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ETHAMBUTOL 400MG TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

ETHAMBUTOL 400 mg TABLETS

(Ethambutol Hydrochloride)
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. If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet
In this leaflet:
1. What Ethambutol Tablets are and what they are used for
2. Before you take Ethambutol Tablets
3. How to take Ethambutol Tablets
4. Possible side effects
5. How to store Ethambutol Tablets
6. Further information

1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Ethambutol Tablets. Ethambutol belongs to a group of medicines called
antituberculosis drugs and is used for the treatment and prevention of tuberculosis, an infectious disease
mainly affecting the lungs.
2. BEFORE YOU TAKE ETHAMBUTOL TABLETS
Do not take Ethambutol Tablets:
· if you have sight problems caused by inflammation of nerves in your eye (optic neuritis).
· if you are allergic (hypersensitive) to ethambutol hydrochloride or to any of the other ingredients (see list
under ‘What Ethambutol Tablets contain’ in Section 6).
Problems with your sight
You should have your eyesight checked before taking these tablets. If you notice any changes to your vision
whilst taking these tablets, you should stop taking them and notify your doctor immediately.
Very young children or patients with communication difficulties should be closely monitored for any signs of
sight problems by their parents or carers.
Taking other medicines
You should not take ethambutol tablets at the same time as antacid medicine containing aluminium
hydroxide (used to treat heartburn and indigestion) as this can make ethambutol less effective.
Please tell your doctor or pharmacist if you are taking or have recently take any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant, breast-feeding or trying for a baby without consulting
your doctor first.
Driving and using machines
Ethambutol occasionally causes sight problems and tingling or numbness in hand or feet. After taking this
medicine you should not drive or use machinery, until you know how it affects you.
3. HOW TO TAKE ETHAMBUTOL TABLETS
Always take Ethambutol Tablets exactly as your doctor has told you to. You should check with your doctor or
pharmacist if you are not sure.
The dosage of ethambutol varies from person to person depending on your age, how much you weigh and
whether it is being used for the treatment or for the prevention of tuberculosis.
Elderly patients who have kidney problems may need blood tests so that their doctor can reduce the dose in
some cases.
Ethambutol Tablets should be taken once per day. They should be swallowed whole with a drink of water; do
not chew or crush the tablets.
If you are not sure how many tablets to take, or when to take them, ask your pharmacist.
Keep taking your tablets for as long as your doctor directed, even if you feel better.
Adults:
Prevention and first time treatment: The usual dose of ethambutol for adults for prevention of
tuberculosis or for first time treatment of tuberculosis is 15mg per kg of body weight per day.
Second time (or subsequent) treatment: The usual dose of ethambutol for adults for second time (or
subsequent) treatment of tuberculosis is 25mg per kg of body weight per day for the first 60 days, reducing
to 15mg per kg of body weight per day for as long as the doctor considers necessary.
Children:
Prevention: The usual dose of ethambutol for children for prevention of tuberculosis is 15mg per kg of body
weight per day.
First, second time (or subsequent) treatment: The usual dose of ethambutol for children for treatment
of tuberculosis is 25mg per kg of body weight per day for the first 60 days, reducing to 15mg per kg of body
weight per day for as long as the doctor considers necessary.
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If you take more Ethambutol Tablets than you should
If you have taken an overdose of Ethambutol Tablets (that is more than the doctor has told you to) get medical
help immediately, either by calling your doctor or going to the nearest hospital casualty department. Remember to take the labelled medicine bottle with you, whether there are any Ethambutol Tablets left or not.
If you forget to take Ethambutol Tablets
If you forget to take a tablet you should take it as soon as you remember. However, if this is within 2 hours of
your next dose you should skip the missed tablet and carry on taking the rest of your tablets as usual. Do not
take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, ethambutol can cause side-effects although not everybody gets them.
The following side-effects may be serious.
·
A severe allergic reaction, signs of which are, difficulty in breathing, wheezing, a flushed appearance,
agitation or an irregular heartbeat. If this occurs, stop taking this medicine and contact your
doctor immediately.
·
Sight problems including colour blindness. In the majority of cases these will return to normal after
stopping treatment. However in rare circumstances, the problem may take longer to heal or become
permanent. If you notice any changes or problems with your sight, contact your doctor
immediately.
·
Kidney problems. If you have pain in your lower back, pain, burning or difficulty when you pass urine or
blood in your urine you should contact your doctor as soon as possible.
Other possible side effects are:
·
Allergic reactions including skin rash and itching
·
Breathing problems
·
Reduction in certain types of blood cells which may cause an increased risk of infection
·
Dizziness, confusion, disorientation, headache hallucination
·
Gut and stomach problems such as loss of appetite, feeling or being sick, diarrhoea, metallic taste, weight
loss, wind or stomach pain
·
Severe skin conditions with blistering of the skin, mouth, eyelids and genitals or peeling skin
·
Numbness; pins and needles, weakness, burning pain, shaking
·
Gout, signs of which are, pain or swelling in your joints (especially big toe) with tender hot skin over
effected joints
·
Skin problems including hard lumps or red patches often on the backs of arms and hands
·
Reduced blood platelets which can cause a purple rash, prolonged bleeding after injury or bruising easily
·
Liver problems which may result in pale stools, dark urine, or make your skin or eyes look slightly yellow
·
Abnormal blood test results for liver function or urea concentration
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet.
You can also report side effects directly via the 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 sight and reach of children.
Do not use Ethambutol Tablets after the expiry date which is stated on the packaging after EXP.
Store below 30ºC in the original packaging to protect from moisture.
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 protect the environment.
6. FURTHER INFORMATION
What Ethambutol Tablets Contain:
The active ingredient is ethambutol (as ethambutol hydrocloride). Each tablet contains 400mg of ethambutol.
Other ingredients are:
Tablet core: Microcrystaline cellulose, sodium starch glycolate, maize starch, povidone, colloidal anhydrous silica
and magnesium stearate.
Tablet coating: Polydextrose, hydroxypropylmethylcellulose, polyethylene glycol 4000, purified water, titanium
dioxide (E171), iron oxide yellow (E172) and iron oxide black (E172)
What Ethambutol Tablets look like and contents of the pack:
Ethambutol 400mg Tablets are round grey coated tablets, plain on both sides.The tablets are available in
bottles of 56 tablets or blister packs of 60 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer:
Peckforton Pharmaceuticals Ltd., Crewe Hall, Crewe, Cheshire, CW1 6UL, England.
This leaflet was last revised in 06/2015.
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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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