KLACID TABLET 500MG

देश: मलेशिया

भाषा: अंग्रेज़ी

स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

सक्रिय संघटक:

CLARITHROMYCIN

थमां उपलब्ध:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (इंटरनेशनल नाम):

CLARITHROMYCIN

पैकेज में यूनिट:

14 Tablets; 28 Tablets

द्वारा बनाया गया:

AbbVie S.r.l

सूचना पत्रक

_Consumer Medication Information Leaflet (RiMUP) _
KLACID TABLET 500MG
_Clarithromycin _
(500mg)
1
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.
The full name of your medicine is
KLACID
®
TABLET 500MG. In
this leaflet the shorter name
Klacid
®
is used.
WHAT IS IN THIS LEAFLET
1.
What Klacid
®
is used for
2.
How Klacid
®
works
3.
Before you use Klacid
®
4.
How to use Klacid
®
5.
While you are using Klacid
®
6.
Side effect
7.
Storage and Disposal of
Klacid®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT KLACID
® IS USED FOR
Each
Klacid
®
tablet
contains
500
mg of the active ingredient
_clarithromycin_
.
Klacid
®
tablets are used to treat
infections such as:
1.
Chest infections such as
bronchitis and pneumonia
2.
Throat and sinus infections
3.
Mild to moderate tisu
infections, such as cellulitis,
folliculitis and erysipelas
4.
_Helicobacter pylori _
infection
associated with duodenal ulcer
Klacid 500mg Tablets is
indicated in adults and children
12 years and older.
2.
HOW KLACID
® WORKS
Klacid belongs to a group of
medicines called macrolide
antibiotics. Antibiotics stop the
growth of bacteria (bugs) which
cause infections.
3.
BEFORE YOU USE KLACID
®
-
Do not take Klacid if you are
taking any of the following
medicines: domperidone (used for
nausea & vomiting).
DO NOT TAKE KLACID
® TABLETS IF
YOU;
•
know that you are
ALLERGIC
to
_clarithromycin_
, side
antibiotics such as
erythromycin or
azithromycin, or any of
the other ingredients in
the tablets.
•
are taking medicines
ca

उत्पाद विशेषताएं

1.
NAME OF THE MEDICINAL PRODUCT
Klacid
®
Tablet 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 500 mg Clarithromycin.
Tablet sodium content: 6.1mg per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL DESCRIPTION
A pale yellow, ovaloid, film-coated immediate release tablet
containing 500 mg of clarithromycin as active
substance
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to
susceptible organisms in adults and children
12 years and older. Such infections include:
•
Treatment of infections caused by pathogens sensitive to
Clarithromycin.
•
Infection of nose-pharynx tract (tonsillitis, pharyngitis) and of
paranasal sinuses.
•
Infections of lower respiratory tract: bronchitis, bacterial pneumonia
and atypical pneumonia.
•
Skin infections: impetigo, erysipelas, folliculitis, furunculosis and
septic wounds.
•
Eradication of H.pylori in patients with duodenal ulcers in the
presence of acid suppression effected
by omeprazole.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
_Adults _
The usual recommended dosage of clarithromycin in adults and children
12 years of age or older, is one
250mg tablet twice daily. In more severe infections, the dosage can be
increased to 500mg twice daily. The
usual duration of therapy is 5 to 14 days, excluding treatment of
community acquired pneumonia and
sinusitis which require 6 to 14 days of therapy.
_Eradication of H.pylori in patients with duodenal ulcers _
Adults: The usual dose of Clarithromycin is 500 mg three times daily
for 14 days.
Dual therapy:
Klacid should be administered with oral omeprazole 40 mg once daily.
The pivotal study was conducted
with omeprazole 40 mg once daily for 28 days. Supportive studies have
been conducted with omeprazole
40 mg once daily for 14 days.
Triple Therapy:
Klacid 500 mg twice daily should be given with amoxycillin 1000mg
twice daily and omeprazole
20 mg daily for 10 days.
_Elderly: _
As for adults.
_Renal impairm