Levofloxacin 250mg 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:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 8901463112984 8901463112991

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
In chronic obstructive pulmonary disease (COPD) including bronchitis,
complicated
skin and soft tissue infections, acute bacterial
sinusitis
and
in
acute
pyelonephritis
and
complicated urinary tract infections, levofloxacin
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.
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.
Ÿ
Sinuses
1.
WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR
_LEVOFLOXACIN _
_TABLETS _
_CAN _
_BE _
_USED _
_TO _
_TREAT _
_INFECTIONS OF THE:_
Ÿ
Lungs,
in
people
with
long-term
breathing
problems or pneumonia
Ÿ
Urinary tract, including your kidneys or bladder
Ÿ
Prostate gland, where you have a long lasting
infection
Ÿ
Skin
and
underneath
the
skin,
including
muscles. This is sometimes called 'soft tissue’
In some special situations, levofloxacin tablets may
be
used
to
lessen
the
chances
of
getting
a
pulmonary disease named anthrax or worsening of
the disease after you are exposed to the bacteria
causing anthrax.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LEVOFLOXACIN TABLETS
_DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:_
-
You are allergic to levofloxacin, any other quinolone antibiotic such
as
moxifloxacin, ciprofloxacin or ofloxacin or any of the other
ingredients of this
medicine (listed in Section 6)
-
Signs of an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat or tongue
-
You have ever had epilepsy
-
You have ever had a problem with your tendons such as tendonitis that
was
related to treatment with a 'quinolone antibiotic'. A tendon is the
cord that joins
your muscle to your skeleton
-
You are a child or a growing teenager
-
You are pregnant, might become pregnant or think you may be pregnant
WARNINGS AND PRECAUTIONS
Before taking this medicine
You should n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levofloxacin 250 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of levofloxacin as active
substance
corresponding to 256.23 mg of levofloxacin hemihydrate.
Excipient(s) with known effect
Each film-coated tablet contains 3.84 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, film-coated, biconvex 6 x 13mm, scored on one face with
side
scores. Engraved “L” on the unscored face.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levofloxacin tablets are indicated in adults for the treatment of the
following
infections (see sections 4.4 and 5.1):
•
Acute bacterial sinusitis
•
Acute exacerbations of chronic bronchitis
•
Uncomplicated cystitis (see section 4.4)
•
Complicated skin and soft tissue infections
For the above-mentioned infections Levofloxacin 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.
•
Community-acquired pneumonia
•
Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
•
Chronic bacterial prostatitis
•
Inhalation Anthrax: post exposure prophylaxis and curative treatment
(see
section 4.4)
Levofloxacin 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 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 tablets may also be used to complete a course of therapy
in
patients who have shown improvement during initial trea