets.

Cinacalcet Accordpharma is also available in bottles containing 30 mg, 60 mg or 90 mg film-coated tablets. Each bottle contains 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona, Spain

Manufacturer

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

Date of the latest revision of this leaflet: {MM/YYYY}

Other sources of information

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