RHINATHIOL PROMETHAZINE SYRUP

국가: 말레이시아

언어: 영어

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

유효 성분:

CARBOCISTEINE(METHYL); PROMETHAZINE HYDROCHLORIDE

제공처:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

CARBOCISTEINE(METHYL); PROMETHAZINE HYDROCHLORIDE

패키지 단위:

125ml mL

Manufactured by:

Unither Liquid Manufacturing

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
_ _
RHINATHIOL PROMETHAZINE
® SYRUP
Carbocisteine / Promethazine Hydrochloride (100mg / 2.5mg per 5ml)
_ _
WHAT IS IN THIS LEAFLET
1. What Rhinathiol Promethazine is
used for
2. How Rhinathiol Promethazine
works
3. Before you use Rhinathiol
Promethazine
4. How to use Rhinathiol
Promethazine
5. While you are using it
6. Side effects
7. Storage and disposal of Rhinathiol
Promethazine
8. Product description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT RHINATHIOL PROMETHAZINE IS
USED FOR
Rhinathiol Promethazine is used for
symptomatic treatment of troublesome
and non-productive cough, particularly
occurring at night.
HOW RHINATHIOL PROMETHAZINE WORKS
Rhinathiol Promethazine syrup contains
a combination of two active
ingredients, carbocisteine (mucolytics)
and promethazine hydrochloride
(phenothiazines).
Carbocisteine works by making mucus
(phlegm) less sticky. This makes the
mucus easier to cough up.
Phenothiazine works by blocking the
effects of a certain natural substance
(histamine), which causes allergy
symptoms. It also has sedating effects
which is useful in people with
disturbing sleep.
BEFORE YOU USE RHINATHIOL
PROMETHAZINE
_-When you must not use it _
Do not take Rhinathiol Promethazine:
•
for infants (under 2 years of age) due
to the risk of worsening of bronchial
congestion
•
if you are allergic to any of the active
substances (carbocisteine,
promethazine) or any of the other
ingredients of this medicine listed in
section
_Ingredients_
.
•
if you have previously or recently
experienced agranulocytosis (a major
drop in the number of white blood
cells in the blood)
•
if you have difficulty urinating due to
prostate or other problems
•
if you are at risk of certain types of
glaucoma (increased pressure inside
the eye)
•
if you are breast-feeding
This medicine
MUST NOT BE USED
during pregnancy.
CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT
SURE.
_-Before you start to use it _
If you have been told by your doctor

제품 특성 요약

MY/RHIP/09/20/SmPC0120
RHINATHIOL
PROMETHAZINE
SYRUP
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbocisteine
................................................................................
2.0000 g
Promethazine hydrochloride
........................................................
0.0500 g
Sucrose
........................................................................................
60.0000 g
Methyl parahydroxybenzoate (E218)
................................................................
0.1500 g
Powdered caramel colorant (E150)
.............................................
0.0126 g
Cocoa flavoring*
............................................................................
0.5000 mL
Vanillin
..........................................................................................
0.0250 g
Alcohol
..........................................................................................
2.3000 g
Sodium hydroxide
.........................................................................
q.s. pH 6.10-6.30
Purified water
................................................................................
q.s. 100.0000 mL
Per 100.0000 mL of syrup
*Qualitative composition of the cocoa flavoring:
tincture of vanilla, tincture of cocoa with vanillin, acid esters:
acetic; butyric; caproic; isobutyric; valeric,
alcohol esters: ethylic; butylic; amylic; hexylic, and solvent:
ethylic alcohol; propyleneglycol.
Alcohol content of the syrup: 3.09% (v/v).
One 5 ml measuring spoon contains 100 mg of carbocisteine, 2.5 mg of
promethazine hydrochloride, 3 g
of sucrose and 122 mg of anhydrous ethanol.
One 15 ml tablespoon contains 300 mg of carbocisteine, 7.5 mg of
promethazine hydrochloride, 9 g of
sucrose and 366 mg of anhydrous ethanol.
PHARMACEUTICAL FORM
Syrup
THERAPEUTIC INDICATION
Symptomatic treatment of troublesome, non-productive cough,
particularly occurring at night.
DOSAGE AND ROUTE OF ADMINISTRATION
FOR ADULTS AND CHILDREN OVER THE AGE OF 2 YEAR ONLY.
Symptomatic treatment should be for a short period (a few days) an