How does it work?

Bonefos tablets and capsules contain the activeingredient sodium clodronate, which is a type of medicine called abisphosphonate. Bisphosphonates are medicines that reduce the turnover of bonein the body.

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 and bone marrow cancer(multiple myeloma) can cause excessive bone breakdown. This causes areas ofbone weakness that can lead to pain and fractures. Sodium clodronate can beused in these situations to bind to the bone and prevent it being brokendown.

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. Assodium clodronate 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.

Bisphosphonates are often given as a drip into a vein (intravenousinfusion) for lowering of high calcium levels that are a result of tumours.Once the calcium levels are back to an acceptable level, they can often bemaintained at that level by taking sodium clodronate by mouth.

What is it used for?

• Managing bone complications (such as bone pain, bone damage or high blood calcium levels) in people with bone marrow cancer (multiple myeloma) or breast cancer that has spread to the bone.
• Maintaining calcium levels at an acceptable level in people who had a high level of calcium in the blood (hypercalcaemia) caused by a tumour that was initially treated with a bisphosphonate injection.

How do I take it?

• Bonefos tablets and capsules are taken either once or twice a day. The dose prescribed depends on your symptoms. Follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• Bonefos capsules should be swallowed whole. Bonefos tablets can be broken in half, but must not be crushed or dissolved in water before taking.
• Bonefos tablets and capsules should be swallowed with a glass of plain water on an empty stomach. This is because food, some drinks (particularly milk and dairy products) and certain medicines can interfere with the absorption of the medicine from the gut and hence make it less effective.
• If you are taking Bonefos once a day, your dose should be taken in the morning before the first food, drink or medicine of the day. You should not eat or drink anything other than plain water, or take any other medicines by mouth, for at least one hour after taking Bonefos.
• If you are taking Bonefos twice a day, your first dose should be taken in the morning before the first food, drink or medicine of the day. You should then not eat or drink anything other than plain water, or take any other medicines by mouth, for at least one hour. Your second dose should be taken between meals, at least two hours after eating, drinking anything other than plain water, or taking other medicines by mouth. Again, do not eat or drink anything other than plain water, or take any other medicines by mouth, for at least one hour after taking Bonefos.

Warning!

• It is important that you drink plenty of fluid while you are having treatment with this medicine. Ask your doctor for advice on how much you should be drinking.
• You may need to have regular blood tests during treatment with this medicine, so that your doctor can monitor your kidney function, liver function, white blood cells and the amount of calcium in your blood.
• The class of medicines that sodium clodronate 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

• Decreased kidney function.
• People with active disorders of the upper part of the digestive system, such as difficulty swallowing, disorders affecting the foodpipe (eg reflux disease), peptic ulcers, inflammation of the lining of the stomach (gastritis), or inflammation of the small intestine (duodenitis).

Not to be used in

• People being treated with other bisphosphonate medicines.
• Severe kidney failure.
• Pregnancy.
• Breastfeeding.
• This medicine has not been studied in children. It is not recommended for children.

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 anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor 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.

• The safety of this medicine during pregnancy has not been established and, as a result, it is not recommended for pregnant women. Women who could get pregnant should use an effective method of contraception to avoid pregnancy while taking this medicine. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. Women who need treatment with this medicine should not breastfeed while taking it. Ask your doctor for further advice.

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.

Common (affect between 1 in 10 and 1 in 100 people)

• Nausea and vomiting.
• Diarrhoea.
• Low level of calcium in the blood (hypocalcaemia).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Low level of calcium in the blood that causes noticeable symptoms such as pins and needles or muscle spasms/twitches/cramps. Tell your doctor if you experience symptoms like these.
• Allergic skin reactions such as rash, hives or itching.
• Breathing difficulties due to a narrowing of the airways (bronchospasm).
• Unusual fractures of the thigh bone (see warning section above).

Unknown frequency

• Kidney problems such as decreased kidney function, kidney damage or kidney failure.
• Osteonecrosis of the jaw (see warning section above).

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror 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 whiletaking this one, to make sure that thecombination is safe.

Other medicines may interfere with the absorption of Bonefostablets and capsules from the gut and could therefore make the medicine lesseffective. For this reason, you should not take other medicines by mouth in the hour before, or the hour after you havetaken Bonefos tablets or capsules. 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.

This medicine may increase the amount of the chemotherapy medicine estramustine in the blood.

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.

There may be an increased risk of side effects on the kidneys if non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac are taken in combination with this medicine, though this association is not definite. You should ask your doctor or pharmacist for advice before taking this type of painkiller.

Other medicines containing the same active ingredient