PATIENT INFORMATION LEAFLET

DIDRONEL® TABLETS 200MG

(Etidronate Disodium)

What is this leaflet about?

This leaflet is a summary of the information about your Didronel tablets. Read it carefully and keep it in case you need to refer to it again. If you have any questions about your medicine or your illness, ask your pharmacist (chemist) or doctor.

What is in Didronel?

Didronel tablets contain 200mg of the active ingredient, etidronate disodium and are packed in cartons of 60 tablets. The tablets also contain starch (gluten-free), magnesium stearate and microcrystalline cellulose.

What is Didronel for?

Didronel is a non-hormonal therapy used to treat Paget's disease ("osteitis deformans"). It works directly on your bones to relieve the symptoms of pain and prevent deformities and fractures of your bones. If you are not sure why you have been given Didronel, ask your doctor.

Is Didronel right for you?

Tell your doctor BEFORE you take any of the tablets if you:

• have ever had a reaction to Didronel or any of its ingredients listed above
• have, or have had in the past, kidney stones or other kidney problems
• have bowel problems such as "enterocolitis"
• suffer from a bone disease called overt osteomalacia
• have a broken bone (fracture) which is not healed completely yet
• are pregnant, or think you might be pregnant, or are breast feeding. It is important not to become pregnant while you are taking Didronel
• are taking the anticoagulant, warfarin, or any other medicines listed in the next section
• had or have pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth.

Children should not take Didronel.

If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Didronel.

Can you use Didronel while you are taking other medicines?

Didronel alone does not stop you from taking other medicines; however, the following should not be taken within two hours either side of taking a Didronel tablet

• Vitamins with mineral supplements, such as iron.
• Calcium supplements.
• Laxatives containing magnesium.
• Antacids.

Medical Checks

Your doctor will probably want to test your blood and urine every few months. This is to check whether your dose of Didronel is working well for you. You may need a different dose, or you may need to stop taking the tablets for a while. Do not miss these check-ups.

How to take Didronel

Your doctor will tell you how much Didronel to take and when to take it. The amount depends on your weight and your illness. The usual dose to begin with is approximately 5mg a day for each kilogram of your weight. Follow your doctor’s instructions exactly.

The tablets should be swallowed with water. They should not be taken with milk or other drinks. Dairy products and other foods containing calcium can stop your Didronel tablets from being absorbed properly and if the tablets are not absorbed, they cannot work. For this reason, you should not eat or drink anything but water at least two hours before and two hours after taking your Didronel tablets (ie in the middle of a four hour fast).

If you forget to take a tablet, don’t worry, just continue to take your tablets as usual the next day.

How long can you take Didronel for?

If you are taking 5mg or 10mg of Didronel for each kilogram of your weight, you can take the tablets for up to six months. If you are taking more than 10mg for each kilogram of your weight, you must stop after three months.

After three months have lapsed your doctor may want to put you onto another course of tablets, if your condition has flared up again.

What should you do if you take your medicine incorrectly?

If you take too much medicine contact your doctor or nearest casualty department. If you miss a dose do not double up, just continue as normal.

Does Didronel have side effects?

Sometimes stomach upset (nausea), diarrhoea or consti-pation, can occur, when taking Didronel. A few people with stomach ulcers may notice that these get worse. Also a variety of skin rashes have occurred in some patients. A few people who already have asthma may notice that their asthma gets worse. Other side effects that occur very rarely are tingling sensation in arms or legs, burning of the tongue, confusion and hair loss. If you are unable to overcome an infection or experience a sore throat, fever and bruising, contact your doctor as you may need a blood test.

Some people with Paget's disease get new or worse bone pains when starting on treatment. Paget's patients are also more likely to get broken bones. If this occurs, discuss this with your doctor. The doctor will probably ask you to stop taking your tablets until the broken bone has healed. The doctor will tell you when to start treatment again. Tell your doctor if you experience any problems.

Storing Didronel

Do not take the tablets after the "use by" date which is printed on the bottle. Store your medicine in a safe place out of the sight and reach of children.