Ofloxacin 400mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ofloxacin

Inapatikana kutoka:

Mawdsley-Brooks & Company 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

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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Black
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 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
(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
- Uncomplicated urethral and cervical gonorrhea
- 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 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. Larger doses
should be given as
two divided doses. Generally, individual doses are to be given at
approximately equal
intervals. Ofloxacin Film-coated tablets are to be swallowed with
sufficient amount of
liquids. They may be taken on an empty stomach or with meals.
Concomitant
administration with antacids should be avoided (s