Summary of Product Characteristics (SmPC) - Snufflebabe Vapour Rub
1 NAME OF THE MEDICINAL PRODUCT
Snufflebabe Vapour Rub
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eucalyptus Oil 2.00 %, Menthol 1.50 %, Thyme Oil 0.50%.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Inhalation vapour ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To give relief from congestion of the upper respiratory tract.
4.2 Posology and method of administration
Topical.
Snufflebabe may be used without professional supervision from the age of three months. Below this age it is recommended that the mother consults her GP, Pharmacist or Health Visitor.
Rub a small amount on the upper chest and throat. Alternatively Snufflebabe may be placed in a tissue or handkerchief in the clothing. To eliminate the possibility of very young children transferring the product to their eyes, on their fingers, the handkerchief may be tied to their cot just out of reach.
Body heat causes the aromatic oils to vaporise from the product so that they may be breathed in and help give relief of the upper respiratory tract (blocked nose).
4.3 Contraindications
Keep out of reach of children.
4.4 Special warnings and precautions for use
It is dangerous to apply an ointment containing menthol to the nostrils of infants. If symptoms persist consult your GP.
Do not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5 Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.
4.6 Fertility, pregnancy and lactation
None stated.
4.7 Effects on ability to drive and use machines
Not applicable, none reported.
4.8 Undesirable effects
Could give rise to hypersensitivity reactions including contact dermatitis. If symptoms persist consult you GP.
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, website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overdosage may result in skin irritation.
Misuse/Accidental ingestion:
Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.
Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.
Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.
Convulsions may be controlled by the intravenous administration of diazepam 5-10 mg.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Menthol, Eucalyptus Oil and Thyme Oil have all been used for many years for inhalation and in vapour rubs where they have given relief from congestion of the upper respiratory tract.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Soft Paraffin
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C and do not freeze.
6.5 Nature and contents of container
Polyethylene Terephthalate jar with screw on polypropylene cap: 35 g.
6.6 Special precautions for disposal
Snufflebabe may be used without professional supervision from the age of three months. Below this age it is recommended that the mother consults her GP, Pharmacist or Health Visitor.
7 MARKETING AUTHORISATION HOLDER
Dendron Brands Limited
94, Rickmansworth Road
Watford
Hertfordshire
WD18 7JJ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 52731/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th September 2004
10 DATE OF REVISION OF THE TEXT
02/02/2021