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

Logo ESKORNADE Spansule Capsules
ESKORNADE Syrup
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ESKORNADE Spansule Capsules
ESKORNADE Syrup

COMPOSITION:
Each ESKORNADE spansule capsule contains phenylpropanolamine hydrochloride 50 mg and diphenylpyraline hydrochloride 5 mg.
Each 5 mL ESKORNADE syrup contains phenylpropanolamine hydrochloride 12,5 mg and diphenylpyraline hydrochloride 1,5 mg.
Preserved with methyl p-hydroxybenzoate 0,175% m/v and propyl p-hydroxybenzoate 0,035% m/v.
Contains 4,86% v/v ethyl alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A.5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
A double acting preparation for the relief of upper respiratory distress. Phenylpropanolamine reduces vascular engorgement and often permits blocked sinus cavities to drain. Diphenylpyraline, an antihistamine, reduces sneezing and rhinorrhoea.

INDICATIONS:
Congestion and hypersecretion in the nasal cavity and paranasal sinuses, associated with the common cold, nasal allergy (e.g. allergic rhinitis), acute and chronic rhinitis, influenza and sinusitis.

CONTRA-INDICATIONS:
Do not use in patients with glaucoma, intestinal obstruction of organic origin or intestinal atony, severe ulcerative colitis, prostatic hypertrophy or incipient urinary retention from any cause, hypertensive disease or heart disease or during or for 14 days after treatment with an MAO inhibitor or together with hypertensive agents.

DOSAGE AND DIRECTIONS FOR USE:
Spansule Capsules:
For adults and children over 12 years: One ESKORNADE capsule every 12 hours.
Syrup:
Adults and children over 12 years: 10 mL (two medicine measures) three times a day.
Children 6 to 12 years old: 5 mL (one medicine measure) three times a day.
Children 2 to 6 years old: 2,5 mL (½ medicine measure) three times a day.
Children under 2 years old: Not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Anticholinergic, sympathomimetic and antihistamine effects may occur. This may include blurred vision, dry mouth, urinary hesitancy or retention, constipation, palpitations, drowsiness or insomnia and dizziness may occur.
Precautions:
Patients who drive or operate machinery should be warned of the possibility of drowsiness. Administer with caution to patients with organic heart disease or angina on effort.
Use in pregnancy:
Not to be used during pregnancy or by lactating females.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdosage with ESKORNADE could be related to any component.
Those related to diphenylpyraline could include a mixture of excitatory and depressive central nervous effects; in children particularly, there may be marked cerebral irritation with jerking of muscles and possible convulsions, which may be followed by coma.
Those of phenylpropanolamine could add hypertension and cardiac arrhythmias to the symptomatology. Treatment would consist of the induction of vomiting and/or gastric lavage, together with supportive and symptomatic measures. Physostigmine salicylate, 1 - 4 mg parenterally in an adult, repeated as necessary, has been reported to reverse the central and peripheral effects of anticholinergic poisoning. Convulsions can be treated with paraldehyde or a short-acting barbiturate such as thiopentone, 100 mg intravenously in an adult.

IDENTIFICATION:
ESKORNADE Spansule Capsules:
Hard gelatin capsule with a clear, colourless body and opaque light grey cap, containing a mixture of orange/brown, grey and white spherical pellets.
ESKORNADE Syrup:
A pale green liquid with a greengage flavour.

PRESENTATION:
ESKORNADE capsules are available in containers of 8, 50 and 250.
ESKORNADE syrup is available in bottles of 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
ESKORNADE capsules should be stored below 25°C in a dry place, and dispensed in moisture-proof containers.
ESKORNADE syrup should be stored below 25° C, protected from light and diluted only with Syrup B.P. after which it is stable for up to 14 days at room temperature (below 25°C).
DO NOT REFRIGERATE.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBERS:
ESKORNADE SPANSULE CAPSULES:         C.622 (Act 101/1965)
ESKORNADE SYRUP:         C.626 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Limited
6 Carey Street,
Wynberg Ext. 6,
Johannesburg 2090

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20.09.1994

P1992

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