Levofloxacin 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Sigma Pharmaceuticals Plc

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

Patient Information leaflet

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Details
LEVOFLOXACIN 250MG & 500MG TABLETS PIL - UK
Black
BBBA6300
R.Paul
20.09.2019
26.09.2019
R.Paul
190x380
7pt
Teva Malta Zejtun
20.09.2019
20.09.2019
2
Version 2
01.11.2017
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.
•
The full name of this medicine is Levofloxacin 250mg and 500mg Tablets
but within the leaflet it will be referred to as Levofloxacin tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN TABLETS
3
HOW TO TAKE LEVOFLOXACIN TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE LEVOFLOXACIN TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
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 cau

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