Pedamed 100 mg/g Cutaneous Powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc undecylenate

Available from:

Phoenix Healthcare Ltd

ATC code:

D01AE; D01AE04

INN (International Name):

Zinc undecylenate

Dosage:

100 milligram(s)/gram

Pharmaceutical form:

Cutaneous powder

Therapeutic area:

Other antifungals for topical use; undecylenic acid

Authorization status:

Marketed

Authorization date:

1986-08-26

Patient Information leaflet

Package Leaflet: Information for the user
PEDAMED 100MG/G CUTANEOUS POWDER
Zinc undecylenate
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again
•
If you need more information or advice, please ask your doctor or
pharmacist
•
You must contact your doctor if your symptoms get worse or do not
improve
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Pedamed Powder is and what it is used for
2.
Before you use Pedamed Powder
3.
How to use Pedamed Powder
4.
Possible side effects
5.
How to store Pedamed Powder
6.
Further information.
1.
WHAT PEDAMED 100MG/G CUTANEOUS POWDER IS AND WHAT IT IS USED FOR
Pedamed Powder contains the active ingredient zinc undecylenate. Zinc
undecylenate is an
antifungal which works by preventing fungal growth that can cause skin
infections.
Pedamed Powder is used for the treatment and prevention of athlete's
foot and other fungal skin
infections. It is also used to remove foot odours and to stop feet
from sweating.
Pedamed Powder is for use on the skin only.
2.
BEFORE YOU USE PEDAMED 100MG/G CUTANEOUS POWDER
DO NOT USE PEDAMED POWDER if you are allergic to zinc undecylenate or
to any of the other
ingredients listed (see ingredients section).
TAKE SPECIAL CARE WITH PEDAMED POWDER IF your skin is damaged - do not
use it on areas of broken
skin.
IF ANY OF THE ABOVE APPLIES, PLEASE TALK TO A DOCTOR OR PHARMACIST
BEFORE USING THIS MEDICINE.
TAKING OTHER MEDICINES:
Always tell your doctor or pharmacist about all the medicines you are
taking. This means medicines
you have bought yourself as well as those you have on prescription
from your doctor.
PREGNANCY AND BREAST-FEEDING:
Please let your doctor or pharmacist know if you are pregnant or
breast feeding or planning on
getting pregnant. If you become pregnant whilst you are using Pedamed
Powder, tell your doctor.
DRIVING AND USING MACHINES:
Pedam

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2021
CRN00CLFK
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
28 October 2021
CRN00CLFK
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: [phone]; Fax: [phone].
Website: www.hpra.ie; E-mail: [e-mail].
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACO