Cephalexin ABM
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
26-07-2023
Summary of Product characteristics
(SPC)
01-05-2023
Active ingredient:
Cefalexin monohydrate 262.9mg equivalent to 250 mg Cefalexin anhydrous.
Available from:
Boucher & Muir (New Zealand) Limited t/a BNM Group
INN (International Name):
Cefalexin monohydrate 262.9 mg (equivalent to 250 mg Cefalexin anhydrous.)
Dosage:
250 mg
Pharmaceutical form:
Capsule
Composition:
Active: Cefalexin monohydrate 262.9mg equivalent to 250 mg Cefalexin anhydrous. Excipient: Hard gelatin capsules size "2" TekPrint SW-9008 black ink Magnesium stearate Microcrystalline cellulose
Units in package:
Blister pack, PVC/Al or PVC/PVDC/Al, 20 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Lupin Limited
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 20 capsules - 24 months from date of manufacture stored at or below 30°C
Authorization date:
2006-05-12
Patient Information leaflet
1
CONSUMER MEDICINE INFORMATION
CEPHALEXIN ABM CAPSULES
(Cephalexin monohydrate)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Cephalexin ABM
Capsules. It does not
contain all the available information. It does not take the place of
talking with your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of you taking Cephalexin ABM
Capsules against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEPHALEXIN ABM CAPSULES ARE USED FOR
The name of your medicine is Cephalexin ABM Capsules. It contains the
active ingredient
cephalexin monohydrate.
Cephalexin is used to treat infections in different parts of the body
caused by bacteria.
Cephalexin can be used to treat infections of the:
• respiratory tract (throat, tonsils, chest and lungs)
• nose (sinusitis)
• ears (otitis media)
• skin and soft tissue
• kidneys and bladder (genitourinary tract)
Cephalexin belongs to a group of medicines called cephalosporins.
These antibiotics work by
killing the bacteria that are causing your infection.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS
BEEN PRESCRIBED FOR YOU. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR
ANOTHER REASON.
THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION.
2
BEFORE TAKING CEPHALEXIN ABM CAPSULES
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CEPHALEXIN ABM
CAPSULES IF YOU HAVE AN ALLERGY TO:
• any medicine containing cephalexin monohydrate
• other cephalosporins
• any of the ingredients listed at the end of this leaflet (see
'Product Description')
DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SERIOUS ALLERGIC REACTION
TO PENICILLIN.
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or
difficulty breathing; swelling of the face, lips, tongue or other
parts of the body; rash, itching
or hives on the
Read the complete document
Summary of Product characteristics
1
CEPHALEXIN ABM
CEPHALEXIN MONOHYDRATE CAPSULES 250 MG AND 500 MG
NEW ZEALAND DATA SHEET
1
CEPHALEXIN ABM
CEPHALEXIN ABM 250 MG AND 500 MG CAPSULES
THIS PRODUCT MAY NOT BE INTERCHANGEABLE WITH OTHER PRODUCTS CONTAINING
THIS
INGREDIENT IN THE NEW ZEALAND MARKET.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains cephalexin monohydrate equivalent to 250 mg
cephalexin or
500 mg cephalexin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cephalexin ABM 250 mg Capsules are Size ‘2’ capsules with a dark
green cap imprinted
with “250” in black ink and a white body.
Cephalexin ABM 500 mg Capsules are Size ‘0’ capsules with a dark
green cap imprinted
with “500” in black ink and a light green body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cephalexin capsules are indicated for the treatment of the following
infections when
caused by susceptible strains of the designated microorganisms:
Bacterial sinusitis caused by streptococci,
_S. pneumoniae_
, and
_Staphylococcus aureus _
(methicillin-sensitive only).
Respiratory tract infections caused by
_S. pneumoniae_
and
_S. pyogenes_
(Penicillin is the
usual medicine 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; however, substantial
data establishing
the efficacy of cephalexin in the subsequent prevention of either
rheumatic fever or
bacterial endocarditis are not available at present.)
2
CEPHALEXIN ABM
CEPHALEXIN MONOHYDRATE CAPSULES 250 MG AND 500 MG
Otitis media due to
_S. pneumoniae_
,
_H. influenzae_
, staphylococci, streptococci, and
_M. _
_catarrhalis_
.
Skin and skin-structure infections caused by staphylococci and/or
streptococci.
Bone infections caused by staphylococci and/or
_P. mirabilis_
.
Genitourinary tract infections, including acute prostatitis, caused by
_E. coli_
,
_P. mirabilis_
,
and
_Klebsiella pneumoniae_
.
Dental infections caused by s
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