MYCIL OINTMENT
Active substance: TOLNAFTATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mycil Ointment.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate BP 1.0% w/w Benzalkonium Chloride Solution BP 0.2% v/w.
Excipients: Cetostearly Alcohol
For a full list of excipients see 6.1.
3
PHARMACEUTICAL FORM
Ointment.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the adjunctive treatment and prevention of athlete's foot (Tinea Pedis). It is also effective in other conditions, such as dhobie itch (Tinea Cruris) and prickly heat (Miliaria).
4.2
Posology and method of administration For topical application to the skin. Wash and thoroughly dry the affected area before applying the ointment morning and night. Continue the treatment for at least a week after the infection has cleared up. Routine use of the ointment can help prevent infection.
4.3
Contraindications Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use Keep all medicines out of the reach of children. For external use only. This product contains Cetostearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Pregnancy and lactation No special precautions necessary.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Tonaftate is a well established drug substance having potent antifungal properties. Benzalkonium chloride is a well established drug substance having potent anti-microbial properties.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data There are no preclinical safety data of relevance to the consumer.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Arlatone 983s, cetostearyl alcohol, dimeticone 20, liquid paraffin, glycerol, purified water.
6.2
Incompatibilities None known.
6.3
Shelf life 3 years.
6.4
Special precautions for storage Store in a cool place.
6.5
Nature and contents of container Collapsible, internally lacquered metal tube with blind end nozzle containing 25g.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0409
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4 February 2009
10
DATE OF REVISION OF THE TEXT
27/07/2011
1
NAME OF THE MEDICINAL PRODUCT
Mycil Ointment.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate BP 1.0% w/w Benzalkonium Chloride Solution BP 0.2% v/w.
Excipients: Cetostearly Alcohol
For a full list of excipients see 6.1.
3
PHARMACEUTICAL FORM
Ointment.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the adjunctive treatment and prevention of athlete's foot (Tinea Pedis). It is also effective in other conditions, such as dhobie itch (Tinea Cruris) and prickly heat (Miliaria).
4.2
Posology and method of administration For topical application to the skin. Wash and thoroughly dry the affected area before applying the ointment morning and night. Continue the treatment for at least a week after the infection has cleared up. Routine use of the ointment can help prevent infection.
4.3
Contraindications Hypersensitivity to any of the ingredients.
4.4
Special warnings and precautions for use Keep all medicines out of the reach of children. For external use only. This product contains Cetostearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Pregnancy and lactation No special precautions necessary.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Tonaftate is a well established drug substance having potent antifungal properties. Benzalkonium chloride is a well established drug substance having potent anti-microbial properties.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data There are no preclinical safety data of relevance to the consumer.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Arlatone 983s, cetostearyl alcohol, dimeticone 20, liquid paraffin, glycerol, purified water.
6.2
Incompatibilities None known.
6.3
Shelf life 3 years.
6.4
Special precautions for storage Store in a cool place.
6.5
Nature and contents of container Collapsible, internally lacquered metal tube with blind end nozzle containing 25g.
6.6
Special precautions for disposal None.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0409
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4 February 2009
10
DATE OF REVISION OF THE TEXT
27/07/2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
