KLACID MR 500MG TABLET

Land: Maleisië

Taal: Engels

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

Werkstoffen:

CLARITHROMYCIN

Beschikbaar vanaf:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Algemene Internationale Benaming):

CLARITHROMYCIN

Eenheden in pakket:

5tablet Tablets

Geproduceerd door:

AbbVie S.r.l

Bijsluiter

_Consumer Medication Information Leaflet (RiMUP) _
KLACID MR 500MG TABLET
Clarithromycin
(500mg)
1
WHAT IS IN THIS LEAFLET
1.
What Klacid
®
MR is used
for
2.
How Klacid
®
MR works
3.
Before you use Klacid
®
MR
4.
How to use Klacid
®
MR
5.
While you are using Klacid
®
MR
6.
Side effect
7.
Storage and Disposal of
Klacid
®
MR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT KLACID
® MR IS USED
FOR
Each KLACID
®
MR 500 MG
TABLET contains 500 mg of
the active ingredient
Clarithromycin.
KLACID
®
MR 500 MG
TABLET are used to treat
infections such as:
1.
Chest infections such as
bronchitis and pneumonia
2.
Throat and sinus infections
3.
Mild to moderate skin and
tissue infections, e.g.
cellulitis,folliculitis or
erysipelas.
KLACID
®
MR 500 MG
TABLET are used in
adultsand children 12
years and older.
HOW KLACID
® MR WORKS
Klacid belongs to a group of
medicines called macrolide
antibiotics. Antibiotics stop
thegrowth of bacteria (bugs)
which cause infections.
BEFORE YOU USE KLACID
®
MR
-
_When you must not use it _
Do not take KLACID
®
MR 500 MG TABLET if
_ _
you are taking any of the
following medicines:
domperidone (usedfor
nausea & vomiting).
Do not take Klacid
®
MR if
you;
•
know that you are
allergic to
clarithromycin, other
macrolide antibiotics
such as erythromycin
or azithromycin, or
any of the other
ingredients in the
tablets.
•
are taking medicines
called ergot alkaloid
tablets (e.g.
ergotamine or
dihydroergotamine) or
use ergotamine
inhalers for migraine.
are taking medicines
called terfenadine or
astemizole (widely
taken for hay fever or
allergies) or cisapride
(for stomach
problems) or pimozide
(for mentalhealth
problems) as
combining these drugs
can sometimes cause
serious disturbances in
heart rhythm. Consult
your
doctor for advice on
alternative medicines.
•
are taking other
medicines which
areknown to cause
serious
disturbancesin
heart rhythm.
•
are taking lovastatin
or simvastatin
(HMG-CoA
reductase inhibitors,
commonly known as
statins

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Klacid
®
MR 500 mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 500 mg Clarithromycin.
Excipient: Lactose 115mg per tablet
Tablet sodium content: 15.3mg per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clarithromycin MR tablets is yellow, ovaloid film-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to
susceptible organisms. Such infections
include:
1.
Lower respiratory tract infections (
_e.g._
, bronchitis, pneumonia)
2.
Upper respiratory tract infections (
_e.g._
, pharyngitis, sinusitis)
3.
Skin and soft tissue infections (e.g., folliculitis, cellulitis,
erysipelas)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
_Adults _
The usual recommended dosage of clarithromycin MR tablets in adults
and children 12 years of age or older
is 500 mg once-daily with food. In more severe infections, the dosage
may be increased to 1000 mg once-
daily (2 x 500 mg). The usual duration of therapy is 5 to 14 days,
excluding treatment of community acquired
pneumonia and sinusitis which require 6 to 14 days therapy.
Do not crush or chew clarithromycin modified release tablets.
_Renal Impairment _
In patients with severe renal impairment (creatinine clearance less
than 30 mL/min), the usual recommended
dose is 250 mg once daily. Because the modified-release tablet cannot
be split, instead immediate-release
tablets should be used. In more severe infections, the recommended
dose is one 500mg modified-release
tablet once daily. No dose adjustment is required for patients with
moderate renal impairment (creatinine
clearance 30 to 60 ml/min).
_Pediatric Population _
The use of clarithromycin MR has not been studied in children less
than 12 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to macrolide antibiotic drugs or any of the
excipients (see section 6.1)
Concomitant administration of clarithromycin and any of the following
drugs is contraindicated: as