Oxacid 200

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OFLOXACIN

Available from:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

ATC code:

J01MA01

INN (International Name):

OFLOXACIN 200 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

OFLOXACIN 200 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-08-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXACID 200 MG CAPSULES
OXACID 400 MG CAPSULES
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 or
nurse.
•
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oxacid capsules are and what they are used for
2.
What you need to know before you take Oxacid capsules
3.
How to take Oxacid capsules
4.
Possible side effects
5.
How to store Oxacid capsules
6.
Contents of the pack and other information
1. WHAT OXACID CAPSULES ARE AND WHAT THEY ARE USED FOR
Oxacid capsules contain a medicine called ofloxacin. This belongs to a
group of medicines called
antibiotics. It works by killling bacteria that cause infections.
Oxacid capsules are used for infections of the:
•
Kidneys or bladder (urinary tract).
•
Chest or lungs.
•
Male or female sex organs (genital tract). This includes gonorrhoea
which is a sexually
transmitted infection that can affect both men and women.
•
Skin and soft tissue. Soft tissue is underneath the skin and includes
muscle.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXACID CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
−
You are allergic (hypersensitive) to ofloxacin or any of the other
ingredients of Oxacid
capsules (listed in section 6 below). Signs of an allergic reaction
include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat or tongue.
−
You have ever had swelling of the tendons (called tendinitis) which
can affect areas such as
the wrist or the achilles tendon.
−
You have epilepsy or are at risk of fits.
1
−
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Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Oxacid 200 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
For 200 mg strength:
Each capsule contains 200 mg ofloxacin.
Excipient(s) with known effect: each capsule also contains 98.00 mg of
lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules.
Oxacid 200 mg capsules are green, hard gelatin capsules, size O,
containing white to yellowish
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with
bactericidal activity against a
wide range of Gram-negative and Gram-positive organisms. It is
indicated for the treatment of the
following infections when caused by sensitive organisms: upper and
lower urinary tract infections;
lower respiratory tract infections; uncomplicated urethral and
cervical gonorrhoea; non-gonococcal
urethritis and cervicitis, skin and soft tissue infections.
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.
Up to 400 mg may be given
as a single dose, preferably in the morning, larger doses should be
given as two divided doses.
Generally, individual doses are to be given at approximately equal
intervals. Oxacid capsules
should
be
swallowed
with
liquid;
they
should
not
be
taken
within
two
hours
of
magnesium/aluminium containing antacids, sucralfate, zinc or iron
preparations since reduction of
absorption of ofloxacin can occur.
Lower urinary tract infection: 200-400 mg daily.
Upper urinary tract infection: 200-400 mg daily increasing, if
necessary, to 400 mg twice a day.
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Lower respiratory tract infection: 400 mg daily increasing, if
necessary, to 400 mg twice a day.
Uncomplicated urethral and cervical gonorrhoea: a single dose of 400
mg.
Non-gonococcal urethritis and cervicitis: 400 mg daily in single or
divided doses.
Skin and soft tissue infection: 400 mg twice daily.
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