Emla

Cream

The amount of cream to be applied to the affected area, and the length of time it is left on the skin, depends on the type of procedure being done. Applying more cream or leaving it on for a longer period of time than recommended by your doctor can cause serious side effects.

Apply the cream to clean, dry skin and cover it with a dressing that does not allow the skin underneath to contact air. This allows the medications to be absorbed into the skin. The numbing effect starts about 1 hour after the cream is applied. Do not apply it near the eyes or inside the ears or mouth. After applying the cream, cover it with an air-tight dressing to allow the cream to be absorbed.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. Do not apply more cream than is recommended by your doctor and do not leave the medication on the skin for longer than advised.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Patch

The number of patches applied at one time and the length of time the patch is left on the skin depend on the size of the area being treated and the type of procedure being done. The numbing effect of the patch starts about 1 hour after the patch is applied.

Apply the patch to clean, dry skin. The round, white pad containing the medication should cover the area to be treated. Press firmly around the edges of the patch to make sure that the patch sticks well to the skin. Gently press the white pad, to make sure that the medication is in contact with the skin. Do not apply it near the eyes or inside the ears or mouth.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. Do not apply more patches than is recommended by your doctor and do not leave the medication on the skin for longer than advised, as this can cause serious side effects.

When you remove the patch or the dressing, fold it so the side with medication is on the inside. This will prevent accidental contact with the remaining medication.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Cream
Each 1 gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine. *Nonmedicinal ingredients: *carboxypolymethylene, polyoxyethylene, hydrogenated castor oil, sodium hydroxide to adjust pH to 8.7–9.7, and purified water.

Patch
Each cellulose and cotton disc in the patch contains 25 mg of lidocaine and 25 mg of prilocaine. Nonmedicinal ingredients: carboxypolymethylene, polyoxyethylene, hydrogenated castor oil, sodium hydroxide to adjust pH to 8.7–9.7, and purified water. Patch components: cellulose and cotton disc, polyethylene foam with acrylate adhesive, polyamide / aluminium / plastic, and polypropylene / aluminium / plastic laminates.

Do not use this medication if you:

• are allergic to lidocaine, prilocaine, other "-caine" type anaesthetics, or any ingredients of the medication

• have methemoglobinemia

• need large amounts of this medication and are not in a health-care facility

• are using other medications that are known to cause methemoglobinemia (children less than 12 months old)

• are using this for a pre-term infant (born at less than 37 weeks of pregnancy)

**Many medications can cause side effects. **A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning or itching where medication is applied

• puffiness at application site

• skin tingling

• small red dots or purple spots where medication is applied

• whitening or redness to the skin

Stop taking the medication and seek immediate medical attention if any of the following occur:

• eye irritation

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• signs of methemoglobinemia (reduced oxygen to the body tissues; brownish or greyish skin colour, discoloured lips and nail beds)

• signs of too much medication in the body (e.g., drowsiness, tongue feeling numb, lightheadedness, confusion, headache, hearing problems, vomiting, slow heartbeat, unusual sweating, seizures)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: It is possible to experience a severe allergic reaction to topical anesthetics. Before you use lidocaine - prilocaine, inform your doctor about any previous adverse reactions you have had to medications, especially medications used to numb the skin. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

**Eyes: **Avoid applying this medication to the skin near the eyes. If it happens to come into contact with an eye, immediately rinse the eye with water or sodium chloride solution.

Liver function: Lidocaine - prilocaine is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Methemoglobinemia: **Methemoglobinemia is a condition where the blood cannot carry enough oxygen through the body because the "wrong" form of hemoglobin, called methemoglobin, is produced. Prilocaine promotes the body's production of methemoglobin. Usually, only a small amount of prilocaine is absorbed, so the amount of methemoglobin produced is not a problem. When too much prilocaine is in the body, or you have a condition that already causes excess methemoglobin to be produced (e.g., glucose-6-phosphate dehydrogenase deficiency), the extra production of methemoglobin may be noticed. If you or your child develop greyish or brownish skin colour, or discoloration around the lips or nail beds, remove the medication and seek immediate medical attention.

**Overdose: Lidocaine - prilocaine **is absorbed into the body. As such, it is possible to receive too much medication. It is important to apply the medication only to the areas that are being treated and to leave it on only for the length of time your doctor has suggested. Applying this medication to a large area of the body may cause a dangerous amount of medication to be absorbed into the body. Contact with the medication remaining on the patch or dressing can also cause this to happen to children.

Symptoms of too much of this medication in the body include confusion, dizziness, seizures, and very slow heart rate, leading to the heart and breathing to stop. If you or your child experience any of these symptoms, seek immediate medical help.

**Skin problems: **If you have a skin condition, such as allergic dermatitis, you may need to use this medication for a shorter period of time to get the same numbing effect. Let your doctor know if you have any skin conditions.

The skin where you apply this medication will stay numb for several hours. Be careful to avoid accidental injury or exposure to extremely hot or cold temperatures until complete skin sensation returns.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Lidocaine passes into breast milk. If you are breast-feeding and are taking lidocaine - prilocaine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Children should be closely watched during and after use of this medication, since they are more at risk of serious side effects. Infants under the age of 3 months are more at risk of methemoglobinemia. This medication should not be used on the genitals of children or infants.

There may be an interaction between lidocaine - prilocaine and any of the following:

• amiodarone

• benzocaine

• certain beta-adrenergic blockers (e.g., propranolol, sotalol)

• dapsone

• digoxin

• flecainide

• mexiletine

• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate, nitroglycerin)

• nitrofurantoin

• phenobarbital

• phenytoin

• primaquine

• procainamide

• quinidine

• quinine

• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)

• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Emla