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DISODIUM ETIDRONATE 400MG TABLETS

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PATIENT INFORMATION LEAFLET
Disodium Etidronate 400 mg Tablets
Read this leaflet carefully before you start taking this medicine even if you have only collected a repeat prescription.
This leaflet contains a summary of information about your medicine.
You may wish to keep this leaflet, as you may want to read it again.
If you have further questions, please ask your doctor or your pharmacist.
In this leaflet:
1. What Disodium Etidronate Tablets are and what they are used for
2. Before you take Disodium Etidronate Tablets
3. How to take Disodium Etidronate Tablets
4. Possible side effects
5. How to store Disodium Etidronate Tablets
6. Further Information

1.

What Disodium Etidronate Tablets are and what they are used for

Disodium Etidronate Tablets are used as a non-hormonal therapy in the treatment of osteoporosis and to prevent
bone loss in women who are at risk of getting osteoporosis. Disodium Etidronate tablets can also be used to prevent
and treat osteoporosis which has been caused by corticosteroid treatment and as a non-hormonal therapy for Paget’s
disease (‘osteitis deformans’).
2.

Before you take Disodium Etidronate Tablets

Do not take your medicine if:





You have had an allergic reaction to disodium etidronate or any of the other ingredients
You are suffering from a bone disease called overt osteomalacia
You have a severe kidney disease
You already have a high concentration of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
You are pregnant, likely to become pregnant or are breast-feeding.

Tell your doctor before you start taking your medicine if:
You have, or have had in the past, kidney stones or other kidney problems

You are suffering from a significant chronic diarrhoeal disease such as ‘enterocolitis’

You have a broken bone (fracture) which is not yet completely healed

You are taking the anticoagulant, warfarin.

Pregnancy and Breast-feeding
You should not take Disodium Etidronate Tablets if you are pregnant, likely to become pregnant or are breast-feeding.
It is important that you do not become pregnant while you are taking Disodium Etidronate Tablets.
Taking/using other medicines
Disodium Etidronate Tablets alone do not stop you from taking other medicines. However the following should not be
taken within two hours of taking a Disodium Etidronate Tablet:





Vitamins with mineral supplements such as iron
Calcium supplements
Laxatives containing magnesium
Antacids containing calcium or aluminium

Taking Disodium Etidronate Tablets with food and drink
Dairy products and other foods containing calcium can stop your Disodium Etidronate Tablets from being absorbed
properly and if they are not absorbed, they cannot work. For this reason, you should not eat or drink anything but
plain water at least two hours before and two hours after taking your Disodium Etidronate Tablets (i.e. in the middle of
a four hour fast).

3.

How to take Disodium Etidronate Tablets

You should always take this medicine exactly as prescribed by your doctor. Do not take more than the doctor told
you to. Read and follow the instructions on the pharmacist’s label. If you are not sure about anything please ask
your doctor or pharmacist.
There are usually two different dosing regimens depending on your condition. If you are unsure about anything
please ask your doctor or pharmacist.

Osteoporosis
If you are being treated for osteoporosis your doctor will also have prescribed a calcium supplement for you. If so you
should take one Disodium Etidronate Tablet each day for the first 14 days on an empty stomach and with a drink of
plain water. You will then be instructed by your doctor to take the calcium supplement for a stated period of time,
normally once a day for 76 days. However you should always follow your doctor’s instructions.
Paget’s Disease
Your doctor will tell you how many Disodium Etidronate Tablets to take and when to take them. The amount depends
on your weight and illness. The usual dose to begin with is approximately 5mg a day for each kilogram of your weight.

How long can you take your Disodium Etidronate Tablets for? If you are taking 5mg or 10mg of etidronate
disodium 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 elapsed your
doctor may want to put you onto another course of tablets if your condition has flared up again.
For both osteoporosis and Paget’s disease the tablets should be swallowed with plain water. They should not be
taken with milk or other drinks.
Use in children:
Disodium Etidronate is not recommended for use in children.
If you forget to take your Disodium Etidronate Tablets, do not worry. Just continue to take your tablets as usual the
next day. Do not take the missed dose or a double dose to make up for the one you missed.
If you have taken more Disodium Etidronate Tablets than you should contact your doctor immediately or go to
the nearest casualty department. Remember to take the pack and any remaining tablets with you.
4.
Possible side effects
Like all medicines, Disodium Etidronate Tablets can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than I user in 10
Common:
affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less then 1 user in 10,000
Not known:
frequency cannot be estimated from the available data
Very rare:

Confusion
Rare:

Tingling sensation in the arms and legs (pins and needles)

Numbness in fingers and toes

Worsening of asthma

Burning sensation of the tongue

Indigestion

Worsening of stomach ulcers

Flatulence (wind)

Hair Loss

Uncommon:

Headache

Joint disorders

Allergic reactions including skin rashes and/or itching

Common:

Diarrhoea

Stomach upset (nausea) including vomiting
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.

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 beginning their treatment. When therapy
continues the pain resolves in some patients but persists in others. Paget’s patients are also more likely to get

broken bones. If this occurs, discuss this with your doctor. Your doctor will probably ask you to stop taking your
tablets until the broken bone has healed. Your doctor will tell you when to start treatment again.
Talk to your doctor if you notice any other side effects not mentioned in this leaflet or a change in your general health
whilst taking Disodium Etidronate Tablets.

5.

How to store Disodium Etidronate Tablets

Keep medicines out of the reach and sight of children.
Do not store above 25°C.
Blister Packs: Store in the original package.
HDPE Containers: Store in the original container.
Do not take after the expiry date on the carton or bottle.
This medicine has been prescribed for you personally and you should NOT pass it on to others. It may harm them,
even if their symptoms are the same as yours.
6. Further Information
What Disodium Etidronate Tablets contain:
The active substance in your medicine is disodium etidronate. The other ingredients are maize starch, microcrystalline
cellulose, pregelatinized maize starch and magnesium stearate.
What Disodium Etidronate Tablets look like and contents of the pack:
Your medicine is in the form of off-white, capsule shaped tablets, embossed “ED | 4” on one side and “
other.
The tablets are available in blister packs and HDPE bottles containing 14 tablets.
Not all pack sizes are marketed.
Marketing authorisation holder and manufacturer:
Arrow Generics Limited,
Unit 2, Eastman Way, Stevenage, Hertfordshire,
SG1 4SZ, United Kingdom
This leaflet was last approved in August 2011

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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.

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