Levofloxacin 500mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Levofloxacin hemihydrate

Disponível em:

Accord-UK Ltd

Código ATC:

J01MA12

DCI (Denominação Comum Internacional):

Levofloxacin hemihydrate

Dosagem:

500mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05011200; GTIN: 5060149317563 5060149316245

Folheto informativo - Bula

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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

Características técnicas

OBJECT 1
LEVOFLOXACIN 500 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 24-Oct-2014 | Accord
Healthcare Limited
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 as active
substance corresponding to 512.46 mg
of levofloxacin hemihydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
For 500 mg tablets: Pink coloured, capsule shaped, biconvex, film
coated tablet 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 Tablets 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 Tablets 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)
• Chronic bacterial prostatitis
• Uncomplicated cystitis (see section 4.4)
• Inhalation Anthrax: postexposure 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 sensitivity of the presumed causative
pathogen.
_Treatment time_
The duration of therapy varies according to the course of the disease
(see