Levofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Macleods Pharma UK Ltd

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; GTIN: 8901463113004 8901463113011

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 500mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Levofloxacin 500mg Film-coated Tablets
contains 500mg
of levofloxacin equivalent to 512.46mg of levofloxacin hemihydrate.
Excipient with known effect
Each 500mg film-coated tablet contains 7.68mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Levofloxacin 500 mg film-coated tablets
Pink biconvex tablets, scored on one side and marked with “L” on
the other side.
Approximately 16mm long and 8mm wide.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin 500mg Film-coated Tablets is indicated in adults for the
treatment of the
following infections (see sections 4.4 and 5.1):
•
Acute bacterial sinusitis
•
Uncomplicated cystitis (see section 4.4)
•
Acute exacerbation of chronic obstructive pulmonary disease including
bronchitis
•
Complicated skin and soft tissue infections/complicated skin and skin
structure infections
For the above-mentioned infections Levofloxacin 500mg Film-coated
Tablets 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 pyelonephritis and complicated urinary tract infections (see
section 4.4)
•
Chronic bacterial prostatitis
•
Community-acquired pneumonia
•
Inhalation Anthrax: post exposure prophylaxis and curative treatment
(see section 4.4)
Levofloxacin 500mg 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 500mg Film-coated Tablets are administered once or twice
daily.
The dosage depends on the type and