Ethambutol Hydrochloride 400mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethambutol hydrochloride

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

J04AK; J04AK02

INN (International Name):

Ethambutol hydrochloride

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Other drugs for treatment of tuberculosis; ethambutol

Authorization status:

Not marketed

Authorization date:

2010-10-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETHAMBUTOL HYDROCHLORIDE 100MG AND 400MG FILM-COATED TABLETS
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 serious, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Ethambutol Tablets are and what they are 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 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETHAMBUTOL TABLETS
DO NOT TAKE ETHAMBUTOL TABLETS

if you are allergic to ethambutol hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).

if you have sight problems
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 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ethambutol Tablets

if you have a history of

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2021
CRN009ZDD
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethambutol Hydrochloride 400mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
400 mg of ethambutol hydrochloride
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Grey, circular biconvex film-coated tablets, 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-tuberculin-positive reaction. Ethambutol should only be used in
conjunction with other anti-tuberculosis drugs to which
the patient's organisms are susceptible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration:_ Oral
_Posology: _
The dosage of ethambutol must be adjusted according to the body weight
of the patient.
_Adults _
_For primary treatment and prophylaxis_:
Ethambutol should be administered in a single daily oral 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 oral 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.
_Elderly _
As for adults. However, patients with decreased renal function may
need to have the dosage adjusted as determined by blood
levels of ethambutol.
In order to obtain maximum effect due to high serum levels, drug
administration should be once daily.
_ _
_Renal Impairment_