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

Logo ILIADIN® PAEDIATRIC 0,025% DROPS AND METERED SPRAY

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME:
(and dosage form)

ILIADIN® PAEDIATRIC 0,025% DROPS AND METERED SPRAY

COMPOSITION:
Each 1 mL of the solution contains:
  0,25 mg Oxymetazoline Hydrochloride and
  0,015% Benzalkonium chloride as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.16.1 - Nasal Decongestants

PHARMACOLOGICAL ACTION:
ILIADIN Paediatric 0,025% is a topical vasoconstrictor which exerts a decongestant action on mucous membranes of the nasopharyngeal cavity.

INDICATIONS:
ILIADIN Paediatric 0,025% is indicated for the relief of nasal congestion due to the common cold, sinusitis, allergic rhinitis and hay-fever.
Indicated as adjunctive treatment in middle ear infection.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

DOSAGE AND DIRECTION FOR USE:
ILIADIN Paediatric 0,025% Drops and Metered Spray are indicated for children up to the age of six years.
Metered Spray:
Two to three sprays in each nostril 2 - 3 times a day.
For best results keep both the head and spray bottle slightly tilted to the back. Remove the cap by pulling. With the middle and fore-finger around the bottom of the nozzle and the thumb on the base of the bottle, press once to fill the pump mechanism completely. Insert the nozzle of the spray loosely into the nostril, squeeze the pump spray two to three times and simultaneously sniff in to ensure an even distribution of the fine spray. Repeat for other nostril. (illustrated)
Drops:
Fill glass dropper unit by placing the open end into the liquid and depressing the rubber teat. Tilt the head back and instil 2 - 3 drops of the liquid in each nostril two to three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ILIADIN should be used with care in patients with cardiac disease, hypertension or hyperthyroidism.
It may cause local stinging or burning, sneezing and dryness of the mouth and throat. Prolonged use may cause rebound congestion and drug-induced rhinitis. Iliadin should not be used for a period longer than five days.
It is not advisable to use Iliadin more frequently than recommended. If unexpected side-effects appear, consult your doctor immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Local gastric irritation and possible systemic sympathomimetic effects may occur, e.g. sweating, tachycardia, drowsiness possibly leading to coma, convulsions and circulatory collapse.
Treatment should be symptomatic and supportive.

IDENTIFICATION:
Clear, colourless solution, with a maximum of a faint odour.

PRESENTATION:
10 mL metered spray bottle.
10 mL dropper bottle.

STORAGE INSTRUCTIONS:
Keep our of reach of children.
Store below 25°C.
Protect from light.

REGISTRATION NUMBER:
V/16.1/296

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MERCK (PTY) LTD.
Reg. No. 70/04059/07
11 Fedlife Park,
Tonetti Street,
Midrand 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 July 1988.

        F18702
        89F0398
® Registered Trade Mark

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