Moxifloxacin 400mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-08-2018
Summary of Product characteristics
(SPC)
18-05-2020
Active ingredient:
Moxifloxacin hydrochloride
Available from:
A A H Pharmaceuticals Ltd
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: 5025903016991
Patient Information leaflet
Package leaflet: Information for the patient
Moxifloxacin 400 mg film coated tablets
For 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
What Moxifloxacin is and what it is used for
What you need to know before you take Moxifloxacin
How to take Moxifloxacin
Possible side effects
How to store Moxifloxacin
Contents of the pack and other information
What Moxifloxacin is and what it is used for
This medicine contains the active substance moxifloxacin, which
belongs to a group of antibiotics
called fluoroquinolones. Moxifloxacin works by killing bacteria that
cause infections.
Moxifloxacin is used in patients aged 18 years and above for treating
the following bacterial infections
when caused by bacteria against which moxifloxacin is active.
Moxifloxacin 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.
Moxifloxacin tablets are not sufficient on their own for treating this
kind of infection. Therefore, another
antibiotic in addition to Moxifloxacin 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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Moxifloxacin 400 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg moxifloxacin, corresponding to
436.37 mg moxifloxacin hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Pink oblong biconvex film coated tablets with dimensions 19.4 x 7.8 mm
in
diameter and 5.8 mm in thickness
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moxifloxacin 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)
In acute bacterial sinusitis
Moxifloxacin should be used only when it is considered
inappropriate to use other antibacterial agents that are commonly
recommended for
the treatment of these infections.
- Acute exacerbation of chronic obstructive pulmonary disease
including
bronchitis (adequately diagnosed)
_ _
In acute exacerbation of chronic obstructive pulmonary disease
including bronchitis
Moxifloxacin should be used only when it is considered inappropriate
to use other
antibacterial agents that are commonly recommended for the treatment
of these
infections.
- 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.
Moxifloxacin 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 moxi
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