Birch Triterpenes Topical

Birch triterpenes is used for treatment of wounds associated with certain types of epidermolysis bullosa(condition that causes blistering of the skin) in adults and children 6 months of age or older. Birch triterpenes is in a class of medications called botanicals. How it works to help epidermolysis bullosa is not well understood.

Burch triterpenes comes as a gel to apply to the skin. It is usually applied with every dressing change until the wound heals.

Wash hands before and after applying birch triterpenes or wear gloves when applying. Apply a generous (approximately 1 mm) layer of gel directly to the wound and then cover with clean bandage or apply it directly to the bandage to place on the wound.

Each tube is meant to only be used once. After opening, apply gel immediately and throw away any remaining amount and the tube.

If a wound become infected during treatment with birch triterpenes, stop treatment until the infection resolves.

Avoid contact with birch triterpenes and eyes or mucous membranes (example - mouth, vagina, or anus). If contact does occur, flush area with water.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using birch triterpenes,

• tell your doctor and pharmacist if you are allergic to birch triterpenes, any other medications, or any of the ingredients in birch triterpenes gel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using birch triterpenes, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using birch triterpenes.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue with your regular bandage change schedule. Do not apply extra gel to make up for a missed dose.

Birch triterpenes may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching and pain at the application site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives, rash, redness or itching

Birch triterpenes may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Each tube is intended for single use. Any unused portion and tube should be thrown away after each application.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone swallows birch triterpenes, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Filsuvez^®