Sensipar
(Cinacalcet Hydrochloride)

What Sensipar is and what it is used for

Mimpara 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). Mimpara 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 gland is not possible. Mimpara 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.

How to take Sensipar

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 Mimpara you must take. Mimpara must be taken orally, with or shortly after food. The tablets must be taken whole and are not to be chewed, crushed or divided. Mimpara is also available as granules in capsules for opening. Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules. 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 usual starting dose for Mimpara in adults is 30 mg (one tablet) once per day. The usual starting dose of Mimpara 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 usual starting dose for Mimpara in adults is 30 mg (one tablet) twice per day. If you take more Mimpara than you should If you take more Mimpara 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 Mimpara Do not take a double dose to make up for a forgotten dose. If you have forgotten a dose of Mimpara, 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.

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).

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 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 Mimpara 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. 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 Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt e-mail: [email protected]

How to Store Sensipar

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 carton and blister after EXP. The expiry date refers to the last day of that month. This medicinal product 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.