Product Details

What you need to know before you are given Zoledronic Acid Concentrate

Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Concentrate and will check your response to treatment at regular intervals. You should not be given Zoledronic Acid Concentrate: ! if you are breast-feeding. ! if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Concentrate belongs), or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before you are given Zoledronic Acid Concentrate: ! if you have or have had a kidney problem. ! if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Concentrate. ! if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Concentrate and inform your doctor about your dental treatment. While being treated with this Zoledronic Acid Concentrate, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw. Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw. Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients PACKAGE LEAFLET: INFORMATION FOR THE USER Zoledronic Acid 4mg/5ml Concentrate for solution for infusion Zoledronic acid treated with Zoledronic Acid Concentrate. Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia. In some instances the hypocalcaemia may be life-threatening. If any of these apply to you, tell your doctor straight away. If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Concentrate. You will be given adequate calcium and vitamin D supplements. Patients aged 65 years and over Zoledronic Acid Concentrate can be given to people aged 65 years and over. There is no evidence to suggest that any extra precautions are needed. Children and adolescents Zoledronic Acid Concentrate is not recommended for use in adolescents and children below the age of 18 years. Other medicines and Zoledronic Acid Concentrate Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important that you tell your doctor if you are also taking: ! Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low. ! Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys. ! Aclasta (a medicine that also contains zoledronic acid and is used to treat osteoporosis and other non-cancer diseases of the bone), or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Concentrate are unknown. ! Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zoledronic Acid Concentrate has been associated with an increased risk of osteonecrosis of the jaw (ONJ). Pregnancy and breast-feeding You should not be given Zoledronic Acid Concentrate if you are pregnant. Tell your doctor if you are or think that you may be pregnant. You must not be given Zoledronic Acid Concentrate if you are breast-feeding. Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding. Driving and using machines There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Concentrate. You should therefore be careful when driving, using machinery or performing other tasks that need full attention. Important information about Zoledronic Acid Concentrate This medicinal product contains less than 1 mmol sodium (23 mg) per 5ml vial of Zoledronic acid, i.e., essentially “sodium free”.