AVELOX

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

MOXIFLOXACIN HYDROCHLORIDE

Tilgjengelig fra:

Lexon (UK) Ltd

ATC-kode:

J01MA14

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Dosering :

400 Milligram

Legemiddelform:

Film Coated Tablet

Resept typen:

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

Terapeutisk område:

moxifloxacin

Autorisasjon status:

Authorised

Autorisasjon dato:

2017-07-21

Informasjon til brukeren

CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT AVELOX CONTAINS
•
The active substance is moxifloxacin. Each film-coated tablet contains
400
milligram moxifloxacin as hydrochloride.
•
The other ingredients are: Tablet core: microcrystalline cellulose,
croscarmellose sodium, lactose monohydrate _(see section Avelox _
_contains lactose)_ and magnesium stearate.
Film coating: hypromellose, macrogol 4000, ferric oxide (E172),
titanium
dioxide (E171)
WHAT AVELOX LOOKS LIKE AND CONTENTS OF THE PACK
Each 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.
Avelox is available in packs containing 5 film-coated tablets.
Product procured from within the EU, repackaged and distributed by the
Parallel Product Authorisation Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK.
THE MANUFACTURER IS:
Bayer AG, D-51368 Leverkusen, Germany.
Avelox is a
registered trademark of
Bayer AG.
PPA1097/025/001
Revision date: 09/04/2018
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: [phone] for help.
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA
UNDER THE FOLLOWING NAMES:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland,
Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Poland, Portugal, Slovak Republic, Slovenia, Sweden,
United Kingdom: AVELOX
France: IZILOX
Germany, Italy: AVALOX
AVELOX 400 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
•
allergic reaction
•
increase of bilirubin in the blood
•
inflammation of the stomach
•
dehydration
•
severe heart rhythm abnormalities
•
dry skin
•
angina pectoris
RARE (may affect up to 1 in 1,000 people)
•
muscle twitching
•
muscle cramp
•
hallucination
•
high blood pressure
•
swelling (of the hands, feet, ankles, lips, mouth, throat)
•
low blood pressure

Preparatomtale

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.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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
The film-coated tablets are