METVIX 160 mg /G Krem

Treść ulotki

1. Metvix 160 mg/g cream
   1. What is Metvix and what is it used for
   2. What you need to know before using Metvix
   3. How to use Metvix
   4. Possible side effects
   5. How to store Metvix
   6. Contents of the pack and other information

Metvix 160 mg/g cream

Methyl aminolevulinate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Metvix and what is it used for

Metvix is indicated for the treatment of pre-cancerous skin lesions of the face and scalp
(known as actinic keratoses) which appear as areas of skin that have become rough and scaly following
damage from exposure to sunlight. These lesions, if left untreated, can increase the probability
of developing skin cancers over time.
Metvix is also to be used in the treatment of basal cell carcinoma (BCC), a skin cancer
that can cause a reddish, scaly patch (known as superficial BCC) or a small
swelling or a series of small swellings on the skin (known as nodular BCC). These
lesions bleed easily and do not heal. Metvix is to be used when other therapies are
considered inappropriate.
Metvix can also be used in the treatment of Bowen's disease (a pre-cancerous lesion
that manifests with pink-reddish patches that slowly spreads) in cases where surgery is not
appropriate.
The treatment consists of applying Metvix and exposure to light. Damaged skin cells
absorb methyl aminolevulinate from the cream and are destroyed by exposure to
light (known as photodynamic therapy). The surrounding healthy skin surface remains unaffected.

2. What you need to know before using Metvix

Do not use Metvix

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

Warnings and precautions
Talk to your doctor before using Metvix:

• if the skin lesions are of a certain type (coloured, deep-seated or located on the genitals)
• if you have “thick” actinic keratoses
• if you have extensive lesions caused by Bowen's disease
• if you are taking medicines to suppress the immune system such as steroids or ciclosporin
• if Bowen's disease was caused by exposure to arsenic (a harmful chemical)
• if you have a history of high blood pressure

You must avoid direct contact of Metvix with your eyes. Metvix cream must not be applied to the
eyelids and mucous membranes.
The active ingredient can cause skin allergy which can lead to angioedema. If you experience the
following symptoms: swelling of the face, tongue or throat; skin rash, or difficulty in
breathing, stop taking METVIX immediately and contact your doctor.
If you are using red light and you increase the frequency of applications or the light dose, a more
severe skin reaction may occur (see section 4 Possible side effects).
In very rare cases, photodynamic therapy with red light may increase the risk of developing
temporary memory loss (including confusion or disorientation), if these symptoms occur, contact your
doctor immediately.
Sun exposure and UV therapy
As a general precaution, you should avoid sun exposure to the treated areas and the surrounding
skin for a couple of days after treatment.
If you are undergoing ultraviolet light treatment (UV therapy), stop this
treatment before treatment with Metvix.

Pregnancy and breastfeeding
Treatment with Metvix is not recommended during pregnancy.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.

Driving and using machines
No effects on the ability to drive and operate machines have been reported.

Metvix contains peanut oil (groundnut oil), cetostearyl alcohol and methyl and propyl
parahydroxybenzoate.
If you are allergic to peanuts or soya (containing peanut oil), do not use this medicine.
Cetostearyl alcohol can cause local skin reactions (e.g. contact dermatitis). Methyl and
propyl parahydroxybenzoate (E218, E216) can cause allergic reactions (including delayed reactions).

3. How to use Metvix

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

Adults (including the elderly)
Treatment of actinic keratoses, basal cell carcinoma and Bowen’s disease using a
red light lamp
Using Metvix with a red light lamp requires specific knowledge of photodynamic
therapy. Consequently, it must be administered in the presence of a doctor, nurse or
another healthcare professional trained in the use of photodynamic therapy.
Preparation of the lesions and application of the cream
Prepare the surface of each skin lesion before treatment, removing scales,
crusts and thickening of the skin surface. This preparation helps Metvix and the light to
reach all parts of the skin lesion. Some tumorous skin lesions are covered by an
intact layer of skin that must be removed according to the doctor's instructions.
Apply a thin layer of Metvix (approximately 1 mm thick) to the lesions or the
field and to a small area of the surrounding skin using a spatula. Avoid direct contact of Metvix cream with the
eyes. Once the cream has been applied, cover the treated area with a bandage. After 3 hours the bandage
must be removed and the cream washed off with saline solution.
Irradiation using a red light lamp
Immediately after washing, expose the treated area to red light. To protect your eyes
from the strong light, you will be provided with protective glasses to wear during light exposure.
Numerous lesions or fields can be treated during the same therapy session.

Treatment of actinic keratoses with natural sunlight.
Considerations before treatment
Treatment with Metvix with natural sunlight can be used if the temperature is suitable
for comfortably staying outdoors for 2 hours. The effectiveness of the treatment has been shown to be
similar whether the treatment is carried out on a sunny or cloudy day. If the weather is rainy, or
risks becoming so, treatment with Metvix with natural sunlight should not be used.
Preparation of the lesions and application of the cream
Adequate sunscreen should be applied to all areas, including the areas of
treatment that will be exposed to daylight before the lesion or field preparation.
Only sunscreen that has been specifically recommended by the
doctor should be used. Do not use sunscreens with physical filters such as titanium dioxide and zinc oxide as
these filters would inhibit the absorption of visible light and may affect efficacy.
Only protective sunscreens with chemical filters should be used.
Each skin lesion will be prepared before treatment, removing scales and crusts and making the
skin surface rough. This preparation helps Metvix and the light to reach all parts of the
skin lesion.
A thin layer of Metvix should be applied to the lesions or fields with a spatula or with the hand
protected by a glove. Direct contact of Metvix cream with the eyes must be avoided.
Irradiation using natural sunlight
After applying Metvix, or at the latest within 30 minutes, you must go outside and stay for 2
hours in full sunlight or, if necessary, in a shaded outdoor area. It is recommended not to
go indoors during this period of time. Ensure that the area to be treated is continuously
exposed to sunlight and not covered by clothing. It is important to follow these instructions to
ensure the success of the treatment and avoid pain during exposure to sunlight. After the
two-hour exposure period, Metvix cream must be removed with water.
Numerous lesions or fields can be treated during the same therapy session.

