1. Name Of The Medicinal Product
HAPPINOSE™ NASAL DECONGESTANT BALM
2. Qualitative And Quantitative Composition
Levomenthol 0.3% w/w.
3. Pharmaceutical Form
Ointment.
4. Clinical Particulars
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
For adults and the 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 recommended.
4.3 Contraindications
Known sensitivity to the preparation or any of its ingredients. Children under 5 years of age.
4.4 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 reported.
4.6 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 reported.
4.8 Undesirable Effects
None reported.
4.9 Overdose
There is no specific antidote to Happinose. Symptomatic methods should be instituted.
5. Pharmacological Properties
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
No special information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cineole (Eucalyptol); Geranium Oil; White Soft Paraffin; Light Liquid Paraffin.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C. Keep the container tightly closed.
6.5 Nature And Contents Of Container
Collapsible aluminium tube with plastic screw cap, containing 14 g.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Diomed Developments Limited
Tatmore Place, Gosmore
Hitchin, Herts SG4 7QR, UK
8. Marketing Authorisation Number(S)
00173/0177.
9. Date Of First Authorisation/Renewal Of The Authorisation
12 January 2009.
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