Solaraze 3% Gel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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

Do not use Solaraze

• If you are allergic to diclofenac or any of the ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction such as skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other non-steroidal anti-inflammatory agents.
• If you are in the final 3 months of your pregnancy.

Warnings and precautions

• The possibility of systemic side effects from application of Solaraze cannot be excluded if the product is used on large areas of skin and over a prolonged period. Consult your doctor if:
  • you have, or have had in the past, a stomach ulcer or bleeding from the stomach.
  • you have heart, liver or kidney problems.
  • you have any type of bleeding disorder or bruise very easily.
• Avoid sun exposure, including tanning salons, when using Solaraze. If skin reactions occur, discontinue use.
• Do not apply to skin wounds, infected skin or dermatitis.
• Do not allow Solaraze to come into contact with your eyes or the inside of your nose or mouth and do not swallow it. If Solaraze has accidentally been swallowed, consult a doctor immediately.
• Discontinue Solaraze and consult your doctor if you develop a wide-spread skin rash.
• After applying products containing diclofenac on the skin you can use a permeable (non-occlusive) bandage. Do not use an airtight occlusive dressing.

Pregnancy and breast-feeding

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.

Solaraze contains benzyl alcohol

This medicine contains 10 mg benzyl alcohol in each g. Benzyl alcohol may cause allergic reactions and mild local irritation.

If you use more Solaraze than you should

Remove the excess gel by washing with water.

If you forget to use Solaraze

Continue to apply as directed but do not apply twice as much to make up for the missed application.

If you have any of the following side effects, stop using Solaraze and contact your doctor as soon as possible:

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.

Reporting of side effects

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.

What Solaraze contains

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

What Solaraze looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is

The manufacturer is