Summary of Product Characteristics (SmPC) - Happinose 0.3% ointment
1 NAME OF THE MEDICINAL PRODUCT
Happinose 0.3% Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Levomenthol 0.3% w/w.
For excipients, see 6.1.
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, Happmose 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 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 special 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 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. 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
None stated.
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
Membrane sealed internally lacquered aluminium tube with HDPE screw cap.
Pack size 14g.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Diomed Developments Ltd.
Tatmore Place
Gosmore
Hitchin
Herts SG4 7QR
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00173/ 0177
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/04/2005
10 DATE OF REVISION OF THE TEXT
21/05/2015