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Norgine Limited
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS Telephone: +44 (0)1895 826 600 Fax: +44 (0)1895 825 865 E-mail: Medical Information e-mail: medinfo@norgine.com Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 27/08/2004

SPC	Posalfilin Ointment

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 excipients
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

POSALFILIN Ointment.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 10g tube of POSALFILIN Ointment contains 20% w/w Podophyllum Resin BP and 25% w/w Salicylic Acid BP.

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3. PHARMACEUTICAL FORM

Dark brown ointment.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the treatment of plantar warts.

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4.2 Posology and method of administration

Adults (including the elderly) and Children: A corn ring should be placed around the wart, cutting the ring to fit if necessary. A minimal amount of ointment should be applied to the exposed wart, taking care to avoid normal skin. The wart and corn ring should be covered with a plaster and the treatment repeated daily. When the wart appears soft and spongy, it should be left exposed and allowed to drop off. If the wart remains, the procedure should be repeated.

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4.3 Contraindications

Use in pregnancy, breastfeeding mothers, bleeding or friable warts. Patients with peripheral neuropathy, diabetes mellitus or peripheral vascular insufficiency. Should not be used on the skin of the face, armpits or ano-genital region.

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4.4 Special warnings and precautions for use

The patient should be warned that POSALFILIN Ointment is caustic to healthy skin, if such inflammation occurs, treatment should be suspended.

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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

Contraindicated in pregnancy and breastfeeding mothers.

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4.7 Effects on ability to drive and use machines

There is no effect on the ability to drive and use machines.

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4.8 Undesirable effects

Misapplication of POSALFILIN to healthy skin may cause inflammation, desquamation or necrosis. If applied to delicate areas of skin such as the ano-genital area, the skin may be seriously damaged, to an extent dependent on the amount applied.

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4.9 Overdose

Over-application can cause cutaneous necrosis and should be treated as a caustic burn.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

The salicylic acid macerates the horny layer covering the wart and allows the podophyllum to penetrate the wart where it has a specific cytotoxic effect on the nuclei of the hyperplastic cells.

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5.2 Pharmacokinetic properties

Not applicable, as POSALFILIN Ointment applied topically directly to the wart.

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5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Yellow Soft Paraffin BP

Liquid Paraffin BP