Cefalexin 500mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Cefalexin

Dostępny od:

Milpharm Ltd

Kod ATC:

J01DB01

INN (International Nazwa):

Cefalexin

Dawkowanie:

500mg

Forma farmaceutyczna:

Oral capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05010201; GTIN: 5060035110728

Ulotka dla pacjenta

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.

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefalexin 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg of Cefalexin (as monohydrate)
Excipient(s) with known effect
Each capsule contains 53.2 mg lactose.
For full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Capsules, hard
Size 0 grey/orange capsule containing white powder printed CHX 500.
4
CLINICAL PARTICULARS
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 1-4 g daily in divided doses; most
infections will respond to a
dosage of 500 mg every 8 hours. For skin and soft tissue infections,
streptococcal
pharyngitis and mild, uncomplicated urinary tract infections, the
usual dosage is 250 mg
every 6 hours, or 500 mg every 12 hours.
For more severe infections or those caused by less susceptible
organisms, larger doses may