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

What is BONDLIDO?

BONDLIDO is a prescription medicine used in adults for the relief of pain from damaged nerves (neuropathic pain) that follows healing of shingles.

It is not known if BONDLIDO is safe and effective in children.

Do not use BONDLIDO if you:

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

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

have liver problems
have heart or lung problems
are allergic to numbing 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 BONDLIDO will harm your unborn baby.
are breastfeeding or plan to breastfeed. BONDLIDO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use BONDLIDO.

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 BONDLIDO?

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

Use BONDLIDO exactly as your healthcare provider tells you to use it.
Do not apply more than your prescribed number of BONDLIDO. You may apply up to 2 BONDLIDO topical systems at one time.
A BONDLIDO topical system may be worn only 1 time for up to 12 hours within a 24-hour period (12 hours on and 12 hours off).
Apply BONDLIDO to intact skin only. Do not apply BONDLIDO to skin that is not intact, such as skin that is cut, scraped, burned or irritated.
If the BONDLIDO you are wearing comes off completely and will not stick to your skin, throw it away as described below. You may apply a replacement (a new) BONDLIDO topical system. Take off the replacement BONDLIDO at your usual removal time. The total time you may wear the used and replacement BONDLIDO is 12 hours.
To remove and properly throw away (dispose of) BONDLIDO, fold the used BONDLIDO so that the sticky sides stick together. Safely throw away the used BONDLIDO where children, pets, and others cannot get to them.
You may wear clothing over the BONDLIDO application site.
Do not apply external heat sources, such as heating pads or electric blankets, directly on BONDLIDO. This may cause increased levels of lidocaine in your blood.
Avoid contact with water, such as bathing, swimming, or showering, while using BONDLIDO. BONDLIDO may not stick if it gets wet.
Wash your hands right away after handling BONDLIDO (after you apply BONDLIDO, when you try to re-attach it, or when you remove it).
If you start feeling irritation or burning when applying BONDLIDO, remove BONDLIDO. Do not reapply BONDLIDO until the irritation or burning goes away.
If you apply more than 2 BONDLIDO topical systems or apply BONDLIDO for longer than 12 hours of a 24-hour period, call your healthcare provider.

What should I avoid while using BONDLIDO?

Avoid contact of your hands and fingers with your eyes while handling BONDLIDO. Contact of BONDLIDO with your eyes can cause severe eye irritation. Wash your hands right away after handling BONDLIDO. If the medicine in BONDLIDO comes in contact with your eye, wash out your eye with water or saline right away. Protect the eye (for example with eye glasses or eye wear) until the numbness goes away.

What are the possible side effects of BONDLIDO?

BONDLIDO may cause serious side effects, including:

Lidocaine overdose can happen if you apply more than the prescribed number of BONDLIDO, apply BONDLIDO for longer than 12 hours, have liver problems, use BONDLIDO on skin that is not intact, or if you apply external heat sources directly on BONDLIDO. This can result in increased levels of lidocaine in your blood. See " How should I use BONDLIDO?" for information on how to use BONDLIDO.
A serious blood problem called methemoglobinemia. Methemoglobinemia is a serious blood problem where too 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 BONDLIDO, including:
- people with glucose-6-phosphate dehydrogenase deficiency
- people with heart or lung problems
- babies under 6 months of age (BONDLIDO is not approved for use in children)
- 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 local anesthetic
Signs of methemoglobinemia can happen right away or they may not happen for some hours after you 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. Stop using BONDLIDO 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 BONDLIDO application site are common and are usually mild. These reactions can happen during or right after treatment with BONDLIDO. Application site reactions will usually go away within a few minutes to hours. Severe skin irritation may happen with BONDLIDO if you use it for a longer time than instructed. If you develop a skin reaction while wearing BONDLIDO, remove it. Do not reapply BONDLIDO until the site reaction goes away. 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

Allergic reactions can 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.

These are not all the possible side effects of BONDLIDO.

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 BONDLIDO?

Store BONDLIDO at room temperature between 68°F to 77°F (20°C to 25°C).
Do not store BONDLIDO outside the sealed pouch.
Protect BONDLIDO from light.
Each BONDLIDO topical system comes in a child-resistant pouch.

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

General information about the safe and effective use of BONDLIDO.

