Cinacalcet Abdi

Package leaflet: Information for the patient

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

Equivalent medicine
Please read this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Cinacalcet Accord works by controlling the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat diseases caused by problems with organs called parathyroid glands. The parathyroid glands are four small glands located in the neck, near the thyroid gland, which produce parathyroid hormone (PTH).
Cinacalcet Accord is used:

• to treat secondary hyperparathyroidism in patients 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 patients with parathyroid carcinoma.
• to reduce high levels of calcium in the blood (hypercalcemia) in patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible.

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

2. What you need to know before taking Cinacalcet Abdi

Do not use Cinacalcet Abdi

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Cinacalcet Abdi.
Before taking Cinacalcet Abdi, inform your doctor if you have or have ever had:

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

In patients treated with cinacalcet, life-threatening events and fatal outcomes associated with
low calcium levels (hypocalcemia) have been reported.
Low calcium levels can affect heart rhythm. Inform your doctor if, during treatment
with cinacalcet, 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 Abdi, inform your doctor:

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

Children and adolescents
Cinacalcet Abdi must not be used in children under 18 years of age.
Other medicines and Cinacalcet Abdi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are taking the following medicines.
Medicines that may affect the action of Cinacalcet Abdi, such as:

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

Cinacalcet 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 Abdi with food and drink
Cinacalcet should be taken during or immediately after meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Cinacalcet Abdi has not been studied in pregnant women. During pregnancy, your doctor may decide to change your treatment, as cinacalcet could harm the unborn baby.
It is not known whether cinacalcet is excreted in breast milk. Your doctor will discuss with you whether you need to stop breastfeeding or stop treatment with Cinacalcet Abdi.
Driving and using machines
No studies on the ability to drive or use machines have been conducted. Dizziness and
seizures have been reported in patients receiving cinacalcet. If you experience such
symptoms, your ability to drive or use machines may be impaired.
Cinacalcet contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Cinacalcet Abdi

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will tell you how much cinacalcet you should take.
Cinacalcet Abdi should be taken orally with food or immediately after a meal. The tablets must be swallowed whole and must not be 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 Abdi is 30 mg (one tablet) once daily.
If you are being treated for parathyroid carcinoma or primary hyperparathyroidism
The initial dose of Cinacalcet Abdi is 30 mg (one tablet) twice daily.
If you take more Cinacalcet than you should
If you take more Cinacalcet Abdi 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 Abdi
Do not take a double dose to make up for the forgotten dose.
If you have missed a dose of Cinacalcet Abdi, take your next usual dose at the regular time.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you start to feel numbness or tingling around the mouth, muscle pain or cramps, or seizures, you must inform your doctor immediately. These symptoms may indicate that calcium levels are too low (hypocalcemia).

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 (anorexia) or decreased appetite
• Muscle pain (myalgia)
• Weakness (asthenia)
• Skin rash
• Reduced testosterone levels
• Increased potassium levels in the blood (hyperkalemia)
• Allergic reactions (hypersensitivity)
• Headache
• 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 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 pounding heartbeat, which may be associated with low calcium levels in the blood (QT prolongation and ventricular arrhythmia secondary to hypocalcemia)

After administration of cinacalcet, a very small number of patients with heart failure experienced worsening of their condition and/or low blood pressure (hypotension).

Children and adolescents
The use of cinacalcet in children and adolescents has not been established. A fatal event was reported in an adolescent with very low calcium levels in the blood (hypocalcemia) who was participating in a clinical study.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cinacalcet Abdi

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.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Abdi contains

• 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 monohydrate lactose, microcrystalline cellulose, pregelatinized starch, crospovidone, magnesium stearate and talc.
• The tablet coating contains Sheff Coat Green (containing hypromellose, titanium dioxide (E171), monohydrate lactose, triacetin, yellow iron oxide (E172) and indigo carmine lake (E132)).

Description of the appearance of Cinacalcet Abdi and contents of the pack
Cinacalcet Abdi is a light green film-coated tablet. The tablets are oval-shaped, with a 'C' engraved on one side and '30', '60' or '90' on the other side.
Cinacalcet Abdi is available in blister packs containing 30 mg, 60 mg or 90 mg film-coated tablets. Each box contains 14, 28 or 84 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim, Germany

Manufacturer
S.C. Polisano Pharmaceuticals S.A.,
Alba Iulia Road 156,
550052 Sibiu, Sibiu County,
Romania
Meditrial Internationals Ltd.,
Iztok Distr., 3 Charles Darwin Str.,
Sofia 1113,
Bulgaria