Carac® Cream, 0.5% (fluorouracil)
Read this leaflet carefully before you start to use your medicine. Read the
information you get every time you get more medicine. There may be new information
about the drug. This leaflet does not take the place of talks with your doctor.
If you have any questions or are not sure about something, ask your doctor or
What is Carac (fluorouracil) ?
Carac (fluorouracil) (Care ack) is a cream used by adults to treat skin conditions on the
face and front part of the scalp called solar keratosis or actinic keratosis.
Who should not use Carac (fluorouracil) ?
Do not use Carac (fluorouracil)
- if you are pregnant or might become pregnant. Carac (fluorouracil) may harm your unborn
- if you are nursing a baby. We do not know if Carac (fluorouracil) can pass to the baby
through the milk.
- If you have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. The
active ingredient in Carac, fluorouracil, can cause serious side effects in
patients who are DPD enzyme deficient. If you have DPD enzyme deficiency and
use medications containing fluorouracil, you may develop serious side effects
such as stomach pain, bloody diarrhea, vomiting, fever, or chills.
- If you are allergic to the ingredients in Carac (fluorouracil) . Ask your doctor or pharmacist
about the inactive ingredients.
- If under 18 years of age. Carac (fluorouracil) should not be used in children.
Tell your doctor if you are able to become pregnant. Your doctor may advise
you about birth control to avoid pregnancy.
How should I use Carac (fluorouracil) ?
Use Carac (fluorouracil) once a day as instructed by your doctor. Use it only on your skin.
You should use Carac (fluorouracil) for up to 4 weeks.
Clean the area where you will apply Carac (fluorouracil) . Rinse well and dry the area with
a towel and wait 10 minutes before applying Carac (fluorouracil) .
Put Carac (fluorouracil) on your face as directed by your physician, using your fingertips.
Use enough to cover the affected skin.
Avoid contact with your eyes, nostrils, and mouth.
Wash your hands as soon as you finish putting the Carac (fluorouracil) on your skin.
A moisturizer/sunscreen may be applied 2 hours after Carac (fluorouracil) has been applied.
Do not use any other skin products including creams, lotions, medications
or cosmetics –unless instructed by your doctor.
What should I avoid while using Carac (fluorouracil) ?
Avoid sunlight or other ultraviolet light (such as tanning booths) as much
as possible while using Carac (fluorouracil) . Sunlight may increase your side effects. When
exposed to sunlight, wear a hat and use sunscreen.
Do not cover the treated skin with a dressing.
Do not breast feed or become pregnant while using Carac (fluorouracil) . If you do become pregnant,
stop using Carac (fluorouracil) and tell your doctor right away.
What are the possible side effects of Carac (fluorouracil) ?
Most patients using Carac (fluorouracil) get skin reactions where the medicine is used. These
reactions include redness, dryness, burning, pain, erosion (loss of the upper
layer of skin), and swelling. Irritation may continue for two or more
weeks after treatment is over. The treated area may become unsightly during
Some patients get eye irritation. Eye irritation might consist of burning,
sensitivity, itching, stinging, and watering. If you are concerned about side
effects, talk to your doctor.
A few patients have reported side effects such as stomach pain, diarrhea, vomiting,
fever, or chills, possibly due to the lack of a specific enzyme, DPD, in their
body. If you experience any of these symptoms, discontinue therapy immediately,
and contact your doctor.
Keep this medicine at room temperature (68-77°F/ 20-25°C). Throw away
unused medicine. Keep this medicine out of the reach of children.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not described in
patient information leaflets. Do not use it for a condition for which it was
not prescribed. This medicine is for your use only. Never give it to other people.
It may harm them even if their skin problem appears to be the same as yours.
Do not use Carac (fluorouracil) after the expiration date on the tube.
Prescribing Information as of November 2006.