Pliaglis

Not applicable.

Do not use on large areas of the body, cover the area with waterproof bandages or plastic, or apply heat unless directed to do so by your doctor. These may increase the risk of serious side effects.

After applying, wash your hands right away unless you are treating an area on the hands. Avoid getting the product in your eyes, nose, or ears. If the medication gets in these areas, rinse the area right away with clean water.

The dosage is based on your medical condition and response to treatment. Do not use more of this product, use it more often, or use it longer than prescribed by your doctor. Do not use on areas of skin that are broken, irritated, or infected.

Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or tetracaine; or to other amide-type anesthetics (such as bupivacaine, prilocaine); 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 problems, liver disease, a certain blood disorder (methemoglobinemia), breathing problems (such as asthma, bronchitis, emphysema), smoking history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug.

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

Lidocaine passes into breast milk in small amounts, but is unlikely to harm a nursing infant. It is unknown if tetracaine 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: drowsiness, irregular heartbeat, seizure.

Temporary redness, stinging, change in skin color, or swelling may occur at the application site. 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.

Get medical help right away if you have any very serious side effects, including: pale/bluish/gray skin, unusual tiredness, shortness of breath, slow/shallow breathing, fast/slow/irregular heartbeat, seizure.

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 any 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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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

Store in the refrigerator. Do not freeze. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, discard after 3 months. 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.