30 mg, 60 mg, 90 mg film-coated tablets 
cinacalcet

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Cinacalcet Teva is and what it is used for 
2. What you need to know before taking Cinacalcet Teva 
3. How to take Cinacalcet Teva 
4. Possible side effects 
5. How to store Cinacalcet Teva 
6. Contents of the packaging and other information 

1. What Cinacalcet Teva is and what it is used for

Cinacalcet Teva is used to control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat problems in the organ called the parathyroid gland. The parathyroid gland consists of four small glands in the throat near the thyroid gland and produces parathyroid hormone (PTH).

Cinacalcet Teva is used in adults to:

  • treat secondary hyperparathyroidism in adult patients with severe kidney disease who need dialysis to cleanse the blood of waste products.
  • reduce high levels of calcium in the blood ( hypercalcaemia ) in adult patients with thyroid cancer.
  • reduce high levels of calcium in the blood ( hypercalcaemia ) in adult patients with primary hyperparathyroidism when the gland cannot be removed.

Cinacalcet Teva is used in children from 3 years up to 18 years to:

  • treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to cleanse the blood of waste products and whose disease cannot be kept under control with other treatments.

In primary and secondary hyperparathyroidism , too much PTH is produced by the parathyroid gland. “Primary” means that hyperparathyroidism is not caused by another disease and “secondary” means that hyperparathyroidism is caused by another disease, e.g. kidney disease. Both primary and secondary hyperparathyroidism can cause a decrease in skeletal calcium , which can lead to skeletal pain and fractures , heart and blood vessel problems, kidney stones , mental illness and coma .

Cinacalcet contained in Cinacalcet Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Cinacalcet Teva

Do not take Cinacalcet Teva

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

Do not take Cinacalcet Teva if you have low levels of calcium in your blood. Your doctor will check your blood calcium levels.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Cinacalcet Teva.

Before you start taking Cinacalcet Teva, tell your doctor if you have or have ever had:

  • seizures (attacks or convulsions). The risk of seizures is greater if you have had them before
  • liver problem
  • heart failure

Cinacalcet Teva lowers calcium levels in the blood. Life-threatening events and death due to low calcium levels ( hypocalcaemia ) have been reported in adults and children treated with Cinacalcet Teva.

Tell your doctor if you experience any of the following symptoms, which may be signs of low calcium levels: spasms , twitches or cramps in the muscles, numbness or tingling in the fingers, toes or around the mouth, or seizures, confusion or loss of consciousness while you treated with Cinacalcet Teva.

Low calcium levels can affect heart rhythm. Tell your doctor if you have unusually fast or beating heartbeats, if you have a heart rhythm problem, or if you are taking medicines that are known to cause heart rhythm problems while you are being treated with Cinacalcet Teva.

For more information, see section 4.

When taking Cinacalcet Teva, tell your doctor:

  • if you start or stop smoking, as it may affect the way Cinacalcet Teva works.

Children and young people

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

If you are being treated for secondary hyperparathyroidism , your doctor should check your calcium levels before starting treatment with Cinacalcet Teva and regularly during treatment with Cinacalcet Teva. Tell your doctor if you experience any of the signs of low calcium levels described above.

It is important that you take Cinacalcet Teva dose one in accordance with the doctor’s instructions.

Other medicines and Cinacalcet Teva

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, especially ethyl calcium or other medicines that lower your blood calcium levels.

You should not use Cinacalcet Teva in combination with ethyl calcite.

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

Drugs such as these may affect the way Cinacalcet Teva works:

  • medicines used to treat skin and fungal infections ( ketoconazole , itraconazole and voriconazole)
  • medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin )
  • a drug used to treat HIV – infection and AIDS (ritonavir)
  • a drug used to treat depression (fluvoxamine).

Cinacalcet Teva may affect the way medicines work as follows:

  • medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)
  • a drug used to relieve cough (dextromethorphan)
  • medications used to treat changes in heart rate ( flecainide and propafenone )
  • a medicine used to treat high blood pressure ( metoprolol ).

Cinacalcet Teva with food and drink

Cinacalcet Teva should be taken with or after a meal.

Pregnancy, breastfeeding 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 Teva has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as Cinacalcet Teva may harm the unborn baby.

