Ethambutol 400 mg Tablets

País: Reino Unido

Idioma: inglés

Fuente: myHealthbox

Ingredientes activos:

Ethambutol Hydrochloride

Disponible desde:

Peckforton Pharmaceuticals Ltd

Código ATC:

J04AK02.

Designación común internacional (DCI):

Ethambutol Hydrochloride

Dosis:

400 mg

formulario farmacéutico:

Film-coated Tablet

Vía de administración:

Oral use

Unidades en paquete:

Bottles containing 56 tablets or 60 tablets

tipo de receta:

POM - Prescription Only Medicine

Fabricado por:

Peckforton Pharmaceuticals Ltd

Grupo terapéutico:

Antimycobacterial

indicaciones terapéuticas:

It is indicated for the primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculinpositive reaction

Estado de Autorización:

Authorised

Fecha de autorización:

2010-09-07

Información para el usuario

PATIENT INFORMATION LEAFLET
ETHAMBUTOL 400 MG TABLETS
(Ethambutol Hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
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.  Do not
pass it on to others.  It may harm them, even 
if their symptoms are the same as yours. If any of the
side effects get serious or if you notice any side effects 
not listed in this leaflet, please tell your doctor or
pharmacist. 
IN THIS LEAFLET:
1.   What Ethambutol Tablets are and what they are used for
2.   Before you take Ethambutol Tablets
3.   How to take Ethambutol Tablets
4.   Possible side effects
5.   How to store Ethambutol Tablets
6.   Further 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 of medicines called 
antituberculosis drugs and is used for the treatment and
prevention of tuberculosis, an infectious disease 
mainly affecting the lungs.
2. BEFORE YOU TAKE ETHAMBUTOL TABLETS
DO NOT TAKE ETHAMBUTOL TABLETS:
·   if you have sight problems caused by inflammation of
nerves in your eye (optic neuritis). 
·   if you are allergic (hypersensitive) to ethambutol
hydrochloride or to any of the other ingredients (see list  

 under ‘What Ethambutol Tablets contain’ in Section 6).
PROBLEMS WITH YOUR SIGHT
You should have your eyesight checked before taking these tablets.
If you notice any changes to your vision 
whilst taking these tablets, YOU SHOULD STOP TAKING THEM AND NOTIFY
YOUR DOCTOR IMMEDIATELY.
Very young children or patients with communication
difficulties should be closely monitored for any signs of 
sight problems by their parents or carers. 
TAKING OTHER MEDICINES
You should not take ethambutol tablets at the same time as antacid
medicine

Ficha técnica

Ethambutol 400 mg Tablets
Summary of Product Characteristics Updated 11­Jun­2015 | Peckforton Pharmaceuticals
1. Name of the medicinal product
Ethambutol 400 mg Tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 400mg Ethambutol Hydrochloride.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Film coated tablet.
Smooth, grey, circular, biconvex film coated tablet, plain on both sides.
4. Clinical particulars
4.1 Therapeutic indications
The primary treatment and re­treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large­
tuberculinpositive reaction. Ethambutol should only be used in conjunction with other anti­tuberculous drugs to which the
patient's organisms are susceptible.
Consideration should be given to official guidance on the appropriate use of antibacterial agents
4.2 Posology and method of administration
_Route of administration_:
Oral
_Posology:_
Recommended Dosage
The dosage of ethambutol must be adjusted according to the body weight of the patient.
This drug should not be used as a sole anti­tuberculosis agent, but should be given with at least one other
antituberculosis drug to avoid development of resistant strains.
The usual daily dosage is 15­25mg/kg body weight given as a single dose.
_Adults_
For primary treatment and prophylaxis: Ethambutol should be administered in a single daily dose of 15mg/kg,
concomitant drugs being maintained at their recommended dosage levels.
For re­treatment: For the first 60 days of treatment, ethambutol should be administered in a single daily 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 re­treatment: For the first 60