Ofloxacin 400mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ofloxacin

Inapatikana kutoka:

Bristol Laboratories Ltd

ATC kanuni:

J01MA01

INN (Jina la Kimataifa):

Ofloxacin

Kipimo:

400mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 05011200; GTIN: 5060013940910

Taarifa za kipeperushi

Package leaflet: Information for the user
OFLOXACIN 200 MG TABLETS
OFLOXACIN 400 MG TABLETS
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell 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 Tablets are and what are they used for
2.
What you need to know before you take Ofloxacin Tablets
3.
How to take Ofloxacin Tablets
4.
Possible side effects
5.
How to store Ofloxacin Tablets
6.
Contents of the pack and other information
1. WHAT OFLOXACIN TABLETS ARE AND
WHAT ARE THEY USED FOR
This medicine contains an active ingredient called Ofloxacin.
Ofloxacin
belongs
to
a
group
of
medicines
called
fluoroquinolones which are used for treating bacterial
infections. Ofloxacin is used to treat a variety of infections in
adults including elderly which include infections of:
•
Urinary tract infections (bladder and kidneys infection)
•
Genital tract infections in men and women (e.g. gonorrhoea,
a sexually transmitted disease)
•
Chest or lungs (respiratory system) such as pneumonia and
bronchitis.
•
Skin and soft tissue. Soft tissue is underneath the skin and
includes muscle
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OFLOXACIN TABLETS
DO NOT TAKE OFLOXACIN TABLETS :
•
if you are allergic (hypersensitive) to ofloxacin or any of the
other ingredients 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
qui

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ofloxacin 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of ofloxacin.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablets (tablet)
The tablets are white capsule shaped and scored on both sides with
‘BL’ and
‘400’ debossed on one face of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ofloxacin is indicated in adults for the 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
- Bacterial prostatitis, epididymo-orchitis
- Pelvic inflammatory disease, in combination with other antibacterial
agents
- Upper and lower urinary tract infections
- Gonococcal urethritis and cervicitis due to susceptible Neisseria
gonorrhoeae
- Non gonococcal urethritis and cervicitis
For the below-mentioned infections ofloxacin should be used only when
it is
considered inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of these infections (see section
4.4):
- Uncomplicated cystitis
- Urethritis
- Complicated skin and soft-tissue infections
- Acute exacerbation of chronic obstructive pulmonary disease
including
bronchitis
- Community acquired pneumonia
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
General dosage recommendations: 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. A daily dose of up to 400 mg ofloxacin may be given as a
single
dose. In this case, it is preferable to administer ofloxacin in the
morning. 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 appropr