Avelox 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Moxifloxacin hydrochloride

Available from:

Bayer Plc

ATC code:

J01MA14

INN (International Name):

Moxifloxacin hydrochloride

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 5010605250019

Patient Information leaflet

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Page 1 of 10
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVELOX 400MG 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 more 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 aged 18 years and above 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 th

Summary of Product characteristics

OBJECT 1
AVELOX 400 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Sep-2017 | Bayer plc
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 68mg
lactose monohydrate (= 66.56 mg
lactose) (see section 4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
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
4.1 Therapeutic indications
Avelox 400 mg film-coated tablets are indicated for the treatment of
the following bacterial infections in
patients of 18 years and older caused by bacteria susceptible to
moxifloxacin (see sections 4.4, 4.8 and
5.1). Moxifloxacin should be used only when it is considered
inappropriate to use antibacterial agents that
are commonly recommended for the initial treatment of these infections
or when these have failed:
- 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.
Avelox 400 mg film-coated tablets are not recommended for use in
monotherapy of mild to moderate
pelvic inflammatory disease but should be given in combination with
another appropriate antibacterial
agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance
of _Neisseria gonorrhoeae_ unless
moxifloxacin-resistant _Neisseria gonorrhoeae_ can be excluded (see
sections 4.4 and 5.1).
Avelox 400 mg film-coated tablets may also be used to complete a
course of therapy in patients who have
shown improvement during initial treatmen