Clarithromycin 250mg film-coated Tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

CLARITHROMYCIN

Dostopno od:

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

Koda artikla:

J01FA09

INN (mednarodno ime):

CLARITHROMYCIN 250 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

CLARITHROMYCIN 250 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTIBACTERIALS FOR SYSTEMIC USE

Status dovoljenje:

Authorised

Datum dovoljenje:

2014-05-16

Navodilo za uporabo

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

Lastnosti izdelka

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