Skelid

How does it work?

Skelid tablets contain the active ingredient tiludronic acid, which is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that reduce the turnover 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 Paget's disease of bone the normal metabolism of bone is disturbed. There is an increase in bone breakdown by the osteoclasts and increased and irregular formation of new bone by the osteoblasts. The normal bone marrow also becomes replaced with blood vessels and fibrous tissue. In this disease there are often no symptoms for many years, but over time the bones can become enlarged, deformed, painful, weak and prone to breaking. The enlarged and deformed bones can also put pressure on nerves, causing pain and muscle weakness.

Tiludronic acid 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. It also reduces the rate of bone formation by the osteoblasts. The reduced bone turnover helps to reduce deformity and keep the bones strong and less likely to break.

Calcium and vitamin D are also needed for strong bones and your doctor may ask you to take supplements of these if your dietary intake is too low.

What is it used for?

Bone disease called Paget's disease, in which there is excessive breakdown of bone and increased and irregular formation of bone, causing the bones to become enlarged, deformed, painful, weak and prone to breaking.

Warning!

Skelid tablets should be taken with water on an empty stomach, at least two hours after food and at least two hours before food. This is because food, some drinks (particularly milk) and some medicines (see end of factsheet for details) can interfere with the absorption of the medicine from the gut and hence make it less effective.

Your kidney function should be monitored during treatment with this medicine.

Your course of treatment with this medicine will be three months for Paget's disease. If your doctor decides re-treatment is necessary after this time because the disease has flared up again, the medicine should only be re-started after you have had an interval of at least six months without taking it.

The class of medicines that tiludronic 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.

Not to be used in

Juvenile Paget's disease

Allergy to bisphosphonates

Severely decreased kidney function

Low levels of calcium in the blood (hypocalcaemia)

Vitamin D deficiency

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 in pregnancy has not been established. It should not be taken by women who are pregnant. Seek further medical advice from your doctor.

It is not known if this medicine passes into breast milk. It should not be used by women who are 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.

Abdominal pain

Nausea

Diarrhoea

Skin rashes

Headache

Dizziness

Feeling of weakness.

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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