Mimpara 60 mg film-coated tablets

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:

• 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 hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.

In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroids 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 Mimpara:

• DO NOT take Mimpara if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Mimpara.

Take special care with Mimpara:

Children under the age of 18 must not take Mimpara.

Before you start taking Mimpara, 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.

For additional information see section 4.

During treatment with Mimpara, tell your doctor:

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Please tell your doctor if you are taking the following medicines.

These can affect how Mimpara works:

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole, voriconazole);
• antibiotics used to treat bacterial infections (telithromycin, rifampicin);
• medicine used to treat HIV infection and AIDS (ritonavir).

Mimpara may affect how the following work:

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline, clomipramine and fluvoxamine);
• medicines used to treat changes in heart rate (flecainide and propafenone);
• medicine used to treat high blood pressure (metoprolol when given in heart failure);
• antibiotic used to treat bacterial infections (ciprofloxacin).

Taking Mimpara with food and drink

Mimpara should be taken with or shortly after food.

Pregnancy and breast-feeding

Always tell your doctor if you are pregnant or planning to become pregnant. Mimpara has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.

It is not known whether Mimpara is excreted in human milk. Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.

If you are pregnant or planning to become pregnant ask your doctor or pharmacist for advice before taking any 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 Mimpara. If you experience these, your ability to drive or operate machinery may be affected.

If you have an intolerance to some sugars

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

Always take Mimpara exactly as your doctor has told you. You should 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 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 usual starting dose for Mimpara is 30 mg (one tablet) once per day.

If you are being treated for parathyroid cancer or primary hyperparathyroidism

The usual starting dose for Mimpara 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 forgotten doses.

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 product, ask your doctor or pharmacist.

Like all medicines, Mimpara can have 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 side effects (seen in more than 1 in 10 people taking Mimpara):

• nausea and vomiting, these side effects are normally quite mild and do not last for long.

Common side effects (seen in more than 1 in 100 people taking Mimpara):

• dizziness
• numbness or tingling sensation (paraesthesia)
• loss of appetite (anorexia)
• muscle pain (myalgia)
• weakness (asthenia)
• rash
• reduced testosterone levels.

Uncommon side effects (seen in more than 1 in 1000 people taking Mimpara):

• seizures
• indigestion (dyspepsia)
• diarrhoea
• allergic reaction (hypersensitivity).

Frequency not known

• Hives (urticaria).
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).

After taking Mimpara a very small number of patients with heart failure had worsening of their condition. Low blood pressure (hypotension) has also been seen in a very small number of these patients. As so few cases have been seen it is not known whether they are due to Mimpara, or not.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Mimpara after the expiry date which is stated on the outer carton and on the blister. The expiry date refers to the last day of that month.

(or) Do not use Mimpara after the expiry date which is stated on the outer carton and on the bottle.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Mimpara 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:

• Pre-gelatinised maize starch
• Microcrystalline cellulose
• Povidone
• Crospovidone
• Magnesium stearate
• Colloidal anhydrous silica

The tablets are coated with:

• Carnauba wax
• Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
• Opadry clear (containing hypromellose, macrogol)

What Mimpara looks like and contents of the pack

Mimpara is a light green film-coated tablet. They are oval-shaped and have ?30?, ?60? or ?90? marked on one side and ?AMG? on the other side.

Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets. Each blister pack contains either 14, 28 or 84 tablets in a carton.

Mimpara is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton. Each

bottle holds 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711

Amgen Bulgaria EOOD 359 0 2 805 7020 Magyarország Amgen Kft. Tel. 36 1 35 44 700

eská republika Amgen s.r.o Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 0 76 5732500

Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 0 76 5732500

Deutschland AMGEN GmbH Tel 49 089 1490960 Norge Amgen AB Tel 47 23308000

Eesti Amgen Switzerland AG Eesti filiaal Tel 372 5125 501 Österreich Amgen GmbH Tel 43 0 1 50 217

Genesis Pharma S.A. . 30 210 8771500 Polska Amgen Sp. z o.o. Tel. 48 22 581 3000

España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550

France Amgen S.A.S Tél 33 01 40 88 27 00 România Mediplus Exim SRL Tel. 4021 301 74 74

Ireland Amgen Limited United Kingdom Tel 44 01223 420305 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Amgen Switzerland AG, Slovakia Tel 42 1 25939 6456

Italia Amgen Dompé S.p.A. Tel 39 02 6241121 Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767

K Genesis Pharma Cyprus Ltd . 357 22 76 99 46 Sverige Amgen AB Tel 46 08 6951100

Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305

Lietuva

Amgen Switzerland AG Vilniaus filialas
Tel.: +370 6983 6600

This leaflet was last approved in .