Scholl Athlete's Foot Powder
*Company:
Reckitt Benckiser Ireland LimitedStatus:
DiscontinuedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 31 August 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 31 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2:
Wording replaced with posology breakdown (adults & paediatric populations).
Method of administration expanded.
Section 4.3:
"Not recommended for" nail or scalp infections replaced by "Contraindicated in"
Section 4.4:
Addition of "If irritation or rash occurs, use of the the product should be discontinued and medical advice should be sought"
Section 4.6:
Addition of the below in "Pregnancy":
No effects during pregnancy are anticipated since systemic exposure to Tolnaftate is negligible. Tolnaftate can be used during pregnancy.
Addition of "Breast-feeding" and "Fertility" information
Section 4.7:
"None stated" replaced with "This medication has no known effects on the ability to drive and use machines"
Section 4.8
Addition of MEDdra table.
Addition of "Reporting of Suspected Adverse Reactions" information
Section 4.9:
"Not relevant to topical use" replaced with:
Symptoms: There have been no reports of over dosage with the use of this product.
Management: In the case of over dosage, treatment should be symptomatic and supportive
Section 5.1:
Pharmaceutical group: Tolnaftate, replaced with:
Pharmacotherapeutic group: Dermatological, Antifungals for Dermatological use, Antifungals for Topical use other Antifungals for Topical use.
Addition of the below sentence in Mechanism of Action paragraph:
"It is a thiocarbamate derivative that inhibits sterol synthesis at the level of squalene epoxidase in the growing of cells"
Section 5.3:
"Not Applicalbe" replaced with "There are no preclinical safety data of relevant to the consumer"
Wording replaced with posology breakdown (adults & paediatric populations).
Method of administration expanded.
Section 4.3:
"Not recommended for" nail or scalp infections replaced by "Contraindicated in"
Section 4.4:
Addition of "If irritation or rash occurs, use of the the product should be discontinued and medical advice should be sought"
Section 4.6:
Addition of the below in "Pregnancy":
No effects during pregnancy are anticipated since systemic exposure to Tolnaftate is negligible. Tolnaftate can be used during pregnancy.
Addition of "Breast-feeding" and "Fertility" information
Section 4.7:
"None stated" replaced with "This medication has no known effects on the ability to drive and use machines"
Section 4.8
Addition of MEDdra table.
Addition of "Reporting of Suspected Adverse Reactions" information
Section 4.9:
"Not relevant to topical use" replaced with:
Symptoms: There have been no reports of over dosage with the use of this product.
Management: In the case of over dosage, treatment should be symptomatic and supportive
Section 5.1:
Pharmaceutical group: Tolnaftate, replaced with:
Pharmacotherapeutic group: Dermatological, Antifungals for Dermatological use, Antifungals for Topical use other Antifungals for Topical use.
Addition of the below sentence in Mechanism of Action paragraph:
"It is a thiocarbamate derivative that inhibits sterol synthesis at the level of squalene epoxidase in the growing of cells"
Section 5.3:
"Not Applicalbe" replaced with "There are no preclinical safety data of relevant to the consumer"
Updated on 31 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
Section 4.2:
Wording replaced with posology breakdown (adults & paediatric populations).
Method of administration expanded.
Section 4.3:
"Not recommended for" nail or scalp infections replaced by "Contraindicated in"
Section 4.4:
Addition of "If irritation or rash occurs, use of the the product should be discontinued and medical advice should be sought"
Section 4.6:
Addition of the below in "Pregnancy":
No effects during pregnancy are anticipated since systemic exposure to Tolnaftate is negligible. Tolnaftate can be used during pregnancy.
Addition of "Breast-feeding" and "Fertility" information
Section 4.7:
"None stated" replaced with "This medication has no known effects on the ability to drive and use machines"
Section 4.8
Addition of MEDdra table.
Addition of "Reporting of Suspected Adverse Reactions" information
Section 4.9:
"Not relevant to topical use" replaced with:
Symptoms: There have been no reports of over dosage with the use of this product.
Management: In the case of over dosage, treatment should be symptomatic and supportive
Section 5.1:
Pharmaceutical group: Tolnaftate, replaced with:
Pharmacotherapeutic group: Dermatological, Antifungals for Dermatological use, Antifungals for Topical use other Antifungals for Topical use.
Addition of the below sentence in Mechanism of Action paragraph:
"It is a thiocarbamate derivative that inhibits sterol synthesis at the level of squalene epoxidase in the growing of cells"
Section 5.3:
"Not Applicalbe" replaced with "There are no preclinical safety data of relevant to the consumer"
Wording replaced with posology breakdown (adults & paediatric populations).
Method of administration expanded.
Section 4.3:
"Not recommended for" nail or scalp infections replaced by "Contraindicated in"
Section 4.4:
Addition of "If irritation or rash occurs, use of the the product should be discontinued and medical advice should be sought"
Section 4.6:
Addition of the below in "Pregnancy":
No effects during pregnancy are anticipated since systemic exposure to Tolnaftate is negligible. Tolnaftate can be used during pregnancy.
Addition of "Breast-feeding" and "Fertility" information
Section 4.7:
"None stated" replaced with "This medication has no known effects on the ability to drive and use machines"
Section 4.8
Addition of MEDdra table.
Addition of "Reporting of Suspected Adverse Reactions" information
Section 4.9:
"Not relevant to topical use" replaced with:
Symptoms: There have been no reports of over dosage with the use of this product.
Management: In the case of over dosage, treatment should be symptomatic and supportive
Section 5.1:
Pharmaceutical group: Tolnaftate, replaced with:
Pharmacotherapeutic group: Dermatological, Antifungals for Dermatological use, Antifungals for Topical use other Antifungals for Topical use.
Addition of the below sentence in Mechanism of Action paragraph:
"It is a thiocarbamate derivative that inhibits sterol synthesis at the level of squalene epoxidase in the growing of cells"
Section 5.3:
"Not Applicalbe" replaced with "There are no preclinical safety data of relevant to the consumer"
Updated on 19 May 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
None provided
Updated on 19 May 2015
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
None provided