Ethambutol 100mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Ethambutol hydrochloride

Dostopno od:

Kent Pharma (UK) Ltd

Koda artikla:

J04AK02

INN (mednarodno ime):

Ethambutol hydrochloride

Odmerek:

100mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010900; GTIN: 5015201009443

Navodilo za uporabo

• you notice any changes to your vision
THE FOLLOWING OTHER SIDE EFFECTS HAVE ALSO BEEN REPORTED:
COMMON (may affect up to 1 in 10 people) • eye problems; inflammation of the optic nerve, loss of the
sharpness of vision
UNCOMMON (may affect up to 1 in 100 people) • high levels of uric acid in the blood (hyperuricaemia)
RARE SIDE EFFECTS (may affect up to 1 in 1,000 people) • numbness, pins and needles sensation • low blood platelet count (which may result in nosebleeds,
pinpoint red spots,
prolonged bleeding after injury) • minor allergic reactions such as rashes, itching and swollen,
pale red bumps or
plaques (wheals) on the skin
VERY RARE SIDE EFFECTS (may affect up to 1 in 10,000 people) • hypersensitivity or anaphylactic reaction • blood disorders such as reduction in the number of white cells in
the blood and
low level of neutrophils, a type of white blood cell • dizziness, confusion, disorientation, hallucinations, headache,
fever, generally
feeling unwell • joint pains, burning pain, weakness in hands and feet • fluid in the lungs or inflammation of the lungs which may cause
breathlessness,
cough and raised temperature • gout (which results in warmth, swelling, reddish discoloration,
and marked
tenderness of joint especially common to affect big toe) • liver failure
NOT KNOWN (frequency cannot be estimated from the available data) • shaking • stomach problems, including loss of appetite, feeling or being
sick, diarrhoea,
flatulence (wind), stomach pain, metallic taste and weight loss • hepatitis, jaundice, transient increase in liver enzymes,
abnormal liver function
tests in patients on multiple medications
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. You can also report
side effects directly
via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search
for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side
effects you can
help provi

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ethambutol 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ethambutol hydrochloride 100 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round biconvex, film coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For 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.
Consideration should be given to official guidance on the appropriate
use of
antimicrobial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posolo
gy
Dosage should be determined according to the body weight of the
patient. The
usual daily dosage is 15-25mg/kg body weight given as a single dose.
Ethambutol should not be used as a sole anti-tuberculosis agent, but
should be
given with at least one other anti-tuberculosis drug to avoid
development of
resistant strains.
Adults
_For primary treatment and prophylaxis: _Ethambutol should be
administered in
a single daily dose of 15 mg/kg body weight; concomitant drugs should
be
maintained at their usual recommended dosage.
_For re-treatment: _For the first 60 days of treatment, ethambutol
should be
administered in a single daily dose of 25 mg/kg body weight.
Thereafter the
dosage should be reduced to 15 mg/kg body weight; concomitant drugs
should
be maintained at their usual recommended dosage levels.
Paediatric population
_For primary treatment and re-treatment: _For the first 60 days of
treatment, a
single daily dose of 25 mg/kg body weight. Thereafter the dosage
should be
reduced to 15 mg/kg body weight; concomitant drugs being maintained at
their
usual recommended dosage levels.
_For prophylaxis: _A single daily dose of 15 mg/kg body weight;
concomitant
drugs being maintained at their usual recommended dosage levels.