Cefalexin 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefalexin

Available from:

Waymade Healthcare Plc

ATC code:

J01DB01

INN (International Name):

Cefalexin

Dosage:

500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201

Patient Information leaflet

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFALEXIN 250 MG AND 500 MG CAPSULES
Cefalexin
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 is and what it is used for
2.
What you need to know before you take Cefalexin
3.
How to take Cefalexin
4.
Possible side effects
5.
How to store Cefalexin
6.
Contents of the pack and other information
1.
WHAT CEFALEXIN IS AND WHAT IT IS USED FOR
Cefalexin capsules contain the active ingredient cefalexin, which is
an antibiotic.
Antibiotics work by killing the bacteria (germs) that can cause an
infection.
Cefalexin Capsules are used to treat the following infections:

the lungs and breathing airways (bronchitis and mild to moderate
pneumonia)

the skin and soft tissue (such as wound infection)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFALEXIN
DO NOT TAKE THESE CAPSULES IF:

you are allergic (hypersensitive) to cefalexin other cephalosporins
(similar antibiotics) or any
of the other ingredients of these capsules (see list of ingredients 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.
TAKE SPECIAL CARE WITH THESE CAPSULES IF YOU:

have had an allergic reaction to cefalexin, cephalosporins,
penicillins or other drugs
3

develop di

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefalexin 500 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Cefalexin monohydrate equivalent to 500 mg
Cefalexin.
Excipients: Sunset yellow (E110), Quinoline yellow (E104) and Patent
Blue V
(E131).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule.
Cefalexin 500 mg Capsules are size ‘0’ capsules with dark green
cap and light
green body imprinted with ‘500’ in black ink on cap, containing
white to
yellowish-white granular powder.
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 (see also section 4.4 and 5.1):
•
_Exacerbation of chronic bronchitis _
•
_Mild to moderate community-acquired pneumonia _
•
_Uncomplicated upper and lower urinary tract infections _
•
_Skin and soft tissue infections_
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cefalexin is administered orally.
_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 500 mg
every 12
hours.
For more severe infections or those caused by less susceptible
organisms,
larger doses may be needed. If daily doses of cefalexin greater than
4g are
required,
parenteral
cephalosporins,
in
appropriate
doses,
should
be
considered.
_ _
_Patients with impaired renal function:_ Reduce dosage if renal
function is
markedly impaired (see section 4.4).
_ _
_Elderly patients: _
The recommended dose for adults should be used in elderly patients
except
those with impaired renal function.
_Children:_
The recommended daily dosage for chil