Sudocrem Antiseptic Healing Cream - Summary of Product Characteristics (SPC)

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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL, UK Telephone: +44 (0)1322 421 800 Fax: +44 (0)1322 291 306 Medical Information e-mail: medinfo@forest-labs.co.uk

Summary of Product Characteristics last updated on medicines.ie: 08/09/2008

SPC	Sudocrem Antiseptic Healing Cream

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Sudocrem Antiseptic Healing Cream

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

	% w/w
Zinc oxide, EP	15.25
Benzyl alcohol, BP	0.39
Benzyl benzoate, BP	1.01
Benzyl cinnamate	0.15
Wool Fat (Lanolin (hypoallergenic))	4.00

For excipients, see 6.1.

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3. PHARMACEUTICAL FORM

Cream

A smooth, homogeneous, white, water in oil cream with a lavender odour.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

In the management of various dermatoses, including local skin reactions associated with incontinence.

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4.2 Posology and method of administration

Apply a thin layer with suitable covering where necessary. Renew application as required. No distinction is required between indications or for adults, children and the elderly.

Topical cream for external use only.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

For external use only and should not be allowed to come into contact with the eyes and the mucous membranes.

If there is no improvement in the condition or aggravation thereof, the doctor should be consulted.

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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

There are no known contra-indications.

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4.7 Effects on ability to drive and use machines

Not applicable

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4.8 Undesirable effects

Side effects include local hypersensitivity occasionally.

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4.9 Overdose

No cases of overdose have been reported. If large amounts are swallowed accidentally, this may cause vomiting, diarrhoea, CNS stimulation and convulsions. Symptomatic treatment should be provided.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Zinc oxide:

A dermatological agent with astringent, soothing and protective properties.

Benzyl alcohol:

A local anaesthetic with disinfectant properties.

Benzyl benzoate:

An acaricide and has been used as a pediculicide, insect repellent and pharmaceutical solubilising agent.

Lanolin:

Resembles the sebaceous secretions of human skin.

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5.2 Pharmacokinetic properties

Not applicable

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5.3 Preclinical safety data

Not applicable

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Purified Water

Sodium Benzoate

Paraffin wax

Microcrystalline wax

Heavy Liquid Paraffin

Synthetic Beeswax

Sorbitan sesquioleate

Propylene Glycol

Citric Acid

Butylated hydroxyanisole (E320)

Linalyl acetate

Lavender

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

5 years

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6.4 Special precautions for storage

No special precautions for storage.

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6.5 Nature and contents of container

			Pack size (g)
a)	Polypropylene jars with polyethylene tamper-evident caps	(1)	60
		(2)	125
		(3)	250
		(4)	400
b)	Polypropylene jar with polyethylene cap	(1)	25
c)	Aluminium or laminated plastic aluminium tubes with aluminium membrane and plastic cap.	(1)	30

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6.6 Special precautions for disposal and other handling

No special requirements.

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7. MARKETING AUTHORISATION HOLDER

Forest Tosara Limited

Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

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8. MARKETING AUTHORISATION NUMBER(S)

PA 247/1/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1978

Date of last renewal: 01 April 2003

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10. DATE OF REVISION OF THE TEXT

July 2006

Link to this document from your website:
http://www.medicines.ie/medicine/3076/SPC/Sudocrem+Antiseptic+Healing+Cream/

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Active Ingredients

Zinc Oxide

Benzyl Benzoate

Benzyl Alcohol

Benzyl Cinnamate

wool fat

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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Forest Laboratories UK Limited

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Active Ingredients