Ethambutol 100mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Ethambutol hydrochloride

Saatavilla:

Morningside Healthcare Ltd

ATC-koodi:

J04AK; J04AK02

INN (Kansainvälinen yleisnimi):

Ethambutol hydrochloride

Annos:

100 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Other drugs for treatment of tuberculosis; ethambutol

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2010-10-01

Pakkausseloste

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETHAMBUTOL 100MG AND 400MG FILM-COATED TABLETS
Ethambutol Hydrochloride
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

Valmisteyhteenveto

Health Products Regulatory Authority
04 August 2020
CRN009SPZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethambutol 100mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Ethambutol hydrochloride 100 mg.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Yellow, 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_
Health Products Regulatory A