Patient Information Leaflet: Product Information

Soliker 30 mg/g Gel

Diclofenac Sodium

Read this leaflet carefully before you start to use 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Soliker30 mg/g gel contains the active ingredient diclofenac sodium and is a topical dermatological nonsteroidal anti-inflammatory gel.

Soliker30 mg/g gel is a topical gel indicated for the treatment of a skin condition known as solar or actinic keratosis caused by prolonged exposure to solar radiation.

Do not use Soliker 30 mg/g gel

• 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 an allergic reaction, such as skin rash (urticaria), breathing difficulties (sibilant breathing) or nasal discharge (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory agent.
• If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor before using this medication.

• The possibility of systemic adverse effects cannot be excluded when diclofenac gel is applied to a large skin area 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 easy bruising.
• Avoid exposure to the sun, including tanning centers, during treatment with diclofenac gel. If skin reactions occur, discontinue treatment.
• Do not apply the product to open wounds, infected skin or dermatitis.
• Avoid contact between diclofenac gel and the eyes, inside the nose or mouth, and do not ingest it.
• If you accidentally ingest diclofenac gel, consult your doctor immediately.
• If you develop a generalized skin rash, discontinue treatment with diclofenac gel and consult your doctor.
• After applying products containing diclofenac to the skin, a non-occlusive breathable dressing (such as gauze) may be applied. Do not use a tight, occlusive dressing.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Soliker 30 mg/g gel if you are in the last 3 months of pregnancy. Do not use Soliker 30 mg/g gel during the first 6 months of pregnancy unless it is strictly necessary and recommended by your doctor. If treatment is necessary during this period, the minimum dose should be taken for the shortest possible time.

Oral formulations (e.g., tablets) of Soliker 30 mg/g gel may cause adverse reactions in the fetus. The risk of this occurring with Soliker 30 mg/g gel when applied to the skin or in the mouth is unknown.

Breastfeeding

Consult your doctor if you are breastfeeding. Diclofenac gel may be used with caution during breastfeeding, but it should not be applied to the breasts.

This treatment is suitable, diclofenac gel should not be applied to a skin area greater than one-third of the total body surface area and should be limited to a maximum treatment period of three weeks.

Soliker 30 mg/g gel contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per gram.

Benzyl alcohol may cause moderate local irritation.

Follow exactly the administration instructions indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Soliker 30 mg/g gel is indicated for topical use.

Method of use :

• Pierce the aluminum membrane of the tube mouth with the help of the plug before using the product.
• Apply a small amount of gel gently to the area of skin you want to treat. 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 (5 cm x 5 cm), but do not apply more than 8 grams per day.
• This medication may 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 30 days from the end of treatment for complete healing.
• Wash your hands after applying the gel, except if they are being treated.

If you use more Soliker 30 mg/g gel than you should

Wipe off the excess gel by washing the treated skin area 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 Soliker 30 mg/g gel

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 the application of Soliker 30 mg/g gel and inform your doctor as soon as possible:

Urticaria (skin rash); difficulty breathing (sibilant breathing); facial swelling, nasal discharge (allergic rhinitis). These symptoms indicate that you may be allergic to this 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 Soliker and inform your doctor: itching, skin reaction, skin redness, inflammation, contact dermatitis, pain, and blisters.

Other frequent adverse effects: (occur in 1 to 10 of every 100 patients)

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

Rare adverse effects: (occur in 1 to 10 of every 1,000 patients)

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

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

Large blistering dermatitis.

Adverse effects extremely rare: (occur in fewer than 1 of every 10,000 patients)

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

Temporary hair discoloration in the application area has been described. 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: https:// 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 CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Use within 6 months after the first opening.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and themedicines that you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist howto dispose of the containers and the medicines that you no longer need. This way, you will help to protect the environment.

Composition of Soliker 30 mg/g gel:

• The active ingredient is diclofenac sodium. Each gram of gel contains 30 mg of diclofenac sodium (at 3%, p/p).
• The other components are sodium hyaluronate, benzyl alcohol, monothyl ether of macrogol 350, and purified water.

Appearance of the product and contents of the packaging

Soliker 30 mg/g gel is a clear, transparent, colorless, or pale yellow gel packaged in an aluminum tube with a white HDPE cap with a piercing tip containing 25 grams, 50 grams, 60 grams, 90 grams, or 100 grams of product.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany Diclofenac Glenmark 30 mg/g Gel

Spain Soliker 30 mg/g gel

Italy Diclofenac Glenmark

Revision date of this leaflet: March 2025.

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