ERDOMED® 300mg Dispersible Tablets

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

Erdosteine

Dostupné z:

HYPHENS PHARMA SDN. BHD.

INN (Medzinárodný Name):

Erdosteine

Počet v balení:

30 Tablets; 20 Tablets

Výrobca:

EDMOND PHARMA S.R.L

Príbalový leták

ERDOMED
®
300MG
DISPERSIBLE TABLETS
_Consumer Medication Information Leaflet (RiMUP)_
Erdosteine 300mg Dispersible Tablets
1
WHAT IS IN THIS LEAFLET
1. What Erdomed
®
is used for
2. How Erdomed
®
works
3. Before you use Erdomed
®
4. How to use Erdomed
®
5. While you are using Erdomed
®
6. Side effects
7.
Storage
and
disposal
of
Erdomed
®
8. Product description
9. Manufacturer
and
product registration holder
10. Date of revision
11. Serial number
1.
WHAT
ERDOMED®
IS
USED FOR
Erdomed
®
is
used
in
reducing
mucus thickness especially in both
acute
and
severe
respiratory
disorders associated with excessive
mucus production.
2. HOW ERDOMED
® WORKS
Erdomed
®
contains of
_erdosteine_
, a
mucolytic agent, which acts on the
phlegm
(mucus)
in
the
respiratory
tract or airways.
3. BEFORE YOU USE ERDOMED
®
_When you must not use it _
DO NOT USE ERDOMED
®
:
-
if
you
are
hypersensitive
(allergic) to
_erdosteine_
or any of
the
other
ingredients
of
Erdomed
®
;
- if you suffer from severe liver
failure;
-
if
you
suffer
from
severe
decreased kidney function;
- if you have a stomach ulcer.
_Before you start to use it _
PREGNANCY AND BREAST-FEEDING
Talk to your doctor or pharmacist
before
using
this
medicine
if
you
are
pregnant,
might
become
pregnant or are breast-feeding. The
use
of
Erdomed
®
in
pregnant
or
breast-feeding
women
is
not
recommended.
DRIVING AND USING MACHINES
Erdomed
®
has
minor or negligible
influence on the ability to drive and
use machines.
IMPORTANT
INFORMATION
ABOUT
SOME
OF
THE
INGREDIENTS
OF
ERDOMED
®
Erdomed
®
does
not
contain
any
ingredients
which
would
influence
the
safe
and
effective
use
of
the
product.
USE IN CHILDREN
Erdomed
®
is not recommended to be
used in children younger than 18
years old.
_Taking other medicines _
Erdomed
®
does not usually interfere
with other medicines.
However,
you
should
always
tell
your doctor or pharmacist about all
medicines
you
are
taking
or
planning
to
take,
including
any
obtained without a prescription.
4. HOW TO USE ERDOMED
®
HOW MUCH AND WHEN TO USE
IT

Súhrn charakteristických

PACKAGE INSERT
1.
TRADE NAME OF THE MEDICINAL PRODUCT
ERDOMED
®
300 MG HARD CAPSULES
Erdosteine 300 mg capsules are presented as size 1 hard gelatine
capsules, with green cap and yellow
body, containing an ivory powder.
ERDOMED
®
300 MG DISPERSIBLE TABLETS
Erdosteine 300 mg dispersible tablets are round, flat, light orange
tablets with score on one side.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ERDOMED
®
300 mg hard capsules:
Each hard capsule contains: Erdosteine 300 mg
ERDOMED
®
300 mg dispersible tablets
Each dispersible tablet contains: Erdosteine 300 mg
Excipients with known effects:
_Dispersible tablets: _
Lactose and sun-set yellow lake
For complete list of excipients, see section. 6.1
3.
PHARMACEUTICAL FORM
Hard capsules
Dispersible tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic agent for use in adults with acute and chronic respiratory
disorders associated with excessive
mucus production.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ELDERLY AND ADULTS ABOVE 18 YEARS:
Oral formulations:
Posology
300 mg hard capsules: 1 capsule 2-3 times a day, for oral use.
300 mg dispersible tablets: 1 tablet 2-3 times a day, for oral use.
Method of administration for
_dispersible tablets _
The tablets should be dissolved in a glass of water. The dispersion
should be stirred with a spoon and
drunk immediately. The score-line on the tablet does not divide the
tablet into equal half-doses.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
_section 6.1. _
Patients with active peptic ulcer.
Because
of
a
possible
interference
of
the
product
metabolites
with
methionine
metabolism,
ERDOMED
®
is contraindicated in patients suffering from hepatic cirrhosis and
deficiency of the
cystathionine-synthetase enzyme.
SINCE THERE ARE NO DATA IN PATIENTS WITH RENAL FAILURE WITH CREATININE
CLEARANCE < 25 ML/MIN OR
WITH SEVERE LIVER FAILURE, THE USE OF ERDOSTEINE IS NOT RECOMMENDED IN
THESE PATIENTS.
The drug is contraindicated in children younger than 2 years (o