Levofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Waymade Healthcare Plc

ATC code:

J01MA12

INN (International Name):

Levofloxacin hemihydrate

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200

Patient Information leaflet

_LEVOFLOXACIN _
_TABLETS _
_CAN _
_BE _
_USED _
_TO _
_TREAT _
_INFECTIONS OF THE:_
6.
Contents of the pack and other information
You should not take fluoroquinolone/quinolone antibacterial medicines,
including
Levofloxacin, if you have experienced any serious adverse reaction in
the past
when taking a quinolone or fluoroquinolone. In this situation, you
should inform your
doctor as soon as possible.
-
Signs of an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat or tongue
-
If you have any further questions, ask your doctor or pharmacist.
1.
WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is levofloxacin tablets. Levofloxacin
tablets contain a
medicine
called
levofloxacin. This
belongs
to
a
group
of
medicines
called
antibiotics. Levofloxacin is a 'quinolone' antibiotic. It works by
killing the bacteria
that cause infections in your body.
Do not take this medicine if any of the above applies to you. If you
are not sure, talk
to your doctor or pharmacist before taking levofloxacin tablets.
-
You are 60 years of age or older
Before taking this medicine
4.
Possible side effects
WARNINGS AND PRECAUTIONS
-
You are breast-feeding
-
You are pregnant, might become pregnant or think you may be pregnant
-
You are a child or a growing teenager
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their sign 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.
LEVOFLOXACIN 500 MG FILM-COATED TABLETS
-
Keep this leaflet. You may need to read it again.
PACKAGE LEAFLET: INFORMATION FOR THE USER
5.
How to store levofloxacin tablets
levofloxacin
WHAT IS IN THIS LEAFLET:
1.
What levofloxacin tablets are and what they are used for
3.
How to take

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levofloxacin 500 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of levofloxacin as
levofloxacin hemihydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Pink, capsule shaped, film-coated tablets, approximately 16.00 x 8.00
mm, scored on
both sides.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin 500 mg film-coated tablets are indicated in adults for
the following
infections (see sections 4.4 and 5.1):
-
Acute bacterial sinusitis
-
Acute exacerbations of chronic bronchitis
-
Community-acquired pneumonia
-
Complicated skin and soft tissue infections
For the above mentioned infections Levofloxacin 500 mg film-coated
tablets should
be used only when it is considered inappropriate to use antibacterial
agents that are
commonly recommended for the initial treatment of these infections.
-
Pyelonephritis and complicated urinary tract infections (see section
4.4)
-
Chronic bacterial prostatitis
-
Uncomplicated cystitis (see section 4.4)
-
Inhalation Anthrax: post exposure prophylaxis and curative treatment
(see
section 4.4)
Levofloxacin 500 mg film-coated tablets may also be used to complete a
course of
therapy in patients who have shown improvement during initial
treatment with
intravenous levofloxacin.
Consideration
should
be
given
to
official
guidance
on
the
appropriate
use
of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Levofloxacin 500 mg film-coated tablets are administered once or twice
daily. The
dosage depends on the type and severity of the infection and the
susceptibility of the
presumed causative pathogen.
Levofloxacin 500 mg film-coated tablets may also be used to complete a
course of
therapy in patients who have shown improvement during initial
treatment with
intravenous levofloxacin; given the bioequivalence of the parenteral
and oral forms,
the same dosage can