Gris-PEG

What is Gris-PEG?

Gris-PEG is a prescription medicine that is used to treat fungal infections.

Description

Gris-PEG® Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium.

Each Gris-PEG® tablet contains:

Active Ingredient: griseofulvin ultramicrosize …. 125 mg

Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, polyvinylpyrrolidone, and titanium dioxide.

or

Active Ingredient: griseofulvin ultramicrosize …. 250 mg

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, and titanium dioxide.

Before taking Gris-PEG, tell your doctor:

• If you are allergic to Gris-PEG; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Liver disease or porphyria.
• If you are pregnant or may be pregnant. Do not take Gris-PEG if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gris-PEG with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gris-PEG?

• Tell all of your health care providers that you take Gris-PEG. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Do not use longer than you have been told. A second infection may happen.
• If you have lupus, Gris-PEG can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Gris-PEG.
• This medicine may cause harm to an unborn baby. Women must use birth control while taking Gris-PEG. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must not father a child within 6 months after taking Gris-PEG. If your partner gets pregnant, call the doctor right away.

How is Gris-PEG best taken?

Use Gris-PEG as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Gris-PEG as you have been told by your doctor or other health care provider, even if you feel well.
• Talk with your doctor or pharmacist about how to take Gris-PEG with regard to food.
• Swallow whole with a full glass of water.
• You may crush the tablet and sprinkle on 1 tablespoon (15 mL) of applesauce. Swallow right away. Do not chew.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Gris-PEG that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Feeling confused.
• A burning, numbness, or tingling feeling that is not normal.
• Redness or white patches in mouth or throat.
• Very bad and sometimes deadly liver problems have happened with Gris-PEG. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Gris-PEG?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling dizzy, tired, or weak.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gris-PEG?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

LABEL IMAGE FOR 250MG

SRC: NLM .