Film-coated tablet 30 mg
(Light green, oval (approximately 9.9 mm long and 6.2 mm wide), biconvex film-coated tablet, marked with “CN”.)
1. What the medicine is and what it is used for
Cinacalcet Orion is used to 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 Orion 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 (hypercalcemia) in adult patients with thyroid cancer.
reduce high levels of calcium in the blood (hypercalcemia) in adult patients with primary
hyperparathyroidism when the gland cannot be removed.
Cinacalcet Orion 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 can cause a decrease in calcium in the skeleton, which can lead to skeletal pain and
fracture, heart and blood vessel problems, kidney stones, mental illness, and coma.
Cinacalcet contained in Cinacalcet Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions and always follow their instructions.
2. What you need to know before using this medicine
Do not take Cinacalcet Orion if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Do not take Cinacalcet Orion 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 Cinacalcet Orion.
Before you start taking Cinacalcet Orion, tell your doctor if you have or have ever had:
– seizures (convulsions or attacks). The risk of seizures is greater if you have had them before
– liver problem
– heart failure.
Cinacalcet Orion 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 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 that you are being treated with Cinacalcet Orion.
Low calcium levels can affect heart rhythm. Tell your doctor if you have unusually fast or beating heartbeats, 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 Orion.
For more information, see section 4.
When treating with Cinacalcet Orion, tell your doctor:
– if you start or stop smoking, as it may affect the way Cinacalcet Orion works.
Children and young people
Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism should not take Cinacalcet Orion.
If you are being treated for secondary hyperparathyroidism, your doctor should check your calcium levels before starting treatment with Cinacalcet Orion and regularly during treatment with Cinacalcet Orion. Tell your doctor if you experience any of the signs of low calcium levels described above.
It is important that you take Cinacalcet Orion- dose one in accordance with the doctor’s instructions.
Use of other medicines
Tell your doctor or pharmacist if you are taking, 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 Orion with ethyl calcite.
Tell your doctor if you are taking any of the following medicines:
Drugs such as these may affect the way Cinacalcet Orion works:
– medicines used to treat fungal infections (itraconazole and voriconazole)
– ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces excess cortisol )
medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin )
– a drug used to treat HIV – infection s and AIDS (ritonavir)
– a medicine used to treat depression (fluvoxamine).
Cinacalcet Orion may affect the way medicines work like this:
– medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine)
– a medicine 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 ).
Taking the medicine with food, drink, and alcohol
Cinacalcet Orion should be taken with or 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 Orion has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as Cinacalcet Orion may harm the unborn baby.
It is not known whether Cinacalcet Orion is excreted in human milk. Your doctor will discuss with you whether to discontinue either breast-feeding or treatment with Cinacalcet Orion.
Driving and using machines
Dizziness and seizures have been reported in patients taking Cinacalcet Orion. If you experience these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, read all the information in this leaflet
guidance. If you are not sure, talk to your doctor or pharmacist.
The medicine contains excipients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use the medicine
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 Orion to take.
Cinacalcet Orion should be taken orally, with or after a meal.
The tablets must not be chewed or crushed.
Cinacalcet Orion 30 mg film-coated 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 usual starting dose of Cinacalcet Orion for adults is 30 mg (one tablet) once a day.
If you are being treated for thyroid cancer or primary hyperparathyroidism
The usual starting dose of Cinacalcet Orion for adults is 30 mg (one tablet) twice daily.
Use for children and adolescents
The usual starting dose of Cinacalcet Orion for children from 3 years up to 18 years is a maximum of 0.20 mg/kg/day. Children who need a dose lower than 30 mg or who are unable to swallow tablets should be given a more suitable form of medicine, e.g. cinakalcet granules.
If you are being treated for thyroid cancer or primary hyperparathyroidism
If you forget to use the medicine
Do not take a double dose to make up for a forgotten dose.
Even if you forget to take a dose of Cinacalcet Orion, 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 (hypocalcemia).
– swelling of the face, lips, mouth, tongue, or pharynx, which may cause difficulty in 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 )
– skin 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 level of calcium in the blood (hypocalcemia).
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 hypocalcemia)
After taking cina 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 ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
5. How to store the medicine
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.
No special storage instructions.
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, or 90 mg of cina calcium (as hydrochloride).
The other ingredients are pregelatinized maize starch, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), and macrogolmin (Erogol2min). For further information see section 2, Cinacalcet Orion contains lactose.
What the medicine looks like and the contents of the pack
Cinacalcet Orion 30 mg film-coated tablets:
Light green, oval (approximately 9.9 mm long and 6.2 mm wide), biconvex film-coated tablets, marked with “CN” on one side and “30” on the other side.
Cinacalcet Orion 60 mg film-coated tablets:
Light green, oval (approximately 12.4 mm long and 7.8 mm wide), biconvex film-coated tablets, marked with “C” and “N” on each side of the breaker notch on one side and “60” on the other side. The tablet can be divided into two equal doses.
Cinacalcet Orion 90 mg film-coated tablets:
Light green, oval (approximately 14.2 mm long and 8.9 mm wide), biconvex film-coated tablets, marked with “C” and “N” on each side of the breaker notch on one side and “90” on the other side. The tablet can be divided into two equal doses.
Cinacalcet Orion is supplied in clear PVC / PVdC / Aluminum blister packs of 14, 28, 30, 56 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland