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Dabrafenib Oral Capsule 50 mg

Uses

For treating cancer.

Instructions

Swallow the medicine without crushing or chewing it.

Take on empty stomach - 1 hour before or 2 hours after eating.

It is very important that you take the medicine at about the same time every day. It will work best if you do this.

Store at room temperature in a dry place. Do not keep in the bathroom.

Keep the medicine away from heat and light.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 6 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Please tell your doctor and pharmacist about all the medicines you take. Include both prescription and over-the-counter medicines. Also tell them about any vitamins, herbal medicines, or anything else you take for your health.

Do not suddenly stop taking this medicine. Check with your doctor before stopping.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

It is very important that you keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

Avoid touching any powder from an open or broken capsule. If the powder touches the skin, nose, or eyes, rinse thoroughly with water.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine. Symptoms of an allergic reaction can include trouble breathing, skin rash, itching, swelling, or severe dizziness.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

This medicine has been associated with a rare but serious skin rash. If you notice any red, peeling or blistered skin, contact your doctor immediately.

This medicine may increase the risk of some types of cancer. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may cause serious bleeding from the stomach or bowels. Stop this medicine and call your doctor immediately if you see any signs of bleeding. Bleeding can cause pain in the stomach, vomiting up liquid that looks like coffee grounds, and red or dark tarry stools.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

Do not use the medication any more than instructed.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks after stopping treatment.

Do not use this medicine if you are pregnant. If you become pregnant while on this medicine, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

Women of child-bearing age should have a negative pregnancy test before starting this medicine.

Women or men must use reliable forms of birth control while taking this medicine and for 2 weeks after stopping to prevent pregnancy.

Do not take St. John's wort while on this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Ask your pharmacist if this medicine can interact with any of your other medicines. Be sure to tell them about all the medicines you take.

Please tell all your doctors and dentists that you are on this medicine before they provide care.

Do not start or stop any other medicines without first speaking to your doctor or pharmacist.

Do not share this medicine with anyone who has not been prescribed this medicine.

This medicine can cause serious side effects in some patients. Important information from the U.S. Food and Drug Administration (FDA) is available from your pharmacist. Please review it carefully with your pharmacist to understand the risks associated with this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • hair loss
  • headaches
  • pain in the joints

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • increased risk of bruising and bleeding
  • bleeding that is severe or takes longer to stop
  • unusual bruising or discoloration on skin
  • increased risk of cancer
  • confusion
  • coughing up blood or vomit that looks like coffee grounds
  • swelling of the legs, feet, and hands
  • pain in the eye
  • eye redness, itching or discharge
  • fainting
  • fever or chills
  • swelling in the neck or throat
  • severe or persistent headache
  • fast or irregular heart beats
  • high blood sugar
  • sensitivity to light
  • skin irritation such as redness, itching, rash, or burning
  • seizures
  • shortness of breath
  • change in the size or color of a skin mole
  • sore throat
  • slurred speech
  • reduced sperm count in semen
  • blood in stool
  • dark, tarry stool
  • unusual or unexplained tiredness or weakness
  • urinating less often
  • blood in urine
  • blurring or changes of vision
  • weakness on one side of the body
  • sudden or unexplained weight gain

A few people may have an allergic reactions to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it.Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions.Always follow their advice. There is a more complete description of this medicine available in English.Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.

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