Azicine 250mg Hard Capsule

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

AZITHROMYCIN DIHYDRATE

Disponible depuis:

STADPHARM SDN. BHD.

DCI (Dénomination commune internationale):

AZITHROMYCIN DIHYDRATE

Unités en paquet:

6capsule Capsules

Fabriqué par:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Notice patient

_ Consumer Medication Information Leaflet (RiMUP) _
AZICINE 250MG HARD CAPSULE
Azithromycin dihydrate 262mg EQ to 250mg of azithromycin
1
WHAT IS IN THIS LEAFLET
1.
What Azicine is used for
2.
How Azicine works
3.
Before you use Azicine
4.
How to use Azicine
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Azicine
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AZICINE IS USED FOR
Azithromycin is used to treat many
different types of infections caused by
bacteria, such as respiratory infections,
skin infections, ear infections and
sexually transmitted diseases.
HOW AZICINE WORKS
It works by killing bacteria or
preventing their growth. However, this
medicine will not work for colds, flu, or
other viral infections.
BEFORE YOU USE AZICINE
_- When you must not use it _
If you are allergic to Azicine or any
other macrolide antibiotic such as
erythromycin or any of the ingredients
listed at the end of this leaflet.
_If you think any of these apply to you, or if _
_you are in any doubt at all, consult your _
_doctor before taking this drug. _
_ _
_- Before you start use it _
_If any of the situations mentioned below _
_apply to you, you should tell your _
_doctor before taking this drug: _
Inform your doctor if you suffer from
heart, liver or kidney disease.
Let your doctor know if you
are pregnant or breastfeeding.
_- Taking other medicines _
_Please tell your doctor or pharmacist if _
_you are taking or have recently taken _
_any other medicines, including _
_medicines obtained without a _
_prescription. _
-
Antacids (for indigestion)
-
Digoxin (used to treat heart failure)
-
Zidovudine (used to treat HIV).
-
Ergot or ergotamine (used to treat
migraine).
-
Ciclosporin (used to suppress the
immune system to prevent and treat
rejection of a transplanted organ or
bone marrow).
-
Terfenadine (for hay fever or a skin
allergy).
HOW TO USE AZICINE
_- How much to use _
_Always take this drug exactly as your _
_doctor has told you. You should check _
_with yo

Résumé des caractéristiques du produit

_RX PRESCRIPTION ONLY _
1.
NAME OF THE MEDICINAL PRODUCT
AZICINE
2.
SPECIAL NOTICE AND RECOMMENDATION
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
Each hard gelatin capsule contains azithromycin 250 mg (as
azithromycin dihydrate 262 mg).
4.
PHARMACEUTICAL FORM
Hard gelatin capsule.
Hard gelatin capsule size No.0, white cap and white body, imprinted
logo “ ” on cap and “Azicine” on the body with edible black
ink, containing white
powder.
5.
INDICATIONS
Azithromycin is indicated for infections caused by susceptible
organisms; in lower respiratory tract infections including bronchitis
and pneumonia, in skin
and soft tissue infections, in acute otitis media and in upper
respiratory tract infections including sinusitis and
pharyngitis/tonsillitis. (Penicillin is the usual
drug of choice in the treatment of
_Streptococcus pyogenes_
pharyngitis, including the prophylaxis of rheumatic fever.
Azithromycin is generally effective in
the eradication of streptococci from the oropharynx, however, data
establishing the efficacy of azithromycin and the subsequent
prevention of rheumatic
fever are not available at present). In sexually transmitted diseases
in men and women, azithromycin is indicated in the treatment of
uncomplicated genital
infections due to
_Chlamydia trachomatis_
. It is also indicated in the treatment of chancroid due to
_Haemophilus ducreyi_
; and uncomplicated genital infection
due to non-multiresistant
_Neisseria gonorrhoea_
; concurrent infection with
_Treponema pallidum_
should be excluded. Azithromycin is indicated, either alone
or in combination with rifabutin, for prophylaxis against
_Mycobacterium avium-intracellulare complex_
(MAC) infection, an opportunistic infection prevalent
in patients with advanced human immunodeficiency virus (HIV).
Azithromycin is indicated in combination with ethambutol for the
treatment of disseminated
MAC (DMAC) infection in patients with advanced HIV infection.
6.
ADMINISTRATION AND DOSAGE
ADMINISTRATION
Azicine is admi