KAMILLOSAN CHAMOMILE OINTMENT
Active substance: CHAMOMILE EXTRACT
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SUMMARY OF PRODUCT CHARACTERISTICS
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 - - bisabolol active ingredient.
3
PHARMACEUTICAL FORM
Light brown ointment with a characteristic odour.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the 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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
The chamomile extract possesses topical anti-inflammatory properties due to the presence of the natural anti-inflammatory substance L - - bisabolol.
5.2
Pharmacokinetic properties Not applicable
5.3
Preclinical safety data There is none applicable.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Beeswax BP, Emulsifying wax BP, anhydrous lanolin BP, yellow soft paraffin BP, maize oil and 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 25C.
6.5
Nature and contents of container
Aluminium tubes containing 5, 20, 24, 30, 50, 100 and 125g of ointment. Sachets containing 1 and 1.5 g of ointment.
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd. 1st Floor 32 Vauxhall Bridge Road LONDON, SW1V 2SA
8
MARKETING AUTHORISATION NUMBER(S)
PL 02855/0035
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st October 1999
10
DATE OF REVISION OF THE TEXT
30/01/2013
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 - - bisabolol active ingredient.
3
PHARMACEUTICAL FORM
Light brown ointment with a characteristic odour.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the 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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
The chamomile extract possesses topical anti-inflammatory properties due to the presence of the natural anti-inflammatory substance L - - bisabolol.
5.2
Pharmacokinetic properties Not applicable
5.3
Preclinical safety data There is none applicable.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Beeswax BP, Emulsifying wax BP, anhydrous lanolin BP, yellow soft paraffin BP, maize oil and 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 25C.
6.5
Nature and contents of container
Aluminium tubes containing 5, 20, 24, 30, 50, 100 and 125g of ointment. Sachets containing 1 and 1.5 g of ointment.
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd. 1st Floor 32 Vauxhall Bridge Road LONDON, SW1V 2SA
8
MARKETING AUTHORISATION NUMBER(S)
PL 02855/0035
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st October 1999
10
DATE OF REVISION OF THE TEXT
30/01/2013
Source: Medicines and Healthcare Products Regulatory Agency
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