CINACALCET ACCORDPHARMA 60 mg FILM-COATED TABLETS

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

Do not take Cinacalcet Accordpharma:

• if you are allergic to cinacalcet or 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 check your blood calcium levels.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Cinacalcet Accordpharma.

Before you start taking Cinacalcet Accordpharma, 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.

Cinacalcet Accordpharma lowers calcium levels. In adults and children treated with Cinacalcet Accordpharma, 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 Cinacalcet Accordpharma.

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 can cause heart rhythm problems, while taking Cinacalcet Accordpharma.

For more information, see section 4.

During treatment with Cinacalcet Accordpharma, tell your doctor:

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

Children and adolescents

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

If you are being treated for secondary hyperparathyroidism, your doctor should check your calcium levels before starting treatment with Cinacalcet Accordpharma and during treatment with Cinacalcet Accordpharma. You should tell 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 need less than a full dose of 30 mg. If an alternative dose is required, other formulations of cinacalcet should be used; consult your doctor or pharmacist.

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

Other medicines and Cinacalcet Accordpharma

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

Do not take Cinacalcet Accordpharma with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines like the following may change the effect of Cinacalcet Accordpharma:

• 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).

Cinacalcet Accordpharma 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 Cinacalcet Accordpharma with food and drinks

Cinacalcet Accordpharma should be taken with food or shortly after eating.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cinacalcet Accordpharma has not been studied in pregnant women. In case of 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 to stop breast-feeding or stop Cinacalcet Accordpharma.

Driving and using machines

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

If you experience these effects, do not drive or use machines.

3. How to take Cinacalcet Accordpharma

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

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

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 Cinacalcet Accordpharma in adults is 30 mg (one tablet) once a day.

The usual starting dose of Cinacalcet Accordpharma in children between 3 years and less than 18 years should not exceed 0.20 mg/kg 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 need doses less than 30 mg, or who are unable to swallow the tablets. If an alternative dose or formulation is required, other formulations of cinacalcet should be used; consult your doctor or pharmacist.

If the treatment is for parathyroid cancer or primary hyperparathyroidism

The usual starting 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 forget to take Cinacalcet Accordpharma

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

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

If you have any further questions on the use of this medicine, 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).
• 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)
• skin rash
• decreased 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 Cinacalcet Accordpharma.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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. Storing Cinacalcet Accordpharma

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 refers to 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 refers to 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. 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 ingredients 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 contents of the pack

Cinacalcet Accordpharma 30 mg film-coated tablets (tablets)

Light green, oval, (approximately 9.65 mm long and 6.00 mm wide), biconvex, with "HB1" engraved on one side and smooth on the other.

Cinacalcet Accordpharma 60 mg film-coated tablets (tablets)

Light green, oval, (approximately 12.20 mm long and 7.60 mm wide), biconvex, with "HB2" engraved on one side and smooth on the other.

Cinacalcet Accordpharma 90 mg film-coated tablets (tablets)

Light green, oval, (approximately 14.00 mm long and 8.70 mm wide), biconvex, with "HB3" engraved on one side and smooth on the other.

Cinacalcet Accordpharma is available in blister packs of 30 mg, 60 mg, or 90 mg film-coated tablets. Cinacalcet Accordpharma is available in PVC/Alu blisters with 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 available in bottles of 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 last 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