Levofloxacin Beximco Coated Tablets 250mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOFLOXACIN

Available from:

Beximco Pharma UK Ltd 102, College Road, Harrow HA1 1ES, United Kingdom

ATC code:

J01MA12

INN (International Name):

LEVOFLOXACIN 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVOFLOXACIN 250 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2015-12-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN BEXIMCO 250 MG FILM-COATED TABLETS
LEVOFLOXACIN BEXIMCO 500 MG FILM-COATED TABLETS
Levofloxacin
READ THIS ALL 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.
WHAT IS IN THIS LEAFLET:
1. What Levofloxacin BeximcoTablet is and what it is used for
2. What you need to know before you take Levofloxacin Beximco Tablet
3. How to take Levofloxacin BeximcoTablet
4. Possible side effects
5. How to store Levofloxacin Beximco Tablet
6. Contents of the pack and other information
1. WHAT LEVOFLOXACIN BEXIMCOTABLET IS AND WHAT IT IS USED FOR
The name of your medicine is Levofloxacin Beximco tablets.
Levofloxacin Beximco 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.
LEVOFLOXACIN BEXIMCO TABLETS CAN BE USED TO TREAT INFECTIONS OF THE:
• Sinuses
• Lungs, in people with long-term breathing problems or pneumonia
• Urinary tract, including your kidneys or bladder
• Prostate gland, where you have a long lasting infection
• Skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
In some special situations, Levofloxacin Beximco 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
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN BEXIMCO TABLET
DO NOT TAKE LEVOFLOXACI

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levofloxacin Beximco 250 mg film-coated tablets
Levofloxacin Beximco 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250/500 mg film-coated tablet contains 250/500 mg of levofloxacin
as levofloxacin
hemihydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Levofloxacin Beximco 250 mg film-coated tablets: Pink coloured,
capsule shaped, biconvex, film
coated tablet of about 13 mm in length and about 6 mm in width, with
break line on both sides.
Debossed ‘L’ and ‘F’ either side of the break line on one
face.
Levofloxacin Beximco 500 mg film-coated tablets: Pink coloured,
capsule shaped, biconvex, film
coated tablet of about 16 mm in length and about 8 mm in width, with
break line on both sides.
Debossed ‘L’ and ‘V’ either side of the break line on one
face.
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 4.4
and 5.1):
• Acute bacterial sinusitis
• Acute exacerbations of chronic bronchitis
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
For the above-mentioned infections Levofloxacin Beximco should be used
only when it is
considered inappropriate to use antibacterial agents that are commonly
recommended for the
initial treatment of these infections.
• Pyelonephritis and complicated urinary tract infections (see
section 4.4)
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• Chronic bacterial prostatitis
• Uncomplicated cystitis (see section 4.4)
• Inhalation Anthrax: post exposure prophylaxis and curative
treatment (see section 4.4)
Levofloxacin Beximco 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
PO