Cinacalcet Mylan 60 mg 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 Mylan is and what it is used for
2. What you need to know before you take Cinacalcet Mylan
3. How to take Cinacalcet Mylan
4. Possible side effects
5. How to store Cinacalcet Mylan
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 Mylan.

Before you start taking Cinacalcet Mylan, 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 Mylan reduces calcium levels. Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in patients 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 Mylan.

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 Mylan.

For additional information see section 4.

During treatment with Cinacalcet Mylan, tell your doctor:

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

Children under the age of 18 must not take Cinacalcet Mylan. Cinacalcet Mylan is not indicated for use in children and adolescents. Other cinacalcet medicines may be available for this population.

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 take Cinacalcet Mylan together with etelcalcetide.

Tell your doctor if you are taking the following medicines.

Medicines such as these can affect how Cinacalcet Mylan 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 Mylan 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 Mylan 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 Mylan.

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

If you take more Cinacalcet Mylan 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 Mylan, 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, pharmacist or nurse. 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 cellulose, microcrystalline; silica, colloidal anhydrous; povidone; crospovidone; magnesium stearate.

The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).

Cinacalcet Mylan 30 mg film-coated tablets are 10.0 mm x 6.4 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI30 on the other side.

Cinacalcet Mylan 60 mg film-coated tablets are 12.5 mm x 8.0 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI60 on the other side.

Cinacalcet Mylan 90 mg film-coated tablets are 14.3 mm x 9.0 mm, green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet CI90 on the other side.

Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs of 28 tablets and perforated unit dose blister packs of 28 x 1, 30 x 1 and 84 x 1 tablets.

Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.

Not all pack sizes may be marketed.