Package leaflet: Information for the user

Solacutan, 30 mg/g, gel
Diclofenacum natricum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Solacutan is and what it is used for
Important information before using Solacutan
How to use Solacutan
Possible side effects
How to store Solacutan
Contents of the pack and other information

1. What Solacutan is and what it is used for

Solacutan is a non-steroidal anti-inflammatory gel for topical application. Solacutan is applied to the skin in the treatment of a skin condition called actinic keratosis, caused by long-term exposure to sunlight.

2. Important information before using Solacutan

When not to use Solacutan

if the patient is allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6),
if the patient has experienced allergic reactions such as rash (urticaria), breathing problems (wheezing) or nasal inflammation (allergic rhinitis) after taking aspirin or other non-steroidal anti-inflammatory drugs,
if the patient is in the last three months of pregnancy.

Warnings and precautions
Before starting to use Solacutan, discuss this with your doctor or pharmacist.

Systemic adverse reactions cannot be ruled out when Solacutan is used over large areas of skin or for prolonged periods. Contact your doctor if the patient:
- has or has had stomach ulcer or gastrointestinal bleeding in the past,
- has heart, liver or kidney disease,
- has any blood clotting disorders or is prone to bruising.
While using Solacutan, avoid exposure to sunlight and the use of sunbeds (solariums). If skin reactions occur, discontinue use of the medicine.
Do not apply to wounds, infected skin or skin lesions caused by skin inflammation.
Avoid contact of Solacutan with eyes or mucous membranes in the nose or mouth. Do not swallow the gel. If accidental ingestion of Solacutan occurs, consult a doctor immediately.
Discontinue use of Solacutan and consult a doctor if extensive rash develops.
After applying topical preparations containing diclofenac, breathable (non-occlusive) dressings may be used. Do not use airtight, non-breathable occlusive dressings.

Children and adolescents
The dosage range and indications for use of Solacutan in children and adolescents have not been established.

Solacutan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Do not use Solacutan during the last three months of pregnancy. During the first six months of pregnancy, Solacutan should not be used unless necessary and recommended by a doctor. If use is necessary, the lowest effective dose for the shortest possible duration should be applied.

After oral administration of diclofenac-containing medicines (e.g. tablets), adverse effects in the unborn child may occur. It is not known whether the same risk applies to diclofenac applied to the skin.

Consult your doctor if the patient is breastfeeding. Solacutan may be used with caution during breastfeeding, but should not be applied to the skin of the breast area.

If the patient is pregnant, planning to become pregnant, or breastfeeding, and the doctor considers treatment with Solacutan gel appropriate, it must not be applied to an area larger than one-third of the body surface and must not be used for longer than three weeks.

Before using any medicine, consult your doctor or pharmacist.

Driving and operating machinery
No special precautions are required.

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 a physician. In case of doubt, consult your doctor.
Solacutan is intended for topical use only.
Before use, pierce the aluminum seal using the cap.
Gently spread a small amount of gel over the affected skin area and rub it in gently. The amount of gel used depends on the size of the skin area to be treated. Usually, 0.5 g of gel (corresponding to the size of a pea) is sufficient for an area of 5 cm x 5 cm. Do not use more than 8 grams of gel per day.
Solacutan may be applied twice daily unless otherwise directed by a physician. A mild cooling sensation may be felt on the skin during application.
The usual duration of treatment is 60 to 90 days. Maximum effect of the medicinal product was observed after a treatment period approaching 90 days. Complete healing may not occur until one month after the end of treatment.
After applying the gel, wipe hands with a paper towel and then wash them, unless the hands are the area to be treated.
If too much gel is accidentally applied, wipe off the excess with a paper towel.
The paper towel should be disposed of in a household waste container to prevent unused product from entering the aquatic environment. Allow the gel to dry on the skin for several minutes before applying a bandage.

Use of more than the recommended dose of Solacutan
If a significantly larger amount of gel is applied to the skin than recommended, remove the excess gel
(e.g. with a paper towel, which should be disposed of in a mixed waste container) and then wash off with water.
Missed dose of Solacutan
Continue using the medicinal product as directed. Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using
Solacutan and contact your doctor as soon as possible:
rash (urticaria), breathing difficulties (wheezing), facial swelling, runny nose (allergic rhinitis).
Such symptoms may indicate hypersensitivity to Solacutan.
If any of the following common adverse reactions are severe or persist for more than a few days, stop using Solacutan and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain, and blisters.
Other common adverse reactions: (may affect up to 1 in 10 people)
irritation or tingling at the site of gel application, conjunctivitis, hypersensitivity, pain on touching the skin, numbness and tingling, muscle stiffness, dermatitis, rash, dry skin, swelling, rash (including scaling or blistering), skin atrophy, and skin ulcer.
Uncommon adverse reactions: (may affect up to 1 in 100 people)
eye pain, watery or dry eyes, abdominal pain, diarrhoea, nausea, hair loss, facial swelling, excessive bleeding or excessive sebum secretion, rash similar to measles.
Rare adverse reactions: (may affect up to 1 in 1,000 people)
skin inflammation with large blisters.
Very rare adverse reactions: (occur in fewer than 1 in 10,000 patients)
gastric bleeding, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including urticaria, sudden swelling of skin and mucous membranes), infected rash, photosensitivity.
Transient hair discoloration at the application site has been reported, usually resolving after discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Solacutan

Keep the 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 stated month.
Do not store above 25°C.
Usable period after first opening
After first opening of the tube, do not store for longer than 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the
environment.

6. Package contents and other information

What Solacutan contains
The active substance is:
diclofenac sodium.
Each 1 g of gel contains 30 mg of diclofenac sodium.
Other ingredients are:
hyaluronic acid sodium salt, macrogol 400, benzyl alcohol, purified water.

What Solacutan looks like and what the package contains
Solacutan is a clear, transparent, colourless or slightly yellow gel packed in aluminium tubes containing 26 g or 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised 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