Ethambutol 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethambutol hydrochloride

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

J04AK02

INN (International Name):

Ethambutol hydrochloride

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900

Patient Information leaflet

_Colours_
_(Printed)_
_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Ethambutol 400mg PIL
Eth/MA Holder: RxFarma/10
25/04/20
150x290
22/05/20
PROCESS
BLACK
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 you get any side effects,
talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
IN THIS LEAFLET
1.
What Ethambutol Talets 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 of medicines 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
any of the other ingredients (see list
under ‘What Ethambutol Tablets contain’ in section 6).
Problems with your sight
You should have your eyesight checked before taking these tablets. If
you notice any changes to your vision
whilst taking these tablets,
YOU SHOULD STOP TAKING THEM AND NOTIFY 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 changes may become
permanent.
Take special care with Ethambutol if you have a history of kidney
problems. Before treatment with Ethambutol
you should have your kidneys checked.
If you develop symptoms suggestive of hepatit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ethambutol 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 400mg Ethambutol Hydrochloride.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
Smooth, grey, circular, biconvex film coated tablet, plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The primary treatment and re-treatment of tuberculosis and for
prophylaxis in cases
of inactive tuberculosis or large-tuberculinpositive reaction.
Ethambutol should only
be used in conjunction with other anti-tuberculous drugs to which the
patient’s
organisms are susceptible.
Consideration
should
be
given
to
official
guidance
on
the
appropriate
use
of
antibacterial agents
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration_:
Oral
_Posology: _
Recommended Dosage
The dosage of ethambutol must be adjusted according to the body weight
of the
patient.
This drug should not be used as a sole anti-tuberculosis agent, but
should be given
with at least one other antituberculosis drug to avoid development of
resistant strains.
The usual daily dosage is 15-25mg/kg body weight given as a single
dose.
_ _
_ADULTS _
For primary treatment and prophylaxis: Ethambutol should be
administered in a
single
daily
dose
of
15mg/kg,
concomitant
drugs
being
maintained
at
their
recommended dosage levels.
For
re-treatment:
For
the
first
60
days
of
treatment,
ethambutol
should
be
administered in a single daily dose of 25mg/kg. Thereafter the dosage
should be
reduced to 15mg/kg, concomitant drugs being maintained at their
recommended
dosage levels.
_ _
_CHILDREN _
For primary treatment and re-treatment: For the first 60 days of
treatment, a single
daily oral dose of 25mg/kg. Thereafter the dosage should be reduced to
15mg/kg,
concomitant drugs being maintained at their recommended dosage
levels._ _
For prophylaxis: A single daily oral dose of 15mg/kg, concomitant
drugs being used
at their recommended dosage levels
As ch