Pedamed 100 mg/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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:

Cream

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

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.
•
Do not get Pedamed Cream in your eyes, nose or
mouth. If you get this medicine in your eyes,
nose or mouth, rinse immediately with cool
tap water
•
Wash and dry your hands before and after using
this medicine
•
Clean and dry the affected area
•
Apply a thin layer of Pedamed Cream over the
affected area twice daily and rub the cream in
gently. For athlete’s foot apply the cream in
between the toes as well
•
Keep using Pedamed Cream for at least one
week after all signs of infection have gone
•
For the best results, Pedamed Cream should be
used together with an antifungal powder such as
Pedamed 100mg/g Cutaneous Powder
•
To stop any reoccurrence of the infection, use
regularly after showering and bathing.
IF PEDAMED 100MG/G CREAM IS USED INCORRECTLY:
If anyone accidently swallows this medicine
contact your doctor or go to your hospital casualty
department as soon as possible. Take your
medicine and pack with you.
IF YOU FORGET TO USE PEDAMED 100MG/G CREAM:
If you forget to use Pedamed Cream don’t worry.
Apply the cream as soon as possible and then
continue the rest of your treatment as usual. Do not
apply this cream more than twice daily.
IF YOUR SYMPTOMS DO NOT GO AWAY OR YOU ARE NOT
SURE HOW TO USE THIS MEDICINE AND WOULD LIKE
FURTHER INFORMATION, THEN PLEASE CONTACT YOUR
DOCTOR OR PHARMACIST. 4. POSSIBLE SIDE EFFECTS
Like all medicines Pedamed Cream may
sometimes cause side effects, although not
everyone will get them. Skin irritation can occur
occasionally when using this product.
IN THIS LEAFLET:
1. What Pedamed Cream is and what it is used for
2. Before you use

Summary of Product characteristics

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
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
No information available.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
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