Product Description :

• BONTEO® contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.


• BONTEO® is used to treat osteoporosis in adults


• Osteoporosis is a disease that causes your bones to become thin and fragile


• This disease is especially common in women after the menopause, but it can also occur in men


• Osteoporosis is also common in patients receiving cortcosteroids.

How to use:

• Always use this medicine exactly as your doctor has told you to


• Check with your doctor or pharmacist if you are not sure


• The recommended dose is 20 micrograms given once daily by injecton under the skin (subcutaneous injection) in the thigh or abdomen


• To help you remember to take your medicine, inject it at about the same time each day


• Inject BONTEO® each day for as long as your doctor prescribes it for you


• The total duration of treatment with BONTEO® should not exceed 24 months


• You should not receive more than one treatment course of 24 months over your lifetime


• BONTEO® can be injected at meal times


• Read the user manual booklet, which is included in the carton for instructions on how to use the BONTEO® pen


• You should take your BONTEO® injection shortly after you take the pen out of the refrigerator as described in the user manual


• Put the pen back into the refrigerator immediately after you have used it.

Warnings and Precautions:

Do not use BONTEO® If you are allergic to teriparatide or any of the other ingredients of this medicine

• If you suffer from high calcium levels (pre-existing hypercalcemia)


• If you suffer from serious kidney problems


• If you have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to your bones


• If you have certain bone diseases


• If you have a bone disease, tell your doctor


• If you have unexplained high levels of alkaline phosphatase in your blood, it means you might have Paget’s disease of bone (disease with abnormal bone changes)


• If you are not sure, ask your doctor


• If you have had radiation therapy involving your bones


• If you are pregnant or breast-feeding.

BONTEO® may cause an increase in the amount of calcium in your blood or urine

• Talk to your doctor or pharmacist before or while using BONTEO®:


• If you have contnuing nausea, vomiting, constipation, low energy, or muscle weakness


• These may be signs there is too much calcium in your blood


• If you suffer from kidney stones or have a history of kidney stones


• If you suffer from kidney problems (moderate renal impairment)


• Some patients get dizzy or get a fast heartbeat after the frist few doses


• For the first doses, inject BONTEO® where you can sit or lie down right away if you get dizzy


• The recommended treatment time of 24 months should not be exceeded


• BONTEO® should not be used in growing adults


• Children and adolescents BONTEO® should not be used in children and adolescents (less than 18 years)


• Other medicines and BONTEO® Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease)

Pregnancy and breast-feeding

• Do not use BONTEO® if you are pregnant or breast-feeding


• If you are a woman of child-bearing potential, you should use effectve methods of contraception during the use of BONTEO®


• If you become pregnant, BONTEO® should be discontinued


• Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

• Some patients may feel dizzy after injecting BONTEO®


• If you feel dizzy you should not drive or use machines untl you feel better


• BONTEO® contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentally “sodium-free”.

Ingredients:

• The actve substance is Teriparatide


• Each milliliter of the solution for injection contains 250 micrograms of Teriparatide.


• The other ingredients are glacial acetic acid, sodium acetate, mannitol, metacresol, and water for injection.