How does it work?

Bondronat tablets and injection contain the active ingredientibandronic acid, which is a type of medicine called a bisphosphonate.Bisphosphonates are medicines that reduce the turnover of bone in thebody.

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

Biphosphonates work by binding very tightly to the bone tissueand preventing the calcium being removed by the osteoclasts. This stops theosteoclasts from breaking down the bone.

Breast cancer that has spread to the bone can cause excessivebone breakdown. This causes areas of bone weakness that can lead to pain andfractures. Ibandronic acid can be used in this situation to bind to the bone andprevent it being broken down. Bondronat tablets are taken by mouth every dayfor this purpose. Alternatively, Bondronat injection may be given as a dripinto a vein (intravenous infusion) once every three to four weeks.

When the osteoclasts remove calcium from the bones, the calciumthen seeps into the blood. The excessive breakdown of bone that occurs whencancer spreads to the bones can therefore lead to high levels of calcium in theblood. This can cause symptoms such as nausea, tiredness and confusion. Asibandronic acid prevents the calcium being removed from the bone, it can beused to treat high levels of calcium in the blood that are a result of cancer.Bondronat injection is usually given as a single dose via a drip into a vein(intravenous infusion) to return the calcium levels back to normal.

What is it used for?

• Bondronat tablets and injection are used for preventing bone damage (such as fractures, or bone complications requiring radiotherapy or surgery) in people with breast cancer that has spread to the bone.
• Bondronat injection is also used for reducing high levels of calcium in the blood (hypercalcaemia) that are caused by tumours.

How do I take it?

• It is very important that the instructions for taking Bondronat 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.
• Bondronat tablets should be taken in the morning after an overnight fast (at least six hours) and before the first food, drink or medicine of the day.
• 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 crush, chew or suck the tablets.
• You should not lie down for one hour after taking your Bondronat tablet.
• You should not eat or drink anything other than plain water for at least 30 minutes 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 Bondronat tablet, at the same time as your Bondronat tablet, or in the hour after you have taken the tablet. See the end of this factsheet for more details.

Warning!

• 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 Bondronat tablets and inform your doctor.
• Your doctor will want you to have regular blood tests to monitor your kidney function and the level of calcium, phosphate and magnesium 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 people were also having treatment with chemotherapy or corticosteroids. However, the condition has also been seen in people taking bisphosphonates by mouth. The risk may also be increased by poor oral hygiene, dental problems such as gum disease or poorly fitting dentures, teeth extractions, oral surgery and smoking. For this reason, you should 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 taking this medicine. You should have regular check-ups with your dentist and get advice straight away if you have any problems with your mouth or teeth. When you see a dentist during treatment, make sure they know you are taking this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible.
• Some people being treated with bisphosphonates (mainly people having long-term treatment for osteoporosis) have experienced an unusual fracture of their thigh bone. For this reason it is important to let your doctor know if you get any pain in your thighs, hips or groin while you are having treatment with this medicine. These symptoms could be an early indication of a possible fracture.

Use with caution in

• People who are allergic to other bisphosphonate medicines.
• Decreased kidney function.
• Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism).
• Vitamin D deficiency.
• Bondronat tablets should be used with caution in people with active disorders of the upper part of the digestive system, such as difficulty swallowing, disorders affecting the foodpipe (eg reflux disease), ulcers, inflammation of the lining of the stomach (gastritis), inflammation of the small intestine (duodenitis).

Not to be used in

• Pregnancy.
• Breastfeeding.
• People who have a low level of calcium in their blood (hypocalcaemia). If your dietary intake ofcalcium andvitamin D is low your doctor may askyou to take calcium and vitamin D supplements.
• Bondronat tablets should not be used in people who have any abnormality of the foodpipe (oesophagus) that causes difficulty swallowing or delayed passage of food through the foodpipe, eg narrowing or achalasia of the foodpipe.
• Bondronat tablets should not be used in people who cannot stand or sit upright for at least 60 minutes.
• Bondronat tablets contain lactose and should not be taken people with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Bondronat is not recommended for children under 18 years of age.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

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

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, 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 individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Low blood calcium level (hypocalcaemia).
• Flu-like symptoms.
• Indigestion.
• Nausea and vomiting.
• Abdominal pain.
• Diarrhoea.
• Bone pain.
• Pain in the muscles or joints.
• Feeling of weakness.
• Headache.
• Dizziness.
• Taste disturbance.
• Inflammation of the foodpipe (oesophagitis - Bondronat tablets only).
• Difficulty swallowing.
• Inflammation of the stomach (gastritis).
• Pins and needles sensations.
• Anaemia.
• Itching.
• Eye inflammation.
• Osteonecrosis of the jaw (see warning section above).
• Unusual fractures of the thigh bone (see warning section above).

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

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

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whilehaving treatment with this one, to make sure that thecombination is safe.

Other medicines may interfere with the absorption of Bondronattablets from the gut and could therefore make the medicine lesseffective. For this reason, you should not take other medicines by mouth in the six hoursbefore you take your Bondronat tablet, or in the hour after you have taken thetablet. This is particularly important for the medicines listed below:

• antacids (indigestion remedies)
• calcium supplements
• iron supplements
• laxatives containing magnesium
• mineral supplements
• multivitamins containing minerals such as calcium, iron, magnesium or zinc
• zinc supplements.

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

There may an increased chance of the amount of calcium in the blood falling too low if aminoglycoside antibiotics such as gentamicin are used in combination with this medicine.

Other medicines containing the same active ingredient