Ellimans Universal Muscle Rub Lotion

1. Name Of The Medicinal Product

Ellimans Universal Muscle Rub Lotion

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

3. Pharmaceutical Form

Cutaneous emulsion

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

4. Clinical Particulars

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.

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None known.

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.

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.

5. Pharmacological Properties

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.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dried whole egg powder (melange)

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

None.

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

6.6 Special Precautions For Disposal And Other Handling

Shake the bottle before each use.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0075

9. Date Of First Authorisation/Renewal Of The Authorisation

15 January 2003

10. Date Of Revision Of The Text

4 February 2009

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)