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ETHAMBUTOL TABLETS 100MG

Active substance(s): ETHAMBUTOL HYDROCHLORIDE

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Ethambutol
Each tablet contains 100mg
Ethambutol Hydrochloride BP

EXP:

D.O.M.:

B/N:

Tablets 100mg
56 tablets
PIP 107 5951

Ethambutol Tablets 100mg also
contain E104. To be taken by mouth.
Use as directed by your doctor.
Keep out of the sight and reach
of children.
Store at room temperature
(15-30ºC) in the original pack.
MA holder:
Genus Pharmaceuticals,
Linthwaite, Huddersfield,
HD7 5QH, UK.
*Trademark

POM

PL 17225/0004 PM/01/863

Package leaflet: information for the user

Ethambutol 100mg 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 any of the side-effects get serious, or if you notice any side-effects not listed in
this leaflet, please tell your doctor or pharmacist.

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.
Very rare is a severe allergic reaction known as an anaphylactoid reaction,

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
called antituberculosis drugs and is used for the treatment and prevention of
tuberculosis, an infectious disease mainly affecting the lungs.

which is characterised by difficulty in breathing, a flushed appearance,
agitation or an irregular heartbeat. If this occurs, stop taking this medicine
and contact your doctor immediately.
If you notice any changes or problems with your sight, contact your
doctor immediately.
• Ethambutol has occasionally caused sight problems. 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. • Ethambutol can cause gout and hyperuricaemia, a condition
similar to gout. • Ethambutol can cause muscle weakness and wasting,
pain, numbness, pins and needles sensations, rashes, itching, and hives.
• Ethambutol can cause thrombocytopenia (which may result in bruising,

2. BEFORE YOU TAKE ETHAMBUTOL TABLETS
Do not take Ethambutol Tablets:
• if you have sight problems
• if you are allergic (hypersensitive) to ethambutol hydrochloride or to any of the
ingredients (see list under ‘What Ethambutol Tablets contain’)
Problems with your sight
You should have your eyesight checked before taking these tablets, and if you
notice any changes to your vision whilst taking these tablets, you should notify
your doctor immediately.
Take special care with Ethambutol if you have a history of kidney problems.
Before treatment with Ethambutol you should have your kidneys checked.

nosebleeds, pinpoint red spots, prolonged bleeding after injury), other blood
disorders leucopenia and neutropenia; allergic reactions, pain or swelling of
joints, headache, dizziness, mental confusion, disorientation, hallucinations,
generally feeling unwell, shortness of breath, chest pains, blisters or peeling,
blistering following exposure to sunlight; a condition known as Stevens
Johnson syndrome (ulceration, angina, mouth sores, joint aches, fever); kidney
problems (lower back pain, pain or burning when passing urine, difficulty
passing urine). • Other unwanted effects include loss of appetite, feeling sick,
being sick, stomach pain and upsets; liver problems which may result in pale
stools, blood in your urine, or make your skin or eyes look yellow.
If any of the side-effects get serious, or if you notice any side-effects not listed
in this leaflet, please tell your doctor or pharmacist.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 numbness or paraesthesia
(abnormal sensation) of the furthest parts of your body. After taking your
medicine you should not drive or use machinery, until you know how
ethambutol affects you.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: 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 take Ethambutol Tablets after the expiry date which is printed on the
pack. The expiry date refers to the last day of that month.
Ethambutol Tablets should be kept in the original package, in a safe, dry place
at room temperature (between 15 to 30°C). Return any unused tablets to your

Important information about the ingredients of Ethambutol Tablets.
This medicine contains sucrose and sorbitol. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
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. • 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 daily. • They should be

pharmacist. 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 substance in Ethambutol Tablets is ethambutol hydrochloride.
Other ingredients are: gelatin 125 bloom; sucrose; sorbitol solution 70%
(non-crystallising); quinoline yellow (E104); magnesium stearate; stearic acid; shellac
solution 40%; colorcon opaglos regular (containing shellac; polyvinylpyrrolidone;
acetylated monoglyceride; industrial methylated spirits); and talc.

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.
Adults:
• Prevention and first time treatment: The usual dose of ethambutol
for adults for prevention of tuberculosis or for first time treatment for
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.

What Ethambutol Tablets look like and the contents of the pack
Ethambutol Tablets 100mg are slightly mottled yellow coated tablets.
Each bottle contains 56 tablets.

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 first time treatment, second time treatment 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.
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

Ethambutol

POM
PL 17225/0004 Ethambutol Tablets 100mg Tablets 100mg
Marketing Authorisation Holder: Genus Pharmaceuticals, Linthwaite,
Each tablet contains 100mg
Huddersfield, HD7 5QH, UK.
Ethambutol Hydrochloride BP
Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove,
56 tablets
East Sussex BN3 3LW, UK.
This leaflet was last revised in September 2014

Ethambutol Tablets 100mg also
contain E104. To be taken by mouth.
Use as directed by your doctor.
Keep out of the sight and
reach of children.
Store at room temperature
(15-30ºC) in the original pack.
MA holder:
Genus Pharmaceuticals,
Linthwaite, Huddersfield,
HD7 5QH, UK.
*Trademark

25174501

POM

PL 17225/0004 PM/01/863

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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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