Ofloxacin 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ofloxacin

Available from:

Viatris UK Healthcare Ltd

ATC code:

J01MA01

INN (International Name):

Ofloxacin

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 5016695410173

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OFLOXACIN 200 MG
TABLETS
OFLOXACIN 400 MG
TABLETS
ofloxacin
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.
WHAT IS IN THIS LEAFLET:
1.
What Ofloxacin is and what it is used for
2.
What you need to know before you take Ofloxacin
3.
How to take Ofloxacin
4.
Possible side effects
5.
How to store Ofloxacin
6.
Contents of the pack and other information
1.
WHAT OFLOXACIN IS AND WHAT IT IS USED
FOR
Ofloxacin belongs to a group of medicines called
quinolone antibiotics. Ofloxacin is an antibiotic that
can be used to treat a variety of different infections.
These include infections of:
•
the chest (respiratory system) such as pneumonia
and bronchitis.
•
the bladder and kidneys (urinary tract).
•
the male and female genital organs when the
infections involve the cervix (neck of the womb
in women) and the lower genital organs in men.
Ofloxacin can be used to treat both gonorrhoea
and some other genital infections of both the male
and female genital organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE OFLOXACIN
DO NOT TAKE OFLOXACIN:
•
If you are allergic to ofloxacin or any of the other
ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue.
•
If you have previously had an allergic reaction to
another quinolone antibiotic e.g. ciprofloxacin or
norfloxacin.
•
If you suffer from epilepsy or are at risk of fits.
•
If you have a history of inflammation and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ofloxacin 200 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ofloxacin.
Excipient with known effect:
Each film-coated tablet also contains 96.00 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White biconvex capsule-shaped, film-coated tablet marked ‘OF’
breakline ‘200’on
one side and ‘G’ on the reverse.
The tablet can be divided into equal doses.
4.1
THERAPEUTIC INDICATIONS
The following indications are restricted to adults.
Ofloxacin is suitable for treatment of the following bacterial
infections if these are caused by
pathogens sensitive to ofloxacin (see sections 4.4 and 5.1):
•
Acute pyelonephritis and complicated urinary tract infections
•
Non-gonococcal urethritis and cervicitis
•
Gonococcal urethritis and cervicitis due to susceptible _Neisseria
gonorrhoeae_
In the following indications, ofloxacin 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 exacerbation of chronic obstructive pulmonary disease including
bronchitis
•
Community-acquired pneumonia
•
Uncomplicated cystitis
•
Urethritis
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The dose of ofloxacin is determined by the type and severity of the
infection.
The dosage range for adults is 200 mg to 800 mg daily.
Up to 400 mg may be given as a single dose, preferably in the morning.
Generally, individual doses should be given at approximately equal
intervals.
In individual cases it may be necessary to increase the dose to a
maximum
total dose of 800 mg daily, which should be given as 400 mg twice
daily, at
approximately equal intervals. This may be appropriate in infections
due to
pathogens known to have reduced or variable