Cinacalcet Accord Pharma

Package leaflet: Information for the patient

Cinacalcet Accordpharma 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets

cinacalcet
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 acts on the regulation of parathyroid hormone (PTH), calcium, and phosphorus levels in your body. It is used to treat diseases caused by disorders of organs called the parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).
Cinacalcet Accordpharma is used in adults:

• to treat secondary hyperparathyroidism in adult patients with severe kidney disease who require dialysis to remove waste products from their blood.
• to reduce elevated levels of calcium in the blood (hypercalcemia) in adult patients with parathyroid carcinoma.
• to reduce elevated levels of calcium in the blood (hypercalcemia) in adult patients with primary hyperparathyroidism, when removal of the glands is not possible.

Cinacalcet Accordpharma is used in children aged between 3 and 18 years:

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to remove waste products from their blood, whose condition is not controlled with other treatments.

In primary and secondary hyperparathyroidism, an excessive amount of PTH is produced by the parathyroid glands. "Primary" means that hyperparathyroidism is not caused by other conditions, and "secondary" means that hyperparathyroidism is caused by another condition, such as kidney disease. Both primary and secondary hyperparathyroidism can lead to calcium loss from the bones, which may cause bone pain and fractures, blood and heart vessel problems, kidney stones, mental disturbances, and coma.

2. What you need to know before using Cinacalcet Accordpharma

Do not use 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 taking Cinacalcet Accordpharma.
Before taking Cinacalcet Accordpharma, inform your doctor if you have or have ever had:

• seizures (sometimes called fits or convulsions). The risk of having seizures is higher if you have previously experienced seizures;
• liver problems;
• heart problems.

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, during treatment with Cinacalcet Accordpharma, you develop any of the following symptoms, which may be signs of low calcium levels: muscle spasms, twitching or cramps, numbness or tingling in the fingers, toes, or around the mouth, seizures, confusion, or loss of consciousness.
Low calcium levels can affect your heart rhythm. Inform your doctor if, while taking Cinacalcet Accordpharma, you experience an unusually fast or pounding heartbeat, have heart rhythm problems, or are taking medicines known to cause heart rhythm disturbances.
For additional information, see section 4.
During treatment with Cinacalcet Accordpharma, inform your doctor:

• if you have started or stopped smoking, as this may affect the action of Cinacalcet Accordpharma.

Children and adolescents
Children under 18 years of age with parathyroid carcinoma or primary hyperparathyroidism must not take Cinacalcet Accordpharma.
If you are being treated for secondary hyperparathyroidism, your doctor must check your calcium levels before starting treatment with Cinacalcet Accordpharma and during treatment with Cinacalcet Accordpharma. You must inform your doctor if any of the signs of low calcium levels as described above occur.
Cinacalcet Accordpharma is available only 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 dose is required, other cinacalcet-containing medicines must be used.
It is important that you take your dose of Cinacalcet Accordpharma exactly as recommended by your doctor.
Other medicines and Cinacalcet Accordpharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially etelcalcetide or any other medicine that lowers calcium levels in the blood.
You must not take Cinacalcet Accordpharma together with etelcalcetide.
Inform your doctor if you are taking the following medicines.
Medicines that may affect the action of Cinacalcet Accordpharma:

• medicines used to treat skin infections or fungal infections (ketoconazole, itraconazole, and voriconazole);
• medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin);
• a medicine used to treat HIV 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).

Cinacalcet Accordpharma with food and drink
Cinacalcet Accordpharma should be taken during or immediately after meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Cinacalcet Accordpharma has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as Cinacalcet Accordpharma could harm the unborn baby.
It is not known whether Cinacalcet Accordpharma is excreted in breast milk. Your doctor will discuss with you whether you need to stop breastfeeding or discontinue treatment with Cinacalcet Accordpharma.
Driving and using machines
Dizziness and seizures have been reported in patients treated with Cinacalcet Accordpharma.
If you experience these side effects, do not drive or operate machinery.

