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Generic Name: enalapril/felodipine (en-AL-a-pril/fe-LOE-di-peen)
Brand Name: Lexxel

Lexxel may cause injury or death to the fetus if taken during pregnancy. If you think you may be pregnant, contact your doctor right away.

Lexxel is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Lexxel is an angiotensin-converting enzyme (ACE) inhibitor and calcium channel blocker combination. It works by relaxing blood vessels, which helps to lower blood pressure and decrease the workload of the heart.

Do NOT use Lexxel if:

  • you are allergic to any ingredient in Lexxel
  • you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), including angioedema caused by treatment with an ACE inhibitor (eg, lisinopril)
  • you are pregnant
  • you are taking dextran sulfate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lexxel:

Some medical conditions may interact with Lexxel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems (eg, aortic stenosis, heart failure), blood vessel problems (eg, in the heart or brain), blood flow problems, bone marrow problems, or kidney problems (eg, renal artery stenosis)
  • if you have a history of stroke, recent heart attack, or kidney transplant
  • if you are receiving dialysis or apheresis treatments, or are scheduled to have surgery or receive anesthesia
  • if you have low blood sodium levels, high blood potassium levels, the blood disease porphyria, or an autoimmune disease (eg, lupus, rheumatoid arthritis, scleroderma)
  • if you are dehydrated, have low blood volume, or are on a low-salt (sodium) diet
  • if you have diabetes, especially if you are also taking aliskiren
  • if you are receiving treatments to reduce sensitivity to bee or wasp stings
  • if you have never taken medicine for high blood pressure

Some MEDICINES MAY INTERACT with Lexxel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased
  • Everolimus or sirolimus because the risk of angioedema may be increased
  • Dextran sulfate because it may increase the risk of allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) and light-headedness upon standing
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen) because they may decrease Lexxel's effectiveness and the risk of kidney damage may be increased
  • Certain gold-containing medicines (eg, sodium aurothiomalate) because flushing, nausea, vomiting, and low blood pressure may occur
  • Angiotensin receptor blockers (eg, losartan) because the risk of serious kidney problems and high blood potassium levels may be increased
  • Aldosterone blockers (eg, eplerenone), aliskiren, potassium-sparing diuretics (eg, amiloride), potassium supplements, or trimethoprim because the risk of high blood potassium levels may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole), cimetidine, clarithromycin, erythromycin, or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of Lexxel's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, or hydantoins (eg, phenytoin) because they may decrease Lexxel's effectiveness
  • Lithium, tacrolimus, or thiopurines (eg, azathioprine) because the risk of their side effects may be increased by Lexxel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lexxel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lexxel:

Use Lexxel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lexxel may be taken by mouth on an empty stomach or with food. However, you must take it the same way each time for it to work best. If you take Lexxel on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
  • Swallow Lexxel whole. Do not break, crush, or chew before swallowing.
  • Eating grapefruit or drinking grapefruit juice may affect the amount of Lexxel in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • Continue to take Lexxel even if you feel well. Do not miss any doses.
  • If you miss a dose of Lexxel, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lexxel.

Important safety information:

  • Lexxel may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Lexxel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Lexxel may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. If light-headedness occurs, especially during the first few days of treatment, contact your doctor.
  • Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Proper dental care is important while you are taking Lexxel. Brush and floss your teeth and visit the dentist regularly.
  • Lexxel may cause a dry, unproductive cough. If caused by Lexxel, this symptom usually stops after treatment with Lexxel is stopped.
  • Lexxel may cause a serious side effect called angioedema. The risk may be higher in black patients. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • Lexxel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Lexxel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Rarely, Lexxel may lower the ability of your body to fight infection. This risk may be greater if you have certain other health problems (eg, kidney problems, collagen vascular disease). Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take Lexxel before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including kidney function, blood electrolyte levels, and blood pressure, may be performed while you take Lexxel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Lexxel with caution in the ELDERLY; they may be more sensitive to its effects.
  • Lexxel should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Lexxel may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Lexxel is found in breast milk. If you are or will be breast-feeding while you take Lexxel, check with your doctor. Discuss any possible risks to your baby. Do not breast-feed while taking Lexxel.

Possible side effects of Lexxel:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; persistent, dry cough.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); breast changes; chest pain; decreased sexual ability; decreased urination; dry mouth; fainting; fast, slow, or irregular heartbeat; mental or mood changes; red, swollen, blistered, or peeling skin; shortness of breath; sluggishness; stomach pain (with or without nausea or vomiting); swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of low blood pressure (eg, fainting, severe dizziness, light-headedness); thirst; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness or light-headedness.

Proper storage of Lexxel:

Store Lexxel at 77 degrees F (25 degrees C) in a tightly-closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lexxel out of the reach of children and away from pets.

General information:

  • If you have any questions about Lexxel, please talk with your doctor, pharmacist, or other health care provider.
  • Lexxel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lexxel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: June 3, 2015