Before taking TARCEVA, tell your doctor if you have, or have ever had:

• Lung disease or infection
• Stomach ulcers
• Eye problems
• Liver disease
• Kidney disease
• Diverticular disease (a condition in which abnormal pouches form in the large intestines and may become inflamed)
• Dehydration
• Allergies to medicines

Also, let your doctor know if you've recently been treated with radiation or chemotherapy.

Smoking tobacco may reduce the effectiveness of TARCEVA. Let your doctor know if you smoke or use tobacco products before taking this medicine.

TARCEVA may cause a skin rash or other skin problems. Exposure to sunlight may increase your odds of developing a rash.

Avoid unnecessary or prolonged exposure to sunlight while taking TARCEVA. Wear protective clothing, sunscreen, and sunglasses while outdoors.

Also, avoid using harsh skin products that may cause irritation or dryness.

Let your healthcare provider know you're taking TARCEVA before having any surgery, including a dental procedure.

TARCEVA can pass into bodily fluids. You or your caregiver should wear rubber gloves when cleaning up urine, feces, vomit, or other bodily fluids from anyone who takes the drug.

Also, wash your hands before and after removing the gloves.

Continue to take TARCEVA even if you feel well. Don't stop taking this drug without talking to your doctor.

Your doctor will most likely perform tests to monitor your body's response to TARCEVA. Keep all appointments with your doctor and laboratory.

Pregnancy and TARCEVA

TARCEVA may harm an unborn baby. Don't take this medicine if you're pregnant.

Use an effective form of birth control while taking this drug, and for at least two weeks after your treatment ends.

Because TARCEVA can be absorbed through the skin, women who are pregnant or may become pregnant shouldn't handle the medicine.

It's not known whether TARCEVA passes into breast milk. Don't breastfeed while taking this drug.

Common Side Effects of TARCEVA

Tell your doctor if any of the following side effects become severe or don't go away:

• Diarrhea
• Nausea or vomiting
• Heartburn or gas
• Constipation
• Stomach pains
• Loss of appetite or weight loss
• Mouth sores
• Tiredness
• Headache
• Bone or muscle pain
• Hair loss
• Changes in the appearance of hair or nails
• Darkening of the skin
• Anxiety or depression
• Numbness, burning, or tingling of the hands or feet
• Swelling of the arms, hands, feet, ankles, or lower legs

Serious Side Effects of TARCEVA

Call your doctor right away if you experience any of the following serious side effects:

• Rash
• Blistering, dry, peeling, itching, burning, or cracked skin
• Cough
• Fever or chills
• Shortness of breath
• Dry, painful, irritated, or red eyes
• Blurred vision
• Growth of eyelashes inside the eyelid
• Chest pain or pressure
• Pain in the arms, neck, or upper back
• Irregular, rapid, or pounding heartbeat
• Slow or difficult speech
• Problems with balance
• Faintness or dizziness
• Unusual bleeding or bruising
• Numbness or weakness in an arm or leg
• Black, tarry, or bloody stools
• Vomit that's bloody or looks like coffee grounds
• Dry mouth
• Sunken eyes
• Dark-colored urine
• Decreased urination
• Rapid weight gain
• Confusion
• Yellow or pale skin
• Redness, pain, warmth, tenderness, or swelling in one leg
• Severe or ongoing vomiting, nausea, or diarrhea
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the TARCEVA Warnings section above, or any of the following:

