SOLIKER 30 MG/G GEL

Introduction

Package Leaflet: Information for the Patient

Soliker 30 mg/g Gel

diclofenac sodium

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Soliker 30 mg/g gel and what is it used for
2. What you need to know before using Soliker 30 mg/g gel
3. How to use Soliker 30 mg/g gel
4. Possible side effects
5. Storage of Soliker 30 mg/g gel
6. Package contents and additional information

1. What is Soliker 30 mg/g gel and what is it used for

Soliker 30 mg/g gel contains the active substance diclofenac sodium and is a non-steroidal anti-inflammatory dermatological gel.

Soliker 30 mg/g gel is a topical gel indicated for the treatment of the skin problem known as solar keratosis or actinic keratosis caused by prolonged exposure to solar radiation.

2. What you need to know before using Soliker 30 mg/g gel

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 any 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 agent.
• If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor before using this medication.

• It cannot be excluded that systemic side effects may occur with the application of diclofenac gel if the medication is used on a large skin surface 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.
• During treatment with diclofenac gel, avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.
• Do not apply the product to open wounds, infected skin, or dermatitis.
• Avoid getting diclofenac gel in your eyes, nose, or mouth, and do not ingest it.
• If you accidentally ingest diclofenac gel, consult your doctor immediately.
• If you develop a widespread skin rash, discontinue treatment with diclofenac gel and consult your doctor.
• After applying products containing diclofenac to the skin, you can apply a non-occlusive dressing. Do not use an airtight bandage.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Do not use Soliker 30 mg/g gel if you are in the last three months of pregnancy. You should not use Soliker 30 mg/g gel 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 take the minimum dose for the shortest possible time.

Oral formulations (e.g., tablets) of Soliker 30 mg/g gel may cause adverse reactions in the fetus. It is not known if this risk applies to Soliker 30 mg/g gel when used on the skin/in the mouth.

Breastfeeding

Consult your doctor if you are breastfeeding. Diclofenac gel can 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 surface larger than one-third of the total body surface area, and its use should be limited to a maximum 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.

3. How to use Soliker 30 mg/g gel

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

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

Method of administration:

• Puncture the aluminum membrane of the tube mouth with the help of the cap before using the product.
• Gently apply a small amount of gel to the skin area you want to treat. 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) are sufficient to treat a skin area (5 cm x 5 cm), but you should not apply more than 8 grams per day.
• This medication can be applied twice a day unless your doctor indicates 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 30 days after 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

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

If you forget to use Soliker 30 mg/g gel

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, discontinue the application of Soliker 30 mg/g gel 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 this medication.

If you consider that any of the following side effects you are experiencing is serious or persists for a few days, discontinue the use of Soliker and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

Other common side effects:(occurring in 1 to 10 out of 100 patients)

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

Uncommon side effects:(occurring in 1 to 10 out of 1,000 patients)

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:(occurring in 1 to 10 out of 10,000 patients)

Dermatitis with large blisters.

Very rare side effects:(occurring in less than 1 patient out of 10,000 patients)

Stomach bleeding, kidney problems, breathing difficulties (asthma), 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Soliker 30 mg/g gel

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

Do not use this medication after the expiration date shown on the tube and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Use within 6 months after the first opening.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Soliker 30 mg/g gel:

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

Appearance of the product and package contents

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

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

Glenmark 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 under the following names:

Germany Diclofenac Glenmark 30 mg/g Gel

Spain Soliker 30 mg/g gel

Italy

Date of the last revision of this package leaflet:March 2025.

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