Klacid 500mg Film-Coated Tablets

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

CLARITHROMYCIN

Disponibbli minn:

Mylan Products Limited

Kodiċi ATC:

J01FA09

INN (Isem Internazzjonali):

CLARITHROMYCIN

Għamla farmaċewtika:

COATED TABLET

Kompożizzjoni:

CLARITHROMYCIN 500 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIBACTERIALS FOR SYSTEMIC USE

L-istatus ta 'awtorizzazzjoni:

Authorised

Fuljett ta 'informazzjoni

LEAFLET: PATIENT INFORMATION
KLACID
®
500 MG COATED TABLETS
Clarithromycin
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT
CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you alone. Do not pass it on to
other
people, even if their symptoms are the same as yours, because it could
be
dangerous.
-
If you develop any side effects including any that are not listed in
this
leaflet, please contact your doctor or pharmacist. See section 4.
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.
Potential 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 ingredient belonging to a
group of
drugs called antibiotic macrolides. Antibiotics are drugs that stop
the growth
of bacteria that cause infections.
KLACID is used to treat:

respiratory infections, such as bronchitis and pneumonia;

throat infections (tonsillitis, pharyngitis) and sinus infections;

skin and tissue infections, for instance impetigo, folliculitis,
erysipelas,
furunculosis and infected wounds;

infections caused by certain bacteria called _Mycobacterium_;

infections by _Helicobacter pylori _(bacterium associated with stomach
and
duodenum ulcers).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID DO NOT TAKE KLACID IF:

you are allergic to clarithromycin or other kinds of macrolide
antibiotics,
such as erythromycin or azithromycin, or any of the other components
of
this medicine (listed in section 6);

you are taking ergotamine or dihydroergotamine, drugs that are used
for
migraine. The combination of these drugs with KLACID could cause
serious
side effects. Speak with your doctor who will recommend alternative
medicines for you;

you are taking terfenadine or astemiz

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KLACID 500 mg Coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:

active ingredient: 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
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
KLACID is indicated in adults and children aged 12 years and older.
Treatment of infections caused by pathogens susceptible to
clarithromycin.
Infections of the rhinopharyngeal tract (tonsillitis, pharyngitis),
paranasal sinuses.
Infections of the lower respiratory tract: bronchitis, bacterial
pneumonia and atypical pneumonia.
Skin and soft tissue infections: impetigo, erysipelas, folliculitis,
furunculosis and infected wounds;
Localised
or
diffuse
mycobacterial
infections,
caused
by
_Mycobacterium _
_avium _
_or _
_Mycobacterium _
_intracellulare. _
_ _
Localised infections caused by _Mycobacterium chelonae, fortuitum or
kansasii_.
In the presence of reduced gastric acidity, clarithromycin is
indicated for the eradication of _ Helicobacter _
_pylori_, thus leading to a resulting decrease in peptic ulcer
recurrence.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
The recommended dose of clarithromycin in adults and children aged 12
years and older is 1 tablet every 12
hours.
In the event of severe infections, the dosage may be increased to 500
mg every 12 hours.
The usual duration of therapy is 5 - 14 days, excluding any treatment
for community-acquired pneumonia
and sinusitis which require 6 - 14 days of therapy.
_Patients with renal impairment _
In
patients
with renal impairment
with
creatinine clearance
of less than 30
mL/min,
the
dosage
of
clarithromycin should be reduced by half, for instance 250 mg once
daily, or 250 mg twice daily for more
severe infections.
In these patients, administration should not be continued for more
than 14 days.
In adult pati