Solacutan

Package leaflet: Information for the patient

Solacutan 3% gel

diclofenac sodium
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you

• Keep this leaflet. 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 dermatological gel. Solacutan is applied to the skin to treat a condition known as actinic or solar keratosis, caused by excessive exposure to sunlight.

2. What you need to know before using Solacutan

Do not take Solacutan

• If you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction such as a skin rash (urticaria), breathing problems (wheezing), or runny nose (allergic rhinitis) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Solacutan.

• The possibility of systemic adverse reactions following the application of Solacutan cannot be ruled out when the medicine is used over a large area of skin or for a prolonged period of time. Consult your doctor if:

• you have or have previously had stomach ulcers or gastrointestinal bleeding,

• you have heart, liver, or kidney problems,

• you have any bleeding disorders or bruise very easily.

• Avoid direct exposure to sunlight and the use of sunbeds during treatment with Solacutan. If skin reactions occur, stop using this medicine.

• Do not apply it to wounds or to skin that is infected or inflamed. Avoid contact of Solacutan with the eyes, inside of the mouth (mucous membranes), or inside the nose, and do not swallow it. If you have accidentally swallowed Solacutan, consult your doctor immediately.

• Stop using Solacutan and consult your doctor if you develop a widespread skin rash. After applying medicines containing diclofenac to the skin, you may use a permeable dressing (non-occlusive). Do not use an occlusive dressing.

Children and adolescents
Dosage recommendations and indications for the use of Solacutan in children and adolescents have not been established.

Other medicines and Solacutan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant or think you might be pregnant, ask your doctor for advice before taking this medicine. Solacutan should be used with caution during the first six months of pregnancy but must not be used during the last three months of pregnancy.
Consult your doctor if you are breastfeeding. Solacutan may be used with caution during breastfeeding but must not be applied to the breast.
If you are pregnant, planning a pregnancy, or breastfeeding, and your doctor considers this treatment appropriate, you must not apply Solacutan to more than one-third of your body surface and must not use it for longer than three weeks.
Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and using machines
No special precautions are required.

Solacutan contains benzyl alcohol
This medicine contains 15 mg of benzyl alcohol per 1 g of gel.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Solacutan

• Solacutan is not suitable for children.
• Always use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
• Before use, pierce the aluminium seal covering the opening of the tube with the cap.
• Gently spread a small amount of gel on the area to be treated. The amount of gel required depends on the size of the area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) is sufficient for an area of 5 cm x 5 cm. However, no more than 8 grams per day should be applied.
• You may apply Solacutan twice daily, unless otherwise directed by your doctor. When applying the gel to the skin, you may experience a mild cooling sensation.
• The usual duration of treatment is 60–90 days. Maximum efficacy has been observed with a treatment duration close to 90 days. Complete healing may not occur until up to one month after stopping therapy.
• After applying the gel, wash your hands, unless they are one of the treated areas.

If you use more Solacutan than you should
Remove excess gel by washing with water.
If you forget to use Solacutan
Continue applying the gel as directed; do not apply a double dose to make up for the missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking Solacutan and contact your doctor as
soon as possible:
Skin rash (urticaria), breathing difficulties (wheezing), facial swelling, runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solacutan.
If any of the following side effects is severe or lasts for more than a few days, you must stop using
Solacutan and contact your doctor: itching, skin rash, facial redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects (may affect up to 1 in 10 people)
Irritation or tingling at the application site, conjunctivitis, allergy, pain sensation when touching the skin, tingling, muscle stiffness, skin inflammation, eczema, dry skin, swelling, skin rash (including peeling and blistering), skin atrophy and skin ulcers.
Uncommon side effects (may affect up to 1 in 100 people)
Eye pain, eye watering/dryness, abdominal pain, diarrhoea, feeling unwell, hair loss, facial swelling, excessive bleeding or oily skin, measles-like rash.
Rare side effects (may affect up to 1 in 1000 people)
Skin inflammation with large blisters.
Very rare side effects (may affect up to 1 in 10,000 people)
Stomach bleeding, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including urticaria, rapid swelling of the skin and mucous membranes), infected skin rash, skin sensitivity to sunlight.
A temporary change in hair colour in the treated area has been reported, which usually resolves when treatment is discontinued.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide 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 packaging after Exp. The expiry date refers to the last day of the month.
Do not store above 25°C.
Storage duration after opening
After opening the tube, Solacutan can be stored for up to 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Solacutan contains

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

Description of the appearance of Solacutan and the contents of the pack
Solacutan is a clear, transparent, colourless or pale yellow gel and is contained in aluminium tubes of 10 g, 25 g, 26 g, 30 g, 50 g, 60 g and 90 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
mibe pharma Italia S.r.l.
Via Leonardo da Vinci, 20/B
39100 Bolzano
Responsible manufacturers for batch release
mibe GmbH Arzneimittel
Muenchener Strasse 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
Łomianki, 05-092
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Diclofenac acis 30 mg/g Gel
Austria: Diclofenac Dermapharm 3% Gel
Belgium: Diclofenac Dermapharm 3% gel
Netherlands: Diclofenac Na Dermapharm 3% gel
Italy: Solacutan 3% gel
Spain: Diclofenaco Dermapharm 30 mg/g Gel
United Kingdom: Solacutan 3% gel