EVAFLOX 400MG TABLET

Država: Malezija

Jezik: engleski

Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivni sastojci:

OFLOXACIN

Dostupno od:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International ime):

OFLOXACIN

Jedinice u paketu:

1x6 Tablets; 10x6 Tablets

Proizveden od:

UNICHEM LABORATORIES LIMITED

Uputa o lijeku

EVAFLOX 200/400
_Consumer Medication Information Leaflet (RiMUP)_
Ofloxacin Tablets USP 200 mg and 400 mg
1
WHAT IS IN THIS LEAFLET
1.
What Evaflox is used for
2.
How Evaflox works
3.
Before you use Evaflox
4.
How to use Evaflox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Evaflox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
1. WHAT IS EVAFLOX USED FOR
Evaflox tablets contain a medicine
called ofloxacin. This belongs to a
group of medicines called antibiotics.
It works by killing bacteria that cause
infections.
Evaflox tablets 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. HOW EVAFLOX WORKS
Evaflox works by killing bacteria
that cause infections
3. BEFORE YOU USE EVAFLOX
_-When you must not use it _
▪
You are allergic (hypersensitive)
to
ofloxacin
or
any
of
the
other
ingredients of Evaflox tablets (listed
in
Section
8
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
▪
You have a problem with your
red blood cells known as ‘glucose-6-
dehydrogenase deficiency’
▪
You
are
pregnant
or
breast-
feeding (see ‘Pregnancy and breast-
feeding’ section below)
▪
You are under 18 years of age or
are still growing
▪
Do not take this medicine if any of
the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Evaflox tablets.
_-Before you start to use it _
Check with your doctor or pharmacist
before taking your medicine if:
▪
You
have
liver
or
kidney
problems
▪

Svojstava lijeka

100 mm
376 mm
SPECIFICATION: 40 gsm bible Paper (Front Back Printing). ITC
Pharmaprint.
COMPANY NAME : UNICHEM LABORATORIES LTD.
DATE: 26-07-2023
AGENCY NAME: UNICORN CREATION
OPEN SIZE: 100 x 376 mm
PRODUCT: Evaflox Tablet Leaflet - With USP in Generic name
PACKING: NA
ITEM CODE: 13012955
LOCATION: Baddi-II
MARKET: Malaysia
COLOUR CODE: Text in black
OLD ITEM CODE: NA
100 mm
376 mm
Date of revision of insert: July 2023
PRODUCT REGISTRATION HOLDER:
13012955
PREFOLDED SIZE: 100 x 47 mm
NO. OF PREFOLDS: 3 horizontal
REASON: New artwork developed to register product under site variation
from Baddi-II
08/11/2021 - Storage condition changed from “Store below 30°C” to
“Store at temperature not exceeding 30°C. Protected from light and
moisture.
Keep medicines out of the reach of children”. As per input received
from Healol-RA.
15/12/2021-Correction made in Indication, Drug Interactions Special
Warning and Precautions as per DRGD labelling requirement of Malaysia.
11/04/2023 - As per Customer requirement, Leaflet inline with DRGD
requirements on Fluoroquinolone Oral Systemic.
19/06/2023 - Correction made as per requirement of NPRA Malaysia.
26/07/2023 - Correction made as per requirement of NPRA Malaysia.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
200 mg
400 mg
400 mg
400 mg
400 mg
DAILY DOSAGE
EVAFLOX 200
EVAFLOX 400
PRODUCT
MAL NO.:
MAL 20040756AZ
Store at temperature not exceeding 30°C. Protected from light and
moisture.
Keep medicines out of the reach of children.
Musculoskeletal and connective tissue disorders*
Nervous system disorders*
General disorders and administrative site site conditions*
Psychiatric disorders*
Eye disorders*
Ear and labyrinth disorders*
*Very rare cases of prolonged (up to months or years), disabling and
potentially irreversible serious drug reactions
affecting several, sometimes multiple, system organ classes and senses
(including reactions such as tendinitis,
tendon rupture, arthralgia, pain in extremities, gait disturbance,