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ETHAMBUTOL 100MG FILM-COATED TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE

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Package leaflet: Information for the user

Ethambutol 100mg and 400mg Film-coated Tablets

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Ethambutol Hydrochloride

Read all of this leaflet carefully before you start taking this
Driving and using machines
medicine because it contains important information for
Ethambutol Tablets may cause visual disturbances that can
you.
impair your ability to drive and to use machines.
!
Keep this leaflet. You may need to read it again.
!
If you have any further questions, ask your doctor or
3. How to take Ethambutol Tablets
pharmacist.
!
This medicine has been prescribed for you only. Do not
Always take Ethambutol Tablets exactly as your doctor has told
pass it on to others. It may harm them, even if their signs of
you. You should check with your doctor or pharmacist if you are
illness are the same as yours.
not sure. The dose of Ethambutol Tablets will be decided by
!
If you get any side effects serious, talk to your doctor or
your doctor based on your age, body weight and whether it is
pharmacist. This includes any possible side effects not
being used for the treatment or prevention of tuberculosis.
listed in this leaflet.
Elderly patients who have kidney problems may need blood
tests so their doctor can prescribe them an appropriate dose.
What is in this leaflet
1. What Ethambutol Tablets are and what they are used for
Adults:
2. What you need to know before you take Ethambutol Tablets
Prevention and treatment for the first time:
3. How to take Ethambutol Tablets
The usual dose of ethambutol for adults for the prevention of
4. Possible side effects
tuberculosis or first time treatment of tuberculosis is 15mg per
5. How to store Ethambutol Tablets
kg of body weight per day.
6. Contents of the pack and other information
Re-treatment:
1. What Ethambutol Tablets are and what they are used
The usual dose of ethambutol for adults in the re-treatment of
for
tuberculosis is 25mg per kg of body weight per day for the first
60 days and then reducing to 15mg per kg of body weight per
Ethambutol is an antibiotic (antibacterial medicine) for treating
day for as long as the doctor considers it necessary.
infections. It belongs to a group of antibiotics called
antituberculosis drugs and is used in combination with other
Children:
antituberculosis agents to treat and prevent tuberculosis (TB),
Prevention:
an infectious disease mainly affecting the lungs.
The usual dose of ethambutol for children for the prevention of
tuberculosis is 15mg per kg of body weight per day.
2. What you need to know before you take Ethambutol
Tablets
Treatment:
The usual dose of ethambutol for children for the treatment of
Do not take Ethambutol Tablets
tuberculosis is 25mg per kg of body weight per day for the first
!
if you are allergic to ethambutol hydrochloride or any of the
60 days and then reducing to 15mg per kg of body weight per
other ingredients of this medicine (listed in section 6).
day for as long as the doctor considers it necessary.
!
if you have poor vision or swelling of the optic nerve which
results in blurring of vision (optic neuritis).
Ethambutol Tablets will always be taken in combination with
other antituberculosis medication; please make sure to follow
Warnings and precautions
the instructions within the supplied package leaflet(s).
Talk to your doctor or pharmacist before taking Ethambutol
Tablets
If you take more Ethambutol Tablets than you should
!
if you have been treated for kidney problems.
If you have taken too many tablets or if someone accidentally
swallows some, immediately contact your doctor, health care
Before treatment with Ethambutol Tablets you doctor may send
provider or the nearest hospital emergency department for
you for an eye test and if you notice any changes to your vision
further advice.
during your treatment you should immediately let your doctor
know.
If you forget to take Ethambutol Tablets
If you miss a dose, just carry on with the next one as normal. Do
Other medicines and Ethambutol Tablets
not take a double dose to make up for a forgotten dose.
It is not known if Ethambutol Tablets interact with other
medicines. However, it is best to tell your doctor or pharmacist if
If you stop taking Ethambutol Tablets
you are taking or have recently taken any other medicines,
Keep taking the medicine for as long as your doctor has told
including medicines obtained without a prescription.
you, even if you are feeling better. If you stop the medicine too
soon, your infection may not be completely cured. You should
Ethambutol Tablets with food and drink
not stop treatment unless your doctor or health care provider
Ethambutol Tablets may be taken with or without food.
tells you to.
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.

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

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4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very rarely you may experience a serious allergic reaction
known as an anaphylactoid reaction which causes difficulty in
breathing or irregular heart beats.

5. How to store Ethambutol Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton and blister. The expiry date refers to the last day of
that month.
Do not store above 25°C.

If you experience any of the above then stop taking the tablets
straight away and tell your doctor immediately.
The following side effects have been reported in patients
treated with ethambutol.
Uncommon: may affect up to 1 in 100 people

Do not throw away any medicines via waste water 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

!
The most commonly reported serious side effects are visual

What Ethambutol Tablets contain
changes due to inflammation of the optic nerve (optic
!
The active substance is ethambutol hydrochloride. Each
neuritis). The frequency depends on the dose and duration
tablet contains either 100mg or 400mg of ethambutol
of therapy. Typical initial signs include impairment of colour
hydrochloride.
vision (red-green blindness) and constriction of visual field
!
The other ingredients are
(central or peripheral scotoma). These changes are often
reversible after discontinuation of treatment with
Core Tablet:
ethambutol. If you notice any visual disturbance, please
Magnesium stearate, maize starch, microcrystalline cellulose,
inform your doctor or health care provider immediately;
!
povidone, silica colloidal anhydrous, sodium starch glycolate.
High levels of uric acid in the blood.
Rare: may affect up to 1 in 1,000 people

Film Coating:

!
Hypromellose 15cP, polydextrose, polyethylene glycol 4000,
Tingling or numbness in the hands or feet, muscle
weakness and wasting;

titanium dioxide.

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!
Rash, itching.

The tablets also contain the following colourants:
Very rare: may affect up to 1 in 10,000 people
100mg - Iron oxide yellow (E172).
!
Changes in white blood cell count, reduction in blood
400mg- Iron oxide black (E172), iron oxide yellow (E172).
platelets, which increases risk of bleeding or bruising;
!
What Ethambutol Tablets look like and contents of the
Dizziness, headaches;
!
pack
Hypersensitivity, red patches often on the back of arms and
hands, and blisters or peeling. Increased sensitivity to
Ethambutol 100mg Tablets are yellow, circular biconvex filmsunlight;
coated tablets, plain on both sides. Ethambutol 400mg Tablets
!
Gout;
are grey circular biconvex film-coated tablets, plain on both
!
Mental confusion, disorientation, hallucination;
sides. Both tablets are supplied in blister packs of 10, 14, 20,
!
Inflammation of the lungs;
28, 30, 56, 60, 84, 90 and 112 tablets.
!
General feeling of unwell, joint pains, fever;
!
Not all pack sizes may be marketed.
Inflammation of the kidney which can cause swollen ankles
or high blood pressure.
Marketing Authorisation Holder and Manufacturer
Not known: frequency cannot be estimated from the available
Marketing Authorisation Holder
data
!
Morningside Healthcare Ltd
Abnormal liver function, hepatitis and yellowing of the skin
or eyes (jaundice);
115 Narborough Road
!
Loss of appetite, nausea, vomiting, diarrhoea.
Leicester
LE3 0PA UK.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
Manufacturer
This includes any possible side effects not listed in this leaflet.
Morningside Pharmaceuticals Ltd
You can also report side effects directly via:
5 Pavilion Way
Loughborough
LE11 5GW UK.
UK
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or
This leaflet was last revised in October 2015.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information
on the safety of this medicine.

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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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