Leaflet:Information for the patient

Metvix 160 mg/g cream

Methyl aminolevulinate

Contents of the leaflet

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

Metvix is used to treat pre-cancerous skin lesions on the face and scalp (known as actinic keratosis) that are areas of damaged skin caused by sunlight and have transformed into rough and scaly areas. Having these lesions means you may have a higher chance of developing skin cancer in the future unless they are treated.

Metvix is also used to treat basal cell carcinoma (BCC), a type of skin cancer that can cause red and scaly patches (called superficial BCC) or a small lump or a series of small lumps on the skin (called nodular BCC). These lesions bleed easily and do not heal. Metvix is used when other treatments are not suitable.

Metvix may also be used to treat Bowen's disease (a pre-cancerous lesion that appears as red to pink patches that slowly grow), when surgery is not appropriate.

The treatment involves applying Metvix and exposure to light. The damaged cells absorb the methyl aminolevulinate from the cream and are destroyed by exposure to light (a process known as photodynamic therapy). The healthy skin around the lesions is not affected.

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Do not use Metvix:

• If you are allergic to aminolevulinic acid methyl ester or any of the ingredients of this medication (listed in section 6). Metvix cream contains peanut oil (arachis oil): Do not use this medication in case of an allergy to peanuts or soy.
• If you have a certain type of skin cancer with white-yellowish spots called morpheaform basal cell carcinoma.
• Or if you have a rare disease called porphyria.

Warnings and precautions

Consult your doctor before starting to use Metvix: Your doctor will consider if the following may be important for you

• If the skin lesions are of a certain type (color, deep, or located in the genital area).
• If you have thick lesions of actinic keratosis.
• If you have extensive lesions caused by Bowen's disease.
• If you are taking medications that suppress your immune system, such as steroids or ciclosporina.
• If your Bowen's disease has been caused by exposure to arsenic (a harmful chemical).
• If you have a history of hypertension.

You must avoid contact of Metvix with the eyes. Metvix cream should not be applied to the eyelids or mucous membranes.

The active ingredient aminolevulinic acid methyl ester may cause skin allergy resulting in angioedema. If you experience the following symptoms: swelling of the face, tongue, or throat; hives or difficulty breathing, you must interrupt the treatment with Metvix and contact your doctor.

If you use a red light source and increase the application time or intensity of the light, a more severe skin reaction may appear (see section 4- Possible side effects). In very rare cases, photodynamic therapy with a red light source may increase the risk of developing temporary memory loss (including confusion or disorientation), in case of symptoms, you should contact your doctor immediately.

Exposure to sunlight and UV therapy

As a general precaution, you should avoid exposure to sunlight of the treated areas and surrounding skin for two days after treatment.Si you are being treated with ultraviolet light (UV therapy), this treatment should be interrupted before starting Metvix treatment.

Pregnancy and breastfeeding

Metvix treatment is not recommended during pregnancy.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking a medication.

Driving and operating machines

No expected effects on the ability to drive or operate machines.

Metvix contains peanut oil (peanut oil), cetoestearic alcohol, and methyl and propyl parahydroxybenzoate.

If you are allergic to peanut oil or soy, do not use this medication. Metvix also contains cetoestearic alcohol, which may cause local skin reactions (contact dermatitis). Methyl and propyl parahydroxybenzoate (E-218, E-216) may cause allergic reactions (possibly delayed).

The treatment consists of the application of Metvix and exposure to light. The light source for the treatment of actinic keratoses can be natural daylight (natural or artificial) or a red light lamp. Your doctor will decide which treatment option to use, depending on your lesions. The light source for the treatment of basal cell carcinoma and Bowen's disease is always a red light lamp.

Adults (including elderly patients)

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

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

Preparation of lesions and application of Metvix

Each skin lesion will be prepared before treatment by removing scales and crusts and scraping the skin surface. This preparation helps Metvix and light to reach all parts of the 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 with a spatula as a layer (about 1 mm thick) over the lesions or fields of carcinomatization and over a small surrounding area of skin. Direct contact of Metvix with the eyes should be avoided. After applying the cream, the treated area is covered with a bandage. The bandage is removed and the cream is then removed by washing after 3 hours.

Lighting using red light lamp

Immediately after washing, the treated area is exposed to red light.To protect your eyes from intense light, you will be given glasses to wear during the light exposure.

During the same treatment session, multiple fields of carcinomatization or lesions can be treated.

Treatment of actinic keratoses with natural daylight

Considerations before treatment

The Metvix daylight treatment can be used if the temperature conditions are suitable to stay comfortably outdoors for 2 hours. The effectiveness of the treatment has been shown to be similar whether the treatment is performed on a sunny or cloudy day. If it is raining, or there is a risk of rain, do not use the Metvix daylight treatment..

