Summary of Product Characteristics (SmPC) - Dubam cream
1 NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Cream
A smooth white to off-white 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.
Reporting of suspected adverse reactions
Reporting 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
4.9. Overdose
4.9. OverdoseNot 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
5.3. Preclinical safety dataNot applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying Wax, Liquid Paraffin, Polysorbate 80, Purified 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
6.5. Nature and contents of container30g 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