Soliker 30 mg/g gel

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Soliker 30 mg/g gel

diclofenac sodium

Read the entire leaflet carefully before you start using this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Soliker 30 mg/g gel is and what it is 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. How to store Soliker 30 mg/g gel
6. Contents of the pack and other information

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

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

Soliker 30 mg/g gel is a topical gel indicated for the treatment of a skin condition known as actinic or solar 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 sodium diclofenac or to any of the other ingredients of this medicine (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 drug.
• If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor before using this medicine.

• Systemic adverse effects cannot be ruled out when using diclofenac gel if the medicine is applied over a large skin surface area for a prolonged period. Consult your doctor in the following cases:
  • if you have or have previously had a stomach ulcer or gastrointestinal bleeding,
  • if you have heart, liver, or kidney problems,
  • if you suffer from any bleeding disorder or are prone to bruising easily.
• During treatment with diclofenac gel, avoid exposure to sunlight, including tanning centers. If skin reactions occur, discontinue treatment.
• Do not apply the product on broken or wounded skin, infected skin, or dermatitis.
• Avoid contact of diclofenac gel with the eyes, inside the nose or mouth, and do not ingest it.
• If diclofenac gel is accidentally ingested, consult your doctor immediately.
• If you develop a generalized skin rash, stop treatment with diclofenac gel 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.

Pregnancy, lactation and fertility

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Pregnancy

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.

Do not use Soliker 30 mg/g gel during the last three months of pregnancy. You should not use Soliker 30 mg/g gel during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.

Oral formulations (e.g., tablets) of Soliker 30 mg/g gel may cause adverse reactions in the fetus. It is unknown whether the same 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 may be used with caution during breastfeeding, but it must not be applied to the breasts.

This treatment is appropriate; however, diclofenac gel should not be applied to a skin surface area larger than one-third of your 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 medicine contains 10 mg of benzyl alcohol in each gram.

Benzyl alcohol may cause moderate local irritation.

3. How to use Soliker 30 mg/g gel

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist.

Soliker 30 mg/g gel is intended for cutaneous use.

Instructions for use:

• Before using the product, pierce the aluminum seal at the tube opening with the cap.
• Gently apply a small amount of gel to the area of skin to be treated. The amount of gel required depends 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 an area of skin (5 cm x 5 cm), but the daily amount applied should not exceed 8 grams.
• This medicine may be applied twice daily unless otherwise directed by your doctor. You may feel a slightly refreshing sensation when applying the gel to the skin.
• The usual treatment period is 60 to 90 days. Maximum effect has been observed with treatments lasting approximately 90 days. Complete healing may take up to 30 days after the end of treatment.
• Wash your hands after applying the gel, unless they are the area 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.

If you forget to use Soliker 30 mg/g gel

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop using Soliker 30 mg/g gel 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 this medicine.

If you consider any of the following adverse effects you are experiencing to be severe or if they persist for several days, discontinue use of Soliker and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

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

Irritation or tingling at the application site, conjunctivitis, allergy, painful sensation upon touching the skin, pricking sensations, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), skin thickening, and cutaneous ulceration.

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

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

Bullous dermatitis (dermatitis with large blisters).

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

Gastrointestinal bleeding, kidney problems, breathing difficulties (asthma), skin rash with infection, photosensitivity (skin sensitivity to sunlight).

Cases of temporary hair discoloration in the area of application have been reported. This effect usually resolves upon discontinuation of treatment.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Soliker 30 mg/g gel

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.

This medicine does not require any special storage conditions.

Use within 6 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Soliker 30 mg/g gel:

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

Appearance of the product and contents of the container

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 puncturing tip, containing 25 grams, 50 grams, 60 grams, 90 grams, or 100 grams of product.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany Diclofenac Glenmark 30 mg/g Gel

Spain Soliker 30 mg/g gel

Italy Diclofenac Glenmark

Date of the most recent review of this leaflet: March 2025.

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