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

Logo ACUNASO SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUNASO SYRUP

COMPOSITION:
Each 5 mL contains
Pseudoephedrine HCl 30 mg
Preserved with: 
Methyl Hydroxybenzoate 0,12% m/v
Propyl Hydroxybenzoate 0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparation for the common cold, including decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
Pseudoephedrine hydrochloride has decongestantproperties.

INDICATIONS:
For symptomatic relief of: Nasal, sinus, eustachian tube mucosal congestion.

CONTRA-INDICATIONS:
In persons on treatment with monoamine oxidase inhibitors, or within two weeks of stopping treatment. Thyrotoxicosis. Safety in pregnancy and lactation has not been established.

WARNINGS:
Do not use this product without consulting a doctor or pharmacist it 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 10 mL
Children 6 to 12 years 5 mL
Children 2 to 6 years 2,5 mL
May be given two or three times daily.
Children 6 months to 24 months 1,25 mL
three times daily on advice of a physician only.

SIDE -EFFECTS AND SPECIAL PRECAUTIONS:
Fixed drug eruption due to pseudoephedrine has been reported. Pseudoephedrine may give rise to side-effects such as giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Pseudoephedrine may cause hypertension resulting in intracranial haemorrhage.
Other side-effects include: agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrythmias, cardiac arrest, confusion, dizziness, dyspnoea, aneurisms, fainting, fear, flushing, disturbances of glucose metabolism, irritability, miosis, dry mouth, psychotic status and weakness.
Pseudoephedrine should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort and in patients receiving digitalis. In patients with prostatic enlargement it may increase difficulty with micturition. ACUNASO SYRUP should be used with caution in patients with diabetes mellitus, closed-angle glaucoma or occlusive vascular disorders (arteriosclerosis). ACUNASO SYRUP should also be used with care in hypersusceptible individuals.
INTERACTIONS
Pseudoephedrine should be used with caution in patients receiving chloroform, cyclopropane, halothane, or other halogenated anaesthetics. The effects of pseudoephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by antidepressants. It may also diminish the effect of guanethidine and may increase the possibility of arrythmias in digitalised patients. Concomitant use of ACUNASO SYRUP with sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic aminas, may cause a rise in blood pressure. ACUNASO SYRUP may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta adrenergic blocking agents. ACUNASO SYRUP should not be given together with tricyclic anti-depressants, cardiac glycosides and quinidine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms may include irritability, convulsions, palpitations, hypertension, difficulty with micturition, and paranoid psychosis. Treatment is symptomatic and supportive.

IDENTIFICATION:
Red raspberry-flavoured, clear syrup.

PRESENTATION:
Amber, glass bottles containing 50 mL, 100 mL, 200 mL, and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/5.8/7

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Reg. Prop: Apotex (Pty) Ltd
Cnr Fleming & Watt Streets
Meadowdale Ext. 1

DATE OF PUBLICATION OF THE PACKAGE INSERT:
19 August 1991
        PX 7/2

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