MIMPARA. 60 mg. 28 tablets

AMGEN
MIMPARA. 60 mg. 28 tablets
€ 549.00
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Mimpara works by controlling the levels of parathyroid hormone (11I X), calcium and phosphorus in your body. Used to treat problems with organs called parathyroid glands. 

MIMPARA. 60 mg. 28 tablets

 
 
What Mimpara is and what it is used ?
Mimpara works by controlling the levels of parathyroid hormone (11I X), calcium and phosphorus in your body . Used to treat problems with organs called parathyroid glands. Parathyroid glands are four small glands in the neck , close to the thyroid gland which produce parathyroid hormone ( PTH ) .

Mimpara used :
• for the treatment of secondary hyperparathyroidism in patients with severe renal disease who need dialysis to clear the blood from waste products.
• to reduce high levels of calcium in the blood ( hypercalcemia ) in patients with parathyroid carcinoma.
• to reduce high levels of calcium in the blood ( hypercalcemia ) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid glands or the removal of the gland is not possible.
In primary and secondary hyperparathyroidism is too much PTH from the parathyroid glands. "Basic " means the hyperparathyroidism is not caused by some other condition , and the " secondary " means that hyperparathyroidism is caused by another disease , such as renal disease . Both the primary and secondary hyperparathyroidism can cause loss of calcium from bones, which can lead to bone pain and fractures, problems with the blood vessels and the heart, kidney stones , mental illness and coma.
2 . What you should know before taking Mimpara?
Do not take Mimpara:
- 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 Mimpara.
Before you start taking Mimpara, tell your doctor if you have or have ever had:
• seizures (fits or convulsions ) . The risk of seizures is higher if you have had seizures ;
• liver problems ;
• heart failure.
Low calcium levels may have an effect on heart rate . Tell your doctor if you experience unusually fast or strong heart beat if you have heart rhythm problems or are taking medications that are known to cause heart rhythm problems while taking Mimpara.
For more information, see section 4 .

During treatment with Mimpara, tell your doctor :
• if you start or stop smoking as it may change the modus operandi of Mimpara.

Children and adolescents
Children under 18 should not take Mimpara. Other medicines and Mimpara
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Tell your doctor if you are taking the following medicines . Drugs such as these can change the operation of Mimpara:
• medicines used to treat skin and fungal infections ( ketoconazole , itraconazole and voriconazole ) ;
• medicines used to treat bacterial infections ( telithromycin, rifampicin and ciprofloxacin) ;
• a medicament for the treatment of HIV infection and AIDS ( ritonavir) ;
• medicine to treat depression ( fluvoxamine ) .

Mimpara may affect the action of drugs such as :
• drugs for the treatment of depression ( amitriptyline, desipramine, nortriptyline , and clomipramine ) ;
• medicines used to treat heart rhythm ( flecainide and propafenone ) ;
• a medicament for the treatment of high blood pressure ( metoprolol ) ; Mimpara with food and drink
Mimpara should be taken with food or shortly after a meal.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
Mimpara has not been studied in pregnant women. In case of pregnancy , your doctor may decide to change your treatment as Mimpara may harm an unborn baby.
It is not known whether Mimpara is excreted in breast milk. Your doctor will discuss with you whether you should stop breast-feeding or treatment with Mimpara.

Driving and using machines
No studies on the effects on ability to drive and use machines. Dizziness and convulsions have been reported by patients taking Mimpara. If you experience this , your ability to drive or operate machinery may be affected .

Mimpara contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3 . How to take Mimpara?
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how Mimpara should take.
Mimpara should be taken orally with or shortly after a meal. The tablets should be swallowed whole and should not be divided .
Your doctor will take regular blood tests during your treatment to monitor your progress and adjust your dose if needed.
If you are being treated for secondary hyperparathyroidism
The usual starting dose Mimpara is 30 mg ( one tablet) once daily.
If you are being treated for parathyroid carcinoma or primary hyperparathyroidism Mimpara usual starting dose is 30 mg ( one tablet) twice daily.

If you take more than the amount of Mimpara
If you take more than the amount of Mimpara, you should contact your doctor immediately . Possible signs of overdose include numbness or tingling around the mouth, muscle pain or cramps and seizures .

If you forget to take Mimpara
Do not take a double dose to make up for a missed dose.
If you miss a dose of Mimpara, you should take the next dose as usual.
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 feel numbness or tingling around the mouth, muscle pain or cramps and seizures , you should inform your doctor immediately. This may indicate that calcium levels are too low ( hypocalcemia ) .
Very common: may affect more than 1 in 10 people
• nausea and vomiting, these side effects are usually very mild and do not last long.

Common: may affect up to 1 in 10 people
• dizziness
• numbness or tingling (paraesthesia)
• loss of appetite ( anorexia)
• muscle pain ( myalgia)
• weakness ( asthenia)
• rash
• reduced levels of testosterone.
Uncommon: may affect up to 1 in 100 people
• seizures
• indigestion (dyspepsia )
• diarrhea
• allergic reaction ( hypersensitivity) .

Not known from the available data can not be estimated
• hives ( urticaria)
• swelling of the face , lips, mouth , tongue or throat which may cause difficulty in swallowing or breathing (angioedema) .
• unusually fast or strong heart beat , which can be associated with low levels of calcium in the blood ( QT prolongation and ventricular arrhythmia as a secondary manifestation of hypocalcaemia ) .
After taking Mimpara a very small number of patients with heart failure had worsening of their condition. Low blood pressure (hypotension) is also observed in a small number of these patients. Due to the few reported cases , it is not known whether they are due to Mimpara.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .

5 . How to store Mimpara?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after " EXP" . Expiry date refers to the last day of that month.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required .. These measures will help to protect the environment.

6 . Contents of the pack and other information
What does Mimpara?
The active substance is cinacalcet. Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride). Other ingredients are:
• Starch ( corn ) , pregelatinized
• Cellulose, microcrystalline
• Povidone
• Crospovidone
• Magnesium stearate
• Silica colloidal anhydrous

The tablets are coated with :
• Carnauba wax
• Opadry green (containing lactose monohydrate , hypromellose , titanium dioxide ( E171), glycerol triacetate , FD & C Blue ( E 132 ), iron oxide yellow (E 172)
• Opadry clear (containing hypromellose , macrogol ) Mimpara looks like and contents of the pack
Mimpara is a light green tablet . The tablets are of oval shape , marked by "30 " , "60" or " 90 " 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 per carton. Mimpara is available in bottles of 30 mg, 60 mg and 90 mg film-coated tablets in a carton. Each bottle contains 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Amgen
 
 
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