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Dubam Cream

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dubam Cream Numark Analgesic Cream

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Methyl Salicylate BP 20%, Menthol BP 2%, Cineole BPC (1973) 1%.

3.    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

External application for the symptomatic relief of muscle stiffness, muscular rheumatism, lumbago, sciatica, fibrositis, sprains and chilblains.

4.2.    Posology and method of administration

Apply externally with gentle massage two to three times a day avoiding broken or inflamed skin.

Do not apply to children under six years old.

4.3.    Contra-indications

Known sensitivity to any of the actives.

Do not apply to children under six years old.

4.4.    Special warnings and precautions for use

Do not apply to broken or inflamed skin.

Application on mucous membranes should be avoided.

Discontinue if rash develops.

Not for use with occlusive dressings.

Topical application may result in systemic effects, including asthma. Patients should be advised against excessive exposure of areas treated to sunlight, in order to avoid possibility of photosensitivity.

For external use only. Keep away from eyes. Wash hands after use

4.5. Interactions with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

As with most medicines, use in pregnancy or breastfeeding should be avoided.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

As with all topical medicines, photosensitivity and application site reactions may occur.

4.9. Overdose

Not applicable.

5.1 Pharmacodynamic properties

All the active ingredients in Dubam Cream are topical vasodilators and their effect is rubifacient.

5.2.    Pharmacokinetic properties

External application of Dubam Cream to intact skin results in negligible systemic absorption.

5.3.    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Emulsifying Wax, Liquid Paraffin, Polysorbate 80, Ponceau 4R (E124), Water.

6.2.    Incompatibilities

None known

6.3.    Shelf life

36 Months.

6.4.    Special precautions for storage

Store between 4°C and 25°C.

6.5.    Nature and contents of container

30g Aluminium Tube

6.6.    Instruction for use/handling

No special handling is required.

7    MARKETING AUTHORISATION HOLDER

Norma Chemicals Ltd.

51-53 Stert Street Abingdon

Oxfordshire OX14 3JF United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 00386/5015R

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

29 December 1083 / 28 February 1995

10 DATE OF REVISION OF THE TEXT

20/04/2009