Ceporex 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefalexin

Available from:

Strides Pharma UK Ltd

ATC code:

J01DB01

INN (International Name):

Cefalexin

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5016298717600 5016298707595

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEPOREX TABLETS 250MG AND 500MG
(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 or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their side effects are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ceporex is and what it is used for
2.
What you need to know before you take Ceporex Capsules
3.
How to take Ceporex Capsules
4.
Possible side effects
5.
How to store Ceporex Capsules
6.
Contents of the pack and other information
1.
WHAT CEPOREX IS AND WHAT IT IS USED FOR
This medicine is called Ceporex Tablets. Ceporex Tablets contain the
active
substance cefalexin, which belongs to a group of medicines called
cephalosporin
antibiotics.
Cefalexin is used to kill bacteria that cause infections in your body.
These include ear,
nose, throat and chest infections, urinary tract infections,
infections of the bone, skin
and soft tissue and genital infections, for example gonorrhoea or
infections resulting
from childbirth. Ceporex may also be prescribed to treat dental
infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEPOREX
TABLETS
DO NOT TAKE CEPOREX TABLETS
−
if you are allergic (hypersensitive) to any cephalosporin antibiotic,
such as
cefalexin, cefuroxime, cefradine or cefaclor
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking this medicine:
−
If you have ever developed a severe skin rash or skin peeling,
blistering
and/or mouth sores after taking cefalexin or other antibacterials
−
if you are allergic to any penicillin antibiotic, such as penicillin,
ampicillin,
amoxicillin or flucloxicillin
−
if you suffer f

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ceporex Tablets 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefalexin Ph.Eur 250mg per tablet
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceporex is a bactericidal antibiotic of the cephalosporin group which
is active
against a wide range of Gram-positive and Gram-negative organisms. It
is
indicated for treatment of the following conditions, when caused by
susceptible
bacteria.
Respiratory tract infections: _ _Acute and chronic bronchitis and
infected
bronchiectasis.
Ear, nose and throat infections: _ _Otitis media, mastoiditis,
sinusitis, follicular
tonsillitis and pharyngitis.
Urinary tract infections: Acute and chronic pyelonephritis, cystitis
and
prostatitis. Prophylaxis of recurrent urinary tract infection.
Gynaecological and obstetric infections.
Skin, soft-tissue and bone infections.
Gonorrhoea (when penicillin is unsuitable).
Dental procedures_:_ Treatment of dental infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Many infections in adults will respond to oral dosage of 1 gram to 2
grams per
day in divided doses; however, for most infections, the following
simple
dosage scheme will be found satisfactory:
_Adults and children over 12 years: _ 1 g b.d.
The following additional information should also be considered:
_Adults: _For severe or deep-seated infections, especially when less
sensitive
organisms are involved, the dosage should be increased to 1g t.d.s. or
3g b.d.
For prophylaxis of recurrent urinary tract infections in adults, a
dose of 125mg
each night is recommended and may be continued for several months (the
125mg/5ml Suspension is suitable for this purpose).
_Children: _Ideally, dosage should be calculated on a body-weight
basis,
particularly in infants. The following dosage recommendations for
children
are derived from a normal dosage of 25 to 60mg/kg/day. For chronic,
severe
or deep-seated infections, this should be increased to 100mg/kg/day
(maximum 4g