NOUMED CEFALEXIN cefalexin 500 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalexin monohydrate, Quantity: 550 mg (Equivalent: cefalexin, Qty 500 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; Gelatin; titanium dioxide; iron oxide yellow; brilliant blue FCF; sunset yellow FCF; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

20 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the following bacterial infections when caused by susceptible strains of the designated micro-organisms. Respiratory tract infections; Strep. pneumoniae and group A B-haemolytic streptococci. Although penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections (including the prophylaxis of rheumatic fever), cephalexin is generally effective in the eradication of streptococci from the nasopharynx. Substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present. Bacterial sinusitis: Streptococci, Strep. pneumoniae and Staph. Aureus (methicillin sensitive only). Otitis media: Strep. pneumoniae, staphylococci (methicillin sensitive only). Skin and skin structure infections: Staphylococci (methicillin sensitive only) and/or streptococci. Genitourinary tract infections, including acute prostatitis: E.coli, P.mirabilis, and Klebsiella sp. The effectiveness of cephalexin in the treatment of bacterial infections of the brain and spinal column has not been established and NOUMED CEPHALEXIN is not indicated in these conditions. Note. Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to NOUMED CEPHALEXIN. Renal function studies should be perfomed when indicated.

Product summary:

Visual Identification: Dark green/light green, self locked hard gelatin capsules of size '0' imprinted with 'RX657' in black edible ink containing white to off white granular powder / pellet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-01-23

Patient Information leaflet

NOUMED CEFALEXIN
1
NOUMED CEFALEXIN
_cefalexin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NOUMED
CEFALEXIN against the benefits it
is expected to have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with this medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
NOUMED CEFALEXIN capsules
contain cefalexin. Cefalexin is an
antibiotic used to treat infections in
different parts of the body caused by
bacteria. NOUMED CEFALEXIN
can be used to treat infections of the:

Respiratory tract (throat, tonsils,
chest and lungs)

Nose (sinusitis)

Ears (otitis media)

Skin

Kidneys and bladder
(genitourinary tract)
NOUMED CEFALEXIN capsules
belong to a group of antibiotic
medicines called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed
NOUMED CEFALEXIN for another
reason. Ask your doctor if you have
any questions about why NOUMED
CEFALEXIN has been prescribed for
you.
NOUMED CEFALEXIN Capsules
are available only with a doctor's
prescription.
BEFORE TAKING THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOUMED
CEFALEXIN IF:

You have had an allergic reaction
to NOUMED CEFALEXIN, any
other medicine containing
cefalexin, or other cephalosporins
or any of the ingredients listed at
the end of this leaflet. Signs of an
allergic reaction may include
itching of the skin, shortness of
breath and swelling of the tongue
or face.

You have had a serious allergic
reaction to penicillin.

The packaging is torn or shows
signs of tampering.

The expiry date on the pack has
passed. If you take this medicine
after the expiry date has passed, it
may have no effect at all, or
worse, an unexpected effect.
Ther

Summary of Product characteristics

Product Information - Australia
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION – NOUMED
CEFALEXIN CAPSULES
(CEFALEXIN MONOHYDRATE)
1. NAME OF THE MEDICINE
Cefalexin monohydrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NOUMED CEFALEXIN capsules contain cefalexin which is a semisynthetic
cephalosporin antibiotic intended for
oral administration. cefalexin is a white or almost white, crystalline
powder. It is sparingly soluble in water and
practically insoluble in alcohol.
NOUMED CEFALEXIN capsules do not contain gluten.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Dark green and light green, self-locked hard gelatin capsules of size
0, imprinted with RX657 in black ink,
containing white to off-white granular powder/pellets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment
of
the
following
bacterial
infections
when
caused
by
susceptible
strains
of
the
designated
microorganisms:
RESPIRATORY TRACT INFECTIONS
_Streptococcus pneumoniae_ and group A ß-haemolytic streptococci.
Although penicillin is the usual drug of choice
in the treatment and prevention of streptococcal infections (including
the prophylaxis of rheumatic fever), cefalexin
is generally effective in the eradication of streptococci from the
nasopharynx. Substantial data establishing the
efficacy of cefalexin in the subsequent prevention of rheumatic fever
are not available at present.
BACTERIAL SINUSITIS
_Streptococci, Streptococcus pneumoniae and Staphlococcus aureus_
(methicillin sensitive only)._ _
OTITIS MEDIA
_Streptococcus pneumoniae_, _staphylococci_ (methicillin sensitive
only)._ _
SKIN AND SKIN STRUCTURE INFECTIONS
_Staphylococci _(methicillin sensitive only) and/or streptococci.
GENITOURINARY TRACT INFECTIONS, INCLUDING ACUTE PROSTATITIS
_E. coli_, P. _mirabilis_ and _Klebsiella sp_.
The effectiveness of cefalexin in the treatment of bacterial
infections of the brain and spinal column has not been
established and NOUMED CEFALEXIN capsules are not indicated in these
conditions. (see sec