• Angiogenesis inhibitors such as Avastin (bevacizumab)
• Antacids
• Biaxin (clarithromycin)
• Blood thinners such as Coumadin (warfarin)
• Certain antifungals such as Nizoral (ketoconazole), Sporanox (itraconazole) or Vfend (voriconazole)
• Cipro (ciprofloxacin)
• Dilantin (phenytoin)
• H2 blockers such as Axid (nizatidine), Pepcid (famotidine), Tagamet (cimetidine), or Zantac (ranitidine)
• HIV protease inhibitors such as Crixivan (indinavir), Fortovase and Invirase (saquinavir), Norvir (ritonavir), Reyataz (atazanavir), or Viracept (nelfinavir)
• Ketek (telithromycin)
• Luminal and Solfoton (phenobarbital)
• Medications for acne such as benzoyl peroxide (found in Epiduo, BenzaClin, Benzamycin, and others)
• Mycobutin (rifabutin)
• Nefazodone
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as Advil and Motrin (ibuprofen) or Aleve and Naprosyn (naproxen)
• Oral steroids such as Decadron, Dexone (dexamethasone), Deltasone (prednisone), or Medrol (methylprednisolone)
• Proton pump inhibitors such as AcipHex (rabeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), or Protonix (pantoprazole)
• Rifadin and Rimactane (rifampin)
• Rifapentine
• St. John's wort
• Taxane medications for cancer such as Taxotere (docetaxel) or Abraxane and Taxol (paclitaxel)
• Tegretol (carbamazepine)
• Troleandomycin (TAO)
• Versed (midazolam)

TARCEVA and Grapefruit

Grapefruit and grapefruit juice may affect how TARCEVA works in your body.

Avoid consuming grapefruit during your treatment.

TARCEVA and Alcohol

Alcohol may increase the severity of certain side effects of TARCEVA.

Avoid drinking alcohol while taking this medicine.

Try to take the medicine around the same time each day.

Your doctor may lower your dose of TARCEVA during your treatment.

Drink plenty of water while taking TARCEVA to avoid dehydration.

Follow the instructions on your prescription label carefully. Don't take more or less TARCEVA than is recommended.

TARCEVA Overdose

Symptoms of a TARCEVA overdose may include a severe skin rash or severe diarrhea.

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of TARCEVA

If you miss a dose of TARCEVA, take it as soon as you remember, but be sure to take it on an empty stomach.

Skip your missed dose if it's almost time for your next scheduled dose.

Don't take extra medicine to make up for a missed dose.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant.

If you have diabetes, you should not use TEKTURNA together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

You should not take TEKTURNA if you are allergic to it.

If you have diabetes, you should not use TEKTURNA together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with TEKTURNA if you have kidney disease.

To make sure you can safely take TEKTURNA, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• heart disease;
• if you are on a low-salt diet; or
• if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

Do not use TEKTURNA if you are pregnant. Stop using and tell your doctor right away if you become pregnant. TEKTURNA can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether TEKTURNA passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; vomiting, severe stomach pain; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.

If you have an allergic reaction to aliskiren you should not take it again.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urinating; or
• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

• dizziness, tired feeling;
• cough;
• diarrhea;
• headache;
• back pain; or
• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb TEKTURNA.

Do not use salt substitutes or potassium supplements while taking TEKTURNA, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of TEKTURNA.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with TEKTURNA, especially:

• atorvastatin (Lipitor);
• antifungal medicine;
• any heart or blood pressure medicines;
• cyclosporine;
• a diuretic or "water pill";
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with TEKTURNA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take TEKTURNA with or without food, but take it the same way every time.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you feel light-headed.

Your blood pressure will need to be checked often.

It may take up to 2 weeks before your blood pressure improves. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant.

If you have diabetes, you should not use TEKTURNA together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

You should not take TEKTURNA if you are allergic to it.

If you have diabetes, you should not use TEKTURNA together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with TEKTURNA if you have kidney disease.

To make sure you can safely take TEKTURNA, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• heart disease;
• if you are on a low-salt diet; or
• if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

Do not use TEKTURNA if you are pregnant. Stop using and tell your doctor right away if you become pregnant. TEKTURNA can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether TEKTURNA passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; vomiting, severe stomach pain; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.

If you have an allergic reaction to aliskiren you should not take it again.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urinating; or
• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

• dizziness, tired feeling;
• cough;
• diarrhea;
• headache;
• back pain; or
• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb TEKTURNA.

Do not use salt substitutes or potassium supplements while taking TEKTURNA, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of TEKTURNA.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with TEKTURNA, especially:

• atorvastatin (Lipitor);
• antifungal medicine;
• any heart or blood pressure medicines;
• cyclosporine;
• a diuretic or "water pill";
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with TEKTURNA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take TEKTURNA with or without food, but take it the same way every time.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you feel light-headed.

Your blood pressure will need to be checked often.

It may take up to 2 weeks before your blood pressure improves. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.