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MYAMBUTOL TABLETS 400MG

Active substance: ETHAMBUTOL HYDROCHLORIDE

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Ethambutol Tablets 400mg also
contain E171 and E172.
To be taken by mouth.
Use as directed by your doctor.

Ethambutol

Each tablet contains 400mg
Ethambutol Hydrochloride BP

EXP:

D.O.M.:

B/N:

Tablets 400mg

PIP 107 5969

56 tablets

Keep out of the sight
and reach of children.
Store below 25ºC in the original pack.
MA holder:
Genus Pharmaceuticals,
Linthwaite,
Huddersfield,
HD7 5QH,
UK.
*Trademark

POM

PL 17225/0005 PM/01/864

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ethambutol 400mg 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.
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

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 the 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, 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.

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.
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.

•  thambutol can cause gout and hyperuricaemia, a condition similar to gout.
E
•  thambutol can cause muscle weakness and wasting, pain, numbness, pins and
E
needles sensations, rashes, itching, and hives.
•  thambutol can cause thrombocytopenia (which may result in bruising,
E
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).
•  ther unwanted effects include loss of appetite, feeling sick, being sick, stomach
O
pain and upsets; liver problems which may result in pale stools, blood in your urine,
or make your skin or eyes look yellow.

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.
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

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
controlled room temperature (below 25°C). Return any unused tablets to your 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.

should check with your doctor or pharmacist if you are not sure.
•  he dosage of ethambutol varies from person to person depending on your age,
T
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 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

6. FURTHER INFORMATION
What Ethambutol Tablets contain
The active substance in Ethambutol Tablets is ethambutol hydrochloride. Other ingredients
are: sucrose; gelatin 125 bloom; sorbitol solution 70%; magnesium stearate; stearic
acid; Opadry-GM-27600 Grey [containing polydextrose, hydroxypropylmethylcellulose,
polyethylene glycol 4000, titanium dioxide (E171); iron oxide yellow (E172); iron oxide
black (E172)]; deionised water.
What Ethambutol Tablets look like and the contents of the pack
Ethambutol Tablets 400mg are grey coated tablets. Each bottle contains 56 tablets.
POM
PL 17225/0005
Ethambutol Tablets 400mg

Marketing Authorisation Holder:
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer:
Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex BN3 3LW, UK.
This leaflet was last revised in December 2014.

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.
•  irst, second time (or subsequent) treatment: The usual dose of ethambutol for
F
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 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

Ethambutol Tablets 400mg also contain E171 and E172.
To be taken by mouth.
Use as directed by your doctor.

Ethambutol
Tablets 400mg

Each tablet contains 400mg
Ethambutol Hydrochloride BP

56 tablets

Keep out of the sight
and reach of children.
Store below 25ºC in the original pack.

MA holder:
Genus Pharmaceuticals,
Linthwaite,
Huddersfield,
HD7 5QH,
UK.
*Trademark

POM

PL 17225/0005
PM/01/864
25250401

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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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