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

Logo PARACODIN Syrup
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

PARACODIN Syrup

COMPOSITION:
5 mL (= 1 medicine measure) contains 12,1 mg of dihydrocodeine bitartrate, and as preservatives 0,1% m/v methyl paraben and 0,02% m/v propyl paraben.

PHARMACOLOGICAL CLASSIFICATION:
A.10.1 Antitussives and expectorants.

PHARMACOLOGICAL ACTION:
Antitussive cough sedative.
Paracodin syrup is particularly suitable for children.

INDICATIONS:
All types of cough and cough irritation, particularly in inflammation of the respiratory tract.
Paracodin is therefore specially indicated in the following conditions: Bronchitis, whooping cough, tracheitis, pharyngitis, laryngitis, as well as in cough associated with emphysema and pulmonary tuberculosis.

CONTRA-INDICATIONS:
Conditions associated with impaired respiratory function; long term administration in chronic constipation.

DOSAGE AND DIRECTIONS FOR USE:
If not otherwise prescribed by the physician:
Infants (4 - 12 months) 1 mL (¼ medicine measure);
Young children (1 - 5 years) 1 - 2,5 mL (¼ - ½ medicine measure);
Older children (6 - 12 years) 2,5 - 5 mL (½ - 1 medicine measure);
Adults 5 - 10 mL (1 - 2 medicine measures) up to 3 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracodin may lead to constipation, especially in small children.
Diabetics are reminded that 5 mL of Paracodin syrup contains about 1 g of glucose equivalent.
As with all other drugs acting on the central nervous system the consumption of alcohol should be avoided under Paracodin therapy.
Paracodin may impair the speed of patient's reaction (eg. in traffic), particularly when administered in high doses.
In accordance with present views on the use of drugs in pregnant women, prescription of Paracodin should be considered carefully during the first 3 months of pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Drowsiness: retention of urine and faeces may occur which should be treated symptomatically according to the severity of the clinical picture.

IDENTIFICATION:
A clear slightly yellowish solution.

PRESENTATION:
Glass bottles containing 100 mL and 200 mL of syrup.

STORAGE INSTRUCTIONS:
Store in a cool (below 30°C), dry place. Keep out of reach of children.

REGISTRATION NUMBER:
B1041 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Knoll Pharmaceuticals
South Africa (Pty) Ltd.
P O Box 3030, Halfway House, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 March 1997

PC2-A1 100                                Knoll logo
                                                        BASF Pharma
                                                        Pro-Print
Updated on this site: December 2002
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004