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

What are the ingredients in BONDLIDO?

Active ingredient: lidocaine

Inactive ingredients: blue ink, hydrocarbon, lactic acid, mono- and di-glycerides, non-woven PET backing membrane, PET film, polyoxyl 40 hydrogenated castor oil, propylene carbonate, styrene/isoprene/styrene block copolymer, tartaric acid, and terpene resin.

Manufactured for: MEDRx USA, Inc., 2030 Main St., Suite 1300, Irvine, CA 92614, USA

For more information, go to www.bondlido.com or call 1-844-633-5436.

INSTRUCTIONS FOR USE

BONDLIDO [BAHND-LYE-DOH]

(lidocaine topical system)

This Instruction for Use contains information on how to apply, remove, and dispose of BONDLIDO. Read this Instructions for Use before you start using BONDLIDO 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 conditions.

Important Information You Need to Know Before Using BONDLIDO:

BONDLIDO is for topical use only (apply on top of skin).
Apply the prescribed number of BONDLIDO at one time.
Do not apply more than your prescribed number of BONDLIDO. You may apply up to 2 BONDLIDO topical systems at one time.
BONDLIDO may be worn only 1 time for up to 12 hours within a 24-hour period (12 hours on and 12 hours off).
Apply BONDLIDO to intact skin only. Do not apply BONDLIDO to skin that is not intact, such as skin that is cut, scraped, burned or irritated.
If the BONDLIDO you are wearing comes off completely and will not stick to your skin, see "How to apply a replacement (a new) BONDLIDO :"
You may wear clothing over the BONDLIDO application site.
Do not apply external heat sources, such as heating pads or electric blankets, directly on BONDLIDO. This may cause increased levels of lidocaine in your blood.
Avoid contact with water, such as bathing, swimming, or showering while using BONDLIDO. BONDLIDO may not stick if it gets wet.
Store BONDLIDO out of the reach of children, pets, and others.

Applying BONDLIDO:

Step 1: Select the application site. BONDLIDO should only be applied to clean, dry, and intact skin to cover the most painful area.
Step 2: Using scissors, carefully cut the pouch along the dotted line and open it to remove BONDLIDO. Do not use BONDLIDO if it is damaged. Throw it away and get a new one. Do not open the BONDLIDO pouch until you are ready to use it. Apply BONDLIDO right away after removing it from the pouch.
Step 3a: Remove the center part of the transparent release liner (clear plastic backing).
Apply the adhesive (sticky) side of the center part of BONDLIDO onto your skin. Apply BONDLIDO to intact skin only. Do not touch the sticky side with your fingers.
Step 3b: While removing the right part of the clear plastic backing with one hand, use your other hand to apply BONDLIDO onto your skin and smooth it down with your fingers. Do not touch the sticky side with your fingers.
Step 3c: Hold the left part of the clear plastic backing, then slowly peel it away and smooth BONDLIDO down onto your skin with your fingers. Press BONDLIDO firmly with the palm of your hand for 20 seconds to make sure it sticks well to your skin.
Step 4: Wash your hands right away after applying BONDLIDO. Avoid contact of your hands or fingers with your eyes until your hands are washed.

Removing and disposing of BONDLIDO:

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

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

Step 6: Throw away (dispose of) the used BONDLIDO where children, pets, and others cannot get to them.

Wash your hands right away after removing BONDLIDO.

How to apply a replacement (a new) BONDLIDO:

If the BONDLIDO you are wearing comes off completely and will not stick to your skin, throw away the used BONDLIDO as instructed above in Steps 5 and 6.
You may apply a replacement BONDLIDO the same way you would apply a new BONDLIDO as described above in Steps 1 through 4.
Take off the replacement BONDLIDO at your usual removal time.
The total time you may wear the used and replacement BONDLIDO is 12 hours. You should not wear BONDLIDO for more than 12 hours within a 24-hour period.

Storing BONDLIDO:

Store BONDLIDO at room temperature between 68°F to 77°F (20°C to 25°C).
Do not store BONDLIDO outside the sealed pouch.
Protect BONDLIDO from light.
Each BONDLIDO topical system comes in a child-resistant pouch.

Store BONDLIDO and all medicines out of the reach of children, pets, and others.