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

Logo UNIVERSAL NASAL DROPS (Solution)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

UNIVERSAL NASAL DROPS (Solution)

COMPOSITION:
Each 1 mL contains:
Phenylephrine hydrochloride   2,5 mg
Preservatives: 
Chlorbutol   0,5% m/v
Nipasept   0,15%

PHARMACOLOGICAL CLASSIFICATION:
A.16.1 Ear, Nose and Throat Preparations - Nasal Decongestants (topical)

PHARMACOLOGICAL ACTION:
Alpha receptor stimulants that reduce nasal congestion by causing vasoconstriction in the nasal mucosa. When topically applied, they are effective locally and not absorbed unless swallowed.

INDICATIONS:
Temporary relief of nasal congestion due to the common cold, hayfever, allergic rhinitis, other upper respiratory allergies, or associated with sinusitis.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
In patients receiving monoamine oxidase inhibitor treatment, or within 14 days of its termination.
Safety in pregnancy and lactation has not been established.

WARNINGS:
This product should not be used for more than 5 days. If symptoms persist, consult a doctor.
Prolonged use or excessive application to the nasal mucosa may produce rebound congestion and rhinorrhoea.
The use of this container by more than one person may spread infection.
Children may be especially sensitive to the effects of these medicines.
Should be used with caution in patients with:
Hypertension; hyperthyroidism; cardiovascular disease such as ischaemic heart disease, arrhythmias, tachycardia; occlusive vascular disease, arteriosclerosis, aneurysms; diabetes mellitus; closed-angle glaucoma; prostatic hypertrophy.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children 6-12 years (with adult supervision): 2-3 drops in each nostril, not more often than every 4 hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
May cause local irritation at the site of application, for example dryness and stinging of the mouth and throat and increased nasal discharge with sneezing.
The following systemic side effects may occur:
Anxiety. restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states.
Appetite reduction and nausea and vomiting may occur.
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. Tachycardia or bradycardia, cardiac arrythmias, palpitations and cardiac arrest may result.
Hypotension with dizziness, fainting and flushing may occur.
Angina may be precipitated.
An increased risk of arrhythmias may occur in patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Difficulty in micturation, urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is common.

INTERACTIONS
Reversal of the action of anti-hypertensive agents may occur and therefore special care is advisable in patients receiving antihypertensive therapy. Interaction with alpha- and beta-blockers may be complex and could produce a hypertensive crisis.
Interactions are possible with guanithidine, reserpine, maprotiline, tricyclic antidepressants, digoxin and alpha-methyldopa.
Should be used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillations. [MD]

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to side effects and special precautions. Treatment is supportive and symptomatic.
Severe increase in blood pressure may occur. Treatment with alpha-adrenergic blocking agents to reduce blood pressure should be instituted if myocardial ischaemia or encephalopathy is provoked.

IDENTIFICATION:
Clear colourless solution.

PRESENTATION:
15 mL Dropper bottle.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
Keep out of reach of children.

REFERENCE NUMBER:
H1542 ·(Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Goldex 775 (Pty) Ltd
8-9 Glen Park
Glen Anil

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 February 1975.

G.P.-S004-0468        GW.12/1(MBR 1)

Amended: 14/1/08

Updated on this site: May 2014
Source: Pharmaceutical Industry

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