Solacutan 30 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solacutan 30 mg/g gel

Diclofenac sodium

Read the 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Solacutan is and what it is used for

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

2. What you need to know before using Solacutan

Do not use Solacutan

• if you are allergic to 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 skin rash (urticaria), breathing difficulties (wheezing), or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory drug (NSAID).
• if you are in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

• Systemic adverse effects cannot be ruled out when applying diclofenac to the skin, especially if the medicine is used over a large skin surface for a prolonged period. Consult your doctor if:

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

• you have heart, liver, or kidney problems,

• you have any bleeding disorder or bruise easily.

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

• Do not apply on wounds, infected or inflamed skin.

• Avoid contact of diclofenac gel with the eyes or the inside (mucosa) of the mouth or nose, and do not swallow it. If Solacutan is accidentally ingested, consult your doctor immediately.

• If you develop a widespread skin rash, stop treatment with this medicine 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

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

Other medicines and Solacutan

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine must not be used during the last three months of pregnancy. You should not use this medicine during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this time, the lowest possible dose for the shortest possible duration should be used. Oral formulations (e.g., tablets) of diclofenac may cause adverse effects on the fetus. It is unknown whether this same risk applies to this medicine when used on the skin.

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

If you are pregnant, planning to become pregnant, or breastfeeding, and your doctor considers treatment appropriate, diclofenac gel should not be applied to more than one-third of your total body surface area, and its use should be limited to a maximum of three weeks.

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

Driving and using machines

No specific precautions are required.

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 exactly the instructions for using the medicine as given by your doctor. If in doubt, consult your doctor again.
• This medicine is for topical use only.
• Pierce the aluminum seal at the mouth of the tube using the cap before first use.
• Gently apply a small amount of gel to the area of skin to be treated and rub in gently. The amount of gel needed depends on the size of the 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, the daily dose should not exceed 8 grams.
• The medicine may be applied twice daily unless otherwise directed by your doctor. You may feel a slightly cooling sensation when applying the gel to the skin.
• The usual treatment duration is 60 to 90 days. Maximum effect has been observed with treatments lasting approximately 90 days. Complete healing may take up to one month after the end of treatment.
• After applying the gel, hands should be wiped with a paper towel and then washed, unless the hands themselves are the area being treated.
• If too much gel is accidentally applied, wipe off the excess with a paper towel.
• The paper towel should be disposed of in household waste to prevent unused product from entering the aquatic environment.
• Allow the gel to dry for a few minutes on the skin before applying a dressing.

If you use more Solacutan than you should

If significantly more than the recommended dose is applied to the skin, the excess gel should be removed (e.g., with a paper towel, disposing of it with residual waste) and the area washed with water.

You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and amount used.

If you forget to use Solacutan

Continue using the medicine as instructed. Do not apply a double dose to make up for a missed application.

4. Possible adverse effects

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

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

If you consider any of the following adverse effects you experience to be severe or if they persist for several days, stop using the medicine and inform your doctor: itching, skin reaction, redness of the skin, 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, pricking sensations, muscle stiffness, skin inflammation, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), thickening of the skin, and skin ulceration.

Uncommon 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, oily skin or measles-like skin rash.

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

Skin inflammation with large blisters.

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

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

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

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 Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the tube and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Expiry after opening

After opening the tube, the medicine expires after 6 months.

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

6. Contents of the pack and other information

Composition of Solacutan

The active substance 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 medicinal product and contents of the pack

Solacutan is a clear, transparent, colourless or pale yellow gel, packed in aluminium tubes containing 10 g, 25 g, 26 g, 30 g, 50 g, 60 g or 90 g.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Munchener Strasse, 15
06796 Brehna
Germany

OR

SUN-FARM SP Z.O.O.
Ul. Dolna, 21
05-092 Lomianki
Poland

Date of the most recent review of this leaflet: December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).