It is not known whether Cinacalcet Teva is excreted in human milk. Your doctor will discuss with you whether to discontinue either breast-feeding or treatment with Cinacalcet Teva.

Driving and using machines

Dizziness and seizures have been reported in patients taking Cinacalcet Teva. If you experience these side effects , do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Cinacalcet Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet Teva to take.

Cinacalcet Teva should be taken orally, with or after a meal. The tablets should be swallowed whole and must not be chewed, crushed or divided.

For children who need a dose lower than 30 mg or who are unable to swallow tablets, other dosage forms are available.

Your doctor will take regular blood tests to check your disease progression and will adjust dose one if necessary .

If you are being treated for secondary hyperparathyroidism

The usual starting dose of Cinacalcet Teva for adults is 30 mg (one tablet) once a day.

The usual starting dose of Cinacalcet Teva for children from 3 years up to 18 years is no more than 0.20 mg / kg / day.

If you are being treated for thyroid cancer or primary hyperparathyroidism

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

Contact your doctor immediately if you have taken too much Cinacalcet Teva. Possible signs of overdose are numbness and tingling around the mouth, muscle aches or cramps and seizures.

If you forget to take Cinacalcet Teva

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

Even if you forget to take a dose of Cinacalcet Teva, take the next dose as usual.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Contact a doctor immediately:

  • if you start to feel numbness or tingling around the mouth, muscle aches or cramps and seizures. These may be signs that your calcium levels are too low ( hypocalcaemia ).
  • if you swell your face, lips, mouth, tongue or pharynx, which may cause difficulty swallowing and breathing ( angioedema ).

Very common: may affect more than 1 in 10 people

  • nausea and vomiting. These side effects are often relatively mild and do not last long.

Common: may affect up to 1 in 10 people

  • dizziness
  • numbness and tingling ( paresthesia )
  • loss of ( anorexia ) or decreased appetite
  • muscle pain ( myalgia )
  • weakness ( asthenia )
  • rash
  • decreased testosterone levels
  • high potassium levels in the blood ( hyperkalemia )
  • allergic reactions (hypersensitivity)
  • headache
  • seizures (convulsions or attacks)
  • low blood pressure ( hypotension )
  • upper respiratory tract infection
  • difficulty breathing ( dyspnoea )
  • cough
  • indigestion ( dyspepsia )
  • diarrhea
  • abdominal pain, abdominal pain – upper
  • constipation
  • muscle spasms
  • back pain
  • low calcium levels in the blood ( hypocalcaemia ).

No known frequency: can not be calculated 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 beating heartbeat, which may be due to low calcium levels in the blood ( QT prolongation and ventricular arrhythmia , secondary to hypocalcaemia)

Following ingestion of Cinacalcet Teva, a very small number of patients with heart failure have experienced worsening of their condition and / or low blood pressure ( hypotension ).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cinacalcet Teva

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

Blister pack

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Can

Do not use this medicine after the expiry date which is stated on the carton and can after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cina calcium. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cina calcium (as hydrochloride).
  • Other ingredients are:
    • pregelatinized corn starch
    • microcrystalline cellulose
    • crospovidone
    • magnesium stearate
    • colloidal anhydrous silica
  • The tablets are coated with:Opadry green (containing polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), indigo carmine aluminum lacquer (E132))

What the medicine looks like and contents of the pack

Cinacalcet Teva is a light green to green film-coated tablet. They are oval-shaped and are marked with “C30”, “C60” or “C90” on one side and glossy on the other side.

Cinacalcet Teva is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28, 30, 84 or 98 tablets in a carton.

Cinacalcet Teva is also available in unit dose blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28, 30, 84 or 98 tablets in a carton.

Cinacalcet Teva is available in cartons of 30 mg, 60 mg or 90 mg film-coated tablets, in a carton. Each jar contains 30 tablets. Jars are available with or without silica gel desiccant. Do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Teva Operations Poland Sp. Zoo

ul. Mogilska 80

PL-31-546 Krakow

Poland

Merckle GmbH

Ludwig-Merckle-Straße 3,

DE-89143 Blaubeuren

Germany

Teva Pharma BV

Swensweg 5

NL-2031 GA Haarlem

Netherlands

PLIVA Hrvatska doo (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25,

10000 Zagreb

Croatia

Muhammad Nadeem

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