Skelid~ 200 mg Tablets

PATIENT INFORMATION LEAFLET

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The name of this medicine is Skelid tablets.

What is in this medicine7

Each Skelid tablet contains 200 mg tiludronic acid as tiludronate disodium.

Each tablet also contains lactose, sodium lauryl sulphate, m ethyl hyd roxyp ro pylcel I u I ose, c rospovidone and magnesium stearate.

Skelid tablets are gluten free.

Skelidtabletsareroundandwhite.Theyaremarked "S.W" on one side and "200" on the other.

Skelid tablets are supplied in packs of 28 tablets.

Skelid controls the way bone is formed.

The product licence holder is: Sanofi Winthrop Ud One Onslow Street, Guildford, Surrey GU1 4YS

The manufacturers are: Sanofi Winthrop Ltd. Edgef eld Avenue, Fawdon, Newcastle upon Tyne NE3 3TT and Sanofi Winthrop Industrie, 1 Rue de la Vierge, 33440 Ambares, France

What is this medicine for7

Skelid is used to treat Paget's disease of bone. Normal bone is continually built up, removed and replaced. In Paget's disease this process happens too quickly and the new bone produced is weaker than normal. The affected bone may become enlarged and can be painful. Skelid controls this process.

Further information about Paget's disease can be found at the end of this leaflet.

Before taking this medicine

You should not take Skelid rf:

• You have severe kidney disease.

Check with your doctor if:

• You have mild or moderate kidney disease.

• You have problems with the way you r body handles

calcium (hypocalcaemia, vitamin D deficiency).

If taken wrth some other medicines The effects of Skelid or the effects of other medicines may be changed. Please check with your doctor if you are taking:

• Calcium supplements - these should not be taken

within 2 hours of taking Skelid tablets.

•Antacids (medicines used to treat indigestion)

these should not be taken within 2 hours of taking Skelid tablets.

•Indomethacin - this should not be taken within 2

hours of taking Skelid tablets.

Taking this medicine Children Skelid is not recommended for use in children.

Adults/Elderly

The usual dose of Skelid is 400 mg (two tablets) taken once per day, for three months. The correct dose for you will have been decided by your doctor. Check the label and if you're not su re of anything ask you r doctor or pharmacist.

Swallowthe tablets with a glass of water.

Take Skelid at least 2 hours after the last meal, and

then do not eat for 2 hours following the dose. In particular, avoid taking milk, dairy products or other foods with a high calcium content within this (four hour) period. Remember, do not take indigestion remedies during this period.

As with all medicines an overdose can be dangerous. If you have taken an overdose tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take your tablets take them as soon as you remember.

Keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop your condition may get worse.

Skelid is not usually given for more than 3 months without a break. However, treatment for longer than this may be prescribed. If you need to have repeat courses of Skelid your doctor will usually leave an interval of 6 months between treatment.

Whilst taking this medicine

Most patients will experience no problems while taking Skelid. Occasionally it causes stomach pain, nausea(feelingofsickness)ordiarrhoea.Theseeffects are not usually troublesome. In rare cases Skelid may cause headache, dizziness, a feeling of weakness or skin rashes.

If you experience any of the above you should tell your doctor, particularly if it becomes troublesome.

If you notice any other unusual symptoms while taking Skelid you should tell your doctor.

Donottakethismedicineaftertheexpirydatewhich you will find on the pack.

Date of last revision of leaflet: December 1995.

The following general information, which has been approved by the National Association for the Relief of Paget's Disease, may answer some of the questions you have about your condition and its treatment.

What is Paget's Disease7

Paget's disease is a common condition of the bone, most often seen in middle ayed or elderly people. It affects approximately one in 20 people over the age of 55 years: although most have no symptoms, these may develop with time.

Bone is constantly being broken down and rebuilt. In Paget's disease, this process happens too quickly. This over-activity is confined to small areas of the bones and does not affect the whole skeleton. Bones affected by Paget's disease become weakened and enlarged, in turn they may become misshapen or painful. When the skull is affected, Paget's disease may cause deafness; elsewhere in the body osteoarthritis may develop.

Why has your doctor prescribed treatment for you7

The aim of treatment is to control the over activity of the bone. To get the greatest benefit from this treatment you should take the full course of tablets in the way your doctor told you.

Your doctor may wish to see you some time after you finish this course of treatment. Even though you may feel well, you should keep this appointment so that your doctor can monitor your progress.

Further information can be obtained from:

National Association for the Relief of Paget's Disease 207 Eccles Old Road,

Salford M6 8HA

Tel: 0161707 9225

This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case so if you haveanyquestionsoryouarenotsureaboutanything, ask your doctor or pharmacist.

Skelidw is a registered trademark. t1995 Sanofi Winthrop Ltd.

81 108A00 016170