Preparation of lesions and application of Metvix

Before preparing the lesion or field of carcinomatization, a suitable sunscreen should be applied to all areas, including the treatment areas that will be exposed to daylight. Only sunscreen recommended specifically by your doctor should be used. Do not use sunscreens with physical filters such as titanium dioxide or zinc oxide, as these filters inhibit the absorption of visible light and may affect the effectiveness.

Only sunscreens with chemical filters should be used.

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

A thin layer of Metvix should be applied with a spatula or with a glove over the lesion or field of carcinomatization. Direct contact of Metvix with the eyes should be avoided.

Lighting with natural daylight

You should go outside after applying Metvix or, at least, 30 minutes after andstay for 2 hours in direct daylight or, if necessary, in an outdoor area with shade. It is recommended not to be indoors during this period of time.Make sure the treatment area is exposed continuously to daylight and is not covered by clothing. It is essential to follow these instructions to ensure the success of the treatment and avoid pain during light exposure. After the 2-hour exposure period, Metvix should be removed by washing.

During the same treatment session, multiple fields of carcinomatization or lesions can be treated.

Treatment of actinic keratoses with artificial daylight lamp

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

Preparation of lesions and application of Metvix

Each skin lesion will be prepared before treatment by removing scales and crusts and scraping the skin surface. This preparation helps Metvix and light to reach all parts of the lesion. A thin layer of Metvix should be applied with a spatula or with a glove over the lesions or fields of carcinomatization.Direct contact of Metvix with the eyes should be avoided.

Lighting with artificial daylight lamp

After applying the cream, or at most, 30 minutes after, the treated area is exposed to artificial daylight for 2 hours. After the 2-hour exposure period, Metvix should be removed by washing.During the same treatment session, multiple fields of carcinomatization or lesions can be treated.

Number of treatments

• For the treatment of actinic keratoses, one session of photodynamic therapy will be applied.
• For the treatment of basal cell carcinoma and Bowen's disease, two sessions will be applied, with a one-week interval between sessions.

Follow-up

Your doctor will decide, at three months, whether your lesion has responded adequately and can take a small sample (biopsy) of the skin and perform a cell examination. The treatment can be repeated after this period, if necessary.

Use in children and adolescents

The treatment with Metvix is not suitable for children and adolescents under 18 years of age.

Stopping Metvix use

If treatment is stopped before starting daylight therapy or before receiving a complete dose of light, when using red light, or before the end of the 2-hour daylight exposure, the effectiveness of the treatment may be reduced.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

The following side effects have been reported when using Metvix with red light. Studies of clinical trials where Metvix was used with daylight showed similar side effectsexcept for a significant decrease in pain when using daylight.

Very common (may affect more than 1 in 10 patients):skin pain (with red light), skin burning sensation, scab, skin redness.

The pain and burning sensations at the treatment site during and after exposure to light were the most frequent side effects, occurring in more than half of the treated patients. These local reactions are generally of mild or moderate severity, but rarely require interruption of light therapy. These reactions usually start during light therapy or shortly after, and last for a few hours, usually improving on the day of treatment. Redness and swelling may persist for 1 or 2 weeks, or occasionally for a longer period of time. Repeating the treatment does not make these reactions worse.

Common (may affect up to 1 in 10 patients):Treatment site effects: numbness, tingling, or itching, bleeding (may occur after wound preparation), skin heat, infection, open wounds (ulceration), skin swelling/edema, blisters, itching, skin peeling, suppuration.

Effects outside the treatment site: headache, and feeling of heat.

Uncommon (may affect up to 1 in 100 patients):Treatment site effects: skin irritation, urticaria, skin areas that are lighter or darker after healing, light sensitivity, photosensitivity reaction, discomfort, eye swelling, eye pain, nausea, hives, and fatigue.

Frequency not known (the frequency cannot be estimated from available data):

• Allergic reaction that may cause angioedema with the following symptoms: facial swelling, tongue, or throat swelling, or difficulty breathing.
• Eyelid swelling, pustules, and eczema (dry, flaky skin) at the application site and signs of contact allergy.
• Increased blood pressure may be induced by the pain associated with the use of red light.

• Temporary memory loss (including confusion or disorientation).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the refrigerator (between 2°C and 8°C).

Once the tube is opened, the cream must be used within 3 months.

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration (for example, darkening of the pale yellow color to brown).

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metvix

• The active ingredient is methyl aminolevulinate 160 mg/g (as hydrochloride).
• The other components are monostearate of glyceryl, cetoestearic alcohol, stearyl polyoxy 40, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), disodium edetate, glycerol, light soft paraffin, cholesterol, isopropyl myristate, peanut oil, refined almond oil, oleic alcohol, and purified water.

Appearance of the product and contents of the packaging

The color of the cream is cream to pale yellow. The cream is packaged in tubes containing2 gof cream.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the Marketing Authorization

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratoire GALDERMA

ZI Montdésir

74540 ALBY SUR CHERAN

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Metvix: Austria, Belgium, Czech Republic, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal, Sweden, Slovakia, United Kingdom

Last review date of this leaflet: June 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es