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ETHAMBUTOL 100 MG FILM-COATED TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE

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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.

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..
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

1. What Ethambutol Tablet is and what it is used for
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 (hypersensitive) 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 MUST inform your doctor straight away.
• if you have kidney problems as your doctor may decide to adjust the dose of
Ethambutol Tablets

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 before taking this medicine.
Driving and using machines
Ethambutol occasionally cause 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 effect you.

3. How to take Ethambutol Tablets
Always take this medicine exactly as your doctor has told you. Check with your
doctor if you are not sure.
• The tablets should be 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.
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 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
Older people:
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.

Page 2

Page 1

Font : Arial (Regular)
Arial (Bold)
Heading : 12pt
Subheading : 10pt
Body text:9.5pt
Leading between two lines: 1pt

21045715

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

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.

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

Do not take a double dose to make up for the forgotten dose.

Keep this medicine out of the sight and reach of children.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Do not store above 25ºC.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
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.
Rare (may affect up to 1 in 1,000 people)
• 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
Very rare (may affect up to 1 in 10,000 people)
• Ethambutol can cause thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury), other blood disorders
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, 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;
Page 3

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
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, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,
United Kingdom.
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 08/2015

21045715

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) 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.

Page 4

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.

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..

Ethambutol
100 mg & 400 mg
Film-coated Tablets
2D
Code
Area
XXXXX

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

1. What Ethambutol Tablet is and what it is used for
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 (hypersensitive) 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 MUST inform your doctor straight away.
• if you have kidney problems as your doctor may decide to adjust the dose of
Ethambutol Tablets

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 before taking this medicine.
Driving and using machines
Ethambutol occasionally cause 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 effect you.

3. How to take Ethambutol Tablets
Always take this medicine exactly as your doctor has told you. Check with your
doctor if you are not sure.
• The tablets should be 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.
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 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
Older people:
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.

Page 2

Page 1

Font : Arial (Regular)
Arial (Bold)
Heading : 12pt
Subheading : 10pt
Body text: 9.5pt
Leading between two lines: 1pt

XXXXX

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

XXXXX

2D
Code
Area

Ethambutol
100 mg & 400 mg
Film-coated Tablets

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) 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.

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.

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.

Keep this medicine out of the sight and reach of children.

Do not take a double dose to make up for the forgotten dose.

Do not store above 25ºC.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

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.

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
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 gout and 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.
Very rare (may affect up to 1 in 10,000 people)
• Ethambutol can cause thrombocytopenia (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury), other blood disorders
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, 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
Page 3
pain and upsets

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
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, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,
United Kingdom.
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 08/2015
XXXXX

4. Possible side effects

5. How to store Ethambutol Tablets

Page 4

UK
Container Pack
PACKAGING DEVELOPMENT
Product Name : Ethambutol 100 & 400mg

Item Code : XXXXX Item : PIL
Date : 13-08-15
Artist : Atul
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Coordinator : Shweta
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BLUE WOOL TEST VALUE 5-8
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INK: Oil based Ink from DIC OR MICRO
Spectro-Densitometer Delta-E reading
( E) for colour: NOT MORE THAN dE2.5
Supersedes / Reference :
Tuck flap:

Glossmeter reading
(for white surface): NOT LESS THAN 80 %
Screen : # 150

Side / Collar flap overlap:

Unwinding Direction :

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The proof must be verified against the approved hardcopy, should be certified and signed by an
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Colour scheme must be as approved by packaging development co-ordinator.

Any deviation must be brought to the notice of packaging development co-ordinator immediately.

For any clarification, please contact packaging development co-ordinator immediately.

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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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