Clarithromycin 250mg film-coated Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

CLARITHROMYCIN

Beschikbaar vanaf:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-code:

J01FA09

INN (Algemene Internationale Benaming):

CLARITHROMYCIN 250 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

CLARITHROMYCIN 250 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisatie-status:

Authorised

Autorisatie datum:

2014-05-16

Bijsluiter

Page 1 of 8
_PACKAGE LEAFLET: INFORMATION FOR THE USER _
CLARITHROMYCIN 250 MG FILM-COATED TABLETS
CLARITHROMYCIN 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 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 is and what it is used for
2.
What you need to know before you take Clarithromycin
3.
How to take Clarithromycin
4.
Possible side effects
5.
How to store Clarithromycin
6.
Contents of the pack and other information.
1.
WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR
Clarithromycin belongs to a group of medicine called macrolide
antibiotics. Antibiotics stop the
growth of bacteria which cause infections.
Clarithromycin is used to treat following infections:
•
Chest infections such as bronchitis and pneumonia,
•
Throat and sinus infections,
•
Skin and soft tissue infections,
•
Helicobacter pylori_ _infections associated with duodenal ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN
DO NOT TAKE CLARITHROMYCIN IF:
•
you are ALLERGIC to clarithromycin, other macrolide antibiotics or any
of the other ingredients of
this medicine (listed in section 6).
•
you have a history of certain abnormal HEART RHYTHMS (ventricular
arrhythmia, including
torsades de pointes) or changes in the heart activity as measured in
the electro-cardiogram
called “QT prolongation”,
•
you suffer from SEVERE liver failure and kidney problems at the same
time,
•
You are taking medicines called terfenadine or astemizole (for hay
fever or allergies) or
cisapride
or domperidone
or pim

Productkenmerken

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250 mg film-coated tablets
Clarithromycin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Clarithromycin 250 mg film-coated tablets: _
Each film-coated tablet contains 250 mg of clarithromycin
_ _
_Clarithromycin 500 mg film-coated tablets: _
Each film-coated tablet contains 500 mg of clarithromycin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Clarithromycin 250 mg film-coated tablets: _
Light yellow coloured, oval shaped, biconvex film-coated tablets, with
‘D’ debossed on one side and ‘62’ on
the other side. The size is 15.1 mm x 7.1 mm
_Clarithromycin 500 mg film-coated tablets: _
Light yellow coloured, oval shaped, biconvex film-coated tablets, with
‘D’ debossed on one side and ‘63’ on the
other side. The size is 18.5 mm x 8.1 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin film-coated tablets are indicated for the treatment of
the following bacterial infections, 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,
•
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer healing
agent for the eradication of Helicobacter pylori in patients with
Helicobacter pylori associated ulcers (see
section 4.2).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Clarithromycin film-coated tablets depends on the type
and severity of the infection and has to
be defined in any case by the physician.
_ _
Page 2 of 20
_Clarithromycin 500 mg film-coated tablet is not suitable for doses
below 500 mg. The