Pedamed 100 mg/g Cream

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Zinc undecylenate

থেকে পাওয়া:

Phoenix Healthcare Ltd

এটিসি কোড:

D01AE04

INN (আন্তর্জাতিক নাম):

Zinc undecylenate

ডোজ:

100 milligram(s)/gram

ফার্মাসিউটিকাল ফর্ম:

Cream

থেরাপিউটিক এলাকা:

undecylenic acid

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1986-08-26

তথ্য লিফলেট

Package Leaflet: Information for the user
PEDAMED 100MG/G CREAM
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 Cream is and what it is used for
2.
Before you use Pedamed Cream
3.
How to use Pedamed Cream
4.
Possible side effects
5.
How to store Pedamed Cream
6.
Further information.
1.
WHAT PEDAMED 100MG/G CREAM IS AND WHAT IT IS USED FOR
Pedamed Cream contains the active ingredient zinc undecylenate. Zinc
undecylenate is an antifungal
which works by preventing fungal growth that can cause skin
infections.
Pedamed Cream 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 Cream is for use on the skin only.
2.
BEFORE YOU USE PEDAMED 100MG/G CREAM
DO NOT USE PEDAMED CREAM if you are allergic to zinc undecylenate or
to any of the other
ingredients listed (see ingredients section).
TAKE SPECIAL CARE WITH PEDAMED CREAM IF YOUR skin is damaged - do not
use it on areas of broken
skin.
IF ANY OF THE ABOVE APPLIES TO YOU, 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
Cream, tell your doctor.
DRIVING AND USING MACHINES:
Pedamed Cream does not affect your abil

পণ্য বৈশিষ্ট্য

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 Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 100 mg zinc undecylenate equivalent to
zinc undecylenate 10% w/w.
Excipients: Bronopol 0.500 mg/g.
Ethyl, Methyl and Propyl parahydroxybenzoates (E214, E218, E216) 1.5
mg/g.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth, white cream.
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 Cream should be
applied twice daily and rubbed in gently. For optimum
effectiveness the cream should be used with an appropriate anti-fungal
powder. 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: meds