Klerimed 250mg film-coated tablet

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

CLARITHROMYCIN

Disponible desde:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Código ATC:

J01FA09

Designación común internacional (DCI):

CLARITHROMYCIN 250 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

CLARITHROMYCIN 250 mg

tipo de receta:

POM

Área terapéutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Estado de Autorización:

Authorised

Fecha de autorización:

2007-04-11

Información para el usuario

PILclaritabs3.4-MT
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KLERIMED 250MG FILM-COATED TABLETS
KLERIMED 500MG 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 e
ff
ects, talk to your doctor or pharmacist. This includes any possible
side
e
ff
ects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Klerimed is and what it is used for
2. What you need to know before you take Klerimed
3. How to take Klerimed
4. Possible side e
ff
ects
5. How to store Klerimed
6. Contents of the pack and other information
1. WHAT KLERIMED IS AND WHAT IT IS USED FOR
Each Klerimed tablet contains 250 mg or 500 mg of the active
ingredient clarithromycin.
Clarithromycin belongs to a group of medicines called macrolide
antibiotics. Antibiotics stop the
growth of bacteria (bugs) which cause infections.
Klerimed tablets are used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections such as cellulitis, folliculitis or
erysipelas
4. Infections caused by certain types of bacteria called Mycobacteriae
5. Helicobacter pylori infection associated with duodenal ulcer
Klerimed is indicated in adults and children 12 years and older.
PILclaritabs3.4-MT
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLERIMED
DO NOT TAKE KLERIMED 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).
-
are taking medicines called ergot alkaloids, for example ergotamine or
dihydroergotamine tablets
or use ergotamine inhalers for migraine

Ficha técnica

SPCclaritabs4.3-MT
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Klerimed 250mg film-coated tablet
Klerimed 500mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg or 500 of clarithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablets.
250mg: yellow, oval shaped, convex tablets, scored on one side,
film-coated, with dimensions 14 x 8
mm.
500mg: yellow, oval shaped convex tablets film-coated tablets with
diameter of nucleus 19.0 x 10.0
mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of infections due to susceptible organisms.
The indications include:
•
upper respiratory tract infection, including pharyngitis and sinusitis
•
lower respiratory tract infection, including acute and chronic
bronchitis and pneumonia
•
skin and soft tissue infections of mild to moderate seriousness (e.g.
folliculitis, cellulitis, erysipelas)
•
disseminated or localized mycobacterial infections due to
Mycobacterium avium or Mycobacterium
intracellulare. Localized infections due to Mycobacterium chelonae,
Mycobacterium fortuitum or
Mycobacterium kansasii
•
prevention of disseminated Mycobacterium avium complex infection in
HIV-infected patients with
CD4 lymphocyte counts less than or equal to 100/mm3
•
clarithromycin in the presence of acid suppression is indicated for
the eradication of H. pylori,
resulting in decreased recurrence of duodenal ulcer (see further
information)
SPCclaritabs4.3-MT
2
Clarithromycin tablets are indicated in adults and children 12 years
and older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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