ETHAMBUTOL 400MG TABLETS
Active substance(s): ETHAMBUTOL HYDROCHLORIDE
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.
ETHAMBUTOL 400 mg TABLETS
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 leaet
In this leaet:
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
4. POSSIBLE SIDE-EFFECTS
Like all medicines, ethambutol can cause side-effects although not everybody gets them.
If you get any of the following symptoms, tell your doctor immediately:
-Severe allergic reaction (e.g. difculty in breathing, ushed appearance, agitation or an irregular heartbeat.) If this occurs,
stop taking this medicine and contact your doctor immediately.
-Eye problems (e.g. colour blindness, loss of vision or visual acuity). If you notice any changes or problems with your
sight, contact your doctor immediately.
Other possible side effects include:
Uncommon side effects (may affect up to 1 in 100 people)
-High levels of uric acid in the blood (hyperuricaemia)
-Eye problems (e.g. colour blindness, loss of vision or visual acuity).
Rare side effects (may affect up to 1 in 1,000 people)
-Thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury)
-Minor allergic reactions such as rashes, itching and hives
-Muscle weakness and wasting, pain, numbness, pins and needles sensations
Very rare side effects (may affect up to 1 in 10,000 people)
-Severe allergic reaction (e.g. difculty in breathing, ushed appearance, agitation or an irregular heartbeat.)
-Blood disorders such as leucopenia and neutropenia
-Gout (a symptom of these conditions is joint inammation), joint pains
-Headache, dizziness, disorientation
-Mental confusion, hallucinations
-Shortness of breath, chest pains, generally feeling unwell, fever
-Blisters or peeling skin (inc. following exposure to sunlight), Stevens-Johnson syndrome (a widespread rash with blisters
and peeling skin, particularly around the mouth, nose, eyes and/or genitals)
-Kidney problems (lower back pain, pain or burning when passing urine, difculty passing urine)
Not known side effects (frequency cannot be estimated from the available data)
-Loss of appetite, feeling sick, being sick, stomach pain/upsets, diarrhoea
-Liver problems (which may result in pale stools, blood in your urine or yellowing of the skin and/or eyes).
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
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.
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 inammation 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 difculties 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 rst.
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
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.
Prevention and rst time treatment: The usual dose of ethambutol for adults for prevention of
tuberculosis or for rst 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 rst 60 days, reducing
to 15mg per kg of body weight per day for as long as the doctor considers necessary.
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, puried 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.
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 rst 60 days, reducing to 15mg per kg of body
weight per day for as long as the doctor considers necessary.
Marketing Authorisation Holder:
Peckforton Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berks, SL6 6PT, UK
Peckforton Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane,
Maidenhead, Berks, SL6 6PT, UK.
This leaﬂet was last revised in September 2017.
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.