CLARITHROMYCIN ACTAVIS 250 Milligram Film Coated Tablet

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

CLARITHROMYCIN

Tersedia dari:

Actavis Group PTC ehf

Kode ATC:

J01FA09

INN (Nama Internasional):

CLARITHROMYCIN

Dosis:

250 Milligram

Bentuk farmasi:

Film Coated Tablet

Jenis Resep:

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

Area terapi:

Macrolides

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-01-07

Selebaran informasi

Clarithromycin 250mg and 500mg Film-coated Tablets PIL - Ireland
item no: 
print proof no: 
origination date: 
originated by:
revision  date:  
revised by: 
dimensions: 
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
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date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAJ2123
2
09.08.16
DR
22.08.16 
S.Anson
IL/Medochemie
 155x300
7 pt
09.08.16 
22.08.16
Package leaflet: Information for the user
CLARITHROMYCIN ACTAVIS 250 MG AND 
500 MG FILM-COATED TABLETS
Clarithromycin
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 further questions, ask your doctor or your 
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 ACTAVIS IS AND WHAT IT 
IS USED FOR
2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
CLARITHROMYCIN ACTAVIS
3

HOW TO TAKE CLARITHROMYCIN ACTAVIS
4

POSSIBLE SIDE EFFECTS
5

HOW TO STORE CLARITHROMYCIN ACTAVIS
6

CONTENTS OF THE PACK AND FURTHER 
INFORMATION
1

WHAT CLARITHROMYCIN ACTAVIS IS AND WHAT IT 
IS USED FOR
Clarithromycin is an antibiotic belonging to a group called 
the macrolides. Antibiotics stop the growth of bacteria 
which cause infections.
Clarithromycin Actavis is used to treat infections such as:
•   Chest infections such as bronchitis and pneumonia
•   Throat and sinus infections
•   Skin and tissue infections
•   Mycobacterial  infections
•  _Helicobacter pylori _infection associated with duodenal 
ulcer.
2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
C

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin Actavis 250mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Clarithromycin 250mg.
Excipients with known effect: Contains 0.11mg glucose per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow, oval-shaped, convex film-coated tablets, scored on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Clarithromycin is indicated in adults and children 12 years and older.
Clarithromcyin Actavis is indicated in the treatment of infections due
to susceptible organisms. Such infections include:
1.
Lower respiratory tract infections (e.g. bronchitis, pneumonia).
2.
Upper respiratory tract infections (e.g. pharyngitis, sinusitis).
3.
Skin and soft tissue infections (e.g. folliculitis, cellulitis,
erysipelas).
4.
Disseminated or
localised mycobacterial
infections
due to_ Mycobacterium avium_ or
_Mycobacterium intracellulare_.
Localised infections due to_ Mycobacterium chelonae_,_ Mycobacterium
fortuitum_, or_ Mycobacterium kansasii_.
5.
Clarithromycin is indicated for the prevention of disseminated_
Mycobacterium avium_ complex infection in HIV-infected
patients with CD4 lymphocyte counts less than or equal to 100/mm
3
.
6.
Clarithromycin in the presence of acid suppression is indicated for
the eradication of_ H._
_pylori_,
resulting in decreased
recurrence of duodenal ulcer.
_FURTHER INFORMATION_
_H. pylori_ is strongly associated with peptic ulcer disease.
Ninety to 100% of patients with duodenal ulcers are infected with this
agent.
Eradication of_ H. pylori_ has been shown to markedly reduce the rate
of duodenal ulcer recurrence, thereby reducing the need for
maintenance anti-secretory therapy.
In a well-controlled double-blind stud