Patient Leaflet Updated 03-Jun-2021 | Almirall Limited
Solaraze
Solaraze 3%, gel
Diclofenac Sodium 3% w/w
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
Solaraze is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Solaraze gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure.
Speak to your doctor if you are, or could be pregnant. Solaraze 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. Solaraze can be used whilst breastfeeding with caution but should not be used on the breasts.
If you are pregnant, trying to get pregnant, or breastfeeding, and your doctor considers treatment appropriate, Solaraze must not be applied to an area of the skin larger than about a third of your body and must not be used for longer than three weeks.
Ask your doctor or pharmacist for advice before taking or using any medicine.
This medicine contains 10 mg benzyl alcohol in each g. Benzyl alcohol may cause allergic reactions and mild local irritation.
Remove the excess gel by washing with water.
Continue to apply as directed but do not apply twice as much to make up for the missed application.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Skin rash (nettle rash); breathing difficulties (wheezing); swelling of the face; runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solaraze.
If any of the following common side effects are severe or last for more than a few days you should stop using Solaraze and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects: (occur in between 1 and 10 out of every 100 patients)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the skin is touched, pins and needles, muscle stiffness, dermatitis, eczema, dry skin, swelling, rash (including scaly or blistering), sagging of the skin, and skin ulcer.
Uncommon side effects: (occur in between 1 and 10 out of every 1,000 patients)
Eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling sick, hair loss, facial swelling, excessive bleeding or oily skin, a measles-like rash.
Rare side effects: (occur in between 1 and 10 out of every 10,000 patients)
Dermatitis with large blisters.
Very rare side effects: (occur in fewer than 1 in 10,000 patients)
Bleeding from your stomach, problems with your kidneys, breathing difficulties (asthma), infected skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping treatment.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below):
Ireland
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (shown as ‘EXP’) which is stated on the tube and carton. The date refers to the last date of that month.
Do not store above 25°C.
Shelf life after opening: 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Solaraze gel is a clear, transparent, colourless or pale yellow gel packed in tubes containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of product.
The marketing authorisation holder is
The manufacturer is
This leaflet was last revised in 10/2020
Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK
+44 (0) 207 160 2500
http://www.almirall.co.uk
0800 0087399
0800 0087399