CLARITHROMYCIN ACTAVIS 500 Milligram Film Coated Tablet

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

CLARITHROMYCIN

Fáanlegur frá:

Actavis Group PTC ehf

ATC númer:

J01FA09

INN (Alþjóðlegt nafn):

CLARITHROMYCIN

Skammtar:

500 Milligram

Lyfjaform:

Film Coated Tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Macrolides

Leyfisstaða:

Authorised

Leyfisdagur:

2011-01-07

Upplýsingar fylgiseðill

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
2.
3.
4.
5.
6.
1.
2.
3.
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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin Actavis 500mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Clarithromycin 500mg
Excipients with known effect: Contains 0.22mg glucose per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow, oval-shaped film-coated tablets.
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.
Clarithromycin 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 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 study,_ H. pylori_ infected patients
with duodenal ulcer received clarithromycin 500 mg
TID for 14 days with omeprazole 40 mg daily for 28 days.
Clarithromycin has been used in other treatment regimens for the
eradication of_ H. pylori_. These regimens include:
clarithromycin plus tinidazole and omeprazole; and clarithromycin