Loron

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How does it work?

Loron tablets contain the active ingredient disodium clodronate, which is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that reduce the turnover of bone in the body.

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.

Biphosphonates work by binding very tightly to the bone tissue and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts 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 of bone weakness that can lead to pain and fractures. Sodium clodronate can be used in these situations to bind to the bone and prevent it being broken down.

When the osteoclasts remove calcium from the bones, the calcium then seeps into the blood. The excessive breakdown of bone that occurs when cancer spreads to the bones can therefore lead to high levels of calcium in the blood. This can cause symptoms such as nausea, tiredness and confusion. As sodium clodronate prevents the calcium being removed from the bone, it can be used to treat high levels of calcium in the blood that are a result of cancer.

Sodium clodronate is given as a drip into a vein (intravenous infusion) 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 be maintained 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.
- Reducing high levels of calcium in the blood (hypercalcaemia) caused by tumours.

Warning!

- Loron tablets should be taken with fluid (but not milk) on an empty stomach, at least one hour before and one hour after food. This is because food and some drinks and medicines (see end of factsheet for more details) can interfere with the absorption of the medicine from the gut and hence make it less effective.
- It is important that you drink plenty of fluid while you are having treatment with this medicine.
- 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 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.

Not to be used in

- Children
- Allergy to bisphosphonates
- People taking other bisphosphonate medicines
- Severely decreased kidney function
- 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.

- The safety of this medicine during pregnancy has not been established and, as a result, it should not be used in pregnant women. Seek medical advice from your doctor. Women who could get pregnant should use effective methods of contraception to avoid pregnancy during treatment with this medicine.
- It is not known if this medicine passes into breast milk. It should not be used during breastfeeding. Seek medical advice from your doctor.

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.

- Nausea and vomiting
- Diarrhoea
- Skin reactions such as rash or itching
- Kidney problems
- Breathing difficulties due to a narrowing of the airways (bronchospasm)

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.

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