Priloheal Plus 30

Lidocaine and prilocaine are local anesthetics (numbing medicines). They block nerve signals in your body.

Priloheal Plus 30 (for the skin) is a combination medicine that numbs the skin or surfaces of the penis or vagina. It is used to prepare you for minor surgery or medical procedures on these areas.

Priloheal Plus 30 may also be used for other purposes not listed in this medication guide.

An overdose of numbing medicine can lead to serious and potentially fatal side effects if too much of the medicine enters your body through your skin. Symptoms of an overdose may include irregular heartbeats, seizures (convulsions), coma, slow breathing, or respiratory failure (breathing stops).

Use only the smallest amount of Priloheal Plus 30 necessary to numb the skin. Do not use large amounts of Priloheal Plus 30, and do not cover the treated areas of skin with a bandage or plastic wrap unless your doctor advises you to do so.

You should not use Priloheal Plus 30 if you are allergic to any numbing medicine.

Fatal overdoses have happened when numbing medicines were used without a doctor's advice (for example, during cosmetic procedures like laser hair removal). Overdose has also occurred in women who received a numbing medicine before having a mammography.

Be aware that many cosmetic procedures are performed without a doctor present.

To ensure Priloheal Plus 30 is safe for you, inform your doctor if you have:

• a blood cell disorder called methemoglobinemia;
• liver disease;
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• a family history of methemoglobinemia, or any genetic enzyme deficiency.

FDA pregnancy category B. Priloheal Plus 30 is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Lidocaine and prilocaine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Priloheal Plus 30 may cause serious side effects. Call your doctor immediately if you experience:

• severe burning, stinging, or irritation at the site of application;
• swelling or redness;
• sudden dizziness or drowsiness after applying the medicine;
• confusion, blurred vision, or ringing in your ears;
• bruising or a purple appearance on the skin; or
• unusual sensations of temperature.

Common side effects of Priloheal Plus 30 may include:

• mild burning at the site of application;
• itching or rash; or
• changes in skin color at the site of application.

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

Follow all directions on your prescription label. Do not apply Priloheal Plus 30 in larger amounts than recommended.

You may need to apply Priloheal Plus 30 at home up to 4 hours before your surgery or procedure. You will be given instructions about how much medicine to use and how long to leave it on the skin. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use the smallest amount of medicine needed to numb the skin. Your body may absorb too much of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

You may need to cover the skin to help keep the medicine in place. Do not cover treated skin unless your doctor has told you to.

Carefully follow dosing instructions when applying this medicine to a child. Priloheal Plus 30 doses are based on weight in children. Do not allow a child to use this medicine without adult supervision.

Store at room temperature away from moisture and heat. Do not allow the cream to freeze.

Call your doctor for instructions if you forget to apply Priloheal Plus 30 at the scheduled time before your surgery or medical procedure.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using too much numbing medicine can lead to serious side effects that may be fatal if too much of the medicine is absorbed into your bloodstream. Symptoms can include uneven heartbeats, seizures (convulsions), slowed breathing, coma, or respiratory failure (breathing stops).

Lidocaine and prilocaine applied to the skin is not likely to cause an overdose unless you use more than the recommended dose.

Do not let Priloheal Plus 30 touch your eyes. If it does, rinse with water.

Do not take by mouth. Priloheal Plus 30 is meant for use only on the skin.

Be careful not to injure areas of skin that have been treated while they are numb. Avoid touching very hot or very cold surfaces.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Priloheal Plus 30, especially:

• chloroquine, dapsone, nitrofurantoin, isosorbide dinitrate, nitroglycerin, nitroprusside, quinine;
• heart rhythm medication--amiodarone, dofetilide, dronedarone, mexiletine, sotalol, tocainide, and others;
• seizure medicine--phenobarbital, phenytoin, primaquine; or
• a sulfa drug--Bactrim, Septra, SMX-TMP or SMZ-TMP, and others.

This list is not complete. Other drugs may interact with lidocaine and prilocaine topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.