Patient information: uses, side effects, how to take - ZTlido

What is ZTLIDO?

ZTLIDO is a prescription medicine used for relief of pain from damaged nerves (neuropathic pain) that follows healing of shingles. It is not known if ZTLIDO is safe and effective in children.

Do not use ZTLIDO if you:

have a history of allergic reactions to numbing medicines (anesthetics). Ask your healthcare provider if you are not sure.
are allergic to any of the ingredients in ZTLIDO. See the end of this leaflet for a complete list of ingredients in ZTLIDO.

Before using ZTLIDO, tell your healthcare provider about all your medical conditions, including if you:

have liver problems
have heart or lung problems
are allergic to para-aminobenzoic acid (PABA) medicines such as procaine, tetracaine, or benzocaine
have been told that you have glucose-6-phosphate dehydrogenase deficiency
were born with (congenital) methemoglobinemia or have had methemoglobinemia from an unknown cause
are pregnant or plan to become pregnant. It is not known if ZTLIDO will harm your unborn baby.
are breastfeeding or plan to breastfeed. ZTLIDO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZTLIDO.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you are using other lidocaine containing products or anesthetic medicines.

How should I use ZTLIDO?

Read the Instructions for Use at the end of this Patient Information leaflet for information about how to apply the ZTLIDO topical system.

Use ZTLIDO exactly as your healthcare provider tells you to use it.
Do not apply more than your prescribed number of ZTLIDO. You may apply up to 3 ZTLIDO topical systems at one time.
A ZTLIDO may be worn only 1 time for up to 12 hours within a 24-hour period (12 hours on and 12 hours off).
Apply ZTLIDO to intact skin only. Do not apply ZTLIDO to skin that is not intact, such as skin that is cut, scraped, burned, or irritated.
ZTLIDO topical systems that come off completely or are lifting at the edges may be reattached by firmly pressing down on the topical system or on the lifted areas.
- If ZTLIDO lifts off the skin or detaches more than 1 time, do nottry to reattach it. Throw it away as described below.
- If the ZTLIDO you are wearing comes off completely, and will not stick to your skin, throw it away as described below.
In either of these cases, you may apply a replacement (a new) ZTLIDO topical system. Take off the replacement ZTLIDO at your usual removal time. The total timeyou may wear the used and replacement ZTLIDO is 12 hours.
You may wear clothing over the ZTLIDO application site.
Do notapply external heat sources, such as heating pads or electric blankets, directly on ZTLIDO. This may cause increased levels of lidocaine in your blood. You may apply ZTLIDO to a treatment site after moderate heat exposure, such as after 15 minutes of heating pad use on a medium setting.
ZTLIDO may be used during moderate exercise, such as biking for 30 minutes.
ZTLIDO may be worn in water such as showering for 10 minutes or bathing for 15 minutes.
After ZTLIDO is exposed to water, pat the topical system dry. Do notrub the topical system.
After using ZTLIDO, fold the used ZTLIDO so that the sticky sides stick together. Safely throw away used ZTLIDO and any pieces of cut ZTLIDO where children and pets cannot get to them.
Wash your hands right away after handling ZTLIDO (after you apply ZTLIDO, when you try to re-attach it, or when you remove it.)
If you start feeling irritation or burning when applying ZTLIDO, remove the ZTLIDO. Do notreapply ZTLIDO until the irritation or burning goes away.
If you apply more than 3 ZTLIDO topical systems or apply ZTLIDO for longer than 12 hours of a 24-hour period, call your healthcare provider.

What should I avoid while using ZTLIDO?

Avoid contact of your hands and fingers with your eyes while handling ZTLIDO. See " Contact of ZTLIDO with your eyes" below.

What are the possible side effects of ZTLIDO?

