INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BENYLIN DMD DECONGESTANT COUGH SYRUP (solution)


SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BENYLIN DMD DECONGESTANT COUGH SYRUP (solution)

COMPOSITION:
Each 5 mL solution contains:
  Dextromethorphan HBr         15 mg
  Pseudoephedrine HCl         30 mg
  Preservative: Sodium Benzoate         0,5% m/v
Sugar Free
Alcohol Free

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and expectorants.

INDICATIONS:
Alleviation of cough.

CONTRA-INDICATIONS:
Sensitivity to dextromethorphan and pseudoephedrine.
Safety in pregnancy and lactation has not been established.
Benylin DMD Decongestant Cough Syrup should not be administered to patients suffering from cardiovascular disease, coronary artery disease, hypertension, diabetes mellitus, closed-angle glaucoma, hyperthyroidism, prostatic hypertrophy, asthma and hepatic dysfunction.
Benylin DMD Decongestant Cough Syrup is contra-indicated in patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Children under the age of two years.

WARNINGS:
Do not use this product without consulting a doctor or pharmacist if you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: Two medicine measuresful (10 mL) every six hours.
Children 6 to 12 years: One medicine measureful (5 mL) every six hours.
Children 2 to 6 years: Half a medicine measureful (2,5 mL) every six hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dextromethorphan hydrobromide:
Dextromethorphan may cause dizziness, gastro-intestinal disturbances, drowsiness, nausea and vomiting, and stomach pain. Respiratory depression is expected to occur at very high doses.
Pseudoephedrine hydrochloride:
Pseudoephedrine may cause fear, anxiety, restlessness, insomnia, reduced appetite, nausea, vomiting, tremor, confusion, psychotic states, irritability, weakness, tachycardia and cardiac arrhythmias, palpitations, difficulty in micturition, troubled breathing, sweating and headache.
In patients with prostatic enlargement it may increase difficulty in micturition. Urinary retention, altered metabolism including disturbances of glucose metabolism, hypersalivation may also occur.

Interactions:
Concurrent use with central nervous system depressants may potentiate the central nervous system depressant effect of Benylin DMD Decongestant Cough Syrup.
The stimulatory effect of Benylin DMD Decongestant Cough Syrup may be potentiated by concurrent use of central nervous system stimulant medicine.
Benylin DMD Decongestant Cough Syrup used concurrently with cardiac glycosides, quinidine, tricyclic antidepressants, levodopa and general anaesthetics such as chloroform, cyclopropane, halothane and other halogenated anaesthetics may increase the risk of cardiac arrhythmias.
Concurrent use of Benylin DMD Decongestant Cough Syrup with beta-blocking agents may result in significant hypertension and bradycardia and possible heartblock. The effect of antihypertensive agents may be reduced or reversed when these are used concurrently with Benylin DMD Decongestant Cough Syrup.

Special precaution:
Persistant coughs should be investigated by a doctor for the possible underlying cause.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Dextromethorphan hydrobromide: Excitation and confusion may occur after overdosage.
Pseudoephedrine hydrochloride: Convulsions, hallucinations, fast breathing, increase in blood pressure, irregular heartbeat, severe shortness of breath or troubled breathing, unusual nervousness, restlessness, or excitement.
Treatment:
Symptomatic and supportive.

IDENTIFICATION:
Dark brown, slightly viscous liquid with a faint odour of menthol and raspberries.

PRESENTATION:
Bottles containing 100 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Keep out of reach of children.

REGISTRATION NUMBER:
27/10.1/0002

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 September 1992.

EXPORT REGISTRATION DETAILS
Botswana:         R9800 288
Ghana:         FDB/SD.02-8231
Kenya:         H2003/041
Malawi:         PMPB/PL 48/12
Tanzania:         TAN 00,915 R05F WAR
Uganda:         3098/25/98
Zimbabwe:         95/22.2.5/3037        P

        Revised: 10/95

Updated on this site: February 2005
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005