Azithromycin 250mg Film-coated Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Azithromycin anhydrous

Доступна с:

Wockhardt UK Limited

код АТС:

J01FA; J01FA10

ИНН (Международная Имя):

Azithromycin anhydrous

дозировка:

250 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Macrolides; azithromycin

Статус Авторизация:

Authorised

Дата Авторизация:

2017-10-20

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZITHROMYCIN 250MG FILM-COATED TABLETS
AZITHROMYCIN 500MG FILM-COATED TABLETS
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 AZITHROMYCIN 250MG FILM-COATED TABLETS OR
AZITHROMYCIN
500MG FILM-COATED TABLETS. IN THE REST OF THIS LEAFLET IT IS CALLED
AZITHROMYCIN TABLETS.
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 further information
1. WHAT AZITHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR
Azithromycin 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 acute worsening of
chronic 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHROMYCIN TABLETS
DO NOT TAKE AZITHROMYCIN TABLETS:
• 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 pha

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azithromycin 250mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin 250mg Film-Coated Tablets contain 250mg azithromycin
(anhydrous), equivalent to 250mg
azithromycin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white film-coated oval shaped biconvex tablet debossed
with W 961 on one side and plain on the other.
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):
Acute bacterial sinusitis (adequately diagnosed)
Acute bacterial otitis media (adequately diagnosed)
Pharyngitis, tonsillitis
Acute exacerbation of chronic bronchitis (adequately diagnosed)
Community acquired pneumonia
Skin and soft tissue infections
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
This medicine should be taken in a single daily dose. The tablets
should be swallowed whole and may be taken with or
without food. The length of treatment for various infectious diseases
is set out below.
_Children and adolescents with a body weight above 45 kg, adults and
the elderly:_
The total dosage of azithromycin is 1500 mg, staggered over three days
(500 mg once daily). Alternatively, the dosage
may be staggered over five days (500 mg as a single dose on the first
day, and then 250 mg once daily).
In the case of uncomplicated_ Chlamydia trachomatis_ urethritis and
cervicitis, the dosage is 1000 mg as a single oral
dose.
_Paediatric population_
_Children and adolescents with a body weight below 45 kg:_
Azithromycin tablets are not suitable for these patients. Other
pharmaceutical forms of azithromycin may be used, such
as suspensions.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
__