Levofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levofloxacin hemihydrate

Available from:

Ipca Laboratories 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: 18901079128024 18901079128796

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 250 MG FILM-COATED TABLETS
LEVOFLOXACIN 500 MG FILM-COATED TABLETS
(LEVOFLOXACIN)
-
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.
What is in this leaflet:
1.
What Levofloxacin Film-coated Tablets are and what they are used for
2.
What you need to know before you take Levofloxacin Film-coated Tablets
3.
How to take Levofloxacin Film-coated Tablets
4.
Possible side- effects
5.
How to store Levofloxacin Film-coated Tablets
6.
Contents of the pack and other information.
1. WHAT LEVOFLOXACIN FILM-COATED TABLETS ARE AND WHAT ARE THEY USED
FOR
THE NAME OF YOUR MEDICINE IS LEVOFLOXACIN 250MG OR 500MG FILM-COATED
TABLETS AND WILL BE
REFERRED TO AS LEVOFLOXACIN FILM-COATED TABLETS THROUGHOUT THIS
LEAFLET.
Levofloxacin Film-coated Tablets contain the active ingredient
levofloxacin. Levofloxacin is a quinolone
antibiotic. It works by killing the bacteria that cause infection in
your body.
LEVOFLOXACIN FILM-COATED TABLETS CAN BE USED IN ADULTS INCLUDING
ELDERLY TO TREAT INFECTIONS OF THE:
•
sinuses
•
lungs, in people with long-term breathing problems or pneumonia
•
urinary tract, including your bladder or kidneys
•
skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
•
prostate gland, where you have a long lasting infection
In some special situations, Levofloxacin film-coated 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. WHAT D

Summary of Product characteristics

OBJECT 1
Levofloxacin 500mg tablets
Summary of Product Characteristics Updated 08-Mar-2021 | Ipca
Laboratories UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Levofloxacin 500mg film-coated tablet
2. Qualitative and quantitative composition
Each film-coated tablet contains Levofloxacin hemihydrate equivalent
to Levofloxacin 500mg. For full
list of excipients, see Section 6.1
3. Pharmaceutical form
Film-coated tablets (tablet)
Pink coloured, capsule shaped, biconvex film coated tablets with a
break line on both sides.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
In adults, Levofloxacin tablets are indicated for the treatment of the
following infections (see sections 4.4
and 5.1):
• Acute bacterial sinusitis
In above-mentioned infections, Levofloxacin tablets product should be
used only when it is considered
inappropriate to use other antibacterial agents