Cefalexin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefalexin

Available from:

Milpharm Ltd

ATC code:

J01DB01

INN (International Name):

Cefalexin

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5060035110711

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read
it again.
-
If you have any further questions, ask
your doctor or pharmacist.
-
This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours
-
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cefalexin Capsules are and what
they are used for
2. What you need to know before you take
Cefalexin Capsules
3. How to take Cefalexin Capsules
4. Possible side effects
5. How to store Cefalexin Capsules
6. Contents of the pack and other
information 1. WHAT CEFALEXIN CAPSULES ARE
AND WHAT THEY ARE USED FOR
Cefalexin Capsules contain cefalexin as
the active ingredient, which belongs to a
class of antibiotics called ‘cephalosporins’.
Cefalexin Capsules are used to treat
following infections caused by bacteria that
can be killed by cefalexin:
•
Respiratory tract (lung and airways) e.g.
tonsillitis, pharyngitis and bronchitis
•
Middle ear infections (otitis media)
•
Skin and soft tissue (e.g. muscle)
infections
•
Bone and joint infections
•
Infections of the reproductive organs
and urinary tract (e.g. cystitis), including
acute inflammation of the prostate gland
(prostatitis)
•
Dental infections.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CEFALEXIN
CAPSULES
DO NOT TAKE CEFALEXIN CAPSULES:
•
If you are allergic to cefalexin, other
cephalosporins (similar antibiotics)
or any of the other ingredients of this
medicine (listed in Section 6). An allergic
reaction may include rash, itching,
difficulty breathing or swelling of the
face, lips, throat or tongue.
TELL YOUR DOCTOR BEFORE TAKING CEFALEXIN:
•
If you have ever developed a severe
skin rash or skin peeling, blistering and/
or mouth sores after taking cefalexin or
other antibacterials.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefalexin 250 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of Cefalexin (as monohydrate)
Excipient(s) with known effect
Each capsule contains 26.6 mg lactose.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules, hard
Size 2 grey/orange capsule containing white powder printed CHX 250.
4.1
THERAPEUTIC INDICATIONS
Cefalexin is a semi synthetic cephalosporin antibiotic for oral
administration.
Cefalexin is indicated in the treatment of the following infections
due to
susceptible micro-organisms:
Respiratory tract infections
Otitis media
Skin and soft tissue infections
Bone and joint infections
Genito-urinary infections, including acute prostatitis
Dental infections.
Cefalexin is active against the following organisms in vitro:
β
-
haemolytic streptococci; staphylococci, including coagulase-positive,
coagulase-negative and penicillinase-producing strains; Streptococcus
pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella species,
Haemophilus influenzae; Branhamella catarrhalis.
Most strains of enterococci (Streptococcus faecalis) and a few strains
of
staphylococci are resistant to cefalexin. Cefalexin is inactive
against
most strains of enterobacter, morganella morganii, pr. Vulgaris,
Colstridium difficule, and the following species: legionella,
campylobacter , pseudomonas or herellea species. When tested by in
vitro methods, staphylococci exhibit cross-resistance between
cefalexin
and methicillin-type antibiotics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The Adult dosage ranges from 1-4g daily in divided doses; most
infections will respond to a dosage of 500mg every 8 hours.
For skin and soft tissue infections, streptococcal pharyngitis and
mild,
uncomplicated urinary tract infections, the usual dosage is 250mg
every
6 hours, or 500mg every 12 hours.
More severe infections, or those caused by less susceptible organisms,
larger doses may be needed. If daily doses