SOLARAZE 3% Gel

Зміст інструкції

1. Solaraze gel 3%
   1. What is Solaraze and what is it used for
   2. What you need to know before using Solaraze
   3. How to use Solaraze
   4. Possible side effects
   5. How to store Solaraze
   6. Contents of the pack and other information

Solaraze gel 3%

Diclofenac sodico 3% w/w
Read this leaflet carefully before you start using 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 because it could 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 Solaraze is and what it is used for
• 2. What you need to know before you use Solaraze
• 3. How to use Solaraze
• 4. Possible side effects
• 5. How to store Solaraze
• 6. Contents of the pack and other information

1. What is Solaraze and what is it used for

Solaraze is a non-steroidal anti-inflammatory dermatological gel. Applied to the skin,
Solaraze gel is used to treat a skin problem known as actinic or solar keratosis,
caused by excessive exposure to the sun.

2. What you need to know before using Solaraze

Do not use Solaraze

• 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 skin rash (urticaria), difficulty breathing (wheezing) or runny nose (allergic rhinitis) after taking aspirin or other non-steroidal anti-inflammatory agents.
• If you are in the last trimester of pregnancy.

Warnings and precautions

• The possibility of systemic side effects with the application of Solaraze cannotbe ruled out if the product is used on large areas of skin and for a prolongedperiod.
• Consult your doctor if:
• You suffer from or have suffered in the past from stomach ulcers or bleeding,
• You have heart, liver or kidney problems,
• You suffer from any bleeding disorder or bruise very easily.
• Avoid exposure to the sun and tanning beds during the use of Solaraze. If skin reactions occur, discontinue use.
• Do not apply to wounds, infected skin or dermatitis.
• Avoid getting Solaraze into your eyes or inside your nose or mouth and do not swallow it. If you accidentally swallow Solaraze, consult your doctor immediately.
• If you experience widespread rash, stop using Solaraze and consult your doctor.
• After applying medicines containing diclofenac to the skin, a permeable (non-occlusive) bandage may be used. Do not use an occlusive bandage that does not allow air to pass through

Pregnancy and breastfeeding
Tell your doctor if you are pregnant or think you may be pregnant. Solaraze 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. Solaraze may be used with caution
during breastfeeding, but should not be applied to the breast.
If you are pregnant, trying to become pregnant or are breastfeeding, and your doctor considers
this treatment appropriate, you should not apply Solaraze 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 any medicine.

3. How to use Solaraze

• Solaraze is not suitable for children.
• Use the gel according to your doctor's instructions.
• Before use, pierce the aluminum membrane located on the opening of the tube with the tip of the cap.
• Gently spread a small amount of gel onto the skin in the area to be treated. The amount needed depends on the size of the area to be treated. Generally 0.5 grams of gel (the size of a pea) is sufficient to treat an area of 5x5 cm, but no more than 8 grams should be applied per day.
• Solaraze can be applied 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 therapy is 60-90 days. Maximum efficacy is achieved with a treatment duration towards the higher end of this range. Complete healing may occur up to one month after cessation of therapy.
• After applying the gel, wash your hands, unless one of the areas to be treated is your hands.

If you use more Solaraze than you should
Remove excess gel by washing with water.

If you forget to use Solaraze
Continue to apply it as indicated, but do not apply a double dose to compensate for the
forgetfulness.

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 using Solaraze and tell your
doctor as soon as possible:
skin rash (urticaria), difficulty breathing (wheezing), swelling of the face, runny nose
(allergic rhinitis). These symptoms indicate a possible allergy to Solaraze.
If any of the common side effects listed below becomes severe or if
it lasts for more than a few days, stop using Solaraze and see your doctor: itching, rash,
redness or inflammation of the skin, contact dermatitis, pain and
blister formation.

Other common side effects:(affect 1-10 patients in 100)
tingling when touching the skin, muscle stiffness, dermatitis, eczema, dry skin,
swelling, rash (including peeling and blistering),
skin sagging and skin ulcers.

Uncommon side effects:(affect 1-10 patients in 1,000)
eye pain, tearing/dry eyes, abdominal pain, diarrhea,
feeling unwell, hair loss, facial swelling, excessive bleeding or oily skin, rash similar to measles.

Rare side effects:(affect 1 to 10 in 10,000 patients)
dermatitis with large blisters

Very rare side effects:(affect less than 1 in 10,000 patients)
stomach bleeding, kidney problems, difficulty breathing (asthma), infected skin rash, skin
sensitivity to sunlight.
Temporary changes in hair color in the application area have been reported, which
usually resolves when treatment is stopped.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Solaraze

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (indicated below “EXP”) which is reported
on the tube and on the packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Validity after first opening: 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Solaraze contains

• the active ingredient is diclofenac sodium. Each gram of gel contains the equivalent of 30 mg of diclofenac sodium.
• The other ingredients are sodium hyaluronate, benzyl alcohol, macrogol monomethyl ether 350 and purified water.

Description of the appearance of Solaraze and contents of the pack
Solaraze gel is a clear, transparent, colorless or pale yellow gel, packaged in tubes
containing 25, 50, 60, 90 or 100 grams of product.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Almirall SA, Ronda General Mitre

• 151 - 08022 Barcelona, Spain

Representative for Italy is Almirall Spa, via Messina 38, Torre C – 20154 Milan
The manufacturer is Almirall Hermal GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany.