Ethambutol 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethambutol hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

J04AK02

INN (International Name):

Ethambutol hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5055132711046

Patient Information leaflet

200mm
280mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
Ethambutol is an antibiotic (antibacterial medicine) for treating
infections.
It
belongs
to
a
group
of
antibiotics
called
antituberculosis drugs and is used in combination with other
antituberculosis agents to treat and prevent tuberculosis (TB),
an infectious disease mainly affecting the lungs.
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 poor vision or swelling of the optic nerve which
results in blurring of vision (optic neuritis).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ethambutol
Tablets
if you have been treated for kidney problems.
Before treatment with Ethambutol Tablets you doctor may send
you for an eye test and if you notice any changes to your vision
during your treatment you should immediately let your doctor
know.
OTHER MEDICINES AND ETHAMBUTOL TABLETS
It is not known if Ethambutol Tablets interact with other
medicines. However, it is best to tell your doctor or pharmacist if
you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
ETHAMBUTOL

Summary of Product characteristics

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.
Before prescribing Ethambutol Tablets, consideration should be given
to national
and/or local guidance on the appropriate use of anti-bacterial agents
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
admini