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Ricesteele Manufacturing Ltd
Unit 31, Cookstown Industrial Estate, Tallaght, Dublin 24,
Telephone: +353 1 451 0144
Fax: +353 1 452 1875


Summary of Product Characteristics last updated on medicines.ie: 23/08/2007
SPC Pedamed 100mg/g Cutaneous Powder



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1. NAME OF THE MEDICINAL PRODUCT

Pedamed 100mg/g Cutaneous Powder


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of powder contains 100 mg zinc undecylenate equivalent to zinc undecylenate 10% w/w.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Cutaneous powder.

Fine, white powder.


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4. CLINICAL PARTICULARS

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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.


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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.


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4.3 Contraindications

Known hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

Do not use on broken skin.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

No information available.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

Skin irritation can occur occasionally to some of the ingredients. If this occurs, use of the product should be discontinued.


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4.9 Overdose

Not applicable.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Zinc Undecylenate is an anti-fungal agent.


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5.2 Pharmacokinetic properties

No information given.


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5.3 Preclinical safety data

No information given.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Zinc Oxide

Alum

Allantoin

Chlorhexidine Hydrochloride

Levomenthol

Talc

Maize Starch.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 25°C.

Keep the container tightly closed.


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6.5 Nature and contents of container

Multidose, well-closed, sifter-top container composed of HDPE. Contains 65g of Pedamed 100 mg/g Cutaneous Powder.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Ricesteele Manufacturing Ltd,

Cookstown Industrial Estate,

Tallaght,

Dublin 24.


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8. MARKETING AUTHORISATION NUMBER(S)

P.A. 95/12/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26th August 1986/ 26th August 2006.


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10. DATE OF REVISION OF THE TEXT

October 2006



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Active Ingredients

 
  Zinc undecylenate