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

Logo NITEPAX SUSPENSION (Suspension)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

NITEPAX SUSPENSION (Suspension)

COMPOSITION:
Each 5 mL contains: Noscapine Resin Complex equivalent to 25 mg
Noscapine
PRESERVATIVES:
Methyl Hydroxybenzoate 0,15% m/v
Propyl Hydroxybenzoate 0,03% m/v

PHARMACOLOGICAL CLASSIFICATION:
A10.1 Antitussives and expectorants.

INDICATIONS:
Alleviation of (an unproductive) cough.

CONTRA-INDICATIONS:
Hypersensitivity to noscapine; Women of childbearing age.

DOSAGE AND DIRECTIONS FOR USE:
Shake well before use.
Adults: 5 mL (1 medicine measureful) three times a day and at bedtime. In severe cases, 10 mL (2 medicine measuresful) may be taken.
Children: 4 - 12 months: ½ - 1½ mL three times a day and at bedtime.
1 - 7 years: 1½ - 2½ mL three times a day and at bedtime.
7 - 12 years: 2½ - 5 mL three times a day and at bedtime.
Sweetened with sorbitol, thus suitable for diabetics.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include slight drowsiness, dizziness, headache, nausea, allergic rhinitis, conjunctivitis and skin rash.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Very large doses of noscapine can depress smooth and cardiac muscle but this effect is not seen with doses used for cough. Toxic doses have produced convulsions in animals. If side-effects occur, the dosage should be reduced or medication stopped, according to severity.

IDENTIFICATION:
NITEPAX is orange flavoured and orange coloured. A sediment forms when the bottle is allowed to stand for a few hours. NITEPAX is thixotropic and requires vigorous shaking before use.

PRESENTATION:
Bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store in a cool, dark place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
G 698 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED - (Co. Reg. No. 04/00252/06)
7 Fairclough Road
Korsten, PORT ELIZABETH, 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 July 1974

CODE 308178 A310        LH&SEL-K4853

Updated on this site: January 2005
Source: Community Pharmacy

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