30 mg, 60 mg, 90 mg film-coated tablets
cinacalcet
What Cinacalcet Mylan is and what it is used for
Cinacalcet Mylan contains the active ingredient cinacalcet, which works by controlling 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).
Cinacalcet Mylan is used 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 parathyroid gland cannot be removed.
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 you take Cinacalcet Mylan
Do not take Cinacalcet Mylan
- if you are allergic to cinacalcate or any of the other ingredients of this medicine (listed in section 6).
- if you have low calcium levels in your blood. Your doctor will check your blood calcium levels.
Warnings and cautions
Talk to your doctor, pharmacist or nurse before taking Cinacalcet Mylan.
Before you start taking Cinacalcet Mylan, 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
Cinacalcet Mylan lowers calcium levels in the blood. Life-threatening events and death due to low calcium levels ( hypocalcaemia ) have been reported in patients treated with cina calcium.
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 Cinacalcet Mylan.
Low calcium levels can affect heart rhythm. Tell your doctor if you have an unusually fast or fast heartbeat, if you have a heart rhythm problem, or if you are taking medicines that are known to cause heart rhythm problems while you are being treated with Cinacalcet Mylan.
For more information, see section 4.
When treating with Cinacalcet Mylan, tell your doctor:
- if you start or stop smoking, as it may affect the way Cinacalcet Mylan works.
Children and young people
Children under 18 years of age are not allowed to take Cinacalcet Mylan. Cinacalcet Mylan is not indicated for use in children and adolescents. Other cinacalcet drugs may be available for this population.
Other medicines and Cinacalcet Mylan
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 Cinacalcet Mylan with ethyl calcite.
Tell your doctor if you are taking any of the following medicines.
Drugs such as these may affect the way Cinacalcet Mylan works:
- medicines used to treat skin and fungal infections ( ketoconazole , itraconazole and voriconazole)
- medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin )
- a drug used to treat HIV – infection s and AIDS (ritonavir)
- a drug used to treat depression (fluvoxamine).
Cinacalcet Mylan may affect the way medicines work like this:
- medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)
- a drug used to relieve cough (dextromethorphan)
- medications used to treat changes in heart rate ( flecainide and propafenone )
- a medicine used to treat high blood pressure ( metoprolol )
Cinacalcet Mylan with food and drink
Cinacalcet Mylan should be taken with or shortly after a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cinacalcet has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as cina calcium can harm the unborn baby.
It is not known whether cina calcium is excreted in human milk. You and your doctor will discuss with you whether to discontinue either breast-feeding or treatment with Cinacalcet Mylan.
Driving and using machines
Dizziness and seizures have been reported in patients taking cina calcium. If you experience these side effects , do not drive or use machines.
How to take Cinacalcet Mylan
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 Cinacalcet Mylan to take.
Cinacalcet Mylan should be taken orally, with or shortly after a meal. The tablets should be swallowed whole and must not be chewed, crushed or divided.
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 recommended starting dose of Cinacalcet Mylan is 30 mg (one tablet) once a day.
If you are being treated for a thyroid tumor or primary hyperparathyroidism
The recommended starting dose of Cinacalcet Mylan is 30 mg (one tablet) twice daily.
If you take more Cinacalcet Mylan than you should
Contact your doctor immediately if you have taken too much Cinacalcet Mylan. Possible signs of overdose are numbness and tingling around the mouth, muscle aches or cramps, and seizures.
If you forget to take Cinacalcet Mylan
Do not take a double dose to make up for a forgotten dose.
Even if you forget to take a dose of Cinacalcet Mylan, take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. 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 ).
Other possible side effects:
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 prolongation and ventricular arrhythmia , secondary to hypocalcaemia)
After taking in calcium, a very small number of patients with heart failure have experienced 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cinacalcet Mylan
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.
6. Contents of the packaging 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.
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, povidone, crospovidone, magnesium stearate.
The tablets are coated with hypromellose, titanium dioxide (E171), glycerol triacetate, indigo carmine (E132), yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Cinacalcet Mylan 30 mg film-coated tablets are 10.0 mm x 6.4 mm, green, oval, biconvex tablets with a bevelled edge, marked with M on one side and CI30 on the other.
Cinacalcet Mylan 60 mg film-coated tablets are 12.5 mm x 8.0 mm, green, oval, biconvex tablets with a bevelled edge, marked with M on one side and CI60 on the other.
Cinacalcet Mylan 90 mg film-coated tablets are 14.3 mm x 9.0 mm, green, oval, biconvex tablets with a bevelled edge, marked with M on one side and CI90 on the other.
Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs containing 28 tablets and perforated blister packs in unit dose containing 28 x 1, 30 x 1 and 84 x 1 tablets.
Cinacalcet Mylan 30 mg film-coated tablets are supplied in a plastic jar containing 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan SAS
117 Allee des Parcs
69 800 Saint Priest
France
Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Branch drop Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352,
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine.