30 mg, 60 mg, 90 mg film-coated tablets
cinacalcet
What Mimpara is and what it is used for
Mimpara is used to control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat problems in the organ called the parathyroid gland. The parathyroid gland consists of four small glands in the throat near the thyroid gland and produces a parathyroid hormone (PTH).
Mimpara is used in adults to:
- treat secondary hyperparathyroidism in adult patients with severe kidney disease who need dialysis to cleanse the blood of waste products.
- reduce high levels of calcium in the blood ( hypercalcaemia ) in adult patients with thyroid cancer.
- reduce high levels of calcium in the blood ( hypercalcaemia ) in adult patients with primary hyperparathyroidism when the gland cannot be removed.
Mimpara is used in children from 3 years up to 18 years to:
- treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to cleanse the blood of waste products and whose disease can not be kept under control with other treatments.
In primary and secondary hyperparathyroidism, too much PTH is produced by the parathyroid gland. “Primary” means that hyperparathyroidism is not caused by another disease and “secondary” means that hyperparathyroidism is caused by another disease, e.g. kidney disease. Both primary and secondary hyperparathyroidism can cause a decrease in skeletal calcium, which can lead to skeletal pain and fractures, heart and blood vessel problems, kidney stones, mental illness, and coma.
What you need to know before taking Mimpara
Do not take Mimpara if you are allergic to cina calcium or any of the other ingredients of this medicine (listed in section 6).
Do not take Mimpara if you have low levels of calcium in your blood. Your doctor will check your blood calcium levels.
Warnings and cautions
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 (attacks or convulsions). The risk of seizures is greater if you have had them before
- liver problem
- heart failure
Mimpara lowers calcium levels in the blood. Life-threatening events and death due to low calcium levels (hypocalcemia) have been reported in adults and children treated with Mimpara.
Tell your doctor if you experience any of the following symptoms, which may be signs of low calcium levels: spasms, twitches or cramps in the muscles, numbness or tingling in the fingers, toes, or around the mouth, or seizures, confusion or loss of consciousness while you treated with Mimpara.
Low calcium levels can affect heart rate. Tell your doctor if you have unusually fast or beating heartbeats, if you have heart rhythm problems, or if you are taking medicines that are known to cause heart rhythm problems while you are being treated with Mimpara.
For more information, see section 4.
When taking Mimpara, tell your doctor:
- if you start or stop smoking, as this may affect the way Mimpara works.
Children and young people
Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism should not take Mimpara.
If you are being treated for secondary hyperparathyroidism, your doctor should check your calcium levels before starting treatment with Mimpara and regularly during treatment with Mimpara. Tell your doctor if you experience any of the signs of low calcium levels described above.
You must take Mimparados one by your doctor’s instructions.
Other medicines and Mimpara
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, especially ethyl calcium or other medicines that lower your blood calcium levels.
You should not use Mimpara with ethyl calcite.
Tell your doctor if you are taking any of the following medicines.
Drugs like these can affect how Mimpara works:
- medicines used to treat skin and fungal infections ( ketoconazole , itraconazole and voriconazole)
- drugs used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin )
- a drug used to treat HIV infections and AIDS ( ritonavir)
- a drug used to treat depression (fluvoxamine).
Mimpara may affect the way medicines work as follows:
- medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)
- a drug used to relieve cough (dextromethorphan)
- medicines used to treat changes in heart rate ( flecainide and propafenone )
- a medicine used to treat high blood pressure ( metoprolol ).
Mimpara with food and drink
Mimpara should be taken with or after a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Mimpara has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as Mimpara may harm the unborn baby.
It is not known whether Mimpara is excreted in human milk. Your doctor will discuss with you whether to discontinue either breastfeeding or treatment with Mimpara.
Driving and using machines
Dizziness and seizures have been reported in patients taking Mimpara. If you experience these side effects, do not drive or use machines.
Mimpara contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Mimpara
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will tell you how much Mimpara to take.
Mimpara should be taken orally, with or after a meal. The tablets should be swallowed whole and must not be chewed, crushed, or divided.
Mimpara is also available as granules in capsules intended to be opened. Children who require a dose lower than 30 mg or who are unable to swallow tablets should be treated with Mimpara granules.
Your doctor will take regular blood tests to check your disease progression and will adjust dose one if necessary.
If you are being treated for secondary hyperparathyroidism
The usual starting dose of Mimpara for adults is 30 mg (one tablet) once a day.
The usual starting dose of Mimpara for children from 3 years up to 18 years is no more than 0.20 mg/kg/day.
If you are being treated for thyroid cancer or primary hyperparathyroidism
The usual starting dose of Mimpara for adults is 30 mg (one tablet) twice a day.
If you take more Mimpara than you should
Contact your doctor immediately if you have taken too much Mimpara. Possible signs of overdose are numbness and 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.
Even if you forget to take a dose of Mimpara, take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you:
- begins to feel numbness and tingling around the mouth, muscle aches or cramps and seizures. These may be signs that your calcium levels are too low ( hypocalcaemia ).
- swelling of the face, lips, mouth, tongue or pharynx, which may cause difficulty swallowing and breathing ( angioedema ).
Very common side effects: may affect more than 1 in 10 people
- nausea and vomiting. These side effects are often relatively mild and do not last long.
Common side effects: may affect up to 1 in 10 people
- dizziness
- numbness and tingling ( paresthesia )
- loss of ( anorexia ) or decreased appetite
- muscle pain ( myalgia )
- weakness ( asthenia )
- rash
- decreased testosterone levels
- high potassium levels in the blood ( hyperkalemia )
- allergic reactions (hypersensitivity)
- headache
- seizures
- low blood pressure ( hypotension )
- upper respiratory tract infection
- difficulty breathing ( dyspnoea )
- cough
- indigestion ( dyspepsia )
- diarrhea
- abdominal pain, abdominal pain – upper
- constipation
- muscle spasms
- back pain
- low calcium levels in the blood ( hypocalcaemia ).
No known frequency: can not be calculated 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 beating heartbeat, which may be due to low calcium levels in the blood ( QT ‑extension and ventricular arrhythmia , secondary to hypocalcaemia)
After taking Mimpara, a very small number of patients with heart failure have experienced worsening of their condition and/or low blood pressure ( hypotension ).
How to store Mimpara
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 expiration date is the last day of the specified month.
This medicine does not require any special storage.
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.
Contents of the package and other information
Content declaration
- The active substance is cina calcium. Each film-coated tablet contains 30 mg, 60 mg and 90 mg of cina calcium (as hydrochloride), respectively.
- Other ingredients are:
- Pregelatinized corn starch
- Microcrystalline cellulose
- Povidon
- Krospovidon
- Magnesium stearate
- Colloidal anhydrous silica
- The tablets are coated with:
- Carnaubavax
- Opadry green (contains lactose monohydrate , hypromellose, titanium dioxide (E171), glycerol triacetate, indigo carmine (E132), yellow iron oxide (E172))
- Opadry colorless (contains hypromellose, macrogol)
What the medicine looks like and contents of the pack
Mimpara is a light green film-coated tablet. The oval tablets have “30”, “60”, and “90” marked on one side and “AMG” on the other.
30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.
60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
90 mg tablets approximately 13.9 mm long and 8.7 mm wide.
Mimpara is available in blister packs containing 30 mg, 60 mg, and 90 mg film-coated tablets. Each blister pack contains 14, 28, or 84 tablets in an outer carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands