VASICAN TABLETS 8MG

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

Bromhexine HCl

Dostopno od:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

Bromhexine HCl

Enote v paketu:

10x10x10 Tablets

Izdeluje:

PT Actavis Indonesia

Navodilo za uporabo

_ Consumer Medication Information Leaflet (RiMUP)_
VASICAN TABLETS 8MG_ _
Bromhexine (8mg)
1
WHAT IS IN THIS LEAFLET
1.
What Vasican is used for
2.
How Vasican work
3.
Before you use Vasican
4.
How to take Vasican
5.
While
you
are
using
Vasican
6.
Side Effects
7.
Storage
and
Disposal
of
Vasican
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
VASICAN IS USED FOR
Vasican
is
a
medication
prescribed
for
coughs
which
works by thinning hard phlegm.
This tends to be given to those
with
respiratory
diseases
who
have difficulty coughing phlegm
out.
HOW
VASICAN WORK
Vasican works by encouraging
the
body's
natural
process
for
clearing
mucus
from
the
respiratory tract. It does this by
increasing
the
production
of
serous mucus which is a thin
type of mucus which dilutes the
phlegm making it less hard and
sticky.
BEFORE YOU USE VASICAN
_-When you must not take it _
Do not take Vasican if:
•
you
are
allergic
(hypersensitive) to bromhexine
or any of the other ingredients in
the tablets or syrup
• you are in your first trimester or
breastfeeding.
_ _
_-Before you start to take it _
You
should
check
with
your
doctor
or
pharmacist
before
taking Vasican if:
• you are pregnant
• you have gastric ulcers.
_ _
_-Taking other medicines_
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines, including medicines
obtained without a prescription,
including the following:
-certain
antibiotics
(e.g.
amoxycillin,
cefuroxime,
erythromycin and doxycycline)
HOW TO TAKE VASICAN
_-How much to take _
Adults
and
children
over
12
years:
8mg, 3 times a day
Children 6 to 12 years:
4mg, 3 times a day
_-When to take it _
Read the label on the carton or
follow what your doctor has told
you.
_-How long to take it _
Always take Vasican exactly as
your doctor has told you. If you
are not sure, check with your
doctor or pharmacist.
_-If you forget to take it _
If you forget to take Vasican,
take it as soon as you can. Take
your next dose at the right time.
Do n

Lastnosti izdelka

VASICAN TABLETS 8 MG
PRODUCT DESCRIPTION:
Green, round and flat tablets, with 8 mm diameter, score-line on one
side
and ‘DHA’ logo on the other side.
COMPOSITION:
Each Vasican tablet contains : Bromhexine HCl BP 8 mg/tablet
Excipients :
Corn Starch, Lactose Mesh, Acacia Powder, FDC Blue No. 1 Aluminum Lake
HT, Quinoline Yellow E104, Magnesium Stearate.
PHARMACOLOGY :
VASICAN contains bromhexine HCl which is a mucolytic agent. It acts on
the
mucous gland in the respiratory tract to change the structure of
bronchial
secretions and to increase the volume and reduce the viscosity of the
sputum.
PHARMACOKINETICS :
Oral administration Bromhexine HCl is absorbed rapidly from the
gastrointestinal tract, with peak plasma concentration achieved in
about one
hour. It undergoes extensive first-pass metabolism in the liver and
has an
elimination half-life of 6.5 hours.
INDICATIONS :
For the reduction of sputum viscosity.
RECOMMENDED DOSAGE :
Adults and children over 12 years
: 8 mg, 3 times a day
Children
: 6 to 12 years
: 4 mg, 3 times a day
WARNINGS AND PRECAUTIONS :
Bromhexine HCl should be given with caution to patient with gastric
ulceration. In very few cases, severe skin disorders such as Stevens
Johnson
Syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM)
and
Acute Generalized Exanthematous Pustulosis (AGEP) have been reported
after administration of mucolytic substances (e.g. bromhexine), which
in
most cases could be explained by the patient’s underlying disease
and/
or the concomitant medication. In addition, during the early phase of
such
severe skin reactions, a patient may first experience non-specific
influenza-
like prodromes (e.g. fever, aching body, rhinitis, cough and sore
throat). It
is possible that a symptomatic treatment is started with a cough and
cold
preparation due to these misleading non-specific influenza-like
prodromes.
Therefore, if new skin or mucosal lesions occur, medical advice should
be
sought immediately and treatment with bromhexine discontinued as a
precaution.
USE I