Clarithromycin Tablet, film coated 500mg

Land: Malta

Sprog: engelsk

Kilde: Malta Medicines Authority

Aktiv bestanddel:

CLARITHROMYCIN

Tilgængelig fra:

Nexcape Pharmaceuticals (T/A Enexi Healthcare) 20-22, Wenlock Road, London, N1 7GU,, United Kingdom

ATC-kode:

J01FA09

INN (International Name):

CLARITHROMYCIN

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

CLARITHROMYCIN 500 milligram(s)

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Authorised

Autorisation dato:

2017-03-15

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN 250MG FILM-COATED TABLETS
CLARITHROMYCIN 500MGFILM-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 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 TABLET SIS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS
3.HOW TO TAKE CLARITHROMYCIN TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLARITHROMYCIN TABLETS
6.CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CLARITHROMYCIN TABLETS IS AND WHAT IT IS USED FOR
This medicine contains clarithromycin. Clarithromycin belongs to a
group of medicines called macrolide
antibiotics. Antibiotics stop the growth of bacteria (bugs) which
cause infections. Clarithromycin tablets are
used in adults and children 12 years and older to treat infections
such as:
-
Bacterial pharyngitis
-
Mild to moderate community acquired pneumonia
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute exacerbation of chronic bronchitis
-
Skin infections and soft tissue infections of mild to moderate
severity
Clarithromycin tablets are also used to treat Helicobacter pylori
associated ulcers in adults
(
in appropriate combination with antibacterial therapeutic regimens and
appropriate ulcer
healing agent)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS
DO NOT TAKE CLARITHROMYCIN TABLETS IF YOU

are
ALLERGIC
to clarithromycin, other macrolide antibiotics such as erythromycin or
azithromycin, or
any of the other ingredients of this medicine (listed in section 6).

ar

Produktets egenskaber

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin Tablets contain 500 mg of clarithromycin.
Excipient(s) with known effect:
Each film coated tablet contains 10.08mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral film-coated tablet
White, oblong, biconvex film-coated tablets of approximately 18mm
length, and 8mm width
with ‘K’ and ‘500’ debossed on one side and plain on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin film-coated tablets are indicated for the treatment of
the following bacterial
infections in adults and children 12 years and older, when caused by
clarithromycin-
susceptible bacteria (see section 4.4 and 5.1).
•
Bacterial pharyngitis
•
Mild to moderate community acquired pneumonia
•
Acute bacterial sinusitis (adequately diagnosed)
•
Acute exacerbation of chronic bronchitis
•
Skin infections and soft tissue infections of mild to moderate
severity
Clarithromycin film-coated tablets are also indicated for the
eradication of Helicobacter
pylori in adult patients with Helicobacter pylori associated ulcers,
in appropriate
combination with antibacterial therapeutic regimens and an appropriate
ulcer healing agent
(see section 4.2).
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
Page 2 of 21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of clarithromycin film-coated tablets depends on the
clinical condition of the
patient and has to be defined in any case by the physician.
_Children older than 12 years and adults: _
•
Standard dosage: The usual dose is 250 mg twice daily.
•
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg
twice daily in severe infections.
Clinical trials have been conducted using clarithromycin pediatric
suspension in children 6
months to 12 years of age. Therefor