IMPORTANT SAFETY INFORMATION

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Lasix^® (furosemide) Tablets

WARNING

LASIX^® (furosemide) tablets are a very potent medication. Using too much of this drug can lead to serious water and salt and mineral loss. Therefore, it is important that you are closely monitored by your doctor while taking this medication. Tell your doctor right away if you become very thirsty or confused, or develop muscle cramps or weakness.

WHAT ARE LASIX TABLETS USED FOR?

Lasix tablets are used to reduce extra fluid in the body (known as edema) caused by conditions such as heart failure, liver disease, kidney disease, and from other diseases that might cause fluid retention in adults and children.

Lasix tablets are also used to treat high blood pressure in adults.

Lasix tablets are a “water pill” (diuretic) that cause you to increase your urinary output. Lasix tablets help your body get rid of extra water and salt.

WHEN SHOULD I NOT TAKE THE DRUG?

You should not take Lasix tablets if you are allergic to furosemide, or if you have any other allergies to any of the inactive ingredients in the drug, or if you are allergic to sulfa drugs.

You should not use Lasix tablets if you are unable to urinate.

If you have diabetes, Lasix tablets may affect your blood sugar level. Check your blood sugar level regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication or diet.

If your doctor detects nitrogen in your blood or if you have urine problems, your doctor may discontinue treatment with Lasix tablets.

Lasix tablets may reduce the potassium level in your blood. Your doctor may instruct you to add potassium-rich foods to your diet (such as bananas, orange juice) or prescribe potassium supplements to prevent potassium loss.

Before using Lasix tablets, tell your doctor if you have kidney disease, enlarged prostate, urination problems, cirrhosis or other liver disease, an electrolyte imbalance, high cholesterol, gout, lupus, diabetes, or an allergy to sulfa drugs.

Tell your doctor if you have recently had an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into your veins.

Do not take more of this medication than is recommended. High doses of Lasix tablets may cause irreversible hearing loss.

If you are being treated for high blood pressure, you must continue to use Lasix tablets even if you feel fine. High blood pressure often has no symptoms.

WHAT WARNINGS SHOULD I KNOW ABOUT LASIX TABLETS?

You should not use this medication if you are unable to urinate.

If you have liver disease and swelling of your stomach, your doctor may require you to receive treatment in the hospital.

Lasix tablets are a diuretic. Excessive urination can cause dehydration.

Older patients are particularly susceptible to blood clots due to excessive urination. You should be aware that excessive urination can cause an electrolyte depletion and low potassium levels in your blood stream. In addition, Lasix tablets do not work as well in older patients.

While taking Lasix tablets, tell your doctor if you have any of the following symptoms:

• Dry mouth
• Excessive thirst
• Weakness
• Lethargy
• Fast or irregular heartbeat
• Nausea or vomiting
• Drowsiness
• Restlessness
• Muscle pains or cramps

If you have a bladder emptying disorder you should be aware that Lasix tablets can cause you to have problems with urine retention. If you have this condition, your doctor will monitor you closely, particularly during the initial phases of your treatment.

Tell your doctor if you have recently had an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into your veins, as use of Lasix tablets during these procedures can lead to loss of kidney function.

If you have low protein levels in your blood, Lasix tablets may not work as intended and may cause hearing damage.

During Lasix treatment, your doctor may monitor you for blood disorders, liver or kidney damage or other reactions.

Do not take more of this medication than is recommended. High doses of Lasix tablets may cause irreversible hearing loss.

If you are being treated for high blood pressure, you must continue to use Lasix tablets even if you feel fine. High blood pressure often has no symptoms. Avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.

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 becoming dehydrated. Follow your doctor’s instructions about the type and amount of liquids you should drink while you are taking Lasix tablets. Lasix tablets may reduce the potassium levels in your blood. Potassium supplements and/or dietary measures may be needed.

If you are a diabetic, Lasix tablets may increase your blood sugar levels and alter your urine tests.

You may be more sensitive to sun while taking Lasix tablets. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk of dehydration. Report prolonged diarrhea or vomiting to your doctor. Follow your doctor’s instructions about the amount of fluids you can drink.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may affect milk production. Consult your doctor before breast-feeding.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

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

• kidney disease
• enlarged prostate, bladder obstruction or other urination problems
• cirrhosis or other liver disease
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood)
• high cholesterol or triglycerides (a type of fat in the blood)
• gout
• lupus
• diabetes
• an allergy to sulfa drugs
• if you are pregnant, planning to become pregnant or breast feeding

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH LASIX TABLETS?

If you are taking sucralfate (Carafate), wait at least 2 hours after you take Lasix tablets before taking Carafate.

Tell your doctor about all other medicines you use, especially:

• cisplatin (Platinol)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• ethacrynic acid (Edecrin)
• lithium (Eskalith, Lithobid)
• methotrexate (Rheumatrex, Trexall)
• phenytoin (Dilantin)
• an antibiotic such as amikacin (Amikin), cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo Fradin, Neo Tab), streptomycin, tobramycin (Nebcin, Tobi)
• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), benazepril (Lotensin), candesartan (Atacand), eprosartan (Teveten), enalapril (Vasotec), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar), quinapril (Accupril), ramipril (Altace), telmisartan (Micardis), valsartan (Diovan), and others
• a laxative (Metamucil, Milk of Magnesia, Colace, Dulcolax, Epsom salts, senna, and others)
• salicylates such as aspirin, Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others;
• steroids (prednisone and others)
• succinylcholine (Anectine,Quelicin)
• norepinephrine (Levophed)
• chloral hydrate (Noctec)
• NSAIDs (Indocin and Tivorbex)

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen swelling (edema).

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

WHAT ARE THE SIDE EFFECTS OF LASIX TABLETS?

A very serious allergic reaction to Lasix tablets is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Dizziness, lightheadedness, headache, or blurred vision may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Get emergency medical help if you have a serious side effect such as:

• ringing in your ears, hearing loss
• itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• severe pain in your upper stomach spreading to your back, nausea and vomiting
• weight loss, body aches, numbness
• swelling, rapid weight gain, urinating less than usual or not at all
• chest pain, new or worsening cough with fever, trouble breathing, fast or irregular heart beat
• pale skin, bruising, unusual bleeding, lightheadedness, rapid heart rate, trouble concentrating
• low potassium (confusion, uneven heart rate, leg discomfort, muscle weakness or limp feeling)
• low calcium (tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes)
• headache, feeling unsteady, weak or shallow breathing
• unusual tiredness, confusion, severe dizziness, fainting, drowsiness
• unusual dry mouth and/or thirst

Less serious side effects may include:

• diarrhea, constipation, stomach pain
• dizziness, spinning sensation
• mild itching or rash

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Validus Pharmaceuticals LLC at 1-866-982-5438.

WHAT IF I OVERDOSE?

There is no specific treatment for suspected overdose.

Seek emergency help. Supportive measures should be taken.

Call the Poison Control Hotline (1-800-222-1222).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch