IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ENALAPRIL-FELODIPINE EXTENDED RELEASE - ORAL

(eh-NAL-uh-prill with fell-OH-dih-peen)

COMMON BRAND NAME(S): Lexxel

WARNING: This drug can cause serious fetal harm (sometimes death) if used during the last six months of pregnancy. If pregnancy occurs, stop using this drug and immediately contact your physician.

USES: This medication is used to treat high blood pressure (hypertension).

HOW TO USE: Take by mouth exactly as directed by your doctor, usually once daily. The tablet should be swallowed whole, not divided, crushed or chewed. The medicine is best taken on an empty stomach or with a light meal. Before using any potassium supplements or salt substitutes with potassium, consult your doctor or pharmacist. Avoid using this product with grapefruit juice. Consult your doctor or pharmacist. The full effect on blood pressure is usually seen in 1-2 weeks.

SIDE EFFECTS: Cough, headache, dizziness or ankle swelling may occur. If these effects persist or worsen, notify your doctor promptly. Report promptly: vomiting, diarrhea. Unlikely but report promptly: unusual weakness, fatigue, muscle cramps, gum swelling, flushing. Very unlikely but report promptly: fainting, chest pain, pounding or irregular heartbeats, mood/mental changes, vision changes, persistent sore throat and fever, easy bruising or bleeding, painful urination, change in amount of urine. This drug may rarely cause serious (possibly fatal) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing of the eyes or skin, dark urine, stomach/abdominal pain, persistent fatigue, persistent nausea. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this product, tell your doctor your medical history, including: allergies (especially drug allergies), kidney problems, liver disease, heart or blood vessel problems, diabetes. Limit alcohol intake, as it may enhance certain side effects of this product. Also, avoid excessive sweating (such as very hot weather or heavy exercise) unless you drink enough extra fluids. Since this product may cause dizziness or fatigue, use caution if operating machinery or performing hazardous tasks. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. This product should be used only when clearly needed during the first 3 months of pregnancy. This product is not recommended for use during the last 6 months of pregnancy. Consult your doctor before using this drug. The enalapril in this product is excreted into breast milk. It is not known whether the felodipine is excreted into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Caution is advised when this product is used in the elderly.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially of: "water pills" (diuretics such as spironolactone, amiloride or triamterene), potassium supplements, azole antifungals (e.g., itraconazole, ketoconazole), other blood pressure medications (e.g., metoprolol, methyldopa, prazosin), intravenous (IV) calcium, certain psychiatric medications (e.g., lithium), certain anti-seizure drugs (e.g., phenytoin, carbamazepine, phenobarbital), cimetidine, aspirin-like pain medications (e.g., ibuprofen), drugs for sleep (e.g., triazolam), macrolide antibiotics (e.g., clarithromycin, erythromycin), sedatives, tranquilizers, drugs for anxiety (e.g., diazepam), narcotic pain relievers (e.g., codeine), certain antihistamines (e.g., diphenhydramine). Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include dizziness, weakness, slow or fast pulse, nausea, drowsiness, confusion, and slurred speech.

NOTES: Do not share this medication with others. Laboratory tests may be performed to monitor side effects.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.