Capsagel Maximum Strength

• Tell all of your health care providers that you take Capsagel Maximum Strength. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
• Take Capsagel Maximum Strength off of the skin if very bad burning or itching happens.
• Use care when using on a large part of the skin. Talk with the doctor.
• Do not breathe in this medicine after it has dried. May cause nose or throat irritation.
• Some of these drugs may catch on fire. Do not use near an open flame or while smoking.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Capsagel Maximum Strength while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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

• Do not take Capsagel Maximum Strength by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Clean affected part before use. Make sure to dry well.
• You may wear gloves when putting on.
• Do not put on irritated skin.
• Do not put on cuts, scrapes, or damaged skin.
• Do not bathe, shower, or swim right after putting on.
• Do not put on right after a shower or bath.
• If this medicine gets in the eyes, rinse with cool water.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Put a thin layer on the affected skin and rub in gently.
• If hands are treated, do not wash your hands for 30 minutes after you put on Capsagel Maximum Strength. Do not touch your eyes, nose, mouth, genitals, irritated skin, or contact lenses until you wash your hands.

What do I do if I miss a dose?

• If you use this medicine on a regular basis, 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.
• Many times Capsagel Maximum Strength (capsaicin cream, gel, liquid, and lotion) is used on an as needed basis. Do not use more often than told by the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.
• Very bad burning or burning that does not go away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning or stinging feeling. Most of the time, this will go away after a few days.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to capsaicin topical: compounding powder, topical cream, topical film, topical gel, topical kit, topical liquid, topical lotion, topical stick

General

The most commonly reported side effects were application site erythema and application site pain.[Ref]

Local

Very common (10% or more): Application site erythema (63%), application site pain (42%)
Common (1% to 10%): Application site pruritus, application site papules, application site edema, application site swelling, application site dryness
Uncommon (0.1% to 1%): Application site urticaria, application site paresthesia, application site dermatitis, application site hyperesthesia, application site excoriation, application site warmth, application site anesthesia, application site bruising, application site inflammation, application site exfoliation[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): First degree atrio-ventricular (AV) block, tachycardia, palpitations, increased blood pressure[Ref]

Dermatologic

Uncommon (0.1% to 1%): Herpes zoster, pruritus
Frequency not reported: Abnormal skin odor, second degree burns[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, bronchitis, sinusitis
Uncommon (0.1% to 1%): Cough, throat irritation
Frequency not reported: Sneezing, dyspnea, wheezing, exacerbation of asthma, irritation of the mucous membranes of the respiratory tract (such as nasal and throat irritation)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Pain in extremity, muscle spasms[Ref]

Nervous system

Uncommon (0.1% to 1%): Dysgeusia, hypoesthesia, burning sensation
Frequency not reported: Headache, peripheral sensory neuropathy, dizziness, dysgeusia, hyperesthesia[Ref]

Ocular

Uncommon (0.1% to 1%): Eye irritation
Frequency not reported: Irritation of the mucous membranes of the eyes, runny eyes[Ref]

Other

Frequency not reported: Peripheral edema[Ref]

Some side effects of Capsagel Maximum Strength may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.