Vasogen Cream

1. Name Of The Medicinal Product

VASOGEN CREAM

2. Qualitative And Quantitative Composition

Dimethicone (as silicone fluid 200) BP	20.0% w/w
Zinc oxide Ph.Eur.	7.5% w/w
Calamine BP	1.5% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

The prevention and treatment of nappy rash and bedsores. Local protection of skin around the stoma after ileostomy and colostomy.

4.2 Posology And Method Of Administration

Vasogen is applied topically to the skin and may be either rubbed in gently or applied thinly and left to dry. Further application can be made as required.

4.3 Contraindications

Use in patients with known hypersensitivity to the product or any of its ingredients, e.g. lanolin or phenonip. Vasogen should not be applied when it is considered that free drainage is necessary, e.g. weeping dermatitis.

4.4 Special Warnings And Precautions For Use

None

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No restrictions

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Side-effects such as local sensitivity reactions are extremely rare.

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dimethicone is an inert polymer which has a low surface tension and is a water repellent. It is widely used in barrier creams. Zinc oxide is a mild astringent and antiseptic. Calamine has a mild astringent activity and is widely used in various dermatological conditions.

5.2 Pharmacokinetic Properties

Not applicable

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Aluminium Hydroxide (wet gel)

Lanolin (anhydrous)

Methylcellulose

Phenonip

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

White low-density polyethylene tube with white polypropylene cap.

Pack sizes 14, 50 and 100g.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

8. Marketing Authorisation Number(S)

PL 0108/5033R

9. Date Of First Authorisation/Renewal Of The Authorisation

29 August 1989/26 March 1996

10. Date Of Revision Of The Text

March 2010

11. Legal Category

GSL