Happinose 0.3% Ointment

Ointment

4.1 Therapeutic indications By topical administration to the nasal passages for the symptomatic relief of nasal congestion associated with the common cold, catarrh, head colds and hay fever. If desired, Happinose may also be rubbed onto the lips, nose, throat and chest and between the shoulders.4.2 Posology and method of administration *Adults and elderly* Blow the nose before application. Carefully apply half an inch of Happinose inside each nostril using the little finger and inhale. If desired, Happinose can also be rubbed on the bridge of the nose, throat and chest and between the shoulders. Re-apply four hourly as required. If symptoms persist after 10-14 days, consult your doctor. *Children over 10 years* As above, but one half the adult dose *Children 5-9 years* As above but one quarter the adult dose *Children under 5 years* Not recommended4.3 Contraindications Known sensitivity to the preparation or any of its ingredients. Children under 5 years of age4.4 Special warnings and precautions for use For external use only. Keep away from the eyes and keep out of reach of children. Hands should be washed after use.4.5 Interaction with other medicinal products and other forms of interaction None stated.4.6 Fertility, pregnancy and lactation There have been no reports of abnormalities or adverse effects associated with the use of Happinose in pregnant women or nursing mothers.4.7 Effects on ability to drive and use machines None stated.4.8 Undesirable effects None stated. **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose There is no specific antidote to Happinose. Symptomatic methods should be instituted.

5.1 Pharmacodynamic properties When inhaled, menthol produces a sensation of cooling in the nasal passages thus providing symptomatic relief.5.2 Pharmacokinetic properties Not applicable.5.3 Preclinical safety data None stated.

6.1 List of excipients Cineole (Eucalyptol) Geranium oil White soft paraffin Light liquid paraffin6.2 Incompatibilities None stated6.3 Shelf life 36 months6.4 Special precautions for storage Do not store above 25°C. Keep the container tightly closed.6.5 Nature and contents of container Membrane sealed internally lacquered aluminium tube with HDPE screw cap. Pack size 14g.6.6 Special precautions for disposal and other handling Not applicable.