Binozyt 500mg Film Coated Tablets

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

Azithromycin Monohydrate

Mevcut itibaren:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Adı):

Azithromycin Monohydrate

Paketteki üniteler:

3 Tablets

Tarafından üretildi:

Sandoz S.R.L.

Bilgilendirme broşürü

BINOZYT
® FILM-COATED TABLETS
Azithromycin (250 mg and 500 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is BINOZYT used for
2.
How BINOZYT works
3.
Before you use BINOZYT
4.
How to use BINOZYT
5.
While you are using it
6.
Side effects
7.
Storage and disposal of BINOZYT
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IS BINOZYT USED FOR
This medicine is usually prescribed to
treat:
•
chest
infections
such
as
chronic
bronchitis, pneumonia
•
skin and soft tissue infections
•
ear infections (acute otitis media)
•
infections
of
the
tonsils,
throat
(pharyngitis) and sinuses
•
urethra and cervix infections caused
by
_chlamydia_
.
HOW BINOZYT WORKS
BINOZYT is an antibiotic that belongs
to the group of macrolide antibiotics. It
stops the growth of certain bacteria.
BEFORE YOU USE BINOZYT
-
_When you must not use it _
•
if you are allergic (hypersensitive)
to azithromycin, erythromycin,
other macrolide or ketolide
antibiotics or to any of the other
excipients of BINOZYT.
PREGNANCY AND LACTATION
Tell your doctor or pharmacist if you
are pregnant, or are planning to become
pregnant or if you are breast-feeding
before taking any medicine. You
should not use this medicine during
pregnancy and when you are breast-
feeding unless your doctor has
specifically recommended it.
-
_Before you start use it _
Tell your doctor if you have any of the
following illnesses before taking this
medicine:
•
Liver problems: your doctor may
need to monitor your liver
function or stop the treatment.
•
Kidney problems: if you have
severe kidney problems, the dose
may have to be adjusted.
•
Nervous (neurological) or mental
(psychiatric) problems.
•
A certain type of muscle
weakness called myasthenia
gravis.
Since azithromycin may increase the
risk of abnormal heart rhythm please
tell your doctor if you have any of the
following problems before taking this
medicine:
•
Heart problems such as a weak
heart (heart failure), very slow
heart

Ürün özellikleri

BINOZYT
® FILM-COATED TABLETS
AZITHROMYCIN MONOHYDRATE (250 MG, 500 MG)
1.
NAME OF THE MEDICINAL PRODUCT
Binozyt

250 mg film-coated tablets
Binozyt

500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg film-coated tablets:
One film-coated tablet contains azithromycin monohydrate equivalent to
250 mg azithromycin.
500 mg film-coated tablets:
One film-coated tablet contains azithromycin monohydrate equivalent to
500 mg azithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
250 mg film-coated tablets: white to off-white, oblong, film-coated
tablet, plain on both sides.
500 mg film-coated tablets: white to off-white, oblong, film-coated
tablet, deep break line on one
side and score line on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for infections caused by susceptible
organisms in:
•
lower respiratory tract infections, including bronchitis and pneumonia
•
skin and soft tissue infections
•
acute otitis media
•
upper respiratory tract infections including sinusitis and
pharyngitis/tonsillitis
•
in sexually transmitted diseases in men and women, azithromycin is
indicated in the treatment
of uncomplicated genital infections due to _ Chlamydia trachomatis. _
_ _
Considerations should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
For the treatment of sexually transmitted diseases caused by
_Chlamydia trachomatis, _ the dose is
1,000 mg as a single oral dose.
For all other indications in which oral formulation is administered,
the total dose of 1,500 mg
should be given, to be administered as 500 mg per day for three
consecutive days. As an
alternative, the same total dose (1,500 mg) can also be administered
over a period of five days with
500 mg on the first day and 250 mg on the second to the fifth day.
Older people
The same dose as in adult patients is used in older people. Since
older patients can be p