AZENIL CAPSULES

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

AZITHROMYCIN AS DIHYDRATE

Disponible depuis:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Code ATC:

J01FA10

forme pharmaceutique:

CAPSULES

Composition:

AZITHROMYCIN AS DIHYDRATE 250 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

HAUPT PHARMA LATINA S.R.L, ITALY

Groupe thérapeutique:

AZITHROMYCIN

Domaine thérapeutique:

AZITHROMYCIN

indications thérapeutiques:

Infections caused by susceptible organisms in lower respiratory tract including bronchitis and pneumonia, skin and soft tissue infections, otitis media, upper respiratory tract infections including sinusitis and pharyngitis, tonsilitis, also in the treatment of uncomplicated genital infections due to chlamydia trachomatis.

Date de l'autorisation:

2015-02-28

Notice patient

Azenil Capsules, Azenil Suspension PIL CC 160723 Technical change
2023-0086619
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor's prescription only
AZENIL
® CAPSULES
AZENIL
® 200 MG / 5 ML SUSPENSION
EACH CAPSULE CONTAINS: azithromycin (as dihydrate) 250 mg
EACH 5 ML OF SUSPENSION CONTAINS: azithromycin (as dihydrate) 200 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this
medicine’s ingredients' and section 6 'Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
Azenil 200 mg/5 ml Suspension is intended for children from 6 months
of age.
Azenil Capsules is intended for children weighing more than 45 kg.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
For the treatment of infections caused by bacteria susceptible to the
preparation in the
respiratory tract (bronchitis, pneumonia, sinusitis, pharyngitis and
tonsillitis), skin and
soft tissue, ear and genital infections caused by _Chlamydia
trachomatis_.
THERAPEUTIC GROUP: macrolide antibiotic.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (azithromycin)
or to any of the
other ingredients in this medicine (see section 6).
•
You have a history of allergic reaction to the preparation or to
erythromycin or to any
other antibiotic from the macrolide or ketolide group.
•
You have suffered in the past from jaundice resulting from bile flow
obstruction in
the liver (cholestatic jaundice) or from hepatic dysfunction that
happened with the
use of azithromycin.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Do not use this medicine without consulting a

Résumé des caractéristiques du produit

Azenil 250mg Capsules, Azenil 200mg/5ml Suspension LPD CC 261221
1
2021-0070541
AZENIL
® CAPSULES
AZENIL
®
200 MG/5 ML SUSPENSION
NAME OF THE MEDICINAL PRODUCT
AZENIL
® CAPSULES
AZENIL
®
200 MG/5 ML SUSPENSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azenil capsules:
Each capsule contains Azithromycin dihydrate 262.05 mg equivalent to
250 mg azithromycin base.
Azenil 200mg/5ml suspension:
Contains Azithromycin 209.64 mg/5ml equivalent to 200mg/5ml of
azithromycin base in Powder for Oral Suspension.
Excipients with known effect:
Azenil capsules: Lactose, sodium
Azenil 200mg/5ml suspension: Sucrose, sodium
For the full list of excipients, see Description (9) in this leaflet.
PHARMACEUTICAL FORM
Azenil capsules-
The capsule is printed in black ink with Pfizer on one end of shell
and “ZTM 250” on the other end.
These capsules are packed in PVC blister packs.
Azenil 200mg/5ml - Powder for suspension
is presented as a dry powder which yields, on reconstitution with
water, a
white to off-white suspension.
The powder for oral suspension is packed in polyethylene bottles.
1
INDICATIONS AND USAGE
Infections caused by susceptible organisms in lower respiratory tract
including bronchitis and pneumonia, skin and soft
tissue infections, otitis media, upper respiratory tract infections
including sinusitis and pharyngitis, tonsilitis, also in the
treatment of uncomplicated genital infections due to chlamydia
trachomatis.
1.1
LIMITATIONS OF USE
Azithromycin should not be used in patients with pneumonia who are
judged to be inappropriate for oral therapy
because of moderate to severe illness or risk factors such as any of
the following:
•
patients with cystic fibrosis,
•
patients with nosocomial infections,
•
patients with known or suspected bacteremia,
•
patients requiring hospitalization,
•
elderly or debilitated patients, or
•
patients with significant underlying health problems that may
compromise their ability to respond to their
illness (including immunodeficiency or functional asplenia).
1.2 USAGE
Azenil