Cefaclor 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefaclor monohydrate

Available from:

Focus Pharmaceuticals Ltd

ATC code:

J01DC04

INN (International Name):

Cefaclor monohydrate

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

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFACLOR 500MG CAPSULES
(CEFACLOR MONOHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may want to read it again.
•
If you have any further questions, please 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 Cefaclor is and what it is used for
2.
What you need to know before you take Cefaclor
3.
How to take Cefaclor
4.
Possible side effects
5.
How to store Cefaclor
6.
Contents of the pack and other information
1. WHAT CEFACLOR IS AND WHAT IT IS USED FOR
Cefaclor belongs to a group of antibiotic medicines called
cephalosporins and works by killing bacteria
that cause infections.
Cefaclor is used to treat the following:
•
A range of infections including ear, nose, and throat infections,
infections of skin and soft tissue
•
Respiratory tract infections, including inflammation of the lungs
(bronchitis, pneumonia), inflammation of
the tonsils (tonsillitis), sore throat (pharyngitis) and swelling of
the lining of the sinuses (sinusitis)
.
•
Urinary tract infections, including inflammation of the bladder
(cystitis) and kidney infections
(pyelonephritis)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFACLOR
DO NOT TAKE CEFACLOR IF:
•
You are allergic to Cefaclor, cephalosporins, penicillin or other
antibiotics or any of the other ingredients
of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING CEFACLOR IF:
•
You have ever suffered from colitis
(inflammation which causes abdominal pain or diarrhoea)
•
You suffer from kidney problems
•
You are due to have a Coombs test or a urine sugar test as Cefaclor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefaclor 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 524.48 mg of cefaclor monohydrate, equivalent to
500 mg of cefaclor.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard gelatine capsule
Size 0. Body: opaque, light grey. Cap: opaque, violet, containing
white to
slightly yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefaclor is indicated for the treatment of the following infections
due to
susceptible micro-organisms:
•
Respiratory tract infections, including pneumonia, bronchitis,
exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and
as part
of the management of sinusitis.
•
Otitis media.
•
Skin and soft tissue infections.
•
Urinary tract infections, including pyelonephritis and cystitis.
•
Cefaclor has been found to be effective in both acute and chronic
urinary
tract infections.
•
Cefaclor is generally effective in the eradication of streptococci
from the
nasopharynx, but data establishing efficacy in the subsequent
prevention of
either rheumatic fever or bacterial endocarditis are not available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS:_ The usual adult dosage is 250mg every eight hours. For more
severe
infections or those caused by less susceptible organisms, doses may be
doubled.
Total daily dosage should not exceed 4g.
Cefaclor 500mg Capsules may be administered in the presence of
impaired
renal function. Under such conditions, dosage is usually unchanged.
(see section 4.4).
_PATIENTS UNDERGOING HAEMODIALYSIS:_ Haemodialysis shortens serum
half-life
by 25-30%. In patients undergoing regular haemodialysis, a loading
dose of
250mg -1g administered prior to dialysis and a therapeutic dose of
250-500mg
every six to eight hours maintained during interdialytic periods is
recommended.
_ELDERLY:_ As for adults.
_PAEDIATRIC POPULATION: _The usual recommended daily dosage for
children is
20mg/kg/day in divided doses, every