Xorimax coated tablets 500 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CEFUROXIME AXETIL

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CEFUROXIME AXETIL

Unit dalam pakej:

7Tablet Tablets; 14Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

SANDOZ GMBH

Risalah maklumat

XORIMAX

COATED TABLETS
Cefuroxime axetil (250 mg, 500 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET:
1.
What Xorimax is used for
2.
How Xorimax works
3.
Before you use Xorimax
4.
How to use Xorimax
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Xorimax
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT XORIMAX IS USED FOR
Xorimax can be used to treat:
•
ear, nose and throat infections
•
chest infections such as
bronchitis
•
infections of the bladder
•
infections in the skin
•
some types of gonorrhoea
infections (a sexually
transmitted disease).
HOW XORIMAX WORKS
Xorimax is in a class of antibiotics
called cephalosporins. This class of
antibiotics acts similarly to
penicillin. It kills bacteria and it
can be used against various sorts of
infections.
Like all antibiotics, Xorimax is
only effective against some types
of bacteria, hence it is only suitable
for treating some types of
infection.
BEFORE YOU USE XORIMAX
-
_When you must not use it _
•
You are allergic (hypersensitive)
to cefuroxime or to any of the
other ingredients of this
medicine.
•
You are allergic to any other
cephalosporin type of
antibiotic.
•
You have or ever had a severe
allergic reaction to any sort of
penicillin or beta-lactam
antibiotics.
If you are not sure about anything,
ask your doctor or pharmacist.
_PREGNANCY AND BREAST-FEEDING _
If you are pregnant, or you think
you might be pregnant, ask your
doctor for advice before taking any
medicine. Although this medicine
is not known to harm the unborn
child, it will only be given to a
pregnant woman if it is really
necessary.
This medicine should not be given
to women who are breastfeeding.
This is because small amounts of it
enter the milk.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start use it _
Talk to your doctor or pharmacist if
any of the below apply to you.
•
If you have severe and
persistent diarrhea while using
or after us

Ciri produk

XORIMAX
® 250 MG AND 500 MG COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Xorimax Coated Tablets 250 mg
Xorimax Coated Tablets 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xorimax 250 mg: Each coated tablet contains 250 mg cefuroxime.
White to slightly yellowish, biconvex, scored on both sides, oblong
(approx. 7 x 18 mm).
Xorimax 500 mg: Each coated tablet contains 500 mg cefuroxime.
White to slightly yellowish, biconvex, oblong (approx. 10 x 22 mm).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Upper respiratory tract infections for example, ear, nose and throat
infections, such as otitis media,
sinusitis, tonsillitis and pharyngitis.
Lower respiratory tract infections for example, pneumonia, acute
bronchitis and acute exacerbations
of chronic bronchitis.
Genito-urinary tract infections for example, pyelonephritis, cystitis
and urethritis.
Skin and soft-tissue infections for example, furunculosis, pyoderma
and impetigo.
Gonorrhea, acute uncomplicated gonococcal urethritis and cervicitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is 7 days (may range from 5 to 10 days).
_ _
_Adults: _
_ _
INDICATION
DOSE
Most infections
250 mg twice daily
Urinary tract infections
125 mg twice daily
Mild to moderate lower tract infections (e.g. bronchitis)
250 mg twice daily
More severe lower tract infections, or if pneumonia is suspected
500 mg twice daily
Pyelonephritis
250 mg twice daily
Uncomplicated gonorrhoea
1 g as single dose
_ _
_Children:_
Most infections:
125 mg twice daily, to a maximum of 250 mg daily.
Children aged two years or older with otitis media or where
appropriate with more severe infections –
250 mg twice daily, to a maximum of 500 mg daily.
Xorimax tablets should not be crushed and are therefore unsuitable for
treatment of patients, such as
younger children, who cannot