MaC Patch

• Tell all of your health care providers that you take MaC Patch. 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 MaC Patch off of the skin if very bad burning or itching happens.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• 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 this medicine, 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 MaC Patch (capsaicin and menthol patch) 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to MaC Patch. 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 this medicine.

Review Date: October 4, 2017

MaC Patch (Menthol 5%/Capsaicin 0.0375%) is comprised of an adhesive material containing Menthol and Capsaicin which is applied to a woven polyester backing and covered with a PET film release line. The release liner is removed prior to application to the skin. The size of the patch is 12.5 cm x 8.5cm. Menthol is checmically designated as 2-Isopropyl-5- methylcyclohexanol. It is colourless, hexagonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odour. If has a melting point between 31°C to 36° C. Capsaicin is chemically designated as (6E)-N-(4-Hydroxy-3- methoxybenzyl)-8-methyl-6-nonenamide. It is a crystalline white powder. It has a melting point of 65° C.

Each adhesive patch contains 850 mg of Menthol and 6.375 mg of Capsaicin. It also contains the following inactive ingredients: Water, Glcerin, Sodium Polyacrylate (250000MV), Polysorbate 80, Aloe Vera Leaf, Edetate Disodium, Diazolidinyl Urea, Methylparaben, Iodopropynyl, Butylcarbamate and Propylparaben.

CLINICAL PHARMACOLOGY: Pharmacodynamics

Menthol works by targeting the opiod receptior on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (8° - 28° C). Menthol causes the neuron to fire at temperatures above normal activation which triggers the characteristic cooling sensation. Also because of menthol's specific targeting of the k-opioid receptor, it is endowed with analgesic properties.  Capsaicin is a naturally occurring compound. Iit is found in chili peppers and is what gives is "heat".  Capsaicin has been found to be effective in reducing inflammation and pain. When Capsaicin enters the body it binds with the protein TRPV1 which is located on pain and heat neurons. When the TRPV1 proton is activated (between 37° - 45° C) it opens the calcium ion channel and give the sensation of pain and heat. When Capsaicin binds to the TRPV1 proton it forces the ion channel to open below its normal activation temperature which is why it gives the distinct heating sensation. It is thought that prolonged activation of these neurons by Capsaicin depletes substance P, a neurotransmitter for pain and heat. the end result appears that the nerves are overwhelmed by the influx and unable to report pain for an extended period of time.

MaC Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

MaC Patch contains 0.05% capsaicin and 5.00% menthol.

Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily
Children under 12 years, consult a physician before use
How to apply:

• Clean and dry affected area
• Cut open pouch and remove patch
• If desired, cut pad to size
• Remove protective film and apply directly to area of pain
• Apply to affected area not more than 3 times daily
• Wash hands with soap after applying patch
• Reseal pouch containing unused patches

Apply MaC Patch to intact skin to cover the most painful area. Apply up to four patches in a 24 hour period. Each patchshould not be applied for more than 8 hours in a given 24-hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination.

If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides.

Analgesic/counterirritant

External analgesic

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.