Ethambutol 400mg Film Coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ethambutol hydrochloride

Disponibil de la:

Pfizer Healthcare Ireland

Codul ATC:

J04AK; J04AK02

INN (nume internaţional):

Ethambutol hydrochloride

Dozare:

400 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Other drugs for treatment of tuberculosis; ethambutol

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1977-04-01

Prospect

PATIENT INFORMATION LEAFLET
ETHAMBUTOL* 400MG TABLETS
(ETHAMBUTOL HYDROCHLORIDE)
WHAT YOU SHOULD KNOW ABOUT ETHAMBUTOL TABLETS
This leaflet provides important information about your medicine.
Please read it
carefully before you start taking ETHAMBUTOL Tablets. If you have any
questions, or there is anything you do not understand, ask your doctor
or
pharmacist (chemist). Keep this leaflet while you are taking
ETHAMBUTOL
Tablets, you may want to read it again.
WHAT IS IN ETHAMBUTOL TABLETS?
ETHAMBUTOL Tablets contain 400mg ethambutol hydrochloride in each
film-
coated tablet. ETHAMBUTOL belongs to a group called antituberculous
drugs.
Other ingredients in ETHAMBUTOL Tablets are: Sucrose, gelatin 125
bloom,
sorbitol
solution
70%,
magnesium
stearate,
stearic
acid,
polydextrose,
hypromellose, macrogol 4000, titanium dioxide (E171), iron oxide
yellow (E172)
and iron oxide black (E172).
The licence holder is: Pfizer Healthcare Ireland, 9 Riverwalk,
National Digital
Park, Citywest Business Campus, Dublin 24, Ireland.
The manufacturer is: Wyeth Laboratories, New Lane, Havant, Hants PO9
2NG,
England.
ETHAMBUTOL Tablets are licensed in bottles of 56, 100 and 500 grey
film-
coated tablets.
ETHAMBUTOL Tablets are supplied in bottles of 56 grey film-coated
tablets.
WHAT CAN ETHAMBUTOL TABLETS BE USED TO TREAT?
ETHAMBUTOL Tablets are used for the treatment and prevention of
tuberculosis, an infectious disease mainly affecting the lungs.
BEFORE TAKING THIS MEDICINE
If the answer to any of the following questions is "YES" you should
talk to your
doctor before taking any tablets as they may not be suitable for you:
•
do you have sight problems?
Ref: EL 3_0
Page
1
of
4
2014-0006167
•
are you pregnant, breast feeding or trying for a baby ?
•
have you ever had an allergic reaction to any of the ingredients in
ETHAMBUTOL TABLETS (see “What is in ETHAMBUTOL TABLETS”
above)?
•
do you have kidney or liver_ _ problems ?
•
are you taking any other medicines or tablets including any that you
have
bought without a prescription

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethambutol 400mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg Ethambutol Hydrochloride.
Excipients: Each tablet contains 130mg sucrose and 23mg sorbitol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Smooth, grey, biconvex, bevel-edged film coated tablets.
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-tuberculous drugs to which
the patient’s organisms are susceptible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration:_ Oral
_Posology:_
Recommended Dosage
The dosage of ethambutol must be carefully calculated on the basis of
individual body weight to minimise the risk of
toxicity.
Adults:
The usual daily dosage is 15-25 mg/kg body weight given as a single
dose.
Children:
The usual daily dosage is 20 (15-25) mg/kg body weight given as a
single dose.
Higher doses may be required, this is to be handled on a case by case
basis with specialists in the field.
Dosing in infants less than 3 months is not recommended due to lack of
data in this population.
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