Solaraze 30 mg/g gel

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Solaraze 30 mg/g gel

diclofenac sodium

Read this entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Contents of the pack and other information

1. What Solaraze is and what it is used for

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

2. What you need to know before starting to use Solaraze

Do not use Solaraze

• If you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced an allergic reaction, such as for example skin rash (urticaria), breathing difficulties (wheezing), or runny nose (allergic rhinitis) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug.
• 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 occurring with the use of Solaraze cannot be ruled out, especially if the medicine is applied over a large skin surface area for a prolonged period. Consult your doctor in the following cases:

• if you have or have previously had a stomach ulcer or gastrointestinal bleeding,

• if you have heart, liver, or kidney problems,

• if you have any bleeding disorder or are prone to bruising easily.

• During treatment with Solaraze, avoid exposure to sunlight, including sunbeds. If skin reactions occur, stop treatment.

• Do not apply the product on skin wounds, infected skin, or dermatitis.

• Avoid contact of Solaraze with the eyes, inside the nose or mouth, and do not ingest it. If Solaraze is accidentally ingested, consult your doctor immediately.

• If you develop a generalized skin rash, discontinue treatment with Solaraze and consult your doctor.

• After applying products containing diclofenac to the skin, a permeable (non-occlusive) dressing may be applied. Do not use an airtight occlusive dressing.

Children and adolescents

Actinic keratosis is a condition generally not observed in children and adolescents, and therefore has not been studied in these patient groups. Thus, dosage recommendations and indications for the use of Solaraze in children and adolescents have not been established. No data are available.

Other medicines and Solaraze

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and lactation

Consult your doctor if you are or might be pregnant. Solaraze should be used with caution during the first six months of pregnancy, but must not be 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 must not be applied to the breasts.

If you are pregnant, planning to become pregnant, or breastfeeding, and your doctor considers 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 medicine.

Driving and use of machines

The effect of Solaraze on the ability to drive and operate machinery is none or negligible.

Solaraze contains benzyl alcohol

This medicine 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 exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Solaraze is for topical use only.

Instructions for use

• Pierce the aluminium membrane covering the tube opening with the cap before using the product.
• Gently apply a small amount of gel to the affected area of skin. The amount of gel needed depends on the size of the skin area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) is sufficient to treat an area of skin measuring 5 cm x 5 cm. However, do not apply more than 8 grams per day.
• Solaraze may be applied twice daily unless your doctor has instructed otherwise. You may notice a slightly cooling sensation when applying the gel to the skin.
• The usual treatment period is 60 to 90 days. Maximum effect has been observed with treatment durations close to 90 days. Complete healing may take up to 30 days after the end of treatment.
• Wash your hands after applying the gel, unless the hands themselves are the area being treated.

If you use more Solaraze than you should

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

If you forget to use Solaraze

Continue applying the gel as instructed, but do not apply a double dose to make up for the missed application.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

If you consider any of the following adverse effects you experience to be severe or if they persist for several days, stop using Solaraze and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

Other frequent adverse effects: (occur in between 1 and 10 out of every 100 patients)

Irritation or tingling in the treated area, conjunctivitis, allergy, painful sensation upon touching the skin, pricking sensations, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), thickening of the skin, and cutaneous ulcer.

Uncommon adverse effects: (occur in between 1 and 10 out of every 1,000 patients)

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

Rare adverse effects: (occur in between 1 and 10 out of every 10,000 patients)

Dermatitis with large blisters.

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

Bleeding in the stomach, kidney problems, breathing difficulties (asthma), skin rash with infection, skin sensitivity to sunlight.

Cases of temporary hair discoloration in the area of application have been reported. This effect usually resolves upon discontinuation of treatment.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solaraze

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

Do not use this medicine after the expiry date stated on the tube and carton (after the abbreviation 'CAD'). The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Solaraze

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

Appearance of the product and contents of the container

Solaraze gel is a clear, transparent, colourless or pale yellow gel packed in tubes containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of gel.

Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation 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 most recent review of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/