3. How to use Cinacalcet Accordpharma

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will tell you how much Cinacalcet Accordpharma you should take.
Cinacalcet Accordpharma should be taken orally during or immediately after meals. The tablets must be swallowed whole and must not be chewed, crushed, or split.
Your doctor will carry out regular blood tests during treatment to monitor your response to therapy and will adjust the dose if necessary.

If you are being treated for secondary hyperparathyroidism
The initial dose of Cinacalcet Accordpharma in adults is 30 mg (one tablet) once daily.
The initial dose of Cinacalcet Accordpharma in children from 3 to less than 18 years of age is no more than 0.20 mg/kg body weight per day.
Cinacalcet Accordpharma is available only as film-coated tablets. Therefore, Cinacalcet Accordpharma cannot be administered to pediatric patients who require less than a full 30 mg dose or who are unable to swallow tablets. If an alternative dose is required, another cinacalcet-containing medicine should be used; please consult your doctor or pharmacist.

If you are being treated for parathyroid carcinoma or primary hyperparathyroidism
The initial 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, 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 the missed dose.
If you have missed a dose of Cinacalcet Accordpharma, take your next scheduled dose at the usual time.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately:

• If you start to experience numbness or tingling around the mouth, muscle pain or cramps, and seizures. These symptoms may indicate that calcium levels are too low (hypocalcemia).
• If you develop 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 side effects are usually mild and short-lived.

Common: may affect up to 1 in 10 people

• dizziness
• numbness or tingling sensation (paresthesia)
• loss of appetite (anorexia) or reduced appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin rash
• reduced testosterone levels
• high potassium levels in the blood (hyperkalemia)
• allergic reactions (hypersensitivity)
• headache
• epileptic seizures (convulsions or fits)
• 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 calcium levels in the blood (hypocalcemia).

Not known: frequency cannot be established from available data

• Hives (urticaria)
• Swelling of the face, lips, oral cavity, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• Unusually fast or pounding heartbeat, which may be associated with low calcium levels in the blood (QT prolongation and ventricular arrhythmia secondary to hypocalcemia).

After taking Cinacalcet Accordpharma, a very small number of patients with cardiac impairment have experienced worsening of their condition and/or low blood pressure (hypotension).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 after
Exp.: The expiry date refers to the last day of that month.
(o) Do not use this medicine after the expiry date stated on the carton and on the bottle. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cinacalcet Accordpharma contains

• 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 tablet coating contains:
• Hypromellose (E464)
• Titanium dioxide (E171)
• Triacetin
• Indigo carmine aluminium lake (E132)
• Iron oxide yellow (E172)

Description of the appearance of Cinacalcet Accordpharma and pack contents
Cinacalcet Accordpharma 30 mg film-coated tablets
Film-coated, biconvex, oval tablets (approximately 9.65 mm long and 6.00 mm wide), light green in colour, marked with "HB1" on one side and plain on the other side.
Cinacalcet Accordpharma 60 mg film-coated tablets
Film-coated, biconvex, oval tablets (approximately 12.20 mm long and 7.60 mm wide), light green in colour, marked with "HB2" on one side and plain on the other side.
Cinacalcet Accordpharma 90 mg film-coated tablets
Film-coated, biconvex, oval tablets (approximately 14.00 mm long and 8.70 mm wide), light green in colour, marked with "HB3" on one side and plain on the other side.
Cinacalcet Accordpharma is available in blisters containing film-coated tablets of 30 mg, 60 mg or 90 mg. Cinacalcet Accordpharma is packaged in PVC/Alu blisters containing 14, 28 or 84 tablets, and in unit dose blisters containing 14 x 1, 28 x 1 or 84 x 1 tablet.
Cinacalcet Accordpharma is also available in bottles containing film-coated tablets of 30 mg, 60 mg or 90 mg. Each bottle contains 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th floor,
08039 Barcelona, Spain

Manufacturers
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

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu