go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

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 Cream



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Pedamed 100mg/g Cream


Go to top of the page
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.


Go to top of the page
3. PHARMACEUTICAL FORM

Cream.

Smooth, white cream.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
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.


Go to top of the page
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.


Go to top of the page
4.3 Contraindications

Known hypersensitivity to any of the ingredients.


Go to top of the page
4.4 Special warnings and precautions for use

Do not use on broken skin.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

No information available.


Go to top of the page
4.7 Effects on ability to drive and use machines

None known.


Go to top of the page
4.8 Undesirable effects

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


Go to top of the page
4.9 Overdose

Not applicable.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Zinc Undecenoate is an anti-fungal agent.


Go to top of the page
5.2 Pharmacokinetic properties

No information given.


Go to top of the page
5.3 Preclinical safety data

No information given


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

Zinc Oxide

Alum

Allantoin

Chlorhexidine Hydrochloride

Levomenthol

Light Liquid Paraffin

White Soft Paraffin

Sorbitol Solution (70 per cent) (non-crystallising)

Macrogol Stearate

Mono and di-glycerides of higher saturated fatty acids (Cutina MD)

Ethyl, Methyl and Propyl Parahydroxybenzoate (E214, E218, E216)

Bronopol

Purified Water


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

3 years.


Go to top of the page
6.4 Special precautions for storage

Do not store above 25°C

Keep the container tightly closed.


Go to top of the page
6.5 Nature and contents of container

Multidose, tamper-proof, air-tight, collapsible aluminium tube with a HDPE closure. The tube is internally coated with an epoxyphenolic liner and has a polyurethane external varnish. Each tube contains 30g Pedamed Cream.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Ricesteele Manufacturing Ltd,

Cookstown Industrial Estate,

Tallaght,

Dublin 24.


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

P.A. 95/12/1


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

26 August 1986

Date of last renewal:

26 August 2006


Go to top of the page
10. DATE OF REVISION OF THE TEXT

October 2006



Link to this document from your website:
http://www.medicines.ie/medicine/2724/SPC/Pedamed+100mg+g+Cream/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
  Zinc undecylenate