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ETHAMBUTOL 400 MG TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE / ETHAMBUTOL HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET
Ethambutol 100 mg Tablets
Ethambutol 400 mg Tablets
(ethambutol hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others; it may harm
them, even if their symptoms are the same as yours.
• If you get any of the side effects, tell your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1. What Ethambutol Tablets are and what they are used for
2. What you need to know before you take Ethambutol Tablets
3. How to take Ethambutol Tablets
4. Possible side effects
5. How to store Ethambutol Tablets
6. Contents of the pack and other information

1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is ethambutol hydrochloride, which belongs to a group of
medicines called anti-tuberculosis drugs. These are used to treat and prevent tuberculosis
which is an infectious disease mainly affecting the lungs.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETHAMBUTOL TABLETS
Do not take these tablets if you:
• are allergic (hypersensitive) to ethambutol, or to any of the other ingredients (these
are listed in section 6, Further Information)
• have problems with your eyes or your eyesight (unless your doctor has decided it is
essential).
Warnings and precautions:
• Talk to your doctor or pharmacist before taking Ethambutol Tablets if you have
problems with your eyesight - your doctor will arrange for a full check of your
eyesight before you start taking this medicine. If you notice any changes to your
vision whilst taking this medicine, you MUST inform your doctor straight away.
Young children or people with communication difficulties should be closely
monitored by their parents or carers for any signs of problems with their eyesight.
• kidney problems as your doctor may decide to adjust the dose of Ethambutol
Tablets.
Other medicines and Ethambutol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Ethambutol Tablets should not be taken at the same time as antacid medicines containing
aluminium hydroxide (used to relieve heartburn and indigestion), as this can make ethambutol
less effective.
Although ethambutol is not known to be affected itself by any other drugs or to affect other
drugs, make sure your doctor knows if you are taking any other medicines.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant or breast-feeding, or if you are trying
for a baby, unless your doctor considers it essential. Speak to your doctor before taking the
tablets.
Driving and using machinery
Ethambutol can cause problems with eyesight, or tingling/numbness in hands or feet. You
should not drive or operate machinery if it has this effect on you.
3. HOW TO TAKE ETHAMBUTOL TABLETS
The tablets should be swallowed whole with a drink of water. They should be taken as a
single dose once a day.
The doctor will decide what dose of tablets you need to take. The dose varies from person to
person depending on age, weight and whether it is being used for treatment or prevention of
tuberculosis.
If you suffer from any kidney problems your doctor may do blood tests to check
whether you need to take a lower dose than usual.
Always take the tablets exactly as the doctor has told you. The dose will be on the
pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking
them for as long as you have been told unless you have any problems in which case, check
with your doctor.
Adults:
For prevention and first time treatment of tuberculosis: The usual dose is 15 mg per kg of
body weight each day.
Second time (or subsequent) treatment of tuberculosis: The usual dose is 25 mg per kg of
body weight each day for the first 60 days, reducing to 15 mg per kg of body weight each
day for as long as necessary.
Children:
For prevention of tuberculosis: The usual dose is 15 mg per kg of body weight each day.
First time, second time (or subsequent) treatment of tuberculosis: The usual dose is 25 mg
per kg of body weight each day for the first 60 days, reducing to 15 mg per kg of body
weight each day for as long as necessary.
Elderly:
The same dosages as for adults are usually used although reduced doses may be required in
the elderly who have kidney problems; in these patients the doctor will carry out blood tests
to determine the dose required.
If you take more tablets than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital

casualty department or tell your doctor or pharmacist immediately.
Remember to take the pack and any remaining tablets with you.
If you forget to take a dose of Ethambutol Tablets
If you forget to take a dose, take it as soon as you remember, however, if this is within a
few hours of when your next dose is due, skip the missed dose and just carry on with the
normal routine. Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, ethambutol can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Ethambutol Tablets and tell your doctor straightaway if you notice the
following effects:




sudden wheeziness, difficulty breathing, swelling of the face, eyes, lips or throat,
flushed appearance, irregular heartbeat. (These may be symptoms of a severe
allergic reaction)
any changes or problems with your eyesight including blurred vision, eye pain or
colour blindness (may affect more than 1 in 100 people). Usually sight will return to
normal after stopping treatment with ethambutol, but in rare cases the problem may
take longer to return to normal or become permanent.

Tell your doctor straightaway if you notice any of the following effects:
• skin rash and itching, a condition known as Stevens-Johnson syndrome which
involves a skin rash, possibly with peeling and blistering and a sore mouth; other skin
problems including hard lumps, red patches often on the backs of arms and hands and
blisters or peeling
• you have pale stools or your skin or whites of your eyes become yellow (as these may
be signs of a liver problem)
• you develop pain in the lower back or you experience difficulty or pain in urinating
(as these may be signs of a kidney problem)
• you notice any unusual bleeding, bruising or discoloured skin (as these may be signs
of a blood disorder).
The following other side effects have also been reported:
Very common side effects (may affect more than 1 in 10 people):
• high levels of uric acid in the blood which may lead to gout (pain or swelling of the
joints) in some people
Rare side effects (may effect up to 1 in 1000 people)
• numbness, pins and needles,
Very rare side effects (may effect up to 1 in 10,000 people)
• dizziness, confusion, disorientation, hallucinations, headache, fever, generally feeling
unwell
• joint pains, burning pain, weakness in hands and feet



fluid in the lungs or inflammation of the lungs which may cause breathlessness,
cough and raised temperature

Not known frequency cannot be estimated from the available data
• shaking
• stomach problems, including loss of appetite, feeling or being sick, diarrhoea,
flatulence (wind), stomach pain, metallic taste and weight loss
• hepatitis, jaundice, transient increase in liver enzymes
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card
Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE ETHAMBUTOL TABLETS
Keep out of the reach and sight of children.
Do not store above 25ºC. Keep your medicine in the pack in which it was given to you.
Do not transfer your medicine to another container.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the
last day of that month.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Ethambutol Tablets are available in two strengths containing either 100 mg or 400 mg
ethambutol hydrochloride as the active ingredient.
The other ingredients are sodium starch glycolate, maize starch, povidone, colloidal
anhydrous silica, microcrystalline cellulose, magnesium stearate and colours containing
polydextrose, hypromellose, titanium dioxide (E171), macrogol and yellow iron oxide
(E172); the 400 mg tablets also contain black iron oxide (E172).
What the medicine looks like and contents of the pack
Ethambutol 100 mg Tablets are yellow, round, film coated tablets.
Ethambutol 400 mg Tablets are grey, round, film coated tablets.
Each pack contains 56 tablets.
Marketing Authorisation Holder:
Fannin (UK) Ltd.,
DCC Vital,
Westminster Industrial Estate,
Repton Road,
Measham,
DE12 7DT,
England.

Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited,
Crowbridge Road,
Ashford,
Kent,
TN24 0GR,
U.K.
Kent Pharmaceuticals Limited,
Repton Road,
Measham,
DE12 7DT,
U.K.
Date leaflet revised: January 2017

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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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