eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Get Medicines Compendium UK app here

Actavis UK Ltd

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
Telephone: +44 (0)1271 311 200
Fax: +44 (0)1271 346 106
WWW: http://www.actavis.co.uk
Medical Information Direct Line: +44 (0)1271 311 257
Medical Information e-mail: medinfo@actavis.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 10/02/2009
SPC Ellimans Universal Muscle Rub Lotion


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Ellimans Universal Muscle Rub Lotion


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ellimans Universal Muscle Rub Lotion contains:

Turpentine oil BP 35.41%

Glacial acetic acid EP 3.562%

For excipients, see 6.1


Go to top of the page
3. PHARMACEUTICAL FORM

Cutaneous emulsion

A creamy, white liniment having an odour of turpentine and acetic acid


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

Symptomatic relief of muscular pain and stiffness including backache, sciatica, lumbago, fibrositis, and rheumatic pain and the massage by athletes of arm or leg muscles.


Go to top of the page
4.2 Posology and method of administration

Shake the bottle immediately before use.

Adults and children aged 12 years and over.

Rub lotion freely onto affected part until thoroughly absorbed.

For the first 24 hours, apply every three hours, then twice daily.

Athletes: Massage of arm and leg muscles before and after activity.

Not to be used on children under 12 years of age.

The elderly

The adult directions for use apply.


Go to top of the page
4.3 Contraindications

Hypersensitivity to any of the ingredients.


Go to top of the page
4.4 Special warnings and precautions for use

Do not apply when skin is broken or inflammed

Keep away from the eyes and other sensitive areas.

Keep out of reach and sight of children.

If symptoms persist, consult your doctor.

For external use only.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

Use in pregnancy and lactation is not contra-indicated, however, as with all medicines, care should be exercised.


Go to top of the page
4.7 Effects on ability to drive and use machines

None known.


Go to top of the page
4.8 Undesirable effects

There have been reports that application to the skin of liniments containing Turpentine Oil may cause vesicular eruption, urticaria and vomiting in susceptible persons.


Go to top of the page
4.9 Overdose

Excessive percutaneous absorption as a result of over-application may rarely lead to reversible toxic nephritis.

Products containing turpentine, if ingested, could cause burning pain in the mouth and throat, abdominal pain, nausea, vomiting and occasionally diarrhoea.

This may be followed by painful urination, respiratory distress and convulsions. In high overdose, death may follow due to respiratory failure.

Treatment on Ingestion

The stomach should be emptied by aspiration and lavage, after which treatment is symptomatic.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

MA02A X – Other topical products for joint and muscular pain

Turpentine oil is a rubefacient and counter-irritant.

Acetic acid is a counter irritant.


Go to top of the page
5.2 Pharmacokinetic properties

Not applicable.


Go to top of the page
5.3 Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

Dried whole egg powder (melange)

Purified Water


Go to top of the page
6.2 Incompatibilities

None known.


Go to top of the page
6.3 Shelf life

3 years


Go to top of the page
6.4 Special precautions for storage

None.


Go to top of the page
6.5 Nature and contents of container

Clear, white flint glass oval section bottles, with a screw-on wadless plastic cap fitted with an internal gasket contained in printed boxboard cartons, containing 100 ml of product


Go to top of the page
6.6 Special precautions for disposal and other handling

Shake the bottle before each use.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PL 30306/0075


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 January 2003


Go to top of the page
10. DATE OF REVISION OF THE TEXT

4 February 2009

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21458/SPC/


Active Ingredients/Generics

 
   glacial acetic acid
   turpentine oil