CEFACLOR

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

CEFACLOR

Διαθέσιμο από:

Chanelle Medical

Φαρμακολογική κατηγορία (ATC):

J01DC04

INN (Διεθνής Όνομα):

CEFACLOR

Δοσολογία:

500 Milligram

Φαρμακοτεχνική μορφή:

Capsules Hard

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

cefaclor

Καθεστώς αδειοδότησης:

Not Marketed

Ημερομηνία της άδειας:

2007-04-13

Φύλλο οδηγιών χρήσης

ID: PL 116/117 M IE
VERSION: 05
REVIEW DATE: 18/01/2017
PREPARED BY:
APPROVED BY:
PAGE 1 OF 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFACLOR 250 MG CAPSULES
CEFACLOR 500 MG CAPSULES
Cefaclor
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 Cefaclor Capsules are and what they are used for
2.
What you need to know before you take Cefaclor Capsules
3.
How to take Cefaclor Capsules
4.
Possible side effects
5.
How to store Cefaclor Capsules
6.
Contents of the pack and other information
Cefaclor capsules contain the active ingredient cefaclor, which is an
antibiotic.
Cefaclor capsules are used to treat the following infections caused by
bacteria that can be killed by cefaclor:

Bronchitis

Infection of lung tissue (pneumonia)

Bladder (cystitis) and kidney infections

Throat infections including tonsillitis and pharyngitis

Middle ear infections (otitis media)

Skin and soft tissue (e.g. muscle) infections

Infection of the sinuses (sinusitis)
DO NOT TAKE CEFACLOR CAPSULES IF:

you are allergic (hypersensitive) to cefaclor, any cephalosporin
(other similar antibiotics) or any of
the other ingredients of Cefaclor capsules (these are listed in
Section 6 of this leaflet).
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 BEFORE TAKING CEFACLOR CAPSULES IF YOU

have had an allergic reaction to penicillins or other drugs in the
past

have a history of gas

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefaclor 500 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg of cefaclor (as monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Cefaclor 500 mg capsules are grey and green.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefaclor is indicated for the treatment of the following infections
due to susceptible microorganisms:
Rispiratory 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, however, 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 (including the elderly):_
The usual adult dosage is 250 mg every eight hours. A dosage of 250
mg, administered 3 times daily for 10 days, is
recommended for sinusitis. For more severe infections or those caused
by less susceptible organisms, doses may be
doubled. Doses of 4 g per day have been administered safely to normal
subjects for 28 days, but the total daily dosage
should not exceed this amount.
_Children:_
The usual recommended daily dose for children is 20 mg/kg/day, in
divided doses, every eight hours, as indicated. For
bronchitis and pneumonia, the dosage is 20 mg/kg/day in divided doses,
administered 3 times daily. For otitis media
and pharyngitis, the total daily dosage may be divided and
administered every 12 hours. Safety and efficacy have not
been established for use in infants aged less than one month.
In more serious infections, otitis media and infections caused by less
suscepti