STEARNS COUGH SYRUP

Land: Sør-Afrika

Språk: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgjengelig fra:

Adcock Ingram Limited

Dosering :

See ingredients

Legemiddelform:

SYRUP

Sammensetning:

EACH 10 ML SYRUP CONTAINS AMMONIUM CHLORIDE 34 MG POLYSORBATE 20 36,33 MG

Autorisasjon status:

Registered

Autorisasjon dato:

1989-02-08

Informasjon til brukeren

Page 1 of 5
1.3.2
PATIENT INFORMATION LEAFLET - CLEAN COPY
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PROPRIETARY NAME; STRENGTH AND PHARMACEUTICAL FORM OF THE
MEDICINE:
STEARNS COUGH SYRUP - PINE TAR AND HONEY FLAVOUR (SYRUP)
READ THIS ENTIRE LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION.
STEARNS IS AVAILABLE WITHOUT A DOCTOR’S PRESCRIPTION, FOR YOU TO
TREAT A MILD ILLNESS.
NEVERTHELESS YOU STILL NEED TO USE STEARNS CAREFULLY TO GET THE BEST
RESULTS.

KEEP THIS LEAFLET AS YOU MAY NEED TO READ IT AGAIN.

DO NOT SHARE STEARNS WITH ANY OTHER PERSON

ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE.

YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE WHILE
TAKING THIS MEDICINE.
1. WHAT DOES STEARNS CONTAINS:
The active ingredient in STEARNS is Guaiphenesin 100 mg per 5 ml.
The syrup contains the following preservative: sodium benzoate _(0, 20
% m/v)._
The other ingredients contained are; citric acid monohydrate, ethanol
96 %, eucalyptus oil,
glycerol, oil of pine tar, polyvinylpyrrolidone K25, propylene glycol,
purified honey, purified
water, saccharin sodium, sodium citrate, sorbitol 70 % solution, Pine
Bark Extract, xanthan
gum and permitted colourants, colour caramel,
S0
Page 2 of 5
2. WHAT STEARNS IS USED FOR:
The active ingredient guaiphenesin has an expectorant [medicine which
promotes coughing
and expulsion of mucous (wet or productive cough)] action and has been
reported to increase
the volume and decrease the viscosity of tenacious phlegm (thick
mucus).
STEARNS is used for the alleviation of cough associated with viscid /
tenacious phlegm (thick
mucus).
3. BEFORE YOU TAKE STEARN:
DO NOT TAKE STEARNS:

If you are allergic to guaiphenesin or any of the other ingredients in
the preparation.

If you have porphyria (inherited disorder of blood pigment
metabolism).
TAKE SPECIAL CARE WITH STEARNS:
A persistent cough may be a sign of a serious condition. If cough
persists for more than one
week, tends to recur or is accompanied by high fever, rash, sore
t

Preparatomtale

Page 1 of 4
1.3.1.1
SCHEDULING STATUS: S0
PROPRIETARY NAME:
STEARNS
COUGH
SYRUP
-
PINE
TAR
AND
HONEY
FLAVOUR
(AND DOSAGE FORM) (SYRUP)
COMPOSITION:
Each 5 ml contains:
Guaiphenesin
100 mg
Preservative:
Sodium benzoate
_0,20 % m/v_
Contains sugar: Sorbitol 70% 2,9 g
LIST OF EXCIPIENTS:
sorbitol 70% solution, glycerin [glycerol], polyvinylpyrrolidone k25,
povidone / polyvidone /
kollidone k2 , honey purified (irradiated), sodium citrate, saccharin
sodium, Pine Bark Extract,
xanthan gum, propylene glycol, acid citric monohydrate, eucalyptus
oil, colour caramel 136
(wb), oil of pine tar, ethanol 96 %, purified water.
STEARNS COUGH SYRUP - PINE TAR AND HONEY FLAVOUR is tartrazine free.
PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants
PHARMACOLOGICAL ACTION:
Guaiphenesin has an expectorant action and has been reported to
increase the volume and
decrease the viscosity of tenacious sputum.
Page 2 of 4
PHARMACOKINETICS:
Following oral administration, guaiphenesin is absorbed from the
gastrointestinal tract.
It is metabolised and then excreted in the urine.
INDICATIONS:
Alleviation of cough associated with viscid/tenacious phlegm.
CONTRAINDICATIONS:
Hypersensitivity to any of the ingredients.
Porphyria (see ‘WARNINGS AND SPECIAL PRECAUTIONS’).
WARNINGS AND SPECIAL PRECAUTIONS:
A persistent cough may be a sign of a serious condition. If cough
persists for more than one
week, tends to recur or is accompanied by high fever, skin rash, sore
throat or persistent
headache, consult a doctor.
STEARNS should not be given to children under 2 years unless
recommended by a doctor.
Porphyria: Safety has not been established.
INTERACTIONS:
Guaiphenesin
interferes
with
urine
tests
for
5-hydroxyindoleacetic
acid
(5-HIAA)
and
vanillylmandelic acid (VMA).
PREGNANCY AND LACTATION:
PREGNANCY:
The safety of this medicine in pregnancy and lactation has not been
established.
Page 3 of 4
LACTATION:
It is not known whether guaiphenesin is distributed into breast milk.
However, problems in
humans have not been documented.
DO