Parareg
cinacalcet
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
What Parareg is and what it is used for
Before you take Parareg
How to take Parareg
Possible side effects
5 How to store Parareg
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6. Further information
Parareg 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).
Parareg is used:
to treat secondary hyperparathyroidism in patients with kidney disease on dialysis.
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. This 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.
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Before you start taking Parareg, tell your doctor if you have or have ever had
During treatment with Parareg, tell your doctor:
if you start or stop smoking, as this may affect the way Parareg works.
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 Parareg 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).
Parareg 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);
Medicinal product no longer authorised
medicine used to treat high blood pressure (metoprolol when given in heart failure) ,
antibiotic used to treat bacterial infections (ciprofloxacin).
Parareg should be taken with or shortly after food.
Always tell your doctor if you are pregnant or planning to become pregnant. Parareg has not been tested in pregnant women. In case of pregnancy, your doctor may decide to modify your treatment, as Parareg might harm the foetus. .
It is not known whether Parareg is excreted in human milk. Your doctor will discuss with if you should discontinue either breast-feeding or treatment with Parareg.
Ask your doctor or pharmacist for advice before taking any medicine.
Parareg should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Parareg and before driving or operating machinery.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Children under the age of 18 must not take Parareg.
Always take Parareg 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 Parareg you must take.
Parareg 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.
The usual starting dose for Parareg is 30 mg (one tablet) once per day.
The usual starting dose for Parareg is 30 mg (one tablet) twice per day.
If you take more Parareg than you should you must contact your doctor immediately.
Medicinal product no longer authorised
Do not take a double dose to make up for forgotten doses.
If you have forgotten a dose of Parareg, 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, Parareg can have side effects, although not everybody gets them.
nausea and vomiting, these side effects are normally quite mild and do not last for long.
dizziness
numbness or tingling sensation (paraesthesia)
loss of appetite (anorexia)
muscle pain (myalgia)
weakness (asthenia)
rash
reduced testosterone levels
seizures
indigestion (dyspepsia)
diarrhoea
allergic reaction (hypersensitivity)
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).
After taking Parareg 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 Parareg, or not.
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions
Do not use Parareg 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 Parareg after the expiry date which is stated on the outer carton and on the bottle.
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.
Medicinal product no longer authorised
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)
The printing ink contains: shellac glaze, iron oxide black (E172).
Parareg is a light green film-coated tablet. They are oval-shaped and have “30”, “60” or “90” printed on one side and “Amgen” on the other side.
Parareg 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.
Parareg 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.
4817 ZK Breda The Netherlands
Dompé Biotec S.p.A. Via San Martino 12
I-20122 Milan Italy
Medicinal product no longer authorised