Azithromycin 500mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Azithromycin

Tilgjengelig fra:

Mawdsley-Brooks & Company Ltd

ATC-kode:

J01FA10

INN (International Name):

Azithromycin

Dosering :

500mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010500

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Tablets are and what they are used for
2.
What you need to know before you take Azithromycin Tablets
3.
How to take Azithromycin Tablets
4.
Possible side effects
5.
How to store Azithromycin Tablets
6.
Contents of the pack and other information
Azithromycin Tablets is an antibiotic. It belongs to a group of
antibiotics called macrolides. It is used to treat infections
caused by bacteria.
This medicine is usually prescribed to treat:
•
chest infections such as chronic bronchitis, pneumonia
•
infections of the tonsils, throat (pharyngitis) and sinuses
•
ear infections (acute otitis media)
•
skin and soft tissue infections, with exception of infected burn
wounds
•
urethra and cervix infections caused by chlamydia.
DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:
•
azithromycin
•
erythromycin
•
any other macrolide or ketolide antibiotic
•
any of the other ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Azithromycin Tablets:
•
Liver problems: your doctor may need to monitor your liver function or
stop the treatment.
•
Kidney problems: if you have severe kidney problems, the dose may have
to be adjusted.
•
Nervous (neurological) or mental (psychiatric) problems.
•
A certain type of muscle weakness called myasthenia gravis.
Since azithromycin may increase the risk of abn

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azithromycin 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: 500 mg of azithromycin (as
monohydrate)
Excipient(s) with known effect:
Each tablet contains 0.36 mg soya lecithin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oblong, film-coated tablet, deep break line on one
side and
score line on other side. The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin tablets can be applied for the treatment of the following
infections, when caused by microorganisms sensitive to azithromycin
(see
sections 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
−
skin and soft tissue infections
−
uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis
Considerations should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
In uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis the
dose is
1000 mg as a single oral dose.
For all other indications the dose is 1500 mg, to be administered as
500 mg per
day for three consecutive days. As an alternative the same total dose
(1500 mg)
can also be administered over a period of five days with 500 mg on the
first day
and 250 mg on the second to the fifth day.
_Elderly people _
The same dose as in adult patients is used for older people. Since
elderly people
can be patients with ongoing proarrhythmic conditions a particular
caution is
recommended due to the risk of developing cardiac arrhythmia and
torsades de
pointes (see section 4.4).
_Paediatric population _
Azithromycin tablets should only be administered to children weighi