Iliadin

Clear, colourless solution.
Baby drops: 1 mL iliadin 0.01% Decongestant Nasal Drops contains in an aqueous solution 0.1 mg Oxymetazoline Hydrochloride.
Children drops: 1 mL iliadin 0.025% Decongestant Nasal Drops contains in an aqueous solution 0.25 mg Oxymetazoline Hydrochloride.
Adult drops: 1 mL lliadin 0.05% Decongestant Nasal Drops contains in an aqueous solution 0.5 mg Oxymetazoline Hydrochloride.
Excipients: Citric acid monohydrate, sodium citrate, glycerol 85%, purified water.
Baby drops: Benzalkonium chloride.
Children drops/Adult drops: Benzalkonium chloride solution 50% (as a preservative).

Pharmacotherapeutic group: Rhinological agents (chemically defined), α-sympathomimetic.
The active ingredient of Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops has a sympathomimetic, vasoconstrictive, and thus a decongestant effect on the mucous membranes.
The action of Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops sets in within a few minutes. The effect of oxymetazoline persists for up to 12 hours.
Baby drops: May take up to 20 minutes for an observed effect.
Adult drops: In a clinical study, the median onset was found to be 25 seconds.

Acute cold, paranasal sinusitis, syringitis, otitis media.

Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops is intended for intranasal application.
Baby drops: Unless otherwise prescribed, up to the age of 4 weeks instill 1 drop of Iliadin 0.01% Decongestant Nasal Drops into each nostril 2-3 times daily. From the 5th week of life until the age of 1 year, instill 1-2 drops of Iliadin 0.01% Decongestant Nasal Drops into each nostril 2-3 times daily. To facilitate and ensure exact dosing, Iliadin 0.01% Decongestant Nasal Drops is supplied with a metering pipette. The numbers on the markings indicate the quantity of drops drawn up. For example, if 1 drop is to be administered, the liquid level should be at mark 1 when filling the pipette. This ensures that exactly the desired dose is dripped into the nostrils. The following procedure has also proved efficient: Depending on the age of the infant, drip 1 or 2 drops of Iliadin 0.01% Decongestant Nasal Drops onto cotton wool to wipe out the nostrils.
Children drops: Iliadin 0.025% Decongestant Nasal Drops is indicated in children aged between 1 and 6 years.
Adult drops: Iliadin 0.05% Decongestant Nasal Drops may only be administered to adults and children of 6 years and older and should not be used in small children and infants.
Children drops/Adult drops: Unless otherwise prescribed, instill 1-2 drops of Iliadin 0.025%/0.05% Decongestant Nasal Drops into each nostril 2-3 times daily.
Duration of treatment: Unless specifically prescribed by the doctor, Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops should only be used for short periods of time (5-7 days).
A treatment-free period of several days should precede any repeated use.
Permanent use of decongestant rhinological agents may attenuate their effect. The abuse of local rhinological agents may cause mucosal atrophy and reactive hyperaemia with rhinitis medicamentosa.
Longer use of oxymetazoline may cause damage to the mucosal epithelium with inhibition of ciliary activity. This may possibly result in irreversible damage to the mucosa with rhinitis sicca.
Long term use and overdosage are to be avoided, especially in children. Special attention should be paid during application to avoid overdosage (baby drops). Medical supervision is indicated in premature or underweight newborns to avoid the risk of overdosage (baby drops). Medical supervision is indicated in patients with chronic rhinitis. Dosage higher than recommended may only be used under medical supervision.
Baby drops: Application for more than 7 consecutive days has to be prescribed by a physician.

