Levofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Actavis 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: 5012617020079 5012617020062

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 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