\n\n30 mg, 60 mg, 90 mg film-coated tablets
cinacalcet<\/p>\n\n\n\n
Cinacalcet Accordpharma contains the active substance cinacalcet which 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 parathyroid hormone (PTH).
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Cinacalcet Accordpharma is used in adults to:<\/p>\n\n\n\n
Cinacalcet Accordpharma is used in children from 3 years up to 18 years to:<\/p>\n\n\n\n
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 .
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Do not take Cinacalcet Accordpharma<\/strong> if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6). Do not take Cinacalcet Accordpharma<\/strong> if you have low levels of calcium in your blood. Your doctor will check your blood calcium levels.<\/p>\n\n\n\n Talk to your doctor, pharmacist or nurse before taking Cinacalcet Accordpharma. Before you start taking Cinacalcet Accordpharma, tell your doctor if you have or have ever had:<\/p>\n\n\n\n Cinacalcet Accordpharma lowers blood calcium levels. Life-threatening events and death due to low calcium levels ( hypocalcaemia ) have been reported in adults and children treated with Cinacalcet Accordpharma. 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 Accordpharma.<\/p>\n\n\n\n Low calcium levels can affect heart rhythm. 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 Cinacalcet Accordpharma.<\/p>\n\n\n\n For more information, see section 4. When treating with Cinacalcet Accordpharma, tell your doctor:<\/p>\n\n\n\n Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism should not take Cinacalcet Accordpharma. If you are being treated for secondary hyperparathyroidism , your doctor should check your calcium levels before starting treatment with Cinacalcet Accordpharma and regularly during treatment with Cinacalcet Accordpharma. Tell your doctor if you experience any of the signs of low calcium levels described above. It is important that you take Cinacalcet Accordpharma- dose one in accordance with the doctor’s instructions. Cinacalcet Accordpharma is only available as a film-coated tablet. Thus, it is not possible to administer Cinacalcet Accordpharma to pediatric patients requiring less than a full dose of 30 mg. If an alternative dose is required, other medicines with cinacalcet that offer such an alternative should be used.<\/p>\n\n\n\n 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 Accordpharma with ethyl calcite. Tell your doctor if you are taking any of the following medicines. Drugs such as these may affect the way Cinacalcet Accordpharma works:<\/p>\n\n\n\n Cinacalcet Accordpharma may affect the way medicines work like this:<\/p>\n\n\n\n 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 Accordpharma has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as Cinacalcet Accordpharma may harm the unborn baby. It is not known whether Cinacalcet Accordpharma is excreted in human milk. Your doctor will discuss with you whether to discontinue either breast-feeding or treatment with Cinacalcet Accordpharma.<\/p>\n\n\n\n Dizziness and seizures have been reported in patients taking Cinacalcet Accordpharma. If you experience these side effects , do not drive or use machines. 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 Accordpharma to take. Cinacalcet Accordpharma 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<\/em><\/p>\n\n\n\n The usual starting dose of Cinacalcet Accordpharma for adults is 30 mg (one tablet) once a day. The usual starting dose of Cinacalcet Accordpharma for children from 3 years up to 18 years is no more than 0.20 mg \/ kg \/ day. Cinacalcet Accordpharma is only available as a film-coated tablet. Thus, it is not possible to administer Cinacalcet Accordpharma to pediatric patients who require less than a full dose of 30 mg or who are unable to swallow tablets. If an alternative dose is required, other medicines with cinacalcet that offer such an alternative should be used, ask your doctor or pharmacist. If you are being treated for thyroid cancer or primary hyperparathyroidism<\/em><\/p>\n\n\n\n The usual starting dose of Cinacalcet Accordpharma for adults is 30 mg (one tablet) twice a day.<\/p>\n\n\n\n Contact your doctor immediately if you have taken too much Cinacalcet Accordpharma. Possible signs of overdose are numbness and tingling around the mouth, muscle aches or cramps and seizures.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose . Even if you forget to take a dose of Cinacalcet Accordpharma, take the next dose asusual. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them. Contact a doctor immediately if you:<\/strong><\/p>\n\n\n\n
<\/p>\n\n\n\nWarnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and Cinacalcet Accordpharma<\/h2>\n\n\n\n
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<\/p>\n\n\n\nPregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Cinacalcet Accordpharma<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you use more Cinacalcet Accordpharma than you should <\/h2>\n\n\n\n
If you forget to use Cinacalcet Accordpharma<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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