Levofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Teva 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: 5017007012498 5017007064459

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 500 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of levofloxacin corresponding
to 512.46 mg
of levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Peach, film-coated capsule shaped tablet, debossed with "LX" on the
left side and
"500" on the right side of the score on one side, scored and smooth on
the opposite
side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LEVOFLOXACIN IS INDICATED IN ADULTS FOR THE TREATMENT OF THE FOLLOWING
INFECTIONS
(SEE SECTIONS
_4.1 THERAPEUTIC INDICATIONS _
Levofloxacin is indicated in adults for the treatment of the following
infections (see sections
4.4 and 5.1):
•
Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
•
Chronic bacterial prostatitis
•
Inhalation Anthrax: postexposure prophylaxis and curative treatment
(see section 4.4)
In the below-mentioned infections Levofloxacin 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 bacterial sinusitis
•
Acute exacerbation of chronic obstructive pulmonary disease including
bronchitis
•
Community-acquired pneumonia
•
Complicated skin and soft tissue infections
•
Uncomplicated cystitis (see section 4.4)
Levofloxacin 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
sensitivity of the
presumed causative pathogen.
Levofloxacin tablets may also be used to complete a course of