Keflex 250 mg/5 ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalexin Anhydrous

Available from:

Flynn Pharma Limited

ATC code:

J01DB; J01DB01

INN (International Name):

Cefalexin Anhydrous

Dosage:

250 mg/5ml

Pharmaceutical form:

Powder for oral suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

First-generation cephalosporins; cefalexin

Authorization status:

Marketed

Authorization date:

1977-04-14

Patient Information leaflet

Package leaflet: Information for the user
KEFLEX 500MG FILM-COATED TABLETS & 250MG HARD CAPSULES
Cefalexin anhydrous
The name of your medicine is Keflex 500mg film-coated tablets and
250mg hard capsules, which will
be referred to as Keflex throughout this document.
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. 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 KEFLEX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KEFLEX
3.HOW TO TAKE KEFLEX
4.POSSIBLE SIDE EFFECTS
5.HOW TO STORE KEFLEX
6.CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT KEFLEX IS AND WHAT IT IS USED FOR
Keflex contains the active ingredient cefalexin monohydrate, which is
an antibiotic.
Keflex is used to treat the following infections caused by bacteria
that can be killed by cefalexin:
•
Respiratory tract (lung and airways) infections e.g. tonsillitis,
pharyngitis and bronchitis
•
Middle ear infection (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 (prostatitis)
•
Dental infections.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KEFLEX
DO NOT TAKE KEFLEX IF
•
you are allergic (hypersensitive) to cefalexin, other cephalosporins
(similar antibiotics) or any
of the other ingredients (these are listed in Section 6). An allergic
reaction may include rash,
itching, difficulty breathing or swelling of the face, lips, throat or
tongue.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist

Summary of Product characteristics

Health Products Regulatory Authority
23 June 2022
CRN00CYCS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Keflex 250 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle when prepared as directed, contains as the active
ingredient cefalexin equivalent to 250 mg / 5 ml cefalexin
anhydrous.
Excipient(s) with known effect
Contains 2.972 g of sucrose per 5ml.
Contains Allura Red AC (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
White, free flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefalexin is a semisynthetic cephalosporin antibiotic for oral
suspension.
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 tract infections, including acute prostatitis
Dental infections
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Keflex 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 500mg every 12 hours.
For more severe infections or those caused by less susceptible
organisms, larger doses may be needed. If daily doses of Keflex
greater than 4g are required, parenteral cephalosporins, in
appropriate doses, should be considered.
_The elderly and patients with impaired renal function: _As for
adults. Reduce dosage if renal function is markedly impaired (see
‘Special warnings’).
_Children:_ The usual recommended daily dosage for children is
25-50mg/kg (10-20mg/lb), 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