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|Lexxel

ENALAPRIL AND FELODIPINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Lexxel

† Not commercially available in Canada.

Category

• Antihypertensive

Description

Enalapril (e-NAL-a-pril) and felodipine (fe-LOE-di-peen) combination belongs to the class of medicines called high blood pressure medicines (antihypertensives). This medicine is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

The exact way in which this medicine works is not known. Enalapril is a type of medicine known as an angiotensin-converting enzyme (ACE) inhibitor. It blocks an enzyme in the body that is necessary in producing a substance that causes blood vessels to tighten. Felodipine is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. The actions of both medicines relax blood vessels, lower blood pressure, and increase the supply of blood and oxygen to the heart.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For enalapril and felodipine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to enalapril or felodipine, as well as to any other ACE inhibitor (benazepril, captopril, fosinopril, lisinopril, moexipril, quinapril, ramipril, or trandolapril). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with this combination medicine have not been done in pregnant women. However, use of any of the ACE inhibitors during pregnancy, especially in the second and third trimesters (after the first 3 months), can cause low blood pressure, kidney failure, an underdeveloped skull, or even death in newborns. Felodipine can cause birth defects and problems with labor and delivery. Therefore, it is important that you check with your doctor immediately if you think that you may be pregnant . Be sure that you have discussed this with your doctor before taking this combination medicine.

Breast-feeding—Enalapril passes into breast milk. It is not known if felodipine passes into breast milk; however, felodipine passes into the milk of lactating rats. Use of this combination medicine is not recommended in women who are breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of enalapril and felodipine in children with use in other age groups.

Older adults—Although this medicine has not been shown to cause different side effects or problems in older people than it does in younger adults, blood levels of the felodipine component may be increased in the elderly.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your health care professional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol) or
• Phenytoin (e.g., Dilantin) or
• Phenobarbital—Effects of felodipine may be greatly decreased

• Diuretics (water pills)—Effects on blood pressure may be increased

• Potassium-containing supplements or
• Salt substitutes that contain potassium—Use of these substances with ACE inhibitors may result in an unusually high potassium level in the blood, which can lead to irregular heart rhythm and other problems

Other medical problems—The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angioedema (an allergic skin disease), family history of or unknown cause—This medicine should not be used in patients with this condition.

• Bee-sting allergy treatments or
• Dialysis—Increased risk of serious allergic reaction occurring

• Dehydration—Lowering effects on blood pressure may be increased

• Diabetes mellitus (sugar diabetes)—Increased risk of potassium levels in the body becoming too high

• Heart attack or stroke or
• Heart or blood vessel disease or
• Hypotension (low blood pressure)—Further lowering of blood pressure may make problems resulting from these conditions worse

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal from the body

• Previous reaction to any ACE inhibitor involving hoarseness; swelling of the face, mouth, hands, or feet; or sudden trouble in swallowing or breathing—Reaction is more likely to occur again

• Scleroderma or
• Systemic lupus erythematosus (SLE) (or history of)—Increased risk of blood problems caused by ACE inhibitors

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor, at the same time each day. Do not take more of it and do not take it more often than directed.

Swallow the tablets whole, without breaking, crushing, or chewing them.

If felodipine is taken with grapefruit juice, its effects may be increased. Check with your doctor before taking this medicine with grapefruit juice.

Dosing—The dose of this medicine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once a day to start. Your doctor may increase your dose up to 4 tablets once a day if needed, to equal 20 mg enalapril and 10 mg felodipine extended-release.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly, to check for unwanted effects, and to change the dosage if needed.

If you think that you may have become pregnant, check with your doctor immediately. Use of this medicine, especially during the second and third trimesters (after the first 3 months) of pregnancy, may cause serious injury or even death to the unborn child.

Do not take any other medicines, potassium supplements, or salt substitutes that contain potassium unless approved or prescribed by your doctor.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you experience these effects.

Call your doctor if you faint or feel lightheaded while you are taking this medicine.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection developing as a result of low white blood cell counts.

Check with your doctor if you notice difficult breathing or swelling of the face, arms, or legs. These could be symptoms of a serious allergic reaction.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing vomiting or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/20/2004

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