Solacutan

Package Leaflet: Information for the User

Solacutan, 30 mg/g, Gel

Diclofenac Sodium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Solacutan and what is it used for
• 2. Important information 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 is Solacutan and what is it used for

Solacutan is a non-steroidal anti-inflammatory gel for topical use. Solacutan is used on the skin to treat a skin condition called solar keratosis, caused by long-term exposure to sunlight.

2. Important information before using Solacutan

When not to use Solacutan

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you have had allergic reactions, such as rash (hives), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after using aspirin or other non-steroidal anti-inflammatory medicines,
• if you are in the last three months of pregnancy.

Warnings and precautions

Before starting to use Solacutan, discuss it with your doctor or pharmacist.

• It cannot be excluded that systemic side effects may occur after using Solacutan on large areas of skin and for a long time. You should contact your doctor if you:
• have or have had stomach ulcers or bleeding from the stomach,
• have heart, liver, or kidney disease,
• have any blood clotting disorders or are prone to bruising.
• While using Solacutan, avoid exposure to sunlight and sunlamps. If skin reactions occur, discontinue use.
• Do not use on wounds, infected skin, or areas affected by skin inflammation.
• Avoid contact of Solacutan with eyes or mucous membranes in the nose or mouth. Do not swallow the gel. If you accidentally swallow Solacutan, consult your doctor immediately.
• You should discontinue use of Solacutan and consult your doctor if you experience a widespread rash.
• After applying Solacutan to the skin, you can use permeable (non-occlusive) dressings. Do not use airtight occlusive dressings.

Children and adolescents

The dosage and indications for Solacutan in children and adolescents have not been established.

Solacutan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Do not use Solacutan during the last three months of pregnancy. During the first six months of pregnancy, do not use Solacutan unless it is necessary and advised by your doctor. If use is necessary, the lowest dose should be used for the shortest possible time.
After oral administration of diclofenac-containing medicines (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to diclofenac-containing medicines used on the skin.
Consult your doctor if you are breastfeeding. Solacutan can be used with caution during breastfeeding, but it should not be applied to the breast skin.
If you are pregnant, plan to have a child, or are breastfeeding, and your doctor considers treatment with Solacutan necessary, it should not be applied to an area of skin larger than one-third of the body surface and should not be used for more than three weeks.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

No special precautions are necessary.

Solacutan contains benzyl alcohol

This medicine contains 15 mg of benzyl alcohol in each gram of gel.
Benzyl alcohol may cause allergic reactions and mild, local irritation.

3. How to use Solacutan

• Solacutan is not intended for use in children.
• Solacutan should always be used as directed by your doctor. If you are unsure, consult your doctor.
• Solacutan is for use on the skin only.
• Before use, pierce the aluminum membrane with the cap.
• Gently spread a small amount of gel on the skin surface that needs treatment and gently rub it into the skin. The amount of gel varies depending on the size of the skin surface that needs treatment. Usually, 0.5 grams of gel (about the size of a pea) is sufficient for a 5 cm x 5 cm skin surface. Do not use more than 8 grams of gel per day.
• Solacutan can be used twice a day, unless your doctor advises otherwise. When spreading the gel, a mild cooling sensation may occur on the skin surface.
• Typically, the treatment period is 60 to 90 days. Maximum effect of the medicine is observed after a treatment period of about 90 days. Full healing may not occur before one month after the end of treatment.
• After applying the gel, wash your hands with paper towels and then wash them, unless they are the area to be treated.
• If you accidentally apply too much gel, wipe off the excess with a paper towel.
• Dispose of the paper towel in the household waste to prevent the unused product from entering the water environment. Before applying a dressing, let the gel dry on the skin for a few minutes.

Using more Solacutan than recommended

If a significant overdose occurs when applying to the skin, remove the gel (e.g., with a paper towel, which should be disposed of in the mixed waste bin) and then wash it off with water.

Missing a dose of Solacutan

Continue using the medicine as directed. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Solacutan can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using Solacutan and contact your doctor immediately:

rash (hives), breathing difficulties (wheezing), face swelling, runny nose (allergic rhinitis). These symptoms may indicate an allergy to Solacutan.
If any of the following common side effects are severe or persist for more than a few days, stop using Solacutan and consult your doctor: itching, rash, redness of the skin, inflammation, contact dermatitis, pain, and blisters.
Other common side effects:(may affect up to 1 in 10 people)
irritation or tingling at the application site, conjunctivitis, hypersensitivity, pain when touching the skin, numbness and tingling, muscle stiffness, skin inflammation, rash, dry skin, swelling, rash (including scaling or blisters), skin thinning, and skin ulcer.
Uncommon side effects:(may affect up to 1 in 100 people)
eye pain, tearing or dry eyes, abdominal pain, diarrhea, nausea, hair loss, face swelling, excessive bleeding or excessive sebum production, rash similar to that seen in measles.
Rare side effects:(may affect up to 1 in 1,000 people)
skin inflammation with large blisters.
Very rare side effects:(occurring in less than 1 in 10,000 people)
stomach bleeding, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including hives, sudden swelling of the skin and mucous membranes), infected rash, increased sensitivity of the skin to sunlight.
Temporary hair discoloration at the application site has been reported, usually resolving after discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store 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.
Do not store above 25°C.

Shelf life after first opening

After first opening the tube, do not store for more than 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Solacutan contains

The active substance is:
diclofenac sodium.
1 g of gel contains 30 mg of diclofenac sodium.
The other ingredients are:
sodium hyaluronate, macrogol 400, benzyl alcohol, purified water.

What Solacutan looks like and contents of the pack

Solacutan is a clear, transparent, colorless or light yellow gel packaged in aluminum tubes containing 26 g or 60 g.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Solacutan 3% Gel
Germany:
Solacutan 30 mg/g Gel
Poland:
Solacutan
Date of last revision of the leaflet:12.2024