Medication Guide

Medication Guide
Solaraze (sol-ar-aze)
(diclofenac sodium) topical gel

What is the most important information I should know about Solaraze and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs

Do not take or use NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)”. Avoid taking NSAIDs after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take or use NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems

NSAIDs should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What is Solaraze?
Solaraze is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Solaraze is not for use in children.

Do not use Solaraze:

•

if you have had an allergic reaction to any of the ingredients in Solaraze. See the end of this Medication Guide for a complete list of ingredients in Solaraze.

•

if you have a history of asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe allergic reactions that can sometimes lead to death, have happened in people with a history of these types of allergic reactions to NSAIDs.

•

on skin that is inflamed, or has eczema, infected sores (lesions), burns or wounds

•

right before or after heart bypass surgery.

Before using Solaraze, tell your healthcare provider about all of your medical conditions, including if you:
• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Solaraze or breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I use Solaraze?

•

Use Solaraze exactly as your healthcare provider tells you to use it.

•

Apply Solaraze 2 times a day.

•

Apply enough Solaraze to cover each skin lesion (usually a pea-sized amount) and gently rub in.

•

Solaraze may be used for 60 to 90 days. You may not see improvement of skin lesions for up to 30 days after stopping treatment. See your healthcare provider if lesions do not respond to treatment.

•

Avoid getting Solaraze in your eyes, nose and mouth. If Solaraze gets into your eyes, nose or mouth wash out your eyes, nose or mouth with water or saline right away. Call your healthcare provider if irritation continues for more than 1 hour.

•

Wash your hands well after applying Solaraze.

What should I avoid while using Solaraze?
• Avoid spending time in sunlight or artificial light, such as tanning beds or sunlamps. Solaraze Gel can make your skin sensitive to sunlight and the light from tanning beds and sunlamps. Talk to your healthcare provider about sun protection measures and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using Solaraze if you notice that you are beginning to get sunburn.
•Do not apply Solaraze to open skin wounds, skin infections, or peeling skin.

What are the possible side effects of Solaraze?

Solaraze and other NSAIDs can cause serious side effects, including:
See “What is the most important information I should know about Solaraze Gel and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

•

life threatening allergic reactions

•

worsening of asthma in people who are aspirin-sensitive

•

life-threatening skin reactions

•

liver problems including liver failure

•

new or worse high blood pressure

•

heart failure

•

kidney problems including kidney failure

•

low red blood cells (anemia)

 

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

 

Get emergency help right away if you get any of the following symptoms:

 

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop using Solaraze and call your healthcare provider right away if you get any of the following symptoms:

• nausea

• more tired or weaker than usual
• diarrhea
• itching
• your skin or eyes look yellow
• indigestion or stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms, legs, hands and feet

Application site skin reactions are common with Solaraze Gel and include: skin redness, itching, rash, dry skin, scaling, and peeling.

If you take too much NSAID, call your healthcare provider or get medical help right away.

Solaraze may cause fertility problems in females, which may affect your ability to have a child. Talk to your healthcare provider if this a concern for you.

These are not all of the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs
Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs.

How should I store Solaraze?
• Store Solaraze at room temperature 68°F to 77°F (20°C to 25°C).
• Keep Solaraze away from heat. Avoid freezing Solaraze.

Keep Solaraze and all medicines out of the reach of children.

General information about the safe and effective use of Solaraze

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Solaraze for a condition for which it was not prescribed. Do not give Solaraze to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about Solaraze, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Solaraze that is written for health professionals.

What are the ingredients in Solaraze?
Active ingredient: diclofenac sodium
Inactive ingredient: benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water.

Manufactured by:
PharmDerm®, A division of Fougera Pharmaceuticals Inc.,
Melville, New York 11747
For more information, go to www.pharmaderm.com or call 1-800-645-9833.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2022