Azithromycin 250mg Capsules

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

azithromycin dihydrate

Available from:

Jubilant Pharmaceuticals nv

ATC code:

J01FA10

INN (International Name):

azithromycin dihydrate

Dosage:

250mg

Pharmaceutical form:

Capsule, hard

Administration route:

Oral use

Units in package:

Blister: 2, 4 or 6 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

PSI supply nv

Therapeutic group:

Antibacterials for systemic use, macrolides

Therapeutic indications:

Treatment of the following bacterial infections induced by micro-organisms susceptible to azithromycin (see sections 4.4 and 5.1): − infections of the lower respiratory tract: acute exacerbation of chronic bronchitis (adequately diagnosed) and mild to moderate communityacquired pneumonia − infections of the upper respiratory tract: sinusitis and pharyngitis/tonsillitis (see 4.4 regarding streptococcal infections) − acute otitis media − infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulites, erysipelas − uncomplicated genital infections due to Chlamydia trachomatis

Authorization status:

Authorised

Authorization date:

2015-04-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
WHAT IS IN THIS LEAFLET
1.
WHAT AZITHROMYCIN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZITHROMYCIN
DO NOT TAKE AZITHROMYCIN IF
WARNINGS AND PRECAUTIONS
STOP TAKING AZITHROMYCIN AND SEE A DOCTOR STRAIGHT AWAY IF YOU NOTICE ANY OF THE
FOLLOWING SERIOUS SIDE EFFECTS WHILE TAKING THIS MEDICINE:
OTHER MEDICINES AND AZITHROMYCIN
AZITHROMYCIN 250 MG CAPSULES
(azithromycin dihydrate)
-
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.
:
1.
What Azithromycin is and what it is used for
2.
What you need to know before you use Azithromycin
3.
How to take Azithromycin
4.
Possible side effects
5.
How to store Azithromycin
6.
Contents of the pack and other information
Azithromycin is an antibiotic. It belongs to a group of antibiotics called `macrolides`.
Azithromycin is used to treat bacterial infections caused by `micro-organisms` such as
bacteria. These infections include:
-
Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat
(pharyngitis) and sinusitis)
-
ear infections
-
skin and soft tissue infections (such as an abscess or boil)
-
sexually transmitted diseases caused by an organism called chlamydia
-
you are allergic (hypersensitive) to azithromycin dihydrate, erythromycin or any of
the other ingredients in this me

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Azithromycin 250 mg Capsules 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION   
Each capsule contains azithromycin dihydrate equivalent to
250 mg of 
azithromycin. 
For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Capsules, hard. 
White cap and white body, size “0” hard gelatin opaque
capsules, imprinted in 
black ink with “250” on cap and body, containing white to off
white granular 
powder. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Treatment of the following bacterial infections
induced by micro-organisms 
susceptible to azithromycin (see sections 4.4 and 5.1): 
−

infections of the lower respiratory tract: acute exacerbation of
chronic 
bronchitis (adequately diagnosed) and mild to moderate community-
acquired pneumonia 
−

 infections of the upper respiratory tract: sinusitis and
pharyngitis/tonsillitis 
(see 4.4 regarding streptococcal infections)  
−

acute otitis media  
−

infections of the skin and soft tissues of mild to moderate
severity e.g. 
folliculitis, cellulites, erysipelas  
−

uncomplicated genital infections due to _Chlamydia trachomatis_  
Consideration should be given to official guidance on
the appropriate use of 
antibacterial agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
_Children and adolescents with a body weight above 45 kg, adults
and the _
_elderly_: 
The total dose of azithromycin is 1500mg, which should be given
over three 
days (500mg once daily).  
In the case of uncomplicated genital infections due to_ Chlamydia
trachomatis_, 
the dose is 1000mg as a single oral dose. 
_Children and adolescents with a body weight below 45 kg_: 
Capsules are not indicated for these patients. Other
pharmaceutical forms of 
azithromycin may be used, such as suspensions. 
_Elderly patients_: 
The same dosage as in adult pa