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Package leaflet: Information for the patient

Cinacalcet 30 mg film-coated tablets Cinacalcet 60 mg film-coated tablets Cinacalcet 90 mg film-coated tablets

Cinacalcet

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    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. This includes any possible side effects not listed in this leaflet. See section 4.

2. What you need to know before you take this medicine

What is in this leaflet

1.    What this medicine is and what it is used for

2.    What you need to know before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

1. What this medicine is and what it is used for

This medicine contains active ingredient called Cinacalcet that works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).

Cinacalcet is used:

•    to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products.

•    to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer.

•    to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyper parathyroidism when removal of the gland is not possible.

In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands. "Primary" means that the hyperparathyroidism is not caused by any other condition and "secondary" means that the hyperparathyroidism is caused by another condition, e.g., kidney disease. Both primary and secondary hyperparathyroidism can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.

Do not take this medicine:

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine. 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.

Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in patients 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 and adolescents

Children under the age of 18 must not take cinacalcet.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

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);

•    medicines used to treat changes in heart rate (flecainide and propafenone);

•    a medicine used to treat high blood pressure (metoprolol).

Cinacalcet with food and drink

Cinacalcet should be taken with or shortly after food.

Pregnancy, breast-feeding 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 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 this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these, your ability to drive or operate machinery may be affected.

This medicine contains lactose

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

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3. How to take this medicine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much medicine you must take.

This medicine must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be divided.

Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.

If you are being treated for secondary hyper parathyroidism The usual starting dose for this medicine is 30 mg (one tablet) once per day.

If you are being treated for parathyroid cancer or primary hyper parathyroidism

The usual starting dose for this medicine is 30 mg (one tablet) twice per day.

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If you take more of this medicine than you should

If you take more of this medicine 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.

If you forget to take this medicine

If you forget to take a dose, just take your next dose as normal.

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

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

4. Possible side effects

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

If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should tell you doctor immediately. These may be signs that your calcium levels are too low (hypocalcaemia).

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 to 10 people)

•    dizziness

•    numbness or tingling sensation (paraesthesia)

•    loss (anorexia) or decrease of appetite

•    muscle pain (myalgia)

•    weakness (asthenia)

•    rash

•    reduced test osterone 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 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).

Children and adolescents

The use of cinacalcet in children and adolescents has not been established. A fatal out come was reported in an adolescent clinical trial patient with very low calcium levels in the blood (hypocalcaemia).

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• This medicine is available in blister packs of 14, 28 or 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Cinacalcet 30 mg film-coated tablets, PL 17907/0544 Cinacalcet 60 mg film-coated tablets, PL 17907/0545 Cinacalcet 90 mg film-coated tablets, PL 17907/0546

This leaflet was last revised in July 2016

5. How to store this medicine

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

•    This medicinal product does not require any special storage conditions.

•    Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What this medicine contains

•    The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet.

•    The other ingredients are:

Tablet core: Pregelatinised maize starch, Microcrystalline cellulose, Croscarmellose sodium, Colloidal silica anhydrous, Magnesium stearate.

Tablet coat: Hypromellose 15cP, Lactose monohydrate, Titanium dioxide (E17l), Triacetin, Indigo carmine aluminium lake (E132), Iron oxide yellow (E172).

What this medicine looks like and contents of the pack

•    30mg: Green, oblong, biconvex film-coated tablets, engraved with '30'on one side and plain on the other side.

•    60mg: Green, oblong, biconvex film-coated tablets, engraved with '60' on one side and plain on the other side.

•    90mg: Green, oblong, biconvex film-coated tablets, engraved with '90'on one side and plain on the other side.

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