Klacid 250 mg Coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

CLARITHROMYCIN

Disponível em:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Código ATC:

J01FA09

DCI (Denominação Comum Internacional):

CLARITHROMYCIN 250 mg

Forma farmacêutica:

COATED TABLET

Composição:

CLARITHROMYCIN 250 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Status de autorização:

Authorised

Data de autorização:

2005-10-26

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KLACID 250 MG 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 KLACID is and what it is used for
2.
What you need to know before you take KLACID
3.
How to take KLACID
4.
Possible side effects
5.
How to store KLACID
6.
Contents of the pack and other information
1.
WHAT KLACID IS AND WHAT IT IS USED FOR
KLACID contains clarithromycin, an active substance belonging to a
group of medicines called
macrolide antibiotics. Antibiotics are medicines that block the growth
of bacteria that cause
infections.
KLACID is used to treat:
▪
respiratory tract infections such as bronchitis and pneumonia;
▪
throat infections (tonsillitis, pharyngitis) and paranasal sinus
infections;
▪
skin and tissue infections, for example impetigo, folliculitis,
erysipelas, furunculosis and infected
wounds;
▪
mouth and tooth infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID
DO NOT TAKE KLACID:
▪
if you are allergic to clarithromycin, to other types of macrolide
antibiotics, such as erythromycin
or azithromycin, or to any of the other ingredients of this medicine
(listed in section 6);
▪
if you are taking ergotamine or dihydroergotamine, medicines used to
treat headaches. The
combination of these medicines with KLACID could result in serious
side effects. Ask your doctor
to recommend alternative medicines;
▪
if you are taking a medicine containing lomitapide
▪
if you are taking astemizole or terfenadine (medicines widely used for

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KLACID 250 mg Coated tablets
KLACID 500 mg Coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KLACID 250 mg Coated tablets
Each coated tablet contains:
▪
active substance: clarithromycin 250 mg.
KLACID 500 mg Coated tablets
Each coated tablet contains:
▪
active substance: clarithromycin 500 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Official guidelines on the appropriate use of antibacterial agents
should be considered.
KLACID is indicated in adults and children 12 years and older.
Treatment for infection caused by pathogens susceptible to
clarithromycin.
Rhino-pharyngeal tract infections (tonsillitis, pharyngitis),
paranasal sinus infections.
Lower respiratory tract infections: bronchitis, bacterial pneumonia
and atypical pneumonia.
Skin infections: impetigo, erysipelas, folliculitis, furunculosis and
infected wounds.
In addition, for KLACID 250 mg Coated tablets:
Acute and chronic dental and periodontal infections sustained by
susceptible germs.
In addition, for KLACID 500 mg Coated tablets:
Mycobacterial infections, localised or diffuse, sustained by
_Mycobacterium avium or Mycobacterium _
_intracellulare. _
Localised infections due to
_Mycobacterium chelonae, fortuitum or kansasii._
In the presence of reduced gastric acidity, clarithromycin is
indicated for the eradication of
_Helicobacter pylori,_
with a consequent decrease in peptic ulcer reoccurrence.
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4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended clarithromycin dose for adults and children over 12
years is one 250-mg tablet
every 12 hours.
For severe infections, the dosage may be increased up to 500 mg every
12 hours.
Treatment normally lasts 5 to 14 days, except for treatment of
community-acquired pneumonia and
sinusitis, which require 6 to 14 days.
_Patients with renal impairment _
The clarithromycin dose should be halved i