Treatment of actinic keratoses using an artificial sunlight lamp
The use of Metvix with an artificial sunlight lamp requires specific knowledge of photodynamic
therapy. Consequently, it must be administered in the presence of a doctor, nurse or
another healthcare 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, removing scales and crusts and making the
skin surface rough. This preparation helps Metvix and the light to reach all parts of the
skin lesion. A thin layer of Metvix is applied to the lesions or fields with a spatula or
with the hand protected by a glove. Direct contact of Metvix cream with the eyes must be avoided.
Irradiation using an artificial sunlight source
After applying the cream, or at the latest 30 minutes later, the treated area is exposed to the lamp for
artificial sunlight for 2 hours. After the 2-hour exposure period, Metvix cream must be
washed off.
Numerous skin lesions or fields can be treated during the same therapy session.

Number of treatments

• Actinic keratoses are treated with one session
• Basal cell carcinoma and Bowen’s disease are treated with two sessions, spaced one week apart.

Follow-up
Three months later, the doctor will assess how each skin lesion has responded to treatment and
may take a small skin sample (biopsy) and have the cells examined. The treatment may
be repeated after this period, if necessary.

Use in children and adolescents
Treatment with Metvix is not appropriate in children or adolescents under the age of 18 years.

If you stop treatment with Metvix
If you stop treatment before undergoing light therapy or receiving the entire dose of
light, when using red light, or before the end of the second hour of exposure to
sunlight, the effectiveness of the treatment may decrease.
If you have any doubts about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during the use of Metvix with red light. Clinical
studies, in which Metvix was used with sunlight, have shown similar side effects, but with a
significant reduction in pain when using sunlight.
Very common (may affect more than 1 in 10 people): skin pain (with red light),
burning sensation of the skin, scab formation, skin redness.
Painful and burning skin sensations at the application site during and after light exposure
are the most common side effects, reported by more than half of the patients treated.
These reactions are usually mild to moderate in severity, but rarely require premature discontinuation
of therapeutic light use. These reactions usually occur during therapeutic light use or immediately
afterwards and last for a few hours, generally improving on the same day of treatment. Redness and
swelling may last from 1 to 2 weeks or occasionally for a longer period. Repeated treatment does not
worsen these reactions.
Common (may affect up to 1 in 10 people):

• Effects at the treatment site: numbness, tingling or prickling sensation, bleeding (may occur following
  wound preparation), skin warmth, infection, open wounds (ulcerations) skin swelling/edema, blisters,
  itching, skin peeling, oozing.
• Effects not involving the treatment site: headache, feeling of warmth.

Uncommon (may affect up to 1 in 100 people):

• Effects at the treatment site: skin irritation, hives, rash, areas of skin that are darker or lighter after
  healing, light sensitivity, discomfort, eye swelling, eye pain, nausea, heat rash, fatigue.

Not known (frequency cannot be estimated from available data):

• Allergic reactions that can cause angioedema with the following symptoms: swelling of the face,
  tongue or throat, or difficulty breathing.
• Eyelid swelling, pustules and eczema (dry and flaky skin) at the application site and signs of contact
  allergy.
• Increased blood pressure, which may be induced by pain associated with the use of red light.
• Temporary memory loss (including confusion or disorientation)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Metvix

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2  C - 8  C).
Once opened, the cream must be used within 28 days.
Do not use this medicine after the expiry date which is stated on the carton and the tube. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration (e.g., colour change from
pale yellow to brown).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsMetvix

• The active ingredient ismethyl aminolevulinate 160 mg/g (as hydrochloride).
• The excipients areglyceryl monostearate, cetostearyl alcohol, polyoxyl 40 stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, glycerol, soft white paraffin, cholesterol, isopropyl myristate, peanut oil (groundnut oil), almond oil, oleyl alcohol, purified water.

Description of the appearance ofMetvix and contents of the pack
The colour of Metvix ranges from cream to light yellow. The cream is available in tubes containing 1 g or 2 g of
cream. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GALDERMA Italia S.p.A.
Via dell’Annunciata, 21 - Milan
Manufacturer
Penn Pharmaceutical Services Ltd.
Tafarnaubach Industrial Estate
Tredegar, Gwent
NP22 3AA
United Kingdom

Or
Laboratoires GALDERMA
ZI Montdésir
74540 ALBY SUR CHERAN
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: Austria, Belgium, Czech Republic, Germany, Denmark, Greece,
Spain, Finland, Ireland, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Sweden, Slovak Republic, United Kingdom: Metvix
Detailed and up-to-date information on this medicinal product is available via
smartphone.ThesameinformationisalsoavailableatthefollowingURL:
https://galdermainfo.it/metvix/.