Clarithromycin 250 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-10-2022
Summary of Product characteristics
(SPC)
28-10-2022
Active ingredient:
Clarithromycin
Available from:
Sun Pharmaceutical Industries Europe B.V.
ATC code:
J01FA; J01FA09
INN (International Name):
Clarithromycin
Dosage:
250 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Macrolides; clarithromycin
Authorization status:
Marketed
Authorization date:
2006-10-20
Patient Information leaflet
V047
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250 MG FILM-COATED TABLETS
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 Clarithromycin Film-Coated Tablets are and what they are used for
2.
What you need to know before you take Clarithromycin Film-Coated
Tablets
3.
How to take Clarithromycin Film-Coated Tablets
4.
Possible side effects
5.
How to store Clarithromycin Film-Coated Tablets
6.
Contents of the pack and other information
_ _
1.
WHAT CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Clarithromycin Film-Coated Tablets contains the active ingredient
clarithromycin,
which is an macrolide antibiotic which stop the growth of bacteria
which cause
infections.
Clarithromycin Film-Coated Tablets is indicated for use in adults and
adolescents over
12 years of age for the treatment of infections caused by
micro-organisms sensitive to
clarithromycin. These infections include:
•
Upper respiratory tract infections (e.g. pharyngitis, sinusitis)
•
Lower respiratory tract infections (e.g. bronchitis, pneumonia)
•
Acute otitis media
•
Skin and soft tissue infections (e.g. impetigo, folliculitis,
cellulitis, abscesses)
•
Tooth and mouth infections (e.g. periapical abscess, periodontitis)
•
Disseminated or localised mycobacterial infections
In HIV-infected patients (CD4 cell count ≤100/mm3), Clarithromycin
is indicated for the prevention
of disseminated infections caused by the Mycobacterium avium (MAC)
complex.
In patients with duodenal ulceration and diagn
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
28 October 2022
CRN00CVZ4
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clarithromycin 250 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow coloured, oval shaped biconvex film-coated tablet,
embossed with “C1” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Clarithromycin is indicated for use in adults and adolescents older
than 12 years for the treatment of infections caused by
micro-organisms sensitive to clarithromycin. These infections include:
Lower respiratory tract infections for example bronchitis, and
pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing).
Upper respiratory tract infections for example sinusitis and
pharyngitis.
Acute otitis media
Skin and soft tissue infections (e.g. impetigo, folliculitis,
cellulitis, abscesses) (see section 4.4 and 5.1 regarding
Sensitivity Testing)
Tooth and mouth infections (e.g. periapical abscess, periodontitis).
Disseminated or localised _Mycobacteriumavium_or
_Mycobacteriumintracellulare;_ infections localised
_Mycobacteriumchelonae_, _Mycobacteriumfortuitum_or
_Mycobacteriumkansasii_ infections
In HIV-infected patients (CD4 cell count ≤100 / mm
3
), clarithromycin is indicated for the prevention of disseminated
infections
caused by the _Mycobacterium avium_ (MAC) complex.
In patients with duodenal ulceration and diagnostically confirmed
Helicobacter pylori infection, clarithromycin treatment is
recommended simultaneously with preparations that suppress gastric
acid secretion and other antibiotics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
Patients with respiratory tract, skin and soft tissue and acute otitis
media infections
Adults:
The usual dose of clarithromycin is 250 mg
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