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Bonviva

Bonviva



How does it work?
Bonviva tablets and injection contain the active ingredient ibandronic acid, which is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that prevent the breakdown of bone.

Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continously deposit and remove calcium and phophorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.

In women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones become weak and brittle and break (fracture) more easily.

Ibandronic acid is used to treat osteoporosis in women who have passed the menopause. It works by binding very tightly to the bone and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts from breaking down the bone, which helps to keep the bones strong and less likely to break.

In women who have passed the menopause, ibandronic acid has been shown to reduce the risk of breaking a bone in the spine, but it is not known if it is effective at preventing hip fractures.

Bonviva can be administered by mouth or by injection into a vein. If taken by mouth, one Bonviva tablet is taken once a month, preferably on the same date each month. Alternatively, Bonviva injection can be administered every three months.

As this medicine slows bone turnover and so prevents calcium being rebsorbed from the bones into the blood, it can cause the amount of calcium in your blood to fall too low. If you are having this medicine as a three-monthly injection, you will need to take calcium and vitamin D supplements to prevent this. If you are taking this medicine as a monthly tablet, your doctor will usually only ask you to take supplements if your dietary intake of calcium and vitamin D is low.

What is it used for?

  • Osteoporosis in women who have passed the menopause.
  • Warning!

  • It is very important that the instructions for taking Bonviva tablets are followed completely. This is because when the ibandronic acid is taken by mouth it can cause irritation and ulceration of the foodpipe (oesophagus). Following the instructions below minimises this risk. If you are unclear about anything ask your pharmacist for advice.
  • Your Bonviva tablet should be taken on the same date each month, in the morning after an overnight fast (at least six hours). The tablet should be swallowed whole with a glass of plain water (180 to 240ml, not mineral water) while you are sitting or standing in an upright position. Do not chew or suck the tablet. You should not lie down for one hour after taking your Bonviva tablet. You should not eat or drink anything other than plain water for one hour after taking the tablet. This is because food and some drinks (including mineral water) can interfere with the absorption of the medicine from the gut and hence make it less effective.
  • You should not take any other medicine by mouth in the six hours before you take your Bonviva tablet, at the same time as your Bonviva tablet, or in the hour after you have taken the tablet. See the end of this factsheet for more details.
  • If you experience any signs of irritation to your foodpipe during treatment with this medicine, for example new or worsening problems with swallowing, pain on swallowing, pain behind your breastbone, or heartburn, you should stop taking these tablets and inform your doctor.
  • If you forget to take your monthly tablet, you should take it the morning after you remember, and then return to taking it once a month on your normal date. However, if you miss a dose but realise that your next dose is due in the next seven days, forget the missed dose and take your next scheduled dose on the day you would normally take it. You should not take two tablets within the same week. You may find it helpful to keep a reminder, eg on a calender, of what date you have taken your tablet and what date your next dose is due.
  • Your doctor may want you to have regular blood tests to monitor your kidney function and the level of calcium in your blood while you are having treatment with this medicine.
  • The class of medicines that ibandronic acid belongs to (bisphosphonates) has been associated with a rare condition called osteonecrosis of the jaw. The majority of cases of this condition have been in cancer patients treated with bisphosphonates by injection into a vein and many of these patients were also having treatment with chemotherapy or corticosteroids. However, the condition has also been seen in people taking bisphosphonates by mouth. The risk may be increased by poor oral hygiene, dental problems, teeth extractions and oral surgery. For this reason, your doctor may want you to have a dental examination and, if necessary, appropriate preventive dentistry, before you start treatment with this medicine. Discuss this with your doctor. It is important to look after your mouth and teeth as much as possible while you are receiving this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible. If you need to see a dentist during treatment, make sure they know you are receiving this medicine.
  • Use with caution in

  • Decreased kidney function.
  • Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism)
  • Vitamin D deficiency.
  • Bonviva tablets should be used with caution in people with conditions that cause difficulty swallowing or delayed passage of food through the foodpipe (oesophagus), eg narrowing of the foodpipe.
  • Not to be used in

  • Low levels of calcium in the blood (hypocalcaemia)
  • Children
  • Pregnancy
  • Breastfeeding.
  • This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

    If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

    Pregnancy and Breastfeeding
    Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • This medicine has not been studied in pregnant women, hence its safety has not been established. It should not be used during pregnancy.
  • It is not known if this medicine passes into breast milk. It should not be used by breastfeeding mothers.
  • Side effects
    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

  • Abdominal pain
  • Indigestion
  • Nausea
  • Flu-like symptoms
  • Bone pain
  • Diarrhoea
  • Headache
  • Fatigue
  • Pain in the muscles or joints
  • Rash
  • Flatulence
  • Vomiting
  • Dizziness
  • Back pain
  • Feeling of weakness
  • Difficulty swallowing (Bonviva tablets only)
  • Inflammation of the stomach (gastritis) (Bonviva tablets only)
  • Inflammation or ulceration of the foodpipe (oesophagus) (Bonviva tablets only)
  • The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

    For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

    How can this medicine affect other medicines?
    It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

    Other medicines may interfere with the absorption of Bonviva tablets from the gut and could therefore make the medicine less effective. This is especially the case with antacids (indigestion remedies), calcium supplements and medicines containing aluminium, magnesium or iron. For this reason, you should not take any other medicines by mouth in the six hours before you take your Bonviva tablet, or in the hour after you have taken the tablet.

    There may be an increased risk of irritation to the foodpipe (oesophagitis) if non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, diclofenac or indometacin are taken in combination with Bonviva tablets. These types of painkiller are best avoided by people taking Bonviva tablets. Ask your pharmacist for further advice.

    Other medicines containing the same active ingredient

    Bondronat
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