AVELOX 400 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOXIFLOXACIN HYDROCHLORIDE

Available from:

LTT Pharma Limited

ATC code:

J01MA

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Dosage:

400 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

available in packs of 5.

Prescription type:

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

Manufactured by:

Bayer Pharma AG

Therapeutic group:

Quinolone antibacterials, fluoroquinolones

Therapeutic area:

FLUOROQUINOLONES

Therapeutic indications:

it is indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin: - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbations of chronic bronchitis (adequately diagnosed) - Community acquired pneumonia, except severe cases - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. It may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: - Community-acquired pneumonia - Complicated skin and skin structure infections

Authorization status:

Authorised

Authorization date:

2015-07-31

Patient Information leaflet

CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT AVELOX CONTAINS
The active substance is moxifloxacin. Each film-coated tablet contains 
400 mg 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, iron oxide (E172) and 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 and
a dimension of 17 x 7 millimeter is marked with “M400” on one side and
“BAYER” on the other side.
Avelox is packaged in cartons containing colourless polypropylene/aluminium
blisters.
Avelox is available in packs containing 5 film-coated tablets. 
THE PARALLEL PRODUCT AUTHORISATION HOLDER IS:
LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, UK.
REPACKAGED BY:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, UK.
THE MANUFACTURER IS:
Bayer Pharma AG, D-51368 Leverkusen, Germany.
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 is a 
Bayer AG.
PPA1562/158/001
Revision date: 28/07/2015
Blind or partially sighted?
Is this leaflet hard to see or read? 
Phone LTT Pharma Limited, 
Tel: [phone] for help.
AVELOX  400MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
•
allergic reaction
•
increase of bilirubin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avelox 400mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipient with known effect: contains lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the Portugal._
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 PA1410/27/1
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/27/1
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
microcrystalline cellulose,
croscarmellose sodium,
lactose monohydrate,
magnesium stearate.
Coating:
hypromellose,
macrogol 4000,
iron oxide (E172),
titanium dioxide (E171).
6.2 INCOMPATIBILITIES
Not applicable.
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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/07/2015_
_CRN 2161114_
_page number: 1_
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
Cartons containing colourless polypropylene/aluminium blisters: The film-coated tablets are available in packs of 5.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 MARKETING AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Ro