Cinacalcet 60mg Film-coated tablets

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to cinacalcet or 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.

Talk to your doctor, pharmacist or nurse before taking cinacalcet.

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

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

Cinacalcet reduces calcium levels. Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with cinacalcet.

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

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Cinacalcet.

For additional information see section 4.

During treatment with Cinacalcet, tell your doctor:

• if you start or stop smoking, as this may affect the way cinacalcet works

Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take cinacalcet.

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium levels before starting treatment with Cinacalcet and during treatment with Cinacalcet. You should inform your doctor if you experience any of the signs of low calcium levels as described above.

It is important that you take your dose of Cinacalcet as advised by your doctor.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.

You should not receive Cinacalcet together with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines such as these can affect how cinacalcet works:

• medicines used to treat skin and 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 how medicines such as the following work:

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

Cinacalcet should be taken with or shortly after food.

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 has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as cinacalcet might harm the unborn baby.

It is not known whether cinacalcet is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with cinacalcet.

Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these side effects, do not drive or operate machines.

Cinacalcet film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

If you take more cinacalcet than you should you must contact your doctor immediately.

Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.

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

If you have forgotten a dose of cinacalcet, you should take your next dose as normal.

• If you start to get 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 experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).

Very common: may affect more than 1 in 10 people

• nausea and vomiting, these side effects are normally quite mild and do not last for long.

Common: may affect up to 1 in 10 people

• dizziness
• numbness or tingling sensation (paraesthesia)
• loss (anorexia) or decrease of appetite
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• reduced testosterone levels
• high potassium levels in the blood (hyperkalaemia)
• allergic reactions (hypersensitivity)
• headache
• seizures (convulsions or fits)
• low blood pressure (hypotension)
• upper respiratory infection
• breathing difficulties (dyspnoea)
• cough
• indigestion (dyspepsia)
• diarrhoea
• abdominal pain, abdominal pain – upper
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcaemia)

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 heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia)

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system “Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store”. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is Cinacalcet.
  Cinacalcet 30 mg film-coated tablets
  Each film-coated tablet contains 30 mg cinacalcet (as hydrochloride).
  Cinacalcet 60 mg film-coated tablets
  Each film-coated tablet contains 60 mg cinacalcet (as hydrochloride).
  Cinacalcet 90 mg film-coated tablets
  Each film-coated tablet contains 90 mg cinacalcet (as hydrochloride).
• The other ingredients are:
  Tablet core:
  Starch, Pregelatinised (Maize starch), crospovidone (Type-A), cellulose, microcrystalline (Grade -102), silica colloidal anhydrous and sodium stearyl fumarate.
  Tablet coating:
  Lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, iron oxide yellow (E172), Indigo carmine aluminium lake (E132), macrogol 6000 (E1521) and macrogol 400 (E1521).

Cinacalcet 30 mg film-coated tablets

Light green, oval shaped, biconvex, film-coated tablets debossed with “CN” on one side and “30” on the other side. The size is 9.9 x 6.2 mm.

Cinacalcet 60 mg film-coated tablets

Light green, oval shaped, biconvex, film-coated tablets debossed with “C” and “N” on either side of break line on one side and “60” on the other side. The tablet can be divided into equal doses. The size is 12.4 x 7.8 mm.

Cinacalcet 90 mg film-coated tablets

Light green, oval shaped, biconvex, film-coated tablets debossed with “C” and “N” on either side of break line on one side and “90” on the other side. The tablet can be divided into equal doses. The size is 14.2 x 8.9 mm.

Cinacalcet film-coated tablets are available in blister packs.

Pack sizes

Blister packs: 14, 28 and 84 film-coated tablets.

Not all pack sizes may be marketed.

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