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ETHAMBUTOL 400 MG FILM-COATED TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE / ETHAMBUTOL HYDROCHLORIDE / ETHAMBUTOL HYDROCHLORIDE

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Package leaflet: Information for the user
Ethambutol 100 mg & 400 mg Film-coated Tablets

have your kidneys checked, as your doctor may decide to adjust the dose of Ethambutol
Tablets
• if you develop symprtoms suggestive of hepatitis (e.g., abdominal pain, fever, loss of
appetite) or feel generally unwell, you may need your liver functions tested.

ethambutol hydrochloride
The name of this medicine is Ethambutol 100 mg & 400 mg Film-coated Tablets which will be
referred to as Ethambutol Tablets throughout this leaflet.
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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness 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. See section 4..

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ethambutol occasionally cause sight problems and numbness, dizziness, disorientation or
paraesthesia (abnormal sensation like pins and needles) after sensation of the furthest parts
of your body and disorientation. After taking your medicine you should not drive or use
machinery, until you know how ethambutol effect you.

What is in this leaflet
1. What Ethambutol Tablet is and what it is 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

3. How to take Ethambutol Tablets

1. What Ethambutol Tablet is and what it is used for
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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.

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 Ethambutol Tablets if you:
• are allergic to ethambutol, or any of the other ingredients of this medicine (listed in
section 6)
• 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:
• 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 should stop taking the tablets and inform your doctor immediately. In the
majority of cases, any changes to vision will return to normal within a few weeks/ months
after stopping treatment however, in rare cases it may take longer for eyesight to recover or
the change may become permanent.
• if you have a history of kidney problems. Before treatment with ethamutol tablets you should

Always take this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.
• The tablets should be taken once daily.
• They should be swallowed whole with a drink of water, do not chew or crush the tablets.
• The dosage of this medicine 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.
• 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 15 mg 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 25 mg per kg of body weight per day for
the first 60 days, reducing to 15 mg per kg of body weight per day for as long as the doctor
considers necessary.
21063777

Ethambutol
100 mg & 400 mg
Film-coated Tablets

Other medicines and Ethambutol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including medicines obtained without a prescription.

Children:
• Prevention: The usual dose of ethambutol for children for prevention of tuberculosis is
15 mg per kg of body weight per day.
• First time, 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
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Date: 10/08/2017

UK

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Container Pack

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21063777

Ethambutol
100 mg & 400 mg
Film-coated Tablets

25 mg per kg of body weight per day for the first 60 days, reducing to 15 mg per kg of body
weight per day for as long as the doctor considers necessary
Elderly:
The same dosages as for adults are usually used although reduced doses may be required in
older people who have kidney problems; in these patients the doctor will carry out blood tests
to determine the dose required.
If you take more Ethambutol Tablets than you should
If you have taken an overdose of this medicine (that is more than the doctor has told you to)
and experience symptoms like gastrointestinal distubances, vomiting, fever, headache,
anorexia, dizziness, hallucination and /or visual disturbances, 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 the forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

blistering following exposure to sunlight, 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
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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help more information on the safety of this medicine.

5. How to store Ethambutol Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date which is stated on the pack after ‘Exp’. The
expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

You must contact your doctor immediately if you notice any of the following:
- severe allergic reaction know as an anaphylactoid reaction, which is characterised by
difficulty in breathing, a flushed appearance, agitation or an irregular heartbeat.
- serious illness with blistering and peeling of the skin, mouth, eyes and genitals
(Stevens-Johnson Syndrome)
- yellowing of the skin or whites of the eyes caused by liver or blood problems (Jaundice).
If you notice any changes or problems with your sight, contact your doctor
immediately.
Uncommon (may affect up to 1 in 100 people)
• Ethambutol has occasionally caused sight problem. In this 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 hyperuricaemia, a condition similar to gout.
Rare (may affect up to 1 in 1000 people)
• Ethambutol can cause muscle weakness and wasting, pain, numbness, pins and needles
sensations, rashes, itching, and hives.
• thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged
bleeding after injury)
Very rare (may affect up to 1 in 10,000 people)
• Ethambutol can cause blood disorders like leucopenia and neutropenia; allergic reactions,
pins or swelling of joints, headache, dizziness, mental confusion, disorientation,
hallucinations, generally feeling unwell, shortness of breath, chest pains, blisters or peeling,

What Ethambutol Tablets contains
• The active substance is ethambutol hydrochloride.
- 100mg: Each film-coated tablet contains 100 mg of ethambutol hydrochloride
- 400mg: Each film-coated tablet contains 400 mg of ethambutol hydrochloride
• 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 Ethambutol Tablets looks like and contents of the pack
Ethambutol 100 mg Film-coated Tablets are yellow, round, film coated tablets.
Ethambutol 400 mg Film-coated Tablets are grey, round, film coated tablets.
Ethambutol Tablets are available in Al/PVC/PE/PVDC blisters and PP tablet containers.
Each pack contains 56 tablets.
Marketing Authorisation Holder:
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone,
Surrey, KT15 2LE, United Kingdom
Manufacturer:
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone,
Surrey, KT15 2LE, United Kingdom
Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium
This leaflet was last revised in 08/2017.

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

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Date: 10/08/2017

UK

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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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