Cefalexin 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefalexin

Available from:

Dowelhurst Ltd

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
Tenkorex Capsules 500mg/Cefalexin 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Cefalexin equivalent to 500 mg anhydrous
cefalexin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefalexin is indicated for the treatment of respiratory tract
infections (RTI’s), urinary
tract infections (UTI’s), skin and soft tissue infections, otitis
media and other
infections due to sensitive organisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dosage is 1-4 g daily in divided doses. Most infections will
respond to 500 mg
every 8 hours. For skin and soft tissue infections, streptococcal
pharyngitis and mild
uncomplicated UTI's, 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 dosages may be needed.
_Older people _
The dosage is as for adults. The dosage should be reduced if renal
function is
markedly impaired.
_Paediatric population and adolescents_
The usual recommended daily dosage for children is 25-50 mg/kg in
divided doses.
For skin and soft tissue infections, streptococcal pharyngitis and
mild, uncomplicated
urinary tract infections, the total daily dose may be divided and
administered every 12
hours. For most infections the following schedule is suggested:
children under 5 years:
125 mg every 8 hours
children 5 years and over:
250 mg every 8 hours
In severe infections the dosage may be doubled. In the therapy of
otitis media,
clinical studies have shown that a dosage of 75-100mg/kg/day in 4
divided doses is
required. In the treatment of beta-haemolytic streptococcal
infections, a therapeutic
dose should be administered for at least 10 days.
Method of administration
Tenkorex capsules 500 mg/Cefalexin 500mg capsules are for oral use.
Each capsule
should be swallowed whole with water.
4.3
CONTRAINDICATIONS
Cefal