Azithromycin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azithromycin

Available from:

Viatris UK Healthcare Ltd

ATC code:

J01FA10

INN (International Name):

Azithromycin

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 5016695001265

Patient Information leaflet

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Myriad Pro
9 pt
9 pt
Azithromycin_500mg_250mg_4_3
Leaflet
1602885
1502394
1602885
PL 04569/0925,
PL 04569/0926
TBC
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101916911/0120
2
United Kingdom
N/A
N/A
19 Feb 19
18:04
1
130 x 520 mm
Black
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v3/Jul 2017
Sandoz SRL
(Targu Mures - RO)
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Technical
Info
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
AZITHROMYCIN 250MG
FILM-COATED TABLETS
AZITHROMYCIN 500MG
FILM-COATED TABLETS
azithromycin
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
•
Keep this leaflet. You may need to
read it again.
•
If you have any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
•
If you get any side effects talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Azithromycin is and what it is
used for
2.
What you need to know before you
take Azithromycin
3.
How to take Azithromycin
4.
Possible side effects
5.
How to store Azithromycin
6.
Contents of the pack and other
information
1. WHAT AZITHROMYCIN IS AND WHAT
IT IS USED FOR
Azithromycin is one of a group of
antibiotics known as macrolides. It is
used to treat bacterial infections caused
by micro organisms such as bacteria.
These infections include:
•
Chest infections such as bronchitis
and pneumonia
•
Infections in your sinuses, throat,
tonsils or ears
•
Mild to moderate skin and soft tissue
infections, e.g. infection of the hair
follicles (fol

Summary of Product characteristics

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azithromycin 500 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg azithromycin (as azithromycin
monohydrate).
Excipients with known effect
Each film-coated tablet contains 0.36 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Azithromycin 500 mg Film-coated Tablets are white to off-white, oblong
film-coated
tablets with a deep break line on one side and a score-line on the
other side.
The tablet can be divided into equal doses.
4.1
THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections, when caused
by microorganisms sensitive to azithromycin (see section 4.4 and 5.1):
•
Acute bacterial sinusitis (adequately diagnosed)
•
Acute bacterial otitis media (adequately diagnosed)
•
Pharyngitis, tonsillitis
•
Acute exacerbation of chronic bronchitis (adequately diagnosed)
•
Mild to moderately severe community acquired pneumonia
•
Infections of the skin and soft tissues of mild to moderate severity
e.g. folliculitis,
cellulitis, erysipelas
•
Uncomplicated Chlamydia trachomatis urethritis and cervicitis
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Azithromycin tablets should be given as a single daily dose. The
duration of treatment
Page 2 of 23
in each of the infectious diseases is given below.
Adults, elderly, children and adolescents over 45 kg body weight
The total dosage of azithromycin is 1500 mg which is spread over three
days (500 mg
once daily).
Alternatively, the dosage can be spread over five days (500 mg as a
single dose on the
first day and thereafter 250 mg once daily).
In uncomplicated Chlamydia trachomatis urethritis and cervicitis the
dosage is 1000
mg as a single oral dose.
For sinusitis, treatment is indicated for adults and adolescents 16
years of