ZTLIDO may cause serious side effects, including:

Lidocaine overdosecan happen if you apply more than the prescribed number of ZTLIDO, applying ZTLIDO for longer than 12 hours, have liver problems, use ZTLIDO on skin that is not intact, or if you apply external heat sources directly on ZTLIDO. This can result in increased levels of lidocaine in your blood.
- Do not apply more than the prescribed number of ZTLIDO.
- Do not wear ZTLIDO longer than 12 hours.
- Do not apply ZTLIDO on skin that is not intact, such as skin that is cut, scraped, burned, or irritated.
- Do not apply external heat sources directly to ZTLIDO. See " How should I use ZTLIDO? " for more information about how to properly use external heat sources when using ZTLIDO.
A serious blood problem called methemoglobinemia.Methemoglobinemia is a serious blood problem where to much methemoglobin is produced in the blood. Methemoglobinemia can happen with the use of local anesthetics and may not let enough oxygen reach the organs and tissues in your body. Anyone who uses or receives local anesthetics is at risk for methemoglobinemia, but certain people are more likely to have serious medical problems and need to be closely monitored by their healthcare provider during treatment with ZTLIDO, including:
- people with glucose-6-phosphate dehydrogenase deficiency
- people with heart of lung problems
- babies under 6 months of age
- people who were born with (congenital) or who have had methemoglobinemia from an unknown cause
- people exposed to certain chemicals at the same time that they use or receive a local anesthetic
Signs of methemoglobinemia can happen right away or they may not happen for some hours after your have used or received a local anesthetic. It is important to get medical treatment right away to help prevent more serious side effects including seizures, coma, abnormal heart rhythms, and death.
You or your caregiver should stop using ZTLIDO and get medical help right away if you develop any of the following signs or symptoms:

pale, gray, or blue colored skin
headache

rapid heart beat
shortness of breath

lightheadedness
tiredness

Application site reactions.Skin irritation and other skin reactions at the ZTLIDO application site are common and are usually mild. These reactions can happen during or right after treatment with ZTLIDO. Application site reactions will usually go away within a few minutes to hours. Symptoms of application site reactions may include:

blisters
bruising
burning or abnormal sensation
change or loss of color of your skin
swelling, redness, and pain of the skin

peeling or flaking of skin
irritation
pimple-like raised skin
itching

If you develop a skin reaction while wearing ZTLIDO, remove it. Do notreapply ZTLIDO until the site reaction goes away.

Allergic reactionscan happen if you have a history of allergic reactions to numbing medicines (anesthetics). Tell your healthcare provider right away if you have any symptoms of an allergic reaction such as swelling or shortness of breath.
Contact of ZTLIDO with your eyescan happen if you touch your eyes while handling the topical system and can cause severe eye irritation. Avoid eye contact with your hands and fingers while handling ZTLIDO. Wash your hands right away after handling ZTLIDO. If the medicine in ZTLIDO comes in contact with your eye, wash out your eye with water or saline right away. Protect the eye (for example eye glasses or eye wear) until the numbness goes away.

These are not all the possible side effects of ZTLIDO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZTLIDO?

Store ZTLIDO at room temperature between 68°F to 77°F (20°C to 25°C).
Keep ZTLIDO topical system in the original packaging unit until ready for use.
Each ZTLIDO topical system comes in a child-resistant envelope.

Keep ZTLIDO and all medicines out of the reach of children, pets, and others.

General information about the safe and effective use of ZTLIDO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZTLIDO for a condition for which it was not prescribed. Do not give ZTLIDO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZTLIDO that is written for health professionals.

What are the ingredients in ZTLIDO?

Active ingredient:lidocaine

Inactive ingredients:butylated hydroxytoluene, dipropylene glycol, isostearic acid, mineral oil, polyisobutylene, silicone dioxide, styrene/isoprene/styrene block copolymer, and terpene resin.

Manufactured for:Scilex Pharmaceuticals Inc., Palo Alto, CA 94303

SCILEX ^®

PHARMACEUTICALS

For more information call [1-844-SCILEX1] or visit www.ZTLIDO.com.

Instructions for Use

ZTLIDO ^®(ZEE-TEE-LIE-DOH)

(lidocaine topical system)

Read this Instructions for Use before you start using ZTLIDO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical treatment or condition.

