AXCEL CEPHALEXIN-250 CAPSULE

Country: Malaysia

Language: English

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

Active ingredient:

CEPHALEXIN MONOHYDRATE

Available from:

KOTRA PHARMA (M) SDN. BHD.

INN (International Name):

CEPHALEXIN MONOHYDRATE

Units in package:

10×10 Capsules; 100×10 Capsules

Manufactured by:

KOTRA PHARMA (M) SDN. BHD.

Patient Information leaflet

AXCEL CEPHALEXIN CAPSULE
Cephalexin Monohydrate (250mg, 500mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Axcel Cephalexin Capsule
is used for
2.
How Axcel Cephalexin Capsule
works
3.
Before you use Axcel Cephalexin
Capsule
4.
How
to
use
Axcel
Cephalexin
Capsule
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Axcel
Cephalexin Capsule
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT AXCEL CEPHALEXIN CAPSULE IS
USED FOR
Axcel Cephalexin Capsule is to treat
infections
caused
by
susceptible
bacteria. It can be used to treat:

Respiratory tract infections.

Ear, nose and throat infections.

Urinary tract infections.

Prevention of recurrent
urinary
tract infection.

Gynaecological
and
obstetric
infections.

Gonorrhoea (venereal disease).

Skin,
soft-tissue
and
bone
infections.

Dental infections.

Prophylaxis
treatment
for
individuals
with
heart
disease
undergoing dental treatment as an
alternative to penicillin.
HOW
AXCEL
CEPHALEXIN
CAPSULE
WORKS
Cephalexin
is
an
antibiotic
that
belongs to the
group of
medicines
called
cephalosporin.
These
medicines work by killing or stopping
the
growth
of
the
bacteria,
which
cause infections.
BEFORE YOU USE AXCEL CEPHALEXIN
CAPSULE
_-When you must not use it _
Do
not
take
Axcel
Cephalexin
Capsule if:

You are allergic or hypersensitive
to cephalosporin.

It is not prescribed by a qualified
doctor or pharmacist for you.

You are pregnant, trying to get
pregnant or think
you
may be
pregnant.

You are breast-feeding. Ask your
doctor or pharmacist for advice
before taking any medicine.
_-Before you start use it _
Tell your doctor if:

You
are
allergic
to
any
medicines, food and dyes.

You
are
taking
any
other
medicines
(including
those
not
prescribed by your doctor).

You are allergic or hypersensitive
to Penicillin.

You
are
having
kidney
impairment.
_-Taking other medicines _
You should tell your doctor if you are
taking the

Summary of Product characteristics

CONTRAINDICATION:
Contraindicated in patient hypersensitive to cephalosporin.
PRECAUTION:
Cephalexin should be used with caution for patient with
penicillin sensitivity. False positive urinary glucose and
false positive Combs’ test have been found during the
treatment of Cephalexin. Patients with renal impairment
should be given with caution. Pseudomembranous colitis
has been reported with nearly all antibacterial agents,
including cephalexin, and may range from mild to life
threatening. Therefore, it is important to consider this
diagnosis in patients with diarrhea subsequent to the
administration of cephalexin. Prolonged use of cephalexin
may result in the overgrowth of non susceptible organisms.
Careful
observation
of
the
patients
is
essential.
If
superinfection
occurs
during
therapy,
appropriate
measures should be taken. Serious and occasionally fatal
hypersensitivity reactions
(including
anaphylactoid and
severe cutaneous adverse reactions) have been reported
in patients receiving therapy with beta-lactams. Before
initiating therapy with Axcel Cephalexin Capsule, careful
inquiry
should
be
made
concerning
previous
hypersensitivity reactions to penicillins, cephalosporins,
carbapenems or other beta-lactam agents. If an allergic
reaction
occurs, Axcel
Cephalexin
Capsule
must
be
discontinued
immediately
and
appropriate
alternative
therapy instituted.
Use in Pregnancy and Lactation:
Cephalexin is widely distributed in the body. It crosses the
placenta and small quantities are found in the milk of
nursing mother. Caution should be taken while given to
pregnant women and nursing mothers.
SIDE EFFECTS:
The most common side effects of cephalexin are generally
gastrointestinal
disturbances
and
hypersensitivity
reactions, including skin rashes, urticaria, eosinophilia,
fever,
reactions
resembling
serum
sickness
and
anaphylaxis.
DRUG INTERACTIONS:
Cephalexin decreases the efficacy of oestrogen containing
oral contraceptives. The concomitant use of probenecid
will reduce the excretion of cephalexin; nephrotoxic drug
su