Azithromycin film-coated tablets 500mg Lesvi Lab

País: Malásia

Língua: inglês

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

Ingredientes ativos:

AZITHROMYCIN DIHYDRATE

Disponível em:

ZIWELL MEDICAL SDN BHD

DCI (Denominação Comum Internacional):

AZITHROMYCIN DIHYDRATE

Unidades em pacote:

3tablet Tablets

Fabricado por:

Neuraxpharm Pharmaceuticals S.L.

Folheto informativo - Bula

Consumer Medica on Informa on Leaflet (RiMUP)
Azithromycin Film-coated Tablets 500mg Lesvi Lab
Azithromycin 500mg
What is in this leaflet
1.
What Azithromycin Film-coated
Tablets 500mg Lesvi Lab is used
for
2.
How it works
3.
Before you use
4.
How to use
5.
While you are using
6.
Side effects
7.
Storage and disposal
8.
Product descrip on
9.
Manufacturer and Product
Registra on Holder
10. Date of Revision

Health problems, including:
i.
Liver problems
ii.
Kidney problems
iii.
Heart problems
iv.
Diabetes
v.
Hereditary fructose
intolerance
vi.
Glucose-galactose
malabsorp on or
saccharise-isomaltase
deficiency
Taking other medicines
recommended total dose for any
treatment is 1500mg. Your doctor or
pharmacist will explain how to use it if
you are unsure.
This medicine should only be given to
children weighing more than 45kg.
How long to use it
Your doctor will tell you how long you
should take the tablets.
If you forget to use it
Do not take a double dose to make up for
a missed dose.
What Azithromycin Film-coated Tablets
500mg Lesvi Lab is used for
This medicine is usually prescribed to
treat:

Chest, throat, ear or nasal
infec
ons (e.g. bronchi
s,
pneumonia, tonsilli
s,
pharyngi
s, acute o
s media
and sinusi
s)

Skin and so
ssue infec
ons

Sexually-transmi
ed diseases
due to Chlamydia, Haemophilus
or Gonorrhoea
How it works
Azithromycin belongs to the macrolide
an bio cs group. It stops the growth of
certain bacteria.
Before you use
When you must not use
Do not take this medicine if you are
allergic to azithromycin, erythromycin,
macrolide or ketolide an bio cs, or any
of the ingredients in this medicine.
Pregnancy and lacta on
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or
breast-feeding before taking any
medicine. You should not use this
medicine during pregnancy or breast-
feeding, unless your doctor has
prescribed it.
Before you start to use it
Tell your doctor if you have any of the
following:

Allergies to medicines, foods,
preserva ves or dyes

Pregnant,

Características técnicas

PACK INSERT
PRODUCT NAME
Azithromycin Film-coated_ _Tablet 500mg
Azithromycin_ _Powder for Oral Suspension 200mg/5ml
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Azithromycin Film-coated tablets 500mg:
Azithromycin dihydrate 524.03mg equivalent to azithromycin 500mg
Azithromycin_ _Powder for Oral Suspension 200mg/5ml:
Azithromycin dihydrate 209.62mg equivalent to azithromycin 200mg/5ml
PRODUCT DESCRIPTION
Film-coated tablets
Oblong, biconvex tablets, scored on one side and with the inscription
“500” on the other.
Powder for oral suspension.
Nearly white powder presented in a bottle. A whitish suspension is
obtained after its reconstitution
with water.
PHARMACODYNAMICS
Azithromycin is the first of a subclass of macrolides antibiotics,
known as azalides, and is chemically
different from erythromycin. Chemically it is derived by insertion of
a nitrogen atom into the lactone
ring of erythromycin A. The mode of action of azithromycin is
inhibition of protein synthesis in
bacteria by binding to the 50s ribosomal subunit and preventing
translocation of peptides.
Azithromycin demonstrates activity in vitro against a wide range of
bacteria including:
Gram-positive Aerobic Bacteria
_Staphylococcus aureus, Streptococcus pyogenes _(group A
beta-hemolytic streptococci),
_Streptococcus pneumoniae, alpha-hemolytic streptococci _(viridans
group) and other streptococci, and
_Corynebacterium diphtheriae_. Azithromycin demonstrates
cross-resistance with erythromycin-
resistant Gram-positive strains, including _Streptococcus faecalis
_(enterococcus) and most strains of
methicillin-resistant staphylococci.
Gram-negative Aerobic Bacteria
_Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella
catarrhalis, Acinetobacter _species,
_Yersinia _species, _Legionella pneumophila_, _Bordetella pertussis,
Bordetella parapertussis, Shigella _
_species, Pasteurella species, Vibrio cholerae _and _parahaemolyticus,
Plesiomonas shigelloides_.
Activities against _Escherichia coli, Salmonella enteritidis,
Salmonella typhi_, _Enterobacter _spec