Important information:

One ZTLIDO (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm® (lidocaine patch 5%).
ZTLIDO is for use on intact skin only.
ZTLIDO comes in a child-resistant envelope. Do not open the ZTLIDO envelope until you are ready to use it.
Apply the prescribed number of ZTLIDO topical systems at one time. Clothing may be worn over ZTLIDO.
You should only use a maximum of 3 ZTLIDO topical systems at a time.
Keep your prescribed number of ZTLIDO topical systems on for up to 12 hours within a 24-hour period (12 hours on and 12 hours off).
ZTLIDO may be used during moderate exercise, such as biking for 30 minutes.
ZTLIDO may be worn in water such as showering for 10 minutes or bathing for 15 minutes.
After ZTLIDO is exposed to water, pat the topical system dry. Do not rub the topical system.
ZTLIDO topical systems that have come off completely or are lifting at the edges may be re-attached to the affected area by firmly pressing down on the topical system or on the lifted areas.
- If ZTLIDO lifts off the skin or detaches more than 1 time, do nottry to re-attach it. Throw it away (See Step 6 ).
- If the ZTLIDO you are wearing comes off completely, and will not stick to your skin, throw it away (see Step 6 ).
In either of these cases, you may put on a replacement (a new) ZTLIDO topical system. Take off the replacement ZTLIDO at your usual removal time. The total time that you may wear the used and replacement ZTLIDO is 12 hours.

Wash your hands well right away after handling ZTLIDO (when you apply ZTLIDO, when you re-attach it, or when you remove it). Avoid eye contact with your hands and fingers while handling ZTLIDO.

Figure A: ZTLIDO Topical System

Applying your ZTLIDO topical system:

Step 1:Select the application site. ZTLIDO should only be applied to clean, dry, and intact skin to cover the most painful area.
Step 2:Using scissors, carefully cut the envelope along the dotted line and open it to remove ZTLIDO. Do not use ZTLIDO if it is damaged. Throw it away and get a new one. ZTLIDO may be cut into smaller sizes with scissors prior to removal of the transparent release liner.
Step 3a:Remove the transparent release liner before applying ZTLIDO to the skin. Apply ZTLIDO right away after removing the transparent release liner. Apply ZTLIDO only to intact skin.
Step 3b:Place the adhesive side of ZTLIDO to skin, while not touching the sticky side. Smooth the ZTLIDO using your hands and firmly press to make sure it sticks well to skin.
Step 4:Wash your hands well right away after applying ZTLIDO. Avoid contact of your hands or fingers with your eyes until after you wash your hands.

Removing your ZTLIDO topical system:

Step 5:Remove ZTLIDO from your skin after you have worn it for up to 12 hours.

Fold the used ZTLIDO so that the sticky sides stick together.

Step 6:Throw away the used whole or cut pieces of ZTLIDO where children and pets cannot get to them.

Wash your hands well right away after removing ZTLIDO. Avoid contact of your hands and fingers with your eyes until after you wash your hands.

How to reattach ZTLIDO or apply a replacement ZTLIDO:

If the ZTLIDO you are wearing comes off completely or lifts at the edges, reattach to the affected area by pressing firmly on the edges of the topical system or lifted areas. If ZTLIDO lifts off the skin or comes off completely more than 1 time, do nottry to re-attach it. Throw away the used ZTLIDO as instructed above in Step 6.
If the ZTLIDO you are wearing comes off completely and will not stick to your skin, throw away the used ZTLIDO as instructed above in Step 6.
Pat dry the area of skin if ZTLIDO came off while swimming or showering.
Apply a replacement ZTLIDO the same way you would apply a new ZTLIDO as described above in Steps 1 through 6.
Remove the replacement ZTLIDO at your usual removal time as described above in Steps 5 and 6.
The total timeyou may wear the used and replacement ZTLIDO is 12 hours.

Manufactured for:

Scilex Pharmaceuticals Inc.

Palo Alto, CA 94303

USA

ZTLIDO ^®is a trademark owned by Scilex Pharmaceuticals Inc.