SALMODEX SYRUP

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

SALBUTAMOL SULPHATE; Bromhexine HCl

Доступна с:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

ИНН (Международная Имя):

SALBUTAMOL SULPHATE; Bromhexine HCl

Штук в упаковке:

60 ml; 100 ml

Производитель:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

тонкая брошюра

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
SALMODEX SYRUP
Salbutamol (2.41mg of Salbutamol Sulphate equivalent to 2mg
Salbutamol)/Bromhexine Hydrochloride (2mg/4mg per 5ml)
1
WHAT IS IN THIS LEAFLET
1.
What SALMODEX is used for
2.
How SALMODEX works
3.
Before you use SALMODEX
4.
How to use SALMODEX
5.
While you are using SALMODEX
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SALMODEX IS USED FOR
SALMODEX
is
a
bronchodilator
(helps open the airways in the lungs)
with
mucolytic
expectorant
(to
breakdown mucus).
HOW SALMODEX WORKS
It contains salbutamol, which works
by relaxing the muscles of the airways
of
the
lungs,
and
facilitates
in
breathing. It also contain bromhexine,
which works by thinning the mucus in
the airways, thus making the mucus less
sticky and it also facilitates the removal
of the mucus.
BEFORE YOU USE SALMODEX
_-When you must not use it _
Tell
your
doctor
before
using
SALMODEX if you

are
allergic
to
Salbutamol
or
Bromhexine or any other ingredients
listed at the end of this leaflet.

have thyrotoxicosis (excessive amount
of thyroid hormone).

have severe heart disease.

have angina (chest pain).

have peptic ulcer (ulcers in the lining
of the stomach or first part of the small
intestine).
_-Pregnancy and breastfeeding _
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or are
breastfeeding. SALMODEX should only
be used during pregnancy if the expected
benefit to mother is greater than any
possible risk to fetus.
As
salbutamol
is
probably
found
in
breast milk, its use in nursing mother is
not recommended unless the expected
benefit outweighs any potential risk.
_ _
_-Before you start to use it_
- Use with caution if you have acute
severe asthma.
_-Taking other medicines _
Inform your doctor or pharmacist before
taking this medicines, including any that
you get without a prescription from your
pharmacy, supermarket or health food
shop.
Some medicines and

Характеристики продукта

SALMODEX SYRUP
COMPOSITION AND STRENGTH OF ACTIVE INGREDIENTS:
Each 5 ml contains:
Salbutamol …………………………………………….. 2 mg
(2.41mg of Salbutamol Sulphate equivalent to 2mg Salbutamol)
Bromhexine Hydrochloride …………………………… 4 mg
Preservative:
Sodium Benzoate ……………………………………… 0.2% w/v
PRODUCT DESCRIPTION
Light pink liquid with cherry flavour.
PHARMACODYNAMICS
Salbutamol is a synthetic sympathomimetic amine. Salbutamol stimulates
beta-adrenergic
receptors and has little or no effect on alpha adrenergic receptors.
Beta-adrenergic agonists
stimulate the production of cyclic adenosine-3`,5`-monophosphate(AMP)
by activation of the
enzyme adenyl cyclase.
Cyclic AMP appears to have greater stimulating effect on beta
receptors of the bronchial,
uterine and vascular smooth muscles (beta-1 receptors).
Bromhexine is a mucolytic agent used in the treatment of respiratory
disorders associated with
viscid or excessive mucus.
PHARMACOKINETICS
Salbutamol sulfate is rapidly and well absorbed following oral
administration.
Peak plasma salbutamol concentrations occur within 2.5 and 2 hours
following administration
of the conventional tablets and oral solution respectively. Following
oral administration of 2
mg of salbutamol every 6 hours as conventional tablets in healthy
individuals, steady-state peak
plasma
salbutamol
concentrations
average
5.3-6.8
and
steady-state
through plasma
concentrations minutes 3.8-4.3 ng/mL. Bronchodilation begins within 30
minutes after oral
administration of conventional tablets, with peak effect in 2-3 hours,
and may persist up to 4-
6 hours.
Results of animal studies indicate that salbutamol does not cross the
blood-brain barrier, but
the drug apparently crosses the placenta. After oral administration,
the plasma half-life is
reportedly 2.7-5 hours.
Following oral administration of salbutamol sulfate to healthy
individuals, about 75% of a
single dose is excreted in urine within 72hours, mainly as the major
metabolite; about