SOLARAZE 30 mg/g GEL

Introduction

PATIENT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS

Solaraze 30 mg/g gel

diclofenac sodium

Read the entire summary of product characteristics carefully before starting to use this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. See section 4.

Contents of the summary of product characteristics:

1. What is Solaraze and what is it used for
2. What you need to know before using Solaraze
3. How to use Solaraze
4. Possible side effects
5. Storage of Solaraze

Contents of the pack and further information

1. What is Solaraze and what is it used for

Solaraze contains the active substance diclofenac sodium and is a topical non-steroidal anti-inflammatory gel. Solaraze is a gel for cutaneous use indicated for the treatment of the skin problem known as actinic keratosis caused by prolonged exposure to solar radiation.

2. What you need to know before using Solaraze

Do not 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 any allergic reaction, such as skin rash (urticaria), breathing difficulties (wheezing) or runny nose (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 side effects with the application of Solaraze cannot be excluded if the medication is used 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 bruising easily.

• During treatment with Solaraze, avoid exposure to the sun, including sunbeds. If skin reactions occur, discontinue treatment.
• Do not apply the product to wounds, infected skin, or dermatitis.
• Avoid getting Solaraze in your eyes, the inside of your nose, or mouth, and do not ingest it. If you accidentally ingest Solaraze, consult your doctor immediately.
• If you develop a widespread skin rash, discontinue treatment with Solaraze and consult your doctor.
• After applying products containing diclofenac to the skin, a non-occlusive permeable dressing may be applied. Do not use an occlusive hermetic bandage.

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 and indications for the use of Solaraze in children and adolescents have been established. No data are available.

Other medications and Solaraze

Tell your doctor or pharmacist if you are using, have recently used, 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, but should 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 it should not be applied to the breasts.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

The influence of Solaraze on the ability to drive and use machines is negligible.

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.

3. How to use Solaraze

Follow the instructions for use of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Solaraze is intended for cutaneous use.

Instructions for use

• Puncture the aluminum membrane of the tube mouth with the help of the cap before using the product.
• Gently apply a small amount of gel to the skin area you want to treat. The amount of gel needed varies depending on 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 can 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 with a duration close to 90 days. It may take up to 30 days after 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

Remove excess gel by washing the treated skin area with water. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Solaraze

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Skin rash (urticaria); breathing difficulties (wheezing); swelling of the face, runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solaraze.

If you consider that any of the following side effects you are experiencing is serious or persists for a few days, discontinue the use of Solaraze and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

Other frequent side effects:(occurring in 1 to 10 out of 100 patients)

Irritation or tingling in the treated area, conjunctivitis, allergy, painful sensation on the skin, pinching, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), skin thickening, and skin ulcers.

Uncommon side effects:(occurring in 1 to 10 out of 1,000 patients)

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

Rare side effects:(occurring in 1 to 10 out of 10,000 patients)

Dermatitis with large blisters.

Very rare side effects:(occurring in less than 1 patient out of 10,000 patients)

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

There have been reports of temporary hair discoloration in the application area. This effect usually disappears when treatment is discontinued.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solaraze

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the tube and carton (after the abbreviation ‘EXP’). The expiration date is the last day of the month indicated.

Do not store above 25°C.

Once the product is opened, use within: 6 months.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Solaraze

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

Appearance of the product and contents of the pack

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 pack sizes may be marketed in all countries.

Marketing authorization holder and manufacturer

The marketing authorization holder is Almirall, S.A., Ronda General Mitre, 151;

08022 Barcelona; Spain

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

Date of the last revision of this summary of product characteristics:May 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/