Cinacalcet Tilomed 90 mg film coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Cinacalcet is 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 (hypersensitive) 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 or pharmacist 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 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.

Cinacalcet must not be given to children under the age of 18 with parathyroid cancer or primary hyperparathyroidism.

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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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, upper abdominal pain
• constipation
• muscle spasms
• back pain
• low calcium levels in the blood (hypocalcaemia).

Not known: frequency cannot be estimated from 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 Yellow Card Scheme at: 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. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
• The other ingredients are:
  • Tablet core: microcrystalline cellulose, low substituted hydroxyl propyl, cellulose, lactose monohydrate, silica colloidal anhydrous, magnesium stearate
  • Tablet coating:
    HPMC 2910/Hypromellose (E464)
    Lactose Monohydrate
    Titanium dioxide (E171)
    Triacetin
    FD&C Blue #2/Indigo Carmine AL 3%- 5% (E132)
    Iron Oxide Yellow (E172)

The 30 mg tablets are light green oval shaped biconvex film coated tablets debossed with "HP" on one side and "363" on other side

The 60 mg tablets are light green oval shaped biconvex film coated tablets debossed with "HP" on one side and "364" on other side.

The 90 mg tablets are light green oval shaped biconvex film coated tablets debossed with "HP" on one side and "365" on other side

Cinacalcet Tillomed are available in unit dose blister packs of 28 and 84 tablets

Not all pack sizes may be marketed

High Density Polyethylene (HDPE) bottle pack with 30 tablets