WOODWARDS BABY CHEST RUB, BABY CHEST RUB - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Baby Chest Rub

Woodwards baby chest rub

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Turpentine Oil BP    5.0 %v/w

Eucalyptus Oil BP    2.0 % v/w

Menthol BP        2.0 % w/w

3 PHARMACEUTICAL FORM

Inhalant rub

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of nasal catarrh and congestion due to cold

4.2 Posology and method of administration

Adults, the Elderly, Children and Babies over Three months

Rub on the chest, throat and back morning and night.

Leave bedding and clothes loose to allow easy inhalation of the vapour. Not to be given to children under three months

4.3 Contraindi­cations

Known hypersensitivity to the active ingredients

4.4 Special warnings and precautions for use

For external use only. Do not apply directly to the nostrils. Keep the rub away from the eyes. Do not use on babies aged under three months

Instruct patients 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

None stated

4.6 Fertility, pregnancy and lactation

None stated

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

None stated

Reporting of suspected adverse reactions

Reporting of 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 or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9 Overdose

(Ingestion of the contests of whole container) causes nausea, vomiting and diarrhoea, breathing difficulties leading to respiratory collapse. Application of a product containing menthol to the nostrils of infants can cause instant collapse. Stomach should be emptied by aspiration and lavage and a purgative given.

Any convulsions can be controlled by intravenous diazepam 5–10mg, or short acting barbiturates

5.1 Pharmacodynamic properties

An inhalant chest rub containing menthol and a mixture of volatile oils. The inhalation of vapours from these ingredients stimulates the membrane of the respiratory tract loosening the mucous and catarrh in the nasal Passages giving relief to congestion

5.2 Pharmacokinetic properties

Not Applicable

5.3 Preclinical safety data

None Stated.

6.1

Oil of cedarwood

Oil of nutmeg

Oil of thyme White soft paraffin

6.2

None known

6.3

60 months unopened

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

White glass jars containing 28g of product with R3/38mm polycarb screw cap and packed into cartons

6.6 Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

Northumbria Pharma Ltd

Netpark

Thomas Wright Way

Sedgefield

County Durham

TS21 3FD

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 48259/0011