Kamillosan Ointment (Chefaro UK Ltd)

1. Name Of The Medicinal Product

Kamillosan Chamomile Ointment

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.

3. Pharmaceutical Form

Light brown ointment with Characteristic odour.

4. Clinical Particulars

4.1 Therapeutic Indications

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

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.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Kamillosan may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

There are no known symptoms of overdosage.

5. Pharmacological Properties

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.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There is none applicable.

6. Pharmaceutical Particulars

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)

6.2 Incompatibilities

None known.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store in a dry place below 25°C.

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.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Chefaro UK Ltd,

4^th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 02855/0035

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st October 1999

10. Date Of Revision Of The Text

December 2009