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 may harm them, even if they show symptoms 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.

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

What Cinacalcet Accordpharma is and what it is used for

Cinacalcet Accordpharma contains the active substance cinacalcet which 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 Accordpharma 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 Accordpharma 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 .

What you need to know before using Cinacalcet Accordpharma

Do not use 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).

Do not take Cinacalcet Accordpharma 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 Accordpharma.

Before you start taking Cinacalcet Accordpharma, 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 Accordpharma lowers blood calcium levels. Life-threatening events and death due to low calcium levels ( hypocalcaemia ) have been reported in adults and children treated with Cinacalcet Accordpharma.

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 Accordpharma.

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

For more information, see section 4.

When treating with Cinacalcet Accordpharma, tell your doctor:

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

Children and young people

Children under 18 years of age 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 regularly during treatment with Cinacalcet Accordpharma. Tell your doctor if you experience any of the signs of low calcium levels described above.

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

Cinacalcet Accordpharma is only available as a film-coated tablet. Thus, it is not possible to administer Cinacalcet Accordpharma to pediatric patients requiring less than a full dose of 30 mg. If an alternative dose is required, other medicines with cinacalcet that offer such an alternative should be used.

Other medicines and Cinacalcet Accordpharma

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 Accordpharma with ethyl calcite.

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

Drugs such as these may affect the way Cinacalcet Accordpharma 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 s and AIDS (ritonavir)
  • a drug used to treat depression (fluvoxamine).

Cinacalcet Accordpharma may affect the way medicines work like this:

  • 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 ).

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

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

Driving and using machines

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

How to use Cinacalcet Accordpharma

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 Accordpharma to take.

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

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

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

Cinacalcet Accordpharma is only available as a film-coated tablet. Thus, it is not possible to administer Cinacalcet Accordpharma to pediatric patients who require less than a full dose of 30 mg or who are unable to swallow tablets. If an alternative dose is required, other medicines with cinacalcet that offer such an alternative should be used, ask your doctor or pharmacist.

If you are being treated for thyroid cancer or primary hyperparathyroidism

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

If you use more Cinacalcet Accordpharma than you should  

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

If you forget to use Cinacalcet Accordpharma

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

Even if you forget to take a dose of Cinacalcet Accordpharma, take the next dose asusual.

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:

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

Very common side effects: may affect more than 1 user in 10

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

Common side effects: 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
  • 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 ).

Has been reported (occurs in an unknown number of users)

  • 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 ‑extension and ventricular arrhythmia , secondary to hypocalcaemia )

Following ingestion of Cinacalcet Accordpharma, 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 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 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, and 90 mg of cina calcium (as hydrochloride), respectively.

Other ingredients are:

  • Cellulose, microcrystalline
  • Krospovidon
  • Magnesium stearate

The tablets are coated with:

  • Hypromellos (E464)
  • Titanium dioxide (E171)
  • Triacetin
  • Indigo carmine aluminum lacquer (E132)
  • Yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Cinacalcet Accordpharma 30 mg film-coated tablets

Light green, oval-shaped (approximately 9.65 mm long and 6.00 mm wide), biconvex, film-coated tablets embossed with “HB1” on one side and smooth on the other side.

Cinacalcet Accordpharma 60 mg film-coated tablets

Light green, oval-shaped (approximately 12.20 mm long and 7.60 mm wide), biconvex, film-coated tablets embossed with “HB2” on one side and smooth on the other side.

Cinacalcet Accordpharma 90 mg film-coated tablets

Light green, oval (approximately 14.00 mm long and 8.70 mm wide), biconvex, film-coated tablets embossed with “HB3” on one side and smooth on the other side.

Cinacalcet Accordpharma is available in blister packs containing 30 mg, 60 mg and 90 mg film-coated tablets. Cinacalcet Accordpharma is available in PVC / Alu blister packs containing 14, 28 or 84 tablets and single-dose blisters containing 14 x 1, 28 x 1 or 84 x 1 tablets.

Cinacalcet Accordpharma is available in a carton of 30 mg, 60 mg and 90 mg film-coated tablets in an outer carton. Each jar contains 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare SLU

World Trade Center, Moll de Barcelona s / n,

Estifici Est, 6 a planta,

08039 Barcelona, ​​Spain

Manufacturer

Accord Healthcare Limited

Ground floor, Sage House, 319 Pinner Road

Harrow, HA1 4HF

UK

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 oo,

ul. Lutomierska 50, Pabianice,

95-200, Poland

Muhammad Nadeem

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