Zithromax 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Azithromycin dihydrate

Available from:

Pfizer Ltd

ATC code:

J01FA10

INN (International Name):

Azithromycin dihydrate

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 5013457016253 5013457016239

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZITHROMAX
® 250 MG CAPSULES
(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.
The name of your medicine is Zithromax 250 mg Capsules but
will be referred to as Zithromax throughout the remainder of this
leaflet.
WHAT IS IN THIS LEAFLET
1.
What Zithromax is and what it is used for
2.
What you need to know before you take Zithromax
3.
How to take Zithromax
4.
Possible side effects
5.
How to store Zithromax
6.
Contents of the pack and other information
1.
WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
This medicine contains azithromycin, which is one of a group of
antibiotics called macrolides. It is used to treat infections caused
by certain bacteria and other micro-organisms, which 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 organisms called
_Chlamydia trachomatis _and _Neisseria gonorrhoea_.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZITHROMAX
DO NOT TAKE ZITHROMAX:
•
if you are allergic to azithromycin or any other macrolide
antibiotic such as erythromycin or clarithromycin or any of the
ingredients of this medicine (listed in section 6). An allergic
reaction may cause skin rash or wheezing.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zithromax if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ZITHROMAX 250 MG CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains azithromycin dihydrate 262.05 mg equivalent to
250 mg azithromycin
base.
Excipients with known effect:
Each capsule contains lactose anhydrous and sulfur dioxide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
White, hard gelatin capsules marked Pfizer and ZTM 250.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections when
known or likely to be due to one or more susceptible microorganisms
(see
section 5.1):
-
bronchitis
-
community-acquired pneumonia
-
sinusitis
-
pharyngitis/tonsillitis (see section 4.4 regarding streptococcal
infections)
-
otitis media
-
skin and soft tissue infections
-
uncomplicated
genital
infections
due
to
_Chlamydia _
_trachomatis_
and_ _
_Neisseria gonorrhoeae_
Considerations should be given to official guidance regarding the
appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Zithromax capsules should be given as a single daily dose.
In common with many other antibiotics Zithromax Capsules should be
taken at least 1 hour
before or 2 hours after food.
CHILDREN OVER 45 KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY
PATIENTS:
The total dose of azithromycin is 1500 mg which should be given over
three days (500 mg
once daily).
In uncomplicated genital infections due to _Chlamydia trachomatis_,
the dose is 1000 mg as a
single oral dose. For susceptible _Neisseria gonorrhoeae_ the
recommended dose is 1000 mg or
2000 mg of azithromycin in combination with 250 mg or 500 mg
ceftriaxone according to
local clinical treatment guidelines. For patients who are allergic to
penicillin and/or
cephalosporins, prescribers should consult local treatment guidelines.
PAEDIATRIC POPULATION:
IN CHILDREN UNDER 45 KG BODY WEIGHT: Zithromax Capsules are not
suitable for children
under 45 kg.
RENAL IMPAIRMENT:
No d