Regulatory Information
PROCTER & GAMBLE (SINGAPORE ) PTE LTD
PROCTER & GAMBLE (SINGAPORE) PTE LTD
Therapeutic
General Sale List
Formulation Information
SOLUTION
**Dosage, mode of administration**  Iliadin 0.01% Decongestant Nasal Drops is intended for intranasal application. 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. **Duration of treatment** Unless specifically prescribed by the doctor, Iliadin 0.01% Decongestant Nasal Drops should only be used for short periods of time (5–7 days). Application for more than 7 consecutive days has to be prescribed by a physician. 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. Medical supervision is indicated in premature or underweight newborns to avoid the risk of overdosage. Medical supervision is indicated in patients with chronic rhinitis. Dosage higher than recommended may only be used under medical supervision.
NASAL
Medical Information
**Indications** Acute cold, paranasal sinusitis, syringitis, otitis media.
**Contraindications** Rhinitis sicca, hypersensitivity to the active ingredients or to any of the excipients. In the following cases this drug may only be used after carefully weighing the risk-to-benefit ratio: - Patients treated with monamine 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% Decongestant Nasal Drops must not be used in known hypersensitivity to this substance.
R01AA05
oxymetazoline
Manufacturer Information
PROCTER & GAMBLE (SINGAPORE) PTE LTD
Delpharm Bladel B.V.
SOFARIMEX - INDUSTRIA QUIMICA E FARMACEUTICA, S.A.
Active Ingredients
Documents
Patient Information Leaflets
07g. Iliadin 0.01% soln PIL Proposed Clean.pdf
Approved: May 4, 2020