Patient leaflet - Cinacalcet 30 mg film-coated tablets

1. What Cinacalcet is and what it is used for

Cinacalcet contains the active ingredient cinacalcet, which 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 in adults:

to treat secondary hyperparathyroidism
in adults 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 adult patients with parathyroid cancer
to reduce high levels of calcium in the blood
(hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the parathyroid gland is not possible. Cinacalcet is used in children aged 3 years to less than 18 years of age:
to treat secondary hyperparathyroidism in
patients with serious kidney disease who need dialysis to clear their blood of waste products, whose condition is not controlled with other treatments.

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.

2. What you need to know before you take Cinacalcet

Do not take Cinacalcet:

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.

Warnings and precautions

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.

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3. How to take Cinacalcet

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet you must take.

Cinacalcet must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be chewed, crushed or 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 hyperparathyroidism

The recommended starting dose for Cinacalcet in adults is 30 mg (one tablet) once per day. The recommended starting dose of Cinacalcet for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.

If you are being treated for parathyroid cancer or primary hyperparathyroidism

The recommended starting dose for Cinacalcet in adults is 30 mg (one tablet) twice per day.

If you take more Cinacalcet than you should

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.

If you forget to take Cinacalcet

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 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. Please tell your doctor immediately:

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).

Other possible side effects:

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).
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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard Or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Cinacalcet

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 blister, carton or bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Cinacalcet contains

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). What Cinacalcet looks like and contents of the pack

Cinacalcet 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 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 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 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 30 mg film-coated tablets are available in plastic bottles of 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder

Viatris,

Station Close,

Potters Bar,

EN6 1TL,

United Kingdom.

Manufacturers

Mylan Hungary Kft,

H-2900 Komárom,

Mylan utca 1,

Hungary.

Mylan Germany GmbH,

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1,

Bad Homburg v. d. Hoehe,

Hessen,

61352,

Germany.

Viatris UK Healthcare Limited,

Building 20,