PATIENT INFORMATION LEAFLET

Solaraze 30 mg/g gel

diclofenac sodium

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Solaraze contains the active substance diclofenac sodium and is a topical dermatological nonsteroidal anti-inflammatory gel. Solaraze is a topical gel indicated for the treatment of a skin condition known as solar or actinic keratosis caused by prolonged exposure to solar radiation.

No use Solaraze

• If you are allergic to diclofenac sodium or any of the other components of this medication (listed in section 6).
• If you have previously experienced an allergic reaction, such as skin rash (urticaria), breathing difficulties (sibilant breathing) or nasal discharge (allergic rhinitis) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory agent.
• If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor before starting to use Solaraze.

• The possibility of systemic adverse effects cannot be ruled out with the application of Solaraze on a large skin surface for a prolonged period. Consult your doctor in the following cases:

• If you have or have had a stomach ulcer or bleeding,
• If you have heart, liver or kidney problems,
• If you have any type of bleeding disorder or are prone to easy bruising.

• During treatment with Solaraze, avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.
• Do not apply the product to skin wounds, infected skin, or dermatitis.
• Avoid contact between Solaraze and the eyes, the inside of the nose or mouth, and do not ingest it. If Solaraze is ingested accidentally, consult your doctor immediately.
• If a generalized skin rash develops, discontinue treatment with Solaraze and consult your doctor.
• After applying products containing diclofenac to the skin, a non-occlusive permeable dressing (bandage) may be applied. Do not use a tight, occlusive dressing.

Children and adolescents

Actinic keratosis is a disease that is generally not observed in children and adolescents, so it has not been studied in these patients. Therefore, no dosage recommendations or indications have been established for the use of Solaraze in children and adolescents. No data are available.

Other medications and Solaraze

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Consult your doctor if you are or may be pregnant. Solaraze should be used with caution during the first six months of pregnancy, butshould notbe used during the last three months of pregnancy.

Consult your doctor if you are breastfeeding. Solaraze may be used with caution during breastfeeding, but should not be applied to the breasts.

If you are pregnant, think you may become pregnant, or are breastfeeding, but your doctor considers the treatment to be appropriate, Solaraze should not be applied to a skin surface greater than one-third of your total body surface area and should be limited to a maximum treatment period of three weeks.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The influence of Solaraze on the ability to drive and operate machinery is negligible or insignificant.

Solaraze contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per gram.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

Follow exactly the usage instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Solaraze is intended for topical use.

Usage Instructions

• Pierce the aluminum membrane of the tube mouth with the cap's help before using the product.
• Apply a small amount of gel gently to the area of skin you wish to treat. The amount of gel needed varies according to the size of the skin area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) are sufficient to treat a skin area (5 cm x 5 cm), but do not apply more than 8 grams per day.
• Solaraze may be applied twice a day unless your doctor tells you otherwise. You will notice a slightly refreshing effect when applying the gel to the skin.
• The usual treatment period is 60 to 90 days. The maximum effect has been observed in treatments of a duration close to 90 days. It may take up to 30 days from the end of treatment for complete healing.
• Wash your hands after applying the gel, except if they are being treated.

If you use more Solaraze than you should

Wash off the excess gel with water from the treated skin area. You may also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Solaraze

Continue application following the instructions, but do not apply a double dose of gel to compensate for the missed application.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If you experience any of the following adverse effects, discontinue use of Solaraze and inform your doctor as soon as possible:

Skin rash (urticaria); difficulty breathing (sibilant breathing); facial swelling, nasal discharge (allergic rhinitis). These symptoms indicate that you may be allergic to Solaraze.

If you consider any of the following adverse effects you are experiencing to be severe or persistent for more than a few days, discontinue use of Solaraze and inform your doctor: itching, skin reaction, skin redness, inflammation, contact dermatitis, pain, and blisters.

Other frequent adverse effects:(occur in 1 to 10 of every 100 patients)

Irritation or tingling in the treated area, conjunctivitis, allergy, painful sensation when touching the skin, pinpricks, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered in scales or blisters), skin thickening, and skin ulcer.

Rare adverse effects:(occur in 1 to 10 of every 1,000 patients)

Eye pain, excessive tearing/dry eyes, abdominal pain, diarrhea, nausea, hair loss, facial edema, excessive bleeding, greasy skin or skin rash similar to measles.

Adverse effects that are rare:(occur in 1 to 10 of every 10,000 patients)

Large blistering dermatitis.

Very rare adverse effects:(occur in fewer than 1 of every 10,000 patients)

Stomach bleeding, kidney problems, difficulty breathing (asthma), skin rash with infection, skin sensitivity to sunlight.

Temporary hair discoloration in the treated area has been described. This effect usually disappears when treatment is discontinued.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the tube and the packaging (after the abbreviation ‘CAD’). The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Once opened, use within: 6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Solaraze

• The active ingredient is diclofenac sodium. Each gram of gel contains the equivalent of 30 mg of diclofenac sodium.
• The other components are sodium hyaluronate, benzyl alcohol, monothyl ether of macrogol 350, and purified water.

Appearance of the product and content of the container

Solaraze gel is a clear, transparent, colorless, or pale yellow gel packaged in tubes with a content of 25 grams, 50 grams, 60 grams, 90 grams, or 100 grams of gel.

Not all container sizes may be marketed in all countries.

Holder of the marketing authorization and responsible manufacturer

The holder of the marketing authorizationis Almirall, S.A., Ronda General Mitre, 151;

08022 Barcelona; Spain

The manufactureris Almirall Hermal GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany.

Date of the last review of this leaflet: May 2024

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