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Chefaro UK Ltd
4th Floor, Hamilton House, Mabledon Place, Bloomsbury, London, WC1H 9BB, UK
Telephone: +44 (0)207 554 8791
Medical Information e-mail: enquiries@chefaro.co.uk
Customer Care direct line: +44 (0)1748 828 860

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Summary of Product Characteristics last updated on the eMC: 07/10/2011
SPC Kamillosan Ointment


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1. NAME OF THE MEDICINAL PRODUCT

Kamillosan Chamomile Ointment


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tube or sachet of Kamillosan Ointment contains 10.5% extracts of chamomile standardised to give 0.01% L- a-bisabolol active ingredient.


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3. PHARMACEUTICAL FORM

Light brown ointment with Characteristic odour.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For prophylaxis and treatment of uncomplicated inflammation of the skin including sore nipples, nappy chafe, nappy rash and chapped hands.


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4.2 Posology and method of administration

Kamillosan ointment is for topical application as follows:

Sore nipples in nursing mothers: after breast feeding.

Nappy chafe and nappy rash: at change of nappy.

Other conditions: twice daily as necessary.


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4.3 Contraindications

None known.


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4.4 Special warnings and precautions for use

None known.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

Kamillosan may be used during pregnancy and lactation.


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4.7 Effects on ability to drive and use machines

None.


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4.8 Undesirable effects

None known.


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4.9 Overdose

There are no known symptoms of overdosage.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

The chamomile extract possesses topical anti-inflammatory properties due to the presence of the natural anti-inflammatory substance L-a-bisabolol.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

There is none applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Beeswax BP

Emulsifying wax BP

Anhydrous lanolin BP

Yellow soft paraffin BP

Maize oil

Mixed esters of p-hydroxybenzoic acid (preservative)


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6.2 Incompatibilities

None known.


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6.3 Shelf life

2 years.


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6.4 Special precautions for storage

Store in a dry place below 25°C.


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6.5 Nature and contents of container

Aluminium tubes containing 5, 20, 24, 30, 50, 100 and 125g of ointment. Sachets containing 1 and 1.5g of ointment.


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6.6 Special precautions for disposal and other handling

None.


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7. MARKETING AUTHORISATION HOLDER

Chefaro UK Ltd,

4th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 02855/0035


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1st October 1999


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10. DATE OF REVISION OF THE TEXT

December 2009



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25044/SPC/


Active Ingredients/Generics

 
  chamomile extracts