Product Information for the User

Solacutan 30 mg/g Gel

Sodium Diclofenac

Read this entire product information carefully before starting to use this medication, as it contains important information for you

• Keep this product information, 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 alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Solacutan and for what it is used

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

3.How to use Solacutan

4.Possible adverse effects

5.Storage of Solacutan

6.Contents of the package and additional information

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

Do not use Solacutan

• If you are allergic to diclofenac 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 problems (sibilant breathing) or nasal discharge (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory medication.
• If you are in the last three months of pregnancy.

Warnings and precautions

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

• The possibility of systemic adverse effects with the application of diclofenac on the skin cannot be ruled out if the medication is used on a large skin surface for a prolonged period. Consult your doctor if:

- 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 easily form bruises.

• During treatment with this medication, avoid direct exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.

• Do not apply on wounds, infected or inflamed skin.
• Avoid contact of the diclofenac gel with the eyes or the inner (mucous) part of the mouth or nose and do not ingest it.If Solacutan is ingested accidentally, consult your doctor immediately.
• If a generalized skin rash develops, discontinue treatment with the medication and consult your doctor.
• After applying products containing diclofenac on the skin, a non-occlusive permeable dressing (bandage) may be applied. Do not use a hermetic occlusive dressing.

Children and adolescents

No indications or dosage recommendations have been established for the use of Solacutan in children and adolescents.

Other medications and Solacutan

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

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. This medication should not be used if you are in the last three months of pregnancy. It should not be used during the first six months of pregnancy, unless it is strictly necessary and recommended by your doctor. If treatment is needed during this period, the minimum possible dose should be used for the shortest possible time. Oral formulations of diclofenac (e.g., tablets) may cause adverse reactions to the fetus. It is unknown whether this risk applies to this medication when used on the skin.

Consult your doctor if you are breastfeeding. This medication 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, and your doctor considers treatment to be appropriate, the diclofenac gel 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 taking/using any medication.

Driving and operating machinery

No specific precautions are necessary.

Solacutan contains benzyl alcohol

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

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

• This medication is not suitable for use in children.
• Follow exactly the medication administration instructions provided by your doctor. In case of doubt, consult your doctor again.
• This medication is only for topical use.
• Pierce the aluminum membrane of the tube mouth with the cap's help before use.
• Apply a small amount of gel gently to the skin area you wish to treat and rub it gently into the skin. 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) is sufficient to treat a skin area (5cm x 5 cm). However, do not apply more than 8 grams per day.
• The medication 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 of a duration close to 90 days. It may take up to a month from the end of treatment for complete healing.
• After applying the gel, hands must be cleaned with a paper towel and then washed, unless the hands are the area being treated.
• If too much gel is accidentally applied, the excess gel must be cleaned with a paper towel.
• The paper towel must be disposed of in household waste to prevent unused product from reaching the aquatic environment.
• Before applying a bandage, the gel must be allowed to dry for a few minutes on the skin.

If you use more Solacutan than you should

If the recommended dose is significantly exceeded when applied to the skin, the gel must be removed again (for example, with a paper towel, to remove it with the residual waste) and washed with water.

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

If you forgot to use Solacutan

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

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

If you experience any of the following adverse effects, discontinue use of Solacutan 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 the medication.

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 the medication and inform your doctor: itching, skin reaction, skin redness, inflammation, contact dermatitis, pain, and blisters.

Other frequent adverse effects:(may affect up to 1 in 10 people)

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

Rare adverse 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, greasy skin or skin rash similar to measles.

Adverse effects that are rare:(may affect up to 1 in 1,000 people)

Large skin blisters with inflammation.

Very rare adverse effects:(may affect up to 1 in 10,000 people)

Stomach bleeding, kidney problems, difficulty breathing (asthma), all types of hypersensitivity reactions (including urticaria, rapid skin and mucous membrane inflammation) skin rash with infection, sun sensitivity.

Temporary hair discoloration in the application area has been reported. 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 Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 box after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Expiration after opening

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

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Solacutan

The active ingredient is:

diclofenac sodium

1 g of gel contains 30 mg of diclofenac sodium

The other components are:

sodium hyaluronate; macrogol 400; benzyl alcohol; purified water

Appearance of the product and content of the container

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.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Manufacturer

Munchener Strasse, 15

06796 Brehna

Germany

Or

SUN-FARM SP Z.O.O.

Ul. Dolna, 21

05-092 Lomianki

Poland

Last review date of this leaflet:December 2024

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