Ethambutol 400mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Ethambutol hydrochloride

थमां उपलब्ध:

Morningside Healthcare Ltd

ए.टी.सी कोड:

J04AK02

INN (इंटरनेशनल नाम):

Ethambutol hydrochloride

डोज़:

400mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 05010900; GTIN: 5055132711053

सूचना पत्रक

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

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ethambutol 400mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Ethambutol hydrochloride 400 mg
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.
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