SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Embrocation Napiers Household Liniment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of liniment contains:

Extract (as liquid extract) of Capsicum 0.041 % w/v Cajuput oil 0.5 % v/v Camphor 5.0% v/v Turpentine 10.0% v/v

For full list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous liquid Medium red brown liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of rheumatic or muscular pain, sprains, stiffness and lower backache including sciatica and lumbago, based on traditional use only

4.2 Posology and method of administration

For cutaneous use only

For adults and the elderly.

Wash hands before and after use..

Apply to unbroken skin, with friction, three or four times daily as necessary.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Patients with known hypersensitivity to any of the active ingredients or the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

A doctor or qualified healthcare practitioner should be consulted if joint pain occurs, accompanied by swelling of the joints, redness or fever

The use of this product is not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

Do not apply to broken skin.

Keep away from the face, especially eyes, ears and mucous membrane

4.5    Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. Therefore in the absence of sufficient data, the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

4.7    Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed

4.8    Undesirable effects

This product may cause skin irritation (such as urticaria). The frequency is not known.

A transient stinging/burning sensation may occur at the treatment site.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported. In case of overdose, irritation and redness may occur. Discontinue use.

In the event of accidental ingestion, symptoms may include nausea and vomiting, euphoria, headaches, pulmonary oedema, dizziness, inebriation, paralysis, cyanosis, narcosis, respiratory paralysis and irreversible damage of the optic nerve. Wash mouth out with plenty of water and obtain immediate medical attention.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2    Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6.1    List of excipients

Soft Soap

Industrial Methylated Spirit

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25^oC. Store in the original container

6.5    Nature and contents of container

Glass bottle with polypropylene or wadded hard plastic screwcap: 150ml. HDPE bottle with wadded hard plastic screwcap: 500ml 1000ml.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd,

Town Park Farm,

Brooke,

Rutland, LE15 8DG.

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0028

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29/04/2013

10 DATE OF REVISION OF THE TEXT

29/04/2013