SOLACUTAN 3% Gel

Зміст інструкції

1. Solacutan 3% gel
   1. What is Solacutan and what is it 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

Solacutan 3% gel

diclofenac sodico
Generic medicine

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 dermatological gel. Solacutan is applied to the
skin to treat a condition known as actinic or solar keratosis, caused by excessive
sun exposure.

2. What you need to know before using Solacutan

Do not take Solacutan

• If you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• If you have ever experienced 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.
• If you are in the last trimester 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 excluded when the medicine is used on a large area of skin or for a prolonged period of time. Consult your doctor if:
• you have or have had in the past stomach ulcers or bleeding,
• you have problems with your heart, liver or kidneys,
• you have any bleeding disorder or bruise very easily.
• Avoid direct exposure to the sun and the use of tanning beds during treatment with

Solacutan. If skin reactions occur, stop using this medicine.

• Do not apply it to wounds, skin with infection or inflammation. Avoid getting Solacutan in your eyes or on the inside of your mouth (the lining mucosa) or 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 should develop an extensive skin rash. Following the application of medicines containing diclofenac to the skin, you may use a permeable (non-occlusive) bandage. Do not use an occlusive dressing.

Children and adolescents
No dosage recommendations and indications for the use of Solacutan in children
and adolescents have been established.

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

Pregnancy and breastfeeding
If you are pregnant or suspect you may 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 notbe used in the last trimester of pregnancy.
Consult your doctor if you are breastfeeding. Solacutan may be used with caution during
breastfeeding but should not be applied to the breast.
If you are pregnant, planning a pregnancy or breastfeeding and
your doctor considers this treatment appropriate, you should not apply Solacutan to an area of
skin larger than one-third of the body and should not use it for more than three weeks.
Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and using machines
No specific precautions are necessary.

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

3. How to use Solacutan

• Solacutan is not suitable for children.
• Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.
• Before use, pierce the aluminum membrane located on the opening of the tube with the cap.
• Gently spread a small amount of gel onto the area to be treated. The amount of gel needed varies depending on the size of the area to be treated. Generally, 0.5 grams of gel (equivalent to approximately the size of a pea) is sufficient for an area of 5cm x 5cm. However, no more than 8 grams should be applied per day.
• You can apply Solacutan twice a day, unless otherwise indicated by your doctor. When spreading the gel on the skin, you may feel a slight cooling sensation.
• The normal 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 one
month after cessation of 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 to apply the gel as indicated, but do not apply a double dose to compensate for a
missed application.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Solacutan and contact your
doctor immediately:
Skin rash (urticaria), difficulty breathing (wheezing), swelling of the face, 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 more than a few days, you should 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 of the treated area, conjunctivitis, allergy, feeling of pain when touching
the skin, tingling, muscle stiffness, skin inflammation, eczema, dry skin, swelling,
skin rash (including peeling and blistering), skin thinning and skin ulcers.

Uncommon side effects(may affect up to 1 in 100 people)
Eye pain, tearing/dry eyes, abdominal pain, diarrhea, 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 10000 people)
Stomach bleeding, kidney problems, difficulty breathing (asthma), all types of hypersensitivity
reactions (including urticaria, rapid swelling of the skin and mucous membranes), infected skin rash,
skin sensitivity to sunlight.
Temporary alteration of hair color in the application area has been reported, which
usually resolves when treatment is stopped.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack after Scad. The expiry
date refers to the last day of the month.
Do not store at a temperature above 25°C.

Shelf life after opening
Once opened, Solacutan has a shelf life of 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Solacutan contains

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

Description of the appearance of Solacutan and contents of the pack
Solacutan is a clear, transparent, colourless or pale yellow gel and is contained in aluminium tubes
containing 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

Manufacturers responsible 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 Member States of the European Economic Area under the
following denominations
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
England Solacutan 3% gel