Ceporex 500mg capsules

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:

500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5016298667554 5016298677560

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEPOREX CAPSULES 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 Capsules. Ceporex Capsules 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
CAPSULES
DO NOT TAKE CEPOREX CAPSULES
−
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 suf

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
TRADE NAME OF THE MEDICINAL PRODUCT
Ceporex Capsules 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefalexin 500mg per capsule.
3
PHARMACEUTICAL FORM
Capsule.
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:_ 1g 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