Pedamed 100 mg/g Cutaneous Powder
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-06-2017
Summary of Product characteristics
(SPC)
17-11-2020
Active ingredient:
Zinc undecylenate
Available from:
Ricesteele Manufacturing Ltd
ATC code:
D01AE; D01AE04
INN (International Name):
Zinc undecylenate
Dosage:
100 milligram(s)/gram
Pharmaceutical form:
Cutaneous powder
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Other antifungals for topical use; undecylenic acid
Authorization status:
Marketed
Authorization date:
1986-08-26
Patient Information leaflet
Leaflet revision date: April 2017
18006/P/02
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.
Leaflet revision date: April 2017
18006/P/02
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
16 November 2020
CRN009Y3R
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pedamed 100 mg/g Cutaneous Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of powder contains 100 mg zinc undecylenate equivalent to
zinc undecylenate 10% w/w.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder
Fine, white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention of athlete's foot and other fungal skin infections.
For the elimination of foot odours and antiperspirant effect.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
After cleansing and drying the affected area, Pedamed Powder should be
applied twice daily and rubbed in gently. For
optimum effectiveness the powder should be used with an appropriate
anti-fungal cream. Treatment should be continued for
one week after all signs of infection have disappeared.
4.3 CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use on broken skin.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
No information available.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Skin irritation can occur occasionally to some of the ingredients. If
this occurs, use of the product should be discontinued.
Health Products Regulatory Authority
16 November 2020
CRN009Y3R
Page 2 of 3
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL -
Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMA
Read the complete document
