Nuvira

Nuvira (for the skin) is a combination product that provides temporary relief from joint and muscle pain, inflammation due to arthritis, muscle cramps, neckache, and back pain or discomfort.

Capsaicin, menthol, methyl nicotinate, and methyl salicylate may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts, or for longer than directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Clean and dry the affected area before application. Wash your hands after applying Nuvira, unless you are using it to treat a hand condition.

Capsaicin, menthol, methyl nicotinate, and methyl salicylate patch is usually applied to the affected area once per day. The patch may be cut into smaller sizes before removing the protective film, and it can be used on up to 2 body parts at the same time. A patch should not be worn for more than 12 hours.

Do not bandage treated skin or expose it to heat. Your skin may absorb the medicine, which could cause harmful effects. Do not apply the patch over irritated or infected skin.

Stop using this medicine and call your doctor if your symptoms do not improve after 7 days, if they get worse, or get better and then come back within 3 days of treatment.

Tell your doctor if you have a planned surgery. You may need to stop using the medicine for a short time before and after surgery.

This medicine is flammable. Do not use near high heat or open flame. Do not smoke while you have a patch on your skin.

Store tightly closed at room temperature, away from moisture and heat.

Capsaicin, menthol, methyl nicotinate, and methyl salicylate can raise your chances of having a fatal heart attack or stroke. Do not use Nuvira just before or after heart surgery. Capsaicin, menthol, methyl nicotinate, and methyl salicylate may also lead to stomach or intestinal bleeding, which can be deadly.

You should not use capsaicin, menthol, methyl nicotinate, and methyl salicylate if you are allergic to them or if you have ever had an allergy (especially to aspirin or other NSAIDs).

Capsaicin, menthol, methyl nicotinate, and methyl salicylate can increase your risk of a fatal heart attack or stroke. Do not use this medicine just before or after heart surgery. Capsaicin, menthol, methyl nicotinate, and methyl salicylate may also cause stomach or intestinal bleeding, which can be fatal. This can happen without warning, especially in older adults.

Some medications should not be used with capsaicin, menthol, methyl nicotinate, and methyl salicylate. Tell your doctor if you are also taking a diuretic ("water pill") or any other medication.

Ask a doctor or pharmacist if this medicine is safe to use if you have or have ever had:

• heart disease, high blood pressure;
• a heart attack, congestive heart failure, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• a habit of drinking more than 3 alcoholic beverages per day;
• if you take a blood thinner (warfarin, Coumadin), or a steroid; or
• liver or kidney disease.

Do not use capsaicin, menthol, methyl nicotinate, and methyl salicylate during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Do not give this medicine to a child younger than 12 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Get emergency medical help if you notice signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using capsaicin, menthol, methyl nicotinate, and methyl salicylate topical and call your doctor right away if you have:

• severe skin irritation;
• wheezing, trouble breathing;
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• kidney problems--swelling, urinating less, feeling tired or short of breath.

Less serious side effects may happen more often, and you may experience none at all.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Capsaicin, menthol, methyl nicotinate, and methyl salicylate topical is used as needed. If you are following a dosing schedule, skip any missed dose. Do not use two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if someone has accidentally swallowed the medicine.

Do not get Nuvira in your eyes, nose, or mouth. If this happens, rinse with water.

Drinking alcohol may increase your risk of liver damage or stomach bleeding.

Ask a doctor or pharmacist before using any other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to capsaicin, menthol, methyl nicotinate, and methyl salicylate (like aspirin, ibuprofen, ketoprofen, or naproxen).

Avoid using other medications on the areas you treat with capsaicin, menthol, methyl nicotinate, and methyl salicylate, unless your doctor tells you to.

Medicine applied to the skin is not likely to be influenced by other medications you take, but many medications can interact. Inform your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.