This information is intended for use by health professionals

1. Name of the medicinal product

Snufflebabe Vapour Rub

2. Qualitative and quantitative composition

Eucalyptus Oil 2.00 %, Menthol 1.5 %, Thyme Oil 0.50%

For excipients, see 6.1

3. Pharmaceutical form

Inhalation vapour ointment ATC Code: R01AX

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.

4.5 Interaction with other medicinal products and other forms of interaction

No significant interactions have been reported.

4.6 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

Polystyrene jar with screw on polypropylene cap contents: 24 g.

6.6 Special precautions for disposal and other handling

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.

Administrative data
7. Marketing authorisation holder

DDD Limited

94, Rickmansworth Road

Watford

Hertfordshire

WD18 7JJ

United Kingdom

8. Marketing authorisation number(s)

PL 00133/0233

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 30 July 2010

10. Date of revision of the text

October 2015