Solaraze

This medication is used to treat a certain skin condition (actinic keratoses). Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID).

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, lithium, methotrexate, pemetrexed, probenecid, other products applied to skin on the treated area, tenofovir.This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Solaraze is a prescription medication used to treat actinic keratoses (AK). This is a condition when the skin grows rough, dry, or scaly patch due to long-term sun exposure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefits to the mother justify the potential risk to the fetus. 

Solaraze gel is to be applied to the skin twice daily for 60 to 90 days. Use exactly as prescribed. Do not use more or less of it, or use it more often than prescribed by your doctor.

• Wash your hands.
• Apply a small amount of gel on the affected skin, covering it completely, gently smoothing the gel on affected area.
• Use this gel twice daily; apply it in the morning before dressing and at night before going to bed.
• Wash your hands after applying the gel. Do not rub or touch your eyes before washing your hands.
  • What to avoid:
    • Be careful not to get this medication in your eyes if you are applying it to your face.
    • Do not apply to open wounds (broken skin), infections, or red, scaly skin.
    • Wear protective clothing, and avoid prolonged sun exposure.
    • Do not use sunscreens, cosmetics, or other medications applied to the skin during treatment.
    • Do not cover treated areas with dressings or bandages.

If you apply too much Solaraze, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Use Solaraze as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use sunscreen, insect repellant, or other drugs on affected part.
• If putting Solaraze on the hand, do not wash your hands for at least 1 hour after putting on.
• Do not use heat or bandages on the treated part.
• Let the drug dry for at least 10 minutes before you cover it with clothes or gloves.
• Do not bathe, shower, or swim for 1 hour after putting on.
• Do not use on open wounds or infected skin.
• If you get this medicine in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Solaraze, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Solaraze. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Solaraze.

Review Date: October 4, 2017

Available in tubes of 100 g (NDC 10337-844-01). Each gram of gel contains 30 mg of diclofenac sodium.

Storage: Store at controlled room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Protect from heat. Avoid freezing.

†Voltaren® is a registered trademark of Novartis.

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Medication Guide
Solaraze (sol-ar-aze)
(diclofenac sodium) Gel, 3%

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

Solaraze Gel is an NSAID medicine that is used on the skin only (topical). Do not use Solaraze Gel in or on the eyes.
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 Gel?
Solaraze Gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis.
Solaraze Gel is not for use in children.

Who should not use Solaraze Gel?
Do not use Solaraze Gel:
• if you have had an allergic reaction to any of the ingredients in Solaraze Gel. See the end of this Medication Guide for a complete list of ingredients in Solaraze Gel.
• right before or after heart bypass surgery.

Before using Solaraze Gel, 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. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take or use NSAIDs after 29 weeks of pregnancy.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Solaraze Gel or breastfeed. You should not do both.

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 Gel?
• Use Solaraze Gel exactly as your healthcare provider tells you to use it.
• Apply Solaraze Gel 2 times a day.
• Apply enough Solaraze Gel to cover each skin lesion and gently rub in.
• Solaraze Gel 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.
• Wash your hands after applying Solaraze Gel.

What should I avoid while using Solaraze Gel?
• 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.
• You should avoid applying Solaraze Gel to open skin wounds, skin infections, or peeling skin.

What are the possible side effects of Solaraze Gel?

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)?
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life threatening allergic reactions

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 Gel 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 Solaraze Gel is accidentally taken by mouth, call your healthcare provider or get medical help right away.
These are not all 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 for more than 10 days.

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

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

General information about the safe and effective use of Solaraze Gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Solaraze Gel for a condition for which it was not prescribed. Do not give Solaraze Gel 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 Gel, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Solaraze Gel that is written for health professionals.

What are the ingredients in Solaraze Gel?
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.
Issued: 02/2016

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