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2. BEFORE YOU TAKE DIDRONEL 200MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
DO NOT take Didronel 200mg Tablets if you:
• re allergic (hypersensitive) to etidronate disodium or any of the
other ingredients in the product (see Section 6 on ‘What Didronel
200mg Tablets contain’)
• have osteomalacia (a disease in which bones soften)
• are pregnant or think you might be pregnant.
Didronel® 200mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Do not give the tablets to CHILDREN.
Take special care with Didronel 200mg Tablets
Consult your doctor before taking this medicine if you have:
• kidney impairment, or kidney stones (now or in the past)
• owel problems such as enterocolitis (inflammation of the large
and small intestine)
• a broken bone which has not yet healed completely
• ain, swelling or numbness of the jaw or a ‘heavy jaw feeling’, or
loosening of a tooth (if you are undergoing dental surgery, tell
your dentist that you are being treated with Didronel).
• he diagnostic utility of bone-imaging agents may be impaired by
current or recent etidronate use.
In this leaflet:
1. What Didronel 200mg Tablets are and what they are used for
2. Before you take Didronel 200mg Tablets
3. How to take Didronel 200mg Tablets
4. Possible side effects
5. How to store Didronel 200mg Tablets
6. Further information
WHAT DIDRONEL 200MG TABLETS ARE AND WHAT THEY ARE
Didronel 200mg Tablets contain the active ingredient etidronate
disodium. This is a non-hormonal therapy used to treat Paget’s
disease which is characterised by the enlargement of bones (long
bones bow and flat bones deform). It works directly on bones to
relieve symptoms of pain and prevent them from deforming and
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
The following should NOT be taken two hours before or after taking a
Didronel 200mg tablet:
• vitamins with mineral supplements, such as iron
• calcium supplements
• laxatives containing magnesium
• antacids containing calcium or aluminium.
Your doctor also needs to know if you are taking the anticoagulant
‘warfarin’ before Didronel is prescribed.
Children should not be given Didronel 200mg Tablets
How long you should take Didronel 200mg Tablets for
If you are taking:
• 5mg or 10mg per kg of body weight - take Didronel for up to 6 months.
• ore than 10mg per kg - stop taking Didronel after 3 months.
After a further 3 months, your doctor may want to put you onto
another course of tablets if your condition has flared up again.
Pregnancy and breast-feeding
It is important not to become pregnant whilst taking Didronel 200mg Tablets,
so adequate contraceptive measures need to be taken where necessary.
It is not known if etidronate disodium (the active ingredient) passes
into breast milk. This medicine should therefore not be taken during
Ask your doctor or pharmacist for advice before taking any medicine.
If you take more Didronel 200mg Tablets than you should
Do not exceed the recommended dose. If you take too much medicine,
tell your doctor immediately or go to your nearest Accident & Emergency
Department (take the pack with you if possible).
Driving and using machines
Didronel 200mg Tablets are not expected to affect your ability to drive
or operate machinery.
If you forget to take Didronel 200mg Tablets
If you miss a dose, continue taking your medicine the next day as
usual. Do not take a double dose to make up for a forgotten Didronel
3. HOW TO TAKE DIDRONEL 200MG TABLETS
Always take Didronel 200mg Tablets exactly as your doctor has told
you. The amount will depend on your weight and condition. The usual
starting dose is 5mg per kilogram (kg) body weight a day.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
The tablets should only 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 200mg Tablets from being
absorbed properly. You should not eat or drink anything but water for
at least two hours before and two hours after taking the tablets (i.e.
take the tablet in the middle of a 4-hour fast).
Your doctor will most likely test your blood and urine every few months
to check whether your dose of Didronel 200mg Tablets is working well
for you. Do not miss these check-ups as you may need a different
dose or have to stop taking the tablets for a while.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Didronel 200mg Tablets can cause side effects,
although not everybody gets them.
You may suffer an allergic reaction, symptoms of which include skin
rash, pruritus (itching) or swelling of the skin. If this happens to you,
stop taking the tablets immediately and seek urgent medical help.
Common side effects:
• nausea (feeling sick).
Uncommon side effects:
• hypersensitivity including fluid retention in the skin (angioedema)
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.
Rare side effects:
• tingling sensation typically in the arms or legs
• blood abnormalities
• burning of the tongue
• hair loss
• erythema multiforme (a type of skin disease)
• worsening of asthma for those who suffer from it
• sensory disturbances (paresthesia)
• joint problems such as arthritis or joint pain.
5. HOW TO STORE DIDRONEL 200MG TABLETS
Keep out of the reach and sight of children.
Store the product below 25ºC.
Do not use Didronel 200mg Tablets after the expiry date which is
stated on the label after ‘Exp’. The expiry date refers to the last day of
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Very rare side effects:
• steonecrosis of the jaw (see section 2 ‘Take special care with
Didronel 200mg Tablets’).
6. FURTHER INFORMATION
What Didronel 200mg Tablets contain
The active substance is etidronate disodium 200mg.
The other ingredients are starch, magnesium stearate and microcrystalline
A few people with stomach ulcers may notice that these get worse
with Didronel treatment.
You may need to contact your doctor for a blood test if you are unable to
overcome an infection or experience a sore throat, fever and bruising.
What Didronel 200mg Tablets look like and contents of the pack
The tablets are white and rectangular in shape, supplied in blisters of
pack size 60s.
Some people with Paget’s disease get new or worse bone pains when
starting Didronel treatment. Patients with Paget’s disease are also
more likely to get broken bones. If this occurs, tell your doctor as you
will probably have to stop taking your tablets until the broken bone has
healed. You will be advised when to start treatment again.
Unusual fracture of the thigh bone particularly in patients on long-term
treatment for osteoporosis may occur rarely. Contact your doctor if you
experience pain, weakness or discomfort in your thigh, hip or groin as
this may be an early indication of a possible fracture of the thigh bone.
Marketing Authorisation Holder
Warner Chilcott UK Limited
Old Belfast Road
Norwich Pharmaceuticals Inc, North Norwich, New York, USA released
onto the European market by Warner Chilcott France, Parc d’activité
de la Grand Brèche, 5 rue Désir Prévost, 91070 Bondoufle, France.
Didronel 200mg Tablets ® is a registered Trademark
Marketing Authorisation Number: PL 10947/0018
This leaflet was last revised in February 2011.
00000000 / MU 2270
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.