The clinical picture following intoxication with imidazole-derivatives may be unclear due to the occurrence of episodes of hyperactivity alternated with episodes of depression of the central nervous system and of the cardiovascular and pulmonary system.
In children, in particular, overdose often causes dominating central nervous effects with convulsion and coma, bradycardia, apnoea as well as hypertension possibly followed by hypotension.
Therapeutic measure after overdosage: In-house intensive-care therapy is indicated in cases of severe overdose.
Administration of medicinal charcoal (absorbent), sodium sulfate (laxative) or gastric lavage (in the case of large quantities) should be performed immediately as oxymetazoline may be absorbed rapidly.
A non-selective alpha blocker can be given as antidote. If required, initiate fever-lowering measures, anticonvulsive therapy and oxygen ventilation.
Vasopressors are contraindicated.
Symptoms of an overdose may be hypertension, tachycardia, palpitations, cardiac arrhythmia, cardiac arrest, sweating, agitation, convulsion, mydriasis, nausea, vomiting, cyanosis, fever, spasms, circulatory collapse, pulmonary oedema, respiratory and psychic disorders, drowsiness, paleness, miosis, decrease in body temperature, bradycardia, shock-like hypotension, apnoea and coma.
Children drops/Adult drops: Overdosage may occur after nasal or accidental oral administration.

Rhinitis sicca, hypersensitivity to the active ingredients or to any of the excipients; infants and small children below 1 year (children drops) and below six (adult drops) year of age.
In the following cases this drug may only be used after carefully weighing the risk-to-benefit ratio: Patients treated with monoamine oxidase inhibitors (MAO-inhibitors) and other drugs potentially increasing blood pressure.
Increased intraocular pressure, especially narrow-angle glaucoma.
Severe cardiovascular diseases (e.g. coronary heart disease, hypertension).
Phaeochromocytoma.
Metabolic disorders (eg. hyperthyroidism, diabetes mellitus, porphyria).
Hyperplasia of the prostate.
Because of the benzalkonium chloride which is contained as preservative, Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops must not be used in known hypersensitivity to this substance.

Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops should only be used after the consultation with a physician during pregnancy and lactation. The recommended dosage must not be exceeded.
Children drops/Adult drops: Medical supervision is indicated in patients with chronic rhinitis.
Effects on the ability to drive a vehicle or operate machinery: Baby drops: Systemic effects with cardiovascular involvement cannot be excluded after prolonged administration or intake of oxymetazoline-containing cold remedies in doses higher than recommended. In these cases, the ability to drive a vehicle or operate machinery can be impaired.
Children drops/Adult drops: No impairment is to be expected if used as recommended.
Systemic effects with involvement of the cardiovascular or central nervous system (children drops) cannot be excluded after prolonged administration or intake of oxymetazoline-containing cold remedies in doses higher than recommended. In these cases, the ability to drive a vehicle or operate machinery can be impaired.

Occasionally, burning or dryness of the nasal mucosa and sneezing. In rare cases, after the effect has worn off, an intense sensation of "blocked" nose (reactive hyperaemia) and epistaxis.
With topical intranasal use, overdose occasionally leads to systemic sympathomimetic effects like palpitations, accelerated pulse (tachycardia) and increase in blood pressure.
Baby drops: Restlessness, insomnia, tiredness and headaches have been observed in very rare cases. Apnoea in newborns and in young infants (especially in case of overdosage), hallucinations and convulsions.
Children drops: Acute cold, paranasal sinusitis, syringitis, otitis media.
Adult drops: Hallucination and convulsions (especially in children).
Children drops/Adult drops: Somnolence, sedation, headache, hypersensitivity reactions (angioedema, rash, pruritus), insomnia, restlessness and tiredness have been observed in very rare cases.

The concomitant use of oxymetazoline containing nasal drops and of medicines with a hypertensive effect (e.g. MAO-inhibitors and tricyclic antidepressants) may lead to an increase in blood pressure due to their cardiovascular activity.
Overdose or swallowing of Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops and use of tricyclic antidepressants or MAO-inhibitors simultaneously or immediately prior to administration of Iliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops can lead to an increase blood pressure.

Store at or below 30°C.
After opening the pack: lliadin 0.01%/0.025%/0.05% Decongestant Nasal Drops should not be used longer than 6 months.

Nasal Decongestants & Other Nasal Preparations

R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.

GSL