Cefalexin Sandoz
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
16-06-2017
Summary of Product characteristics
(SPC)
07-07-2017
Active ingredient:
Cefalexin monohydrate 525.8mg equivalent to Cephalexin 500 mg;
Available from:
Sandoz New Zealand Limited
INN (International Name):
Cefalexin monohydrate 525.8 mg (=Cephalexin 500 mg)
Dosage:
500 mg
Pharmaceutical form:
Capsule
Composition:
Active: Cefalexin monohydrate 525.8mg equivalent to Cephalexin 500 mg Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Titanium dioxide Water
Units in package:
Blister pack, PVC/PVDC/Al foil strip, 20 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
DSM Sinochem Pharmaceuticals Spain, S.A.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil strip - 20 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al foil strip - 100 capsules - 48 months from date of manufacture stored at or below 30°C
Authorization date:
2000-10-12
Patient Information leaflet
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_Version 05 _
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1
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CEFALEXIN SANDOZ
®
_Cephalexin Monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Cefalexin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cefalexin
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CEFALEXIN SANDOZ
IS USED FOR
The name of your medicine is
Cefalexin Sandoz. It contains the
active ingredient cephalexin
monohydrate.
Cefalexin Sandoz is an antibiotic
used to treat infections in different
parts
of
the
body
caused
by
bacteria.
Cefalexin Sandoz belongs to a
group of antibiotics called
cephalosporins. These antibiotics
work by killing the bacteria that are
causing your infection.
Cefalexin Sandoz 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).
Your doctor may have prescribed
Cefalexin Sandoz for another
reason. ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY
CEFALEXIN SANDOZ HAS BEEN
PRESCRIBED FOR YOU.
Cefalexin Sandoz is available only
with a doctor’s prescription. It is
not addictive.
BEFORE YOU TAKE
CEFALEXIN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CEFALEXIN SANDOZ IF:
1.
YOU HAVE AN ALLERGY TO
CEPHALEXIN MONOHYDRATE,
OTHER CEPHALOSPORINS OR ANY
OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
asthma, wheezing, shortness
of breath; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or
breathing; skin rash, itching or
hives.
2.
YOU HAVE HAD A SERIOUS
ALLERGIC REACTION TO ANY
PENICILLINS.
You may be more likel
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Page 1 of 10
1 PRODUCT NAME
Cefalexin Sandoz _ _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefalexin Sandoz capsules contain 250 mg or 500 mg cefalexin
Cefalexin Sandoz granules for oral suspension contain 125 mg or 250 mg
cefalexin per 5mL
when reconstituted
Excipient(s) with known effect: n/a
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cefalexin Sandoz capsules, hard
250 mg: Capsule, powder filled, Size 2, orange opaque cap and grey
opaque body,
approximately 17.5 mm length and 6.3 mm diameter.
500 mg: Capsule, powder filled, Size 0, orange opaque cap and grey
opaque body,
approximately 21.2 mm length and 7.6 mm diameter.
Cefalexin Sandoz granules for oral suspension
125 mg/5 mL: Orange to yellow granules
250 mg/5 mL: Orange to yellow granules
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Cefalexin is 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 - cefalexin is generally
effective in the
eradication of streptococci from the nasopharynx; however, substantial
data establishing
the efficacy of cefalexin in the subsequent prevention of either
rheumatic fever or
bacterial endocarditis are not available at present); _ _
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 sta
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