Distaclor 125mg/5ml Granules for Oral Suspension

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Cefaclor

Dostupné s:

Flynn Pharma Limited

ATC kód:

J01DC; J01DC04

INN (Mezinárodní Name):

Cefaclor

Dávkování:

125 mg/5ml

Léková forma:

Granules for oral suspension

Druh předpisu:

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

Terapeutické oblasti:

Second-generation cephalosporins; cefaclor

Stav Autorizace:

Marketed

Datum autorizace:

1998-11-16

Informace pro uživatele

Package leaflet: Information for the user
DISTACLOR 125MG/5ML & 250MG/5ML GRANULES FOR ORAL SUSPENSION
Cefaclor
The name of your medicine is Distaclor 125mg/5ml & 250mg/5ml Granules
for Oral Suspension,
which will be referred to as Distaclor suspension 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 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 DISTACLOR SUSPENSION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISTACLOR SUSPENSION
3.
HOW TO TAKE DISTACLOR SUSPENSION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DISTACLOR SUSPENSION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION.
1
WHAT DISTACLOR SUSPENSION IS AND WHAT IT IS USED FOR
Distaclor suspension is made from granules of the active ingredient
cefaclor, which is an antibiotic.
Your pharmacist will add fresh clean drinking water to the bottle
containing the granules, to make up
the suspension, before you are given it.
Distaclor suspension is 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).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISTACLOR SUSPENSION.
DO NOT TAKE DISTACLOR SUSPENSION IF

you are allergic (hypersensitive) to cefaclor, any cephalosporin
(other similar antibiotics) or
any of the other ingred

Charakteristika produktu

Health Products Regulatory Authority
23 June 2022
CRN00CYCS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Distaclor 125mg/5ml Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefaclor (as monohydrate), 125 mg/5 ml. Excipient(s) with known effect
Sucrose 3 g/5 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
A dry pink, free-flowing, granular powder, which on reconstitution
with water gives a pink coloured, strawberry flavoured
suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Distaclor 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.
Distaclor 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 250mg every eight hours. A dosage of 250mg,
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 4g 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 20mg/kg/day, in
divided doses, every eight hours, as indicated. For
bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses,
administered 3 times daily.
For otitis media and pharyngitis, the total