Distaclor MR 375mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefaclor monohydrate

Available from:

Flynn Pharma Ltd

ATC code:

J01DC04

INN (International Name):

Cefaclor monohydrate

Dosage:

375mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5060106550064

Patient Information leaflet

Package leaflet: Information for the user
DISTACLOR MR TABLETS
375 MG
Cefaclor
The name of your medicine is Distaclor MR tablets
375 mg, which will be referred to as Distaclor MR tablets
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 MR TABLETS ARE AND
WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DISTACLOR MR TABLETS
3. HOW TO TAKE DISTACLOR MR TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DISTACLOR MR TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT DISTACLOR MR TABLETS ARE AND
WHAT THEY ARE USED FOR
Distaclor MR tablets are a long acting tablet. They contain
the active ingredient cefaclor, which is an antibiotic.
Distaclor MR 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
■
Skin and soft tissue (e.g. muscle) infections
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DISTACLOR MR TABLETS
DO NOT TAKE DISTACLOR MR TABLETS IF:
■
you are allergic to cefaclor, any cephalosporin (other
similar antibiotics) or any of the other ingredients of
this medicine (listed in Section 6). 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 or pharmacist before taking
Distaclor MR tablets
■
if you have had an allergic reacti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Distaclor MR Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended release tablet contains cefaclor monohydrate equivalent
to
375mg of cefaclor as active ingredient.
3
PHARMACEUTICAL FORM
Extended release tablets of cefaclor ‘Modified Release’ are blue
and engraved
with GP5
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Distaclor MR is indicated in the treatment of the following infections
when
caused by susceptible strains of the designated organisms:
_Acute bronchitis and acute exacerbations of chronic bronchitis_
caused by
_Streptococcus pneumoniae_, _Haemophilus influenzae_ (including
beta-lactamase
producing strains), _Haemophilus parainfluenzae_, _Moraxella
catarrhalis_
(including beta-lactamase producing strains) and _Staphylococcus
aureus_.
_Pharyngitis and tonsillitis_ caused by _Streptococcus pyogenes_
(group A
streptococci).
_Pneumonia_ caused by _S. pneumoniae_, _H. influenzae_ (including
beta-lactamase
producing strains) and _M. catarrhalis_ (including beta-lactamase
producing
strains).
_Uncomplicated lower urinary tract infections_, including cystitis and
asymptomatic bacteriuria, caused by _Escherichia coli_, _Klebsiella
pneumoniae_,
_Proteus mirabilis_ and _Staphylococcus saprophyticus_.
_Skin and skin structure infections_ caused by _S. pyogenes_ (group A
streptococci), _S. aureus_ (including beta-lactamase producing
strains) and
_Staphylococcus epidermidis_ (including beta-lactamase producing
strains).
Bacteriological studies, to determine the causative organism and its
susceptibility to cefaclor, should be performed. Therapy may be
started while
awaiting the results of these studies. Once these results become
available,
antimicrobial therapy should be adjusted accordingly.
Note: Distaclor MR is generally effective in the eradication of
streptococci
from the oropharynx. However, data establishing the efficacy of this
antibiotic
in the subsequent prevention of rheumatic fever are not available.
4.2
POSOLOGY AND