RIFASYNT 150 CAPSULE

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

RIFAMPICIN

Saadav alates:

KOMEDIC SDN BHD

INN (Rahvusvaheline Nimetus):

RIFAMPICIN

Ühikuid pakis:

100 Capsules

Valmistatud:

MEDOCHEMIE LTD (CENTRAL FACTORY)

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
RIFASYNT CAPSULES
Rifampicin (150mg, 300mg)
1
WHAT IS IN THIS LEAFLET
1.
What RIFASYNT is used for
2.
How RIFASYNT works
3.
Before you use RIFASYNT
4.
How to take RIFASYNT
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
RIFASYNT
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT RIFASYNT IS USED FOR
“RIFASYNT” is used as:
-
Lung infection (tuberculosis)
-
Prevention
for
inflammation
of
brain
and
spinal
cord
(meningococcal meningitis)
-
Infection
of
skin,
mucous
membrane, nerve (Leprosy)
-
Other
infections
eg.
Brucellosis,
Legionnaires
-
Haemophilus
influenza
(an
infection caused by bacteria)
The doctor will tell you exactly why
you are receiving the product.
HOW RIFASYNT WORKS
RIFASYNT is an antibiotic used to
treat
several
types
of
bacterial
infections. It works by stopping the
production of bacteria.
BEFORE YOU USE RIFASYNT
_-When you must not use it_
You should not take
RIFASYNT if
you have:
-
Allergies to the rifampicin or to
any
of
the
ingredients
of
RIFASYNT mentioned.
-
Jaundice
-
Been
receiving
saquinavir/indinavir therapy
-
Liver impairment
_ _
_-Before you start to use it _
Rifampicin
might
affect
the
liver
function, therefore it is given to you
after investigation and supervision by
doctor.
Rifampicin
may
produce
discoloration of the teeth, urine and
tears, you should be alert if you are
wearing soft contact lenses as it might
permanently stain your lenses.
_Pregnancy and Breastfeeding _
If you are pregnant, or you think you
are pregnant or plan to get pregnant,
consult
doctor
before
you
take
RIFASYNT.
Do
not
take
this
medicine
if
you
are
breast-feeding,
since
the
medicine
may
pass
into
breast milk, unless under the advice of
your doctor.
_ _
_-Taking other medicines _
Before taking this medicine tell your
doctor or pharmacist if you are taking:

Antiviral
eg.
saquinavir,ritonavir,
simeprevir

Anesthetic eg. halothane

Antibiotics
eg.
Isoniazid,
cefazolin,
cephalospo

Toote omadused

SPCRIFACAPSALL-2.0_MY
1
RIFASYNT – PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
RIFASYNT 150mg capsules.
RIFASYNT 300mg capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 150 mg or 300 mg of rifampicin.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
Each 150mg capsule contains lactose monohydrate 23.0mg.
Each 300mg capsule contains lactose monohydrate 28.0mg.
3.
PHARMACEUTICAL FORM
RIFASYNT 150 mg: Hard gelatin capsules, scarlet – scarlet size 2,
for oral administration.
RIFASYNT 300 mg: Hard gelatin capsules, scarlet – scarlet size 1,
for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS

Tuberculosis: In combination with other active anti-tuberculosis drugs
in the treatment of all forms of
tuberculosis, including fresh, advanced, chronic and drug-resistant
cases. RIFASYNT is also effective against
most atypical strains of Mycobacteria.

Prophylaxis of meningococcal meningitis: For the treatment of
asymptomatic carriers of _N. Meningitides_ to
eliminate meningococci from the nasopharynx.

Leprosy: In combination with at least one other active anti-leprosy
drug in the management of multibacillary
and paucibacillary leprosy to effect conversion of the infectious
state to a non-infectious state.

Other Infections: In the treatment of Brucellosis, Legionnaires
Disease, and serious staphylococcal infections.
To prevent emergence of resistant strains of the infecting organisms,
RIFASYNT should be used in combination
with another antibiotic appropriate for the infection.

Haemophilus
influenzae:
For
the
treatment
of
asymptomatic
carriers
of
_H.influenzae_
and
as
chemoprophylaxis of exposed children, 4 years of age or younger.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_TUBERCULOSIS: _
RIFASYNT should be given with other effective anti-tuberculosis drugs
to prevent the possible emergence of
rifampicin-resistant strains of Mycobacteria.
_Adults:_ The recommended single daily dose