Ethambutol 400mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ethambutol hydrochloride

Commercializzato da:

Esteve Pharmaceuticals Ltd

Codice ATC:

J04AK02

INN (Nome Internazionale):

Ethambutol hydrochloride

Dosaggio:

400mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05010900; GTIN: 5039021008257

Foglio illustrativo

290.00 mm
150.00 mm
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 you get any side effects,
talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
IN THIS LEAFLET
1.
What Ethambutol Talets 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.
-
if you are allergic (hypersensitive) to ethambutol hydrochloride or
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.
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.
Take special care with Ethambutol if you have a history of kidney
problems. Before treatment with Ethambutol
you should have your kidneys checked.
If you develop symptoms suggestive of hepatitis (e.g. abdominal pain,
fever, loss of appetite) or feel generally
unwell, you may need your liver functions tested.
TAKING OTHER MEDICIN

Scheda tecnica

OBJECT 1
ETHAMBUTOL 400 MG TABLETS
Summary of Product Characteristics Updated 07-Oct-2022 | Esteve
Pharmaceuticals (formerly Intrapharm
Laboratories)
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 re-treatment of tuberculosis and for
prophylaxis in cases of inactive tuberculosis
or large-tuberculinpositive reaction. Ethambutol should only be used
in conjunction with other anti-
tuberculous 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 adminis