VallaDerm-90 2.5 %-2.5 % topical kit

Generic name:
Lidocaine/prilocaine cream - topical

Pronunciation
(LYE-doe-kane/PRILL-oh-cane)

Brand name(s)
EMLA

This medication contains 2 amide-type local anesthetics, lidocaine and prilocaine. It is used on normal, unbroken skin or on the outer genital area to prevent pain before certain procedures such as inserting a needle, skin grafts, or skin laser surgery. It works by temporarily numbing the skin and surrounding area. Do not use this product in the ears.

If this product alone cannot completely numb the area being treated, it may be used to numb the area before a lidocaine injection is given to provide enough pain relief for certain procedures (such as removal of genital warts).

Read the Patient Information Leaflet if available from your pharmacist before you start using lidocaine/prilocaine cream and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on normal skin and the genital area. Do not apply to broken/irritated skin or open wounds unless directed by your doctor. Wash your hands before using this product.

Apply this product to the area at the proper time as directed. The length of time for the medication to stay on the skin depends on the type of procedure you are having. It is usually applied at least 1 hour before needle sticks and 2 hours before minor skin procedures. It may be applied by a health care professional before certain genital procedures. In this case, it is recommended that you remain lying down so the medication will stay in place.

To apply, squeeze out the prescribed amount of cream directly onto the skin. You can also squeeze it onto a measuring guide to make sure you get the right dose and then apply it to the area. Do not rub in. Cover with an airtight dressing/bandage as directed by your doctor. Allow the cream to remain in place, usually in a thick layer, as directed by your doctor. Remove the dressing and cream and clean the area thoroughly, usually shortly before the procedure or as directed by your doctor.

The dosage and length of application time are based on your age and medical condition and the procedure you are having. Children's dosage may also be based on weight. Do not use larger amounts than prescribed. Do not use on large areas of skin, apply heat, or leave it in place longer than directed or serious side effects may occur.

If you are applying this product on a child, make sure the medication stays in place and that your child does not put the medication or dressing/bandage in his/her mouth. You may want to use a second covering to prevent the child from touching the cream.

Wash hands immediately after use unless you are treating an area on the hands. Avoid getting the product in your eyes, nose, ears, or mouth. If this medication gets in the eyes, rinse the affected eye immediately and completely with water or saline. Numbness in the eye can lead to injury because you cannot feel particles in the eye or other dangers. Protect the eye until feeling returns.

The area may be numb for several hours after the procedure. Protect the area from injury. Be careful not to bump, rub, or scratch the area or expose it to heat/cold until feeling returns.

Redness, swelling, tingling/burning, or lightening of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• blistering of the skin where the drug is applied

Remove the cream and get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing
• dizziness
• fainting
• fast/slow/irregular heartbeat
• mental/mood changes (such as confusion, nervousness)
• seizures
• severe drowsiness
• pale/bluish/gray skin
• unusual tiredness
• shortness of breath

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or prilocaine; or to any other amide anesthetics (such as bupivacaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart disease (such as irregular heartbeat)
• kidney disease
• liver disease
• a certain blood disorder (methemoglobinemia)

Older adults may be more sensitive to the side effects of this drug, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Lidocaine passes into breast milk. It is unknown if prilocaine passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, loss of consciousness.

Do not share this medication with others.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.