Product Details

What you need to know before you receive Bonviva

Do not receive Bonviva • if you have, or had in the past, low blood calcium. Please consult your doctor • if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bonviva for osteoporosis. ONJ can also occur after stopping treatment. It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take. Before receiving treatment, tell your doctor/nurse (health care professional) if: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction • you don’t receive routine dental care or have not had a dental check up for a long time • you are a smoker (as this may increase the risk of dental problems) • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders) • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) • you have cancer Your doctor may ask you to undergo a dental examination before starting treatment with Bonviva. While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bonviva. 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 osteonecrosis of the jaw. Some patients need to be especially careful when using Bonviva. Talk to your doctor before receiving Bonviva: • If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys • If you have any disturbance of mineral metabolism (such as vitamin D deficiency) • You should take calcium and vitamin-D supplements while receiving Bonviva. If you are unable to do so, you should inform your doctor • If you have heart problems and the doctor recommended to limit your daily fluid intake. Cases of serious, sometimesfatal allergic reaction have been reported in patients treated with intravenous ibandronic acid. If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4). Children and adolescents Bonviva 3mg/3mL Solution for injection Atnahs Pharma UK Limited PLGB 43252/0023 Bonviva must not be used in children or adolescents below 18 years. Other medicines and Bonviva Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Bonviva is for use only by postmenopausal women and must not be taken by women who could still have a baby. Do not take Bonviva if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines You can drive and use machines as it’s expected that Bonviva has no or negligible effect on your ability to drive and use machines. Bonviva contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodiumfree”.