• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Metvix is and what it is used for
2. What you need to know before you use Metvix
3. How to use Metvix
4. Possible side effects
5. How to store Metvix
6. Contents of the pack and other information

• if you are allergic to methyl aminolevulinate or any of the other ingredients of this medicine (listed in section 6). Metvix contains arachis oil (peanut oil): Do not use this product if you are allergic to peanut or soya
• if you have a particular type of skin cancer with yellowish-white patches called morpheaform basal cell carcinoma
• if you have a rare disease called porphyria

Talk to your doctor before using Metvix:

• if the skin lesions are of certain types (coloured, deep or located on the genitalia)
• if you have 'thick' actinic keratoses
• if you have large lesions caused by Bowen's disease
• if you are taking medicines to suppress your immune system such as steroids or ciclosporin
• if your Bowen's disease has been caused by exposure to arsenic (a harmful chemical)
• if you have a history of high blood pressure

Direct eye contact with Metvix should be avoided.

Metvix cream should not be applied to the eyelids and mucous membranes.

The active substance may cause skin allergy which can lead to angioedema. If you experience the following symptoms: swelling of the face, the tongue or the throat; rash, or difficulty in breathing, you should immediately stop taking Metvix and contact a doctor.

If using a red-light source and the application time or the light dose is increased, a more severe skin reaction may result (see Section 4 - Possible side effects).

In very rare cases photodynamic therapy with a red light source may increase the risk to develop temporary memory loss (including confusion or disorientation), in case of symptoms, you should contact your doctor immediately.

Sun exposure and UV therapy

As a general precaution, sun exposure on the treated lesion sites and surrounding skin should be avoided for a couple of days following treatment. If you are being treated with ultraviolet light (UV-therapy), this treatment should be stopped before Metvix treatment.

Treatment with Metvix is not recommended during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

No effects on the ability to drive and use machines are expected.

If you are allergic to peanut or soya, (containing arachis oil) do not use this medicinal product. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl- and propyl parahydroxybenzoate (E218, E216) may cause allergic reactions (possibly delayed).

Treatment of actinic keratoses, basal cell carcinoma and Bowen's disease using a red-light lamp

The use of Metvix with a red-light lamp requires specific knowledge in photodynamic therapy. Accordingly, it should be administered in the presence of a doctor, a nurse or another health care professional trained in the use of photodynamic therapy.

Preparation of the lesions and application of the cream

Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion. Some skin cancer lesions are covered by an intact layer of skin which will be removed according to your doctor's instructions. Metvix is applied by a spatula in a layer (about 1 mm thick) to the lesions or fields and a small area of the surrounding skin. Direct eye contact with Metvix cream should be avoided. After the cream is applied, the area is covered with a dressing. The dressing is removed and the cream is washed off with saline solution after 3 hours.

Illumination using a red-light lamp

Immediately after cleaning, the treated area is exposed to a red-light. To protect your eyes from the strong light, you will be given goggles to wear during light exposure.

Several lesions or fields may be treated during the same therapy session.

Considerations before treatment

Natural daylight treatment can be used if the temperature is suitable to stay comfortably outdoors for 2 hours. The efficacy of the treatment has been shown to be similar whether the treatment is done on a sunny or cloudy day. If the weather is rainy, or is likely to become so, natural daylight treatment should not be used.

Preparation of the lesions and application of the cream

An appropriate sunscreen should be applied to all areas, including the treatment areas that will be exposed to daylight before lesion or field preparation. Only the sunscreen that has been recommended specifically by your doctor should be used. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide as these filters would inhibit absorption of visible light and may impact efficacy. Only sunscreens with chemical filters should be used.

Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion.

A thin layer of Metvix is applied on the lesions or fields with a spatula or gloved hand. Direct eye contact with Metvix cream should be avoided.

Illumination using natural daylight

You should go outside after Metvix application, or at the latest, 30 minutes later and stay for 2 hours in full daylight or, if needed, in a shaded outdoor area. It is recommended not to go indoors during this time period. Make sure the treatment area is continuously exposed to daylight, and not covered by clothes. It is important to follow these instructions to ensure treatment success and avoid pain during daylight exposure. Following the 2-hour exposure period Metvix cream is washed off.

Several lesions or fields may be treated during the same therapy session.

The use of Metvix with an artificial daylight lamp requires specific knowledge in photodynamic therapy. Accordingly, it should be administered in the presence of a doctor, a nurse or another health care professional trained in the use of photodynamic therapy.

Preparation of the lesions and application of the cream

Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion. A thin layer of Metvix is applied on the lesions or fields with a spatula or gloved hand. Direct eye contact with Metvix cream should be avoided.

Illumination using an artificial daylight source

After the cream is applied, or at the latest, 30 minutes later, the treated area is exposed to artificial daylight for 2 hours. Following the 2 hour-exposure period, Metvix cream is washed off.

Several lesions or fields may be treated during the same therapy session.

Actinic keratoses are treated with one session.

Basal cell carcinoma and Bowen's disease is treated with two sessions, with an interval of one week in between sessions

Follow up

Your doctor will decide how well each skin lesion has responded after three months and may take a small sample (biopsy) of the skin and have the cells examined. Treatment may be repeated after this period if necessary.

Treatment with Metvix is not suitable for use in children or adolescents below 18 years of age.

If the treatment is stopped before the light therapy is started or full light dose is given, when using the red light, or before the end of the 2 h daylight exposure the effectiveness of the treatment might be reduced.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is methyl aminolevulinate 160 mg/g (as hydrochloride).
• The other ingredients are glyceryl monostearate, cetostearyl alcohol, poloxyl 40 stearate, methyl parahydroxy benzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, glycerol, white soft paraffin, cholesterol, isopropyl myristate, arachis oil (peanut oil), almond oil, oleyl alcohol, purified water.

The colour of Metvix is cream to pale yellow. The cream is available in tubes containing 1 g or 2 g cream.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PL 10590/0048

Manufacturer