Ofloxacin 400mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ofloxacin

Inapatikana kutoka:

DE Pharmaceuticals

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

Taarifa za kipeperushi

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TrackWise PR No.
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v3/July 2017
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1/2
1
Myriad Pro
9 pt
9 pt
170 x 480 mm
Ofloxacin 400 mg,200 mg 5,10
Leaflet
1710933
839618
1710933
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LT1296AI
508
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367148
2
United Kingdom
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18 Dec 2018
20:58
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 geni

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ofloxacin 400 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of ofloxacin.
Excipient with known effect:
Each filmcoated tablet also contains 228.00 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow biconvex capsule-shaped, film-coated tablet marked ‘OF’
breakline ‘400’on
one side and ‘G’ on the reverse.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
The following indications are restricted to adults. Consideration
should be given to official
guidance on the appropriate use of antibiotics.
Ofloxacin is indicated for treatment of the following infections when
these are caused by
organisms sensitive to ofloxacin (see sections 4.4 and 5.1):
•
Acute pyelonephritis and complicated urinary tract infections
•
Bacterial prostatitis, epididymo-orchitis, including infection due to
a sensitive _Neisseria _
_gonorrhoeae _strain
•
Urethritis and cervicitis, including infection due to a sensitive
_Neisseria gonorrhoeae _
strain.
•
Pelvic inflammatory disease (PID), in combination with other
antibiotics
•
Pelvic inflammatory disease (PID), including infection due to a
sensitive Neisseria
gonorrhoeae strain
•
Pulmonary tuberculosis due to resistant mycobacteria, particularly in
immunosuppressed
patients (minor antituberculosis agent)
•
Tuberculosis, in combined therapy
•
Chronic sinusitis of bacterial origin
•
Chronic suppurative otitis media
•
Complicated intraabdominal infections
•
Treatment of febrile neutropenia episodes when bacterial origin is
suspected
•
Prophylaxis of febrile neutropenia when bacterial origin is suspected
In the following indications, ofloxacin should be used only when it is
considered
inappropriate to use other antibiotics that are commonly recommended
for the treatment of
these infections:
•
Urethritis
•
Uncomplicated cystiti