Pholcodyl Syrup

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PHOLCODINE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

PHOLCODINE

Unit dalam pakej:

90ml mL; 60ml mL; 60mlml mL; 90ml mL; 60ml mL; 90ml mL

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

PHOLCODYL SYRUP
Pholcodine (5ml/5mg) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Pholcodyl Syrup is used for
2. How Pholcodyl Syrup works
3. Before you use Pholcodyl Syrup
4. How to use Pholcodyl Syrup
5. While you are using it
6. Side effects
7. Storage and disposal of Pholcodyl Syrup
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT PHOLCODYL SYRUP IS USED FOR
It is used for relief of unproductive
cough
associated
with
common
cold
and
infections of the upper respiratory tract.
HOW PHOLCODYL SYRUP WORKS
The
active
ingredient
in
the
medicine
is
Pholcodine. Pholcodine is an opioid chemi-
cally related to morphine. Pholcodine is
a cough suppressant and has a mild sedative
effect which relieves local irritation of the
respiratory tract. Pholcodine acts primarily
on the central nervous system (CNS) caus-
ing depression of the cough reflex which is
due partly to the direct effect on the
cough centre in the medulla (a part of
brain).
BEFORE YOU USE PHOLCODYL SYRUP
_- When you must not use it _
Do
not
take
this
medicine
if
you
are
hypersensitive to pholcodine or any of the
other
ingredients
listed
at
the
end
of
the
leaflet.
_Pregnancy and breastfeeding _
You should check with your doctor if you are
or think you may be pregnant, planning to
become pregnant or if you are breastfeeding.
It is not recommended for pregnant women
and
nursing
mothers
unless
the
expected
benefit outweighs any potential risks.
_- Before you start to use it _
Tell your doctor before taking this medicine
if you have:

asthma

liver problem
_- Taking other medicines _
There are a few medicines which may inter-
act with Pholcodyl Syrup. It is important to
tell your doctor or pharmacist about all the
medicines that you are taking, including those
obtained without doctor’s prescription.
You should talk to your doctor or pharmacist
if you are taking:-

Central Nervous System (CNS) depressants
such as alcohol, antihistamines, sedatives,
hypnotics and tricyc

Ciri produk

PHOLCODYL SYRUP/
PHOLCODYL FORTE SYRUP
Each 5ml contains:
Pholcodyl Syrup
Pholcodyl Forte Syrup
: Pholcodine 5mg
: Pholcodine 5mg
PHARMACODYNAMICS:
Pholcodine is an opioid chemically related to morphine. Pholcodine is
a cough suppressant and has a mild
sedative effect which relieves local irritation of the respiratory
tract.
Pholcodine acts primarily on the CNS causing depression of the cough
reflex which is due partly to the direct
effect on the cough centre in the medulla.
Pholcodine has little or no analgesic action.
Unlike morphine, codeine and dihydrocodeine, therapeutic doses of
pholcodine do not cause depression of
respiration, CNS excitation, constipation or other side effects
associated with narcotics. Pholcodine has a
selective effect on the cough centre without affecting the respiratory
centre.
Pholcodine is not euphorigenic, therefore psychological dependence is
unlikely to be a problem. There is no
evidence of physical dependence after prolonged administration of
pholcodine so it is not likely to be
habit-forming.
PHARMACOKINETICS:
Pholcodine is readily absorbed from the gastrointestinal tract and
does cross the blood-brain barrier. It is
metabolised in the liver and its action may be prolonged in hepatic
insufficiency. Pholcodine is not
metabolised to morphine in man.
INDICATIONS:
For relief of unproductive cough associated with common cold and
infections of the upper respiratory tract.
SIDE EFFECTS/ADVERSE REACTIONS:
Postmarketing Experience:
_Serotonin syndrome_
(See Warnings and Precautions)
_Adrenal insufficiency_
(See Warnings and Precautions)
_Androgen deficiency_
Cases of androgen deficiency have occurred with chronic use of
opioids. Chronic use of opioids may
influence the hypothalamic-pituitary-gonadal axis, leading to androgen
deficiency that may manifest as low
libido, impotence, erectile dysfunction, amenorrhea, or infertility.
The causal role of opioids in the clinical
syndrome of hypogonadism is unknown because the various medical,
physical, lifestyle, and psychological
stressors that