Azitromycine ratiopharm 250 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

AZITROMYCINE 2-WATER 262,1 mg/stuk SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 250 mg/stuk

Available from:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC code:

J01FA10

INN (International Name):

AZITROMYCINE 2-WATER 262,1 mg/stuk SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 250 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Azithromycin

Product summary:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);

Authorization date:

1900-01-01

Patient Information leaflet

Azithromycin, NL/H/2415/001-002, 09.03.21
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Azitromycine ratiopharm 250 mg, filmomhulde tabletten
Azitromycine ratiopharm 500 mg, filmomhulde tabletten
azithromycin (as dihydrate)
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
Azithromycin is one of a group of antibiotics called macrolides. It is
used to treat infections caused by
micro-organisms such as bacteria. These infections include:
•
Chest infections such as acute exacerbation of chronic 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 (folliculitis),
bacterial infection of the skin and its deeper layers (cellulitis),
skin infection with shiny red
swelling (erysipelas)
•
Infections caused by a bacterium called
_Chlamydia trachomatis_
. They can cause inflammation
of the tube that carries urine from your bladder (urethra) or where
your womb joins your vagina
(cervix).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME}
DO NOT TAKE {PRODUCT NAME}
•
if you are allergic to azithromycin or any of the other ingredients of
this medicine (listed in
section 6)
•
if you are allergic to any other macrol

Summary of Product characteristics

Azithromycin, NL/H/2415/001-002, 25.04.2022
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azitromycine ratiopharm 250 mg, filmomhulde tabletten
Azitromycine ratiopharm 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg tablets: Each film-coated tablet contains 250 mg azithromycin
(as dihydrate).
500 mg tablets: Each film-coated tablet contains 500 mg azithromycin
(as dihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
250 mg tablets: White, oblong biconvex film-coated tablet 14.5 x 7.5
mm with imprint ‘AI 250’ on
one side.
500 mg tablets: Pale blue, oblong, biconvex film-coated tablet 19.0 x
8.0 mm with imprint ‘AI 500’
and score line on one side. The tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following infections when caused by
micro-organisms 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
-
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
The duration of treatment in each of the infectious diseases is given
below.
Paediatric population over 45 kg body weight, adults
The total dosage of azithromycin is 1,500 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).
Azithromycin, NL/H/2415/001-002, 25.04.2022
2
In uncomplicated
_Chlamydia trachomatis _
urethritis and ce