SOLACUTAN 30 MG/G GEL

Introduction

Package Leaflet: Information for the User

Solacutan 30 mg/g Gel

Diclofenac Sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Solacutan and what is it used for

Solacutan is a topical non-steroidal anti-inflammatory gel. This medicine is applied to the skin to treat the skin problem known as solar or actinic keratosis caused by prolonged exposure to solar radiation.

2. What you need to know before you use Solacutan

Do not use Solacutan

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction such as skin rash (urticaria), breathing problems (wheezing), or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory medicine.
• if you are in the last three months of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine.

• It cannot be excluded that systemic side effects may occur with topical application of diclofenac if the medicine is used on a large area of skin for a prolonged period. Consult your doctor if:

• you have or have had stomach ulcers or bleeding,
• you have heart, liver, or kidney problems,
• you have any type of bleeding disorder or bruise easily.
• During treatment with this medicine, avoid direct exposure to the sun, including sunbeds. If skin reactions occur, discontinue treatment.

• Do not apply to wounds, infected, or inflamed skin.
• Avoid contact of the diclofenac gel with the eyes or the inside (mucosa) of the mouth or nose, and do not ingest it. If you accidentally ingest Solacutan, consult your doctor immediately.
• If you develop a widespread skin rash, discontinue treatment with the medicine and consult your doctor.
• After applying products containing diclofenac to the skin, a non-occlusive (permeable) dressing may be applied. Do not use an airtight occlusive dressing.

Children and Adolescents

There are no established indications or dosage recommendations for the use of Solacutan in children and adolescents.

Other Medicines and Solacutan

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. This medicine should not be used if you are in the last three months of pregnancy. You should not use this medicine during the first six months of pregnancy, unless it is strictly necessary and your doctor recommends it. If you need treatment during this period, you should use the minimum possible dose for the shortest possible time. Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions in the fetus. It is not known if this same risk applies to this medicine when used on the skin.

Consult your doctor if you are breastfeeding. This medicine can 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, and your doctor considers that treatment is appropriate, the diclofenac gel should not be applied to a skin surface larger than one-third of the total body surface area and should be limited to a maximum period of three weeks.

Consult your doctor or pharmacist before taking or using any medicine.

Driving and Using Machines

No special precautions are necessary.

Solacutan Contains Benzyl Alcohol

This medicine contains 15 mg of benzyl alcohol per gram of gel.

Benzyl alcohol may cause moderate local irritation and may cause allergic reactions.

3. How to Use Solacutan

• This medicine is not suitable for use in children.
• Follow the instructions for administration of the medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.
• This medicine is for cutaneous use only.
• Puncture the aluminum membrane of the tube mouth with the help of the cap before use.
• Gently apply a small amount of gel to the area of skin you want to treat and rub gently onto the skin. 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) is sufficient to treat a skin area (5cm x 5 cm). However, do not apply more than 8 grams per day.
• The medicine 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 a month after the end of treatment for complete healing.
• After applying the gel, the hands should be cleaned with a paper towel and then washed, unless the hands are the area being treated.
• If too much gel is applied accidentally, the excess gel should be cleaned with a paper towel.
• The paper towel should be disposed of with household waste to prevent the unused product from entering the aquatic environment.
• Before applying a dressing, the gel should be allowed to dry on the skin for a few minutes.

If You Use More Solacutan Than You Should

If the recommended dose is significantly exceeded when applied to the skin, the gel should be removed again (e.g., with a paper towel, to dispose of it with household waste) and washed with water.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If You Forget to Use Solacutan

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using Solacutan 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 the medicine.

If you consider that any of the following side effects you are suffering from is serious or persists for a few days, stop using the medicine and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

Other Common Side Effects:(may affect up to 1 in 10 people)

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

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

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:(may affect up to 1 in 1,000 people)

Inflammation of the skin with large blisters.

Very Rare Side Effects:(may affect up to 1 in 10,000 people)

Stomach bleeding, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including urticaria, rapid inflammation of the skin and mucous membranes), skin rash with infection, sensitivity to sunlight.

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solacutan

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

Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Shelf Life After Opening

Once the tube is opened, the medicine expires after 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Solacutan

The active substance is:

diclofenac sodium

1 g of gel contains 30 mg of diclofenac sodium.

The other ingredients are:

sodium hyaluronate; macrogol 400; benzyl alcohol; purified water

Appearance of the Product and Contents of the Pack

Solacutan is a clear, transparent, colorless, or pale yellow gel packaged in aluminum tubes with a content of 10 g, 25 g, 26 g, 30 g, 50 g, 60 g, or 90 g.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Manufacturer

Munchener Strasse, 15

06796 Brehna

Germany

Or

SUN-FARM SP Z.O.O.

Ul. Dolna, 21

05-092 Lomianki

Poland

Date of Last Revision of this Leaflet:December 2024

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