Avelox 400 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Moxifloxacin

Dostępny od:

IMED Healthcare Ltd.

Kod ATC:

J01MA; J01MA14

INN (International Nazwa):

Moxifloxacin

Dawkowanie:

400 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

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

Dziedzina terapeutyczna:

Fluoroquinolones; moxifloxacin

Status autoryzacji:

Authorised

Data autoryzacji:

2018-03-16

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVELOX 400 MG FILM-COATED TABLETS
For use in adults.
moxifloxacin
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 Avelox is and what it is used for
2. What you need to know before you take Avelox
3. How to take Avelox
4. Possible side effects
5. How to store Avelox
6. Contents of the pack and other information 1. WHAT AVELOX IS AND WHAT IT IS USED FOR
Avelox contains the active substance moxifloxacin which belongs to a
group of antibiotics called fluoroquinolones. Avelox works by killing
bacteria that cause infections.
Avelox is used in patients of 18 years and older for treating the
following bacterial infections when caused by bacteria against which
moxifloxacin is active. Avelox should only be used to treat these
infections when usual antibiotics cannot be used or have not worked:
Infection of the sinuses, sudden worsening of long term inflammation
of the airways or infection of the lungs (pneumonia) acquired outside
the hospital (except severe cases).
Mild to moderate infections of the female upper genital tract (pelvic
inflammatory disease), including infections of the fallopian tubes and
infections of the uterus mucous membrane.
Avelox tablets are not sufficient for sole therapy of this kind of
infections and therefore another antibiotic in addition to Avelox
tablets
should be prescribed by your doctor for the treatment of infections of
the female upper genital tract (see section _2. What you need to know
_
_before you take Avelox, Warni

Charakterystyka produktu

Health Products Regulatory Authority
23 May 2022
CRN00CXNM
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipient with known effect: The film-coated tablet contains lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece _
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17 x 7 mm, and marked with 'M400' on one
side and 'BAYER' on the other side.
4 CLINICAL PARTICULARS
As per PA1410/027/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/027/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Film-coat:
Hypromellose
Macrogol 4000
Ferric oxide (E172)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister pack and outer packaging of the product as
marketed in the country of origin.
Health Products Regulatory Authority
23 May 2022
CRN00CXNM
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cartons containing colourless or white opaque polypropylene/aluminium
blisters:
The film-coated tablets are available in packs of 5 film-coated
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/118/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
March 2018
10 DATE OF REVISION OF THE TEXT
May 2022