CINACALCET 30 mg Film-Coated Tablets

Зміст інструкції

1. Cinacalcet Abdi 30 mg film-coated tablets, 60 mg film-coated tablets, 90 mg film-coated tablets
   1. What is Cinacalcet Accord 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

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

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 it is used for

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

• to treat secondary hyperparathyroidism in patients with severe kidney disease who require dialysis to purify their blood from waste products.
• 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 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 and “secondary”
means that the hyperparathyroidism is caused by another condition, such as kidney disease. Both
primary and secondary hyperparathyroidism can cause calcium loss from the bone, which can
cause bone pain and fractures, blood and heart vessel problems, kidney stones, mental disorders 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, tell your doctor if you have or have ever had:

• seizures(fits or convulsive attacks). The risk of having seizures is greater if you have had seizures before;
• liver problems;
• heart failure.

In patients treated with cinacalcet, life-threatening events and fatal outcomes associated with
low levels of calcium (hypocalcemia) have been reported.
Low levels of calcium can have an effect on heart rhythm. Tell your doctor if, while taking
cinacalcet, you experience an unusually fast or racing heartbeat, have heart rhythm problems, or are taking medicines known to cause heart rhythm problems.
For additional information see section 4.
During treatment with Cinacalcet Abdi, tell your doctor:

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

Children and adolescents
Children under the age of 18 years should not take Cinacalcet Abdi.

Other medicines and Cinacalcet Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking the following medicines.
Medicines that can have an effect on the action of Cinacalcet Abdi, such as these:

• medicines used to treat skin infectionsor 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 can have an effect on 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 irregular heartbeats(flecainide and propafenone);
• a medicine used to treat high blood pressure(metoprolol).

Cinacalcet Abdiwith food and drink
Cinacalcet should be taken during or immediately after meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Cinacalcet Abdi has not been studied in pregnant women. If you become pregnant, your doctor
may decide to change your treatment, as cinacalcet may harm the unborn baby.
It is not known whether cinacalcet is excreted in breast milk. Your doctor will discuss with you whether it is necessary
to stop breastfeeding or stop treatment with Cinacalcet Abdi.

Driving and using machines
No studies have been performed on the ability to drive and use machines. Dizziness and
seizures have been reported by patients treated with cinacalcet. If these symptoms occur, your ability to drive or use machines may be affected.

Cinacalcet contains lactose
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before
taking this medicine.

3. How to take Cinacalcet Abdi

Take this medicine following exactly the instructions of 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 must be taken orally during or immediately after meals. The tablets must be
swallowed whole and must not be divided.
Your doctor will regularly perform blood tests during treatment to assess the response to
therapy and will adjust the dose, if necessary.
If you are undergoing therapy for the treatment of secondary hyperparathyroidism
The initial dose of Cinacalcet Abdi is 30 mg (one tablet) once a day.
If you are undergoing therapy for the treatment of parathyroid carcinoma or primary hyperparathyroidism
The initial dose of Cinacalcet Abdi is 30 mg (one tablet) twice a day.

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
convulsions.

If you forget to take Cinacalcet Abdi
Do not take a double dose to make up for a missed dose.
If you have forgotten a dose of Cinacalcet Abdi, you should take the next usual dose.
If you have any doubts about 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.
If you start to experience numbness or tingling around the mouth, muscle pain or cramps and
convulsions , you must tell 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 decrease in appetite
• muscle pain (myalgia)
• weakness (asthenia)
• skin rash (rash)
• reduced testosterone levels
• high potassium levels in the blood (hyperpotassemia)
• 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, pain in the upper abdomen
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcemia)

Not known: frequency cannot be estimated from available data

• urticaria (hives)
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema).
• unusually fast or racing heartbeat that may be associated with low calcium levels in the blood (prolongation of the QT interval and ventricular arrhythmia secondary to hypocalcemia).

After the administration of cinacalcet, a very small number of patients with heart failure have
experienced a 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 (hypocalcemia) who was participating in a
clinical study.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
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 which is stated on the package and on the blister after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

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

Description of the appearance of Cinacalcet Abdi and contents of the pack
Cinacalcet Abdi is a film-coated tablet of light green colour. The tablets are oval in shape
and have a ‘C’ imprinted on one side and ‘30’, ‘60’ or ‘90’ on the other side.
Cinacalcet Abdi is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each pack
contains 14, 28 or 84 tablets packaged in blisters.
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