Warticon Cream (Stiefel)

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1. Name Of The Medicinal Product

Warticon 0.15% w/w Cream

2. Qualitative And Quantitative Composition

Podophyllotoxin 1.5 mg/g (0.15% w/w).

The cream also contains the following excipients:

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Sorbic acid

Stearyl alcohol

Cetyl alcohol

Butylhydroxyanisole (BHA) E320

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Topical cream

A homogenous white cream.

4. Clinical Particulars 4.1 Therapeutic Indications

Route of administration: Topical

For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia.

4.2 Posology And Method Of Administration

The affected area should be thoroughly washed with soap and water, and dried prior to application.

Using a fingertip, the cream is applied twice daily for 3 days using only enough cream to just cover each wart.

Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment.

Where lesions are greater than 4 cm2 , it is recommended that treatment takes place under the direct supervision of medical staff.

4.3 Contraindications

Known hypersensitivity to any of the ingredients

Open wounds eg. Following surgical procedures.

Use in children.

Hypersensitivity to podophyllotoxin.

Concomitant use with other podophyllotoxin containing preparations.

Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes. Should the cream accidentally come into the eye, the eye should be thoroughly rinsed with water.

The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since cream contains an active pharmaceutical substance which could be harmful on healthy skin.

This cream contains:

• methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

• sorbic acid, stearyl alcohol and cetyl alcohol which may cause local skin reactions, (e.g. contact dermatitis).

• butylhydroxyanisole which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None presently known.

4.6 Pregnancy And Lactation

The product is not for use in pregnancy or lactation.

Reproduction toxicity studies in animals have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproductive process. However, since podophyllotoxin is a mitosis inhibitor, Warticon Cream should not be used during pregnancy or lactation.

It is not known if the substance is excreted into breast milk.

Observations in man indicate that podophyllin, a crude mixture of lignans, can be harmful to pregnancy. Such observations have not been reported in patients treated with podophyllotoxin.

4.7 Effects On Ability To Drive And Use Machines

None presently known.

4.8 Undesirable Effects

Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases the reactions are mild. Tenderness, itching, smarting, erythema, superficial epithelial ulceration and balanoposthitis have been reported. Local irritation decreases after treatment.

4.9 Overdose

There have been no reported overdosages with Warticon cream. However, excessive use of podophyllotoxin 0.5% solution has been reported as causing two cases of severe local reactions. In cases of excessive use of Warticon cream resulting in severe local reaction, the treatment should be stopped, the area washed and symptomatic treatment introduced.

No specific antidote is known. In the event of accidental ingestion, give emetic or stomach washout. Treatment should be symptomatic and in severe oral overdose ensure the airway is clear and give fluids. Check and correct electrolyte balance, monitor blood gases and liver function. Blood count should be monitored for at least 5 days.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group, D06BB antivirals

Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleo side transport through the cell membrane.

The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells.

5.2 Pharmacokinetic Properties

Systemic absorption of podophyllotoxin after topical application with a higher strength, 0.3% is low. Thus no study was performed on the present strength, 0.15%. The Cmax (1.0 – 4.7 ng/ml) and Tmax (0.5 – 36 hrs) are comparable for the 0.3% cream and 0.5% solution in both males and females.

5.3 Preclinical Safety Data

No relevant findings

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified Water

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Sorbic acid

Phosphoric acid

Stearyl alcohol

Cetyl alcohol

Isopropyl myristate

Paraffin, liquid

Fractionated coconut oil

Butylhydroxyanisole (BHA) E320

Macrogol –7 stearyl ether

Macrogol – 10 stearyl ether

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5g and 10g.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 26th April 1999

Date of last renewal: 17th January 2010

10. Date Of Revision Of The Text

5th February 2011

Warticon Cream Stiefel

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