Peteha 250mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Protionamide

Commercializzato da:

Imported (Germany)

INN (Nome Internazionale):

Protionamide

Dosaggio:

250mg

Forma farmaceutica:

Oral tablet

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF:

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
PETEHA®, 250 mg, film-coated tablets
Active substance: prothionamide
WHAT IS IN THIS LEAFLET
1.
What PETEHA® is and what it is used for
2.
What you need to know before you take PETEHA®
3.
How to take PETEHA®
4.
Possible side effects
5.
How to store PETEHA®
6.
Further information
1. WHAT PETEHA® IS AND WHAT IT IS USED FOR
PETEHA® is medicine used to treat tuberculosis, diseases caused by
atypical mycobacteria and
leprosy.
PETEHA® IS TAKEN
-
in the treatment of all forms and stages of pulmonary and
extrapulmonary tuberculosis as a
second line medicine in cases of proven multidrug- resistance of
pathogens toward primary
medicines,
-
in the treatment of diseases which are caused by so-called
nontuberculous mycobacteria,
-
in the treatment of leprosy in the scope of modified therapy regimes.
PETEHA® is always applied in combination with other medicines
effective against the pathogen and
only if the pathogen's sensitivity to prothionamide has been proven.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PETEHA®
DO NOT TAKE PETEHA®
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, please 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. See section 4.
-
if you are hypersensitive (allergic) against prothionamide, yellow
orange S or one of the other
excipients of PETEHA®
-
if you have a severe liver disease or an acute inflammation of the
liver (hepatitis),
-
if you are known to suffer from cerebral seizures (cerebral seizures)
or psychoses,
-
during pregnancy and lactation (see Section “Pregnancy and
Lactation”).
TAKE SPECIAL CARE WITH PETEHA®
-
because of the liver-damaging action of prothionamide and

Scheda tecnica

PETEHA
®
1
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
PETEHA
®
250 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: prothionamide
One film-coated tablet contains 250 mg prothionamide (PTH).
Other excipients:
Contains lactose monohydrate (see Section 4.4) and Orange Yellow S
(see section
4.3 and 4.8)
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Orange, round, biconvex film-coated tablets with a breaking notch on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment
of
all
forms
and
stages
of
pulmonary
and
extrapulmonary
tuberculosis as second line drug in the case of proven multidrug
resistance of
the pathogens against first line drugs
-
Treatment of diseases caused by so-called ubiquitous (atypical)
mycobacteria
-
Treatment of leprosy in the context of modified therapy regimens
PETEHA
®
is
always
used
in
combination
with
other
anti-mycobacterial
chemotherapeutics and only if susceptibility of the pathogen against
prothionamide
has been proven.
The official guidelines for the proper use of anti-microbial agents
need to be taken
into account when using PETEHA
®
.
PETEHA
®
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prothionamide is a second line drug (reserve drug) for the treatment
of tuberculosis
and of diseases caused by so-called ubiquitous (atypical)
mycobacteria. It is always
part of a combination therapy with other anti-mycobacterial
chemotherapeutics if the
susceptibility of the pathogen to prothionamide has been proven. The
choice of the
therapy regimen is based on the results of the susceptibility test of
the specific patient
isolate. For the treatment of leprosy, prothionamide is used in the
context of modified
therapy regimens.
DOSAGE FOR TUBERCULOSIS AND DISEASES CAUSED BY ATYPICAL MYCOBACTERIA
Adults
Prothionamide is dosed according to body weight. Adults are given 15
mg/kg body
weight per day.
A maximum daily dose of 1,000 mg should not be exceeded.
The table below shows the number