Medication Guide — Lotrel

FDA-Approved Patient Labeling

LOTREL ® ‚ (low-TREL)

amlodipine besylate/benazepril hydrochloride capsules

Read this Patient Information leaflet before you start taking LOTREL and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor. If you have any questions, ask your doctor or pharmacist.

• LOTREL can cause harm or death to an unborn baby.
• Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
• If you get pregnant while taking LOTREL, tell your doctor right away.

What is LOTREL?

LOTREL contains two prescription medicines that work together to lower blood pressure: amlodipine besylate (the active ingredient found in Norvasc®), a calcium channel blocker, and benazepril hydrochloride (Lotensin®), an ACE inhibitor. Your doctor will prescribe LOTREL only after other medicines haven’t worked.

High Blood Pressure (hypertension). Blood pressure is the force of blood in your blood vessels. You have high blood pressure when the force is too much. LOTREL can help your blood vessels relax so your blood pressure is lower.

LOTREL has not been studied in children.

Who should not take LOTREL?

Don’t take LOTREL if you are allergic to any of the ingredients. There is a complete list at the end of this leaflet.

What should I tell my Doctor before taking LOTREL?

Tell your doctor about all your medical conditions, including if:

• you are pregnant or plan to become pregnant. See “What is the most important information I should know about LOTREL?”
  
• you are breastfeeding. LOTREL may pass into your milk. Don’t breastfeed while you are taking LOTREL.
  
• you have a heart condition
  
• you have liver problems
  
• you have kidney problems
  
• you have diabetes (high blood sugar)
  
• you have systemic lupus erythematosus (SLE), scleroderma or a collagen vascular disease. Ask your doctor if you are not sure.

Keep a list of your medicines with you, including vitamins and natural or herbal remedies, to show your doctor or pharmacist. Some of your other medicines and LOTREL could affect each other, causing serious side effects. Tell your doctor about all your medicines, especially:

• medicines for high blood pressure or heart failure
  
• water pills, extra potassium or a salt substitute
  
• Lithium (Eskalith®, Lithobid®)

How do I take LOTREL?

• Take LOTREL exactly as your doctor tells you.
  
• Take LOTREL at the same time each day, with or without food.
  
• If you miss a dose, take it as soon as you remember. If it is more than 12 hours, just take your next dose at the regular time.
  
• Your doctor may test for kidney problems or check your blood potassium level.
  
• If you take too much LOTREL, call your doctor or Poison Control Center, or go to the emergency room.
  
• Tell all your doctors or dentist you are taking LOTREL if you:
  - are going to have surgery
  - are getting allergy shots for bee stings
  -  go for kidney dialysis

What are the possible side effects of LOTREL?

LOTREL can cause serious side effects including:

• serious allergic reactions that can be life threatening.
  Stop LOTREL and get emergency help right away if you get:
        -       swelling of your face, eyelids, lips, tongue or throat
        -       have trouble swallowing
        -       asthma (wheezing) or other breathing problems
  These allergic reactions are rare but happen more times in people who are African-American.

• low blood pressure (hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low salt diet, get dialysis treatments, have heart problems or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy.
  
• liver problems. Call your doctor if:
  
• you have nausea
  
• you feel more tired or weaker than usual
  
• you have itching
  
• your skin or eyes look yellow
  
• you have pain in your upper right stomach
  
• you have flu-like symptoms
  
• low white blood cells. Low white blood cells happen more in people who have kidney problems and collagen vascular diseases. Low white blood cells can give you a higher chance for getting infections. Call your doctor if you get a fever, sore throat, or other signs of infection that do not go away.
  
• kidney problems. Kidney problems may get worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and need a lower dose of LOTREL. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.
  
• more chest pain and heart attacks in people that already have severe heart problems. Get emergency help if you get worse chest pain or chest pain that does not go away.

The more common side effects of LOTREL are:

• Cough      
  
• Dizziness
  
• Headache
  
• Swelling of the feet, ankles, and hands

These are not all the side effects of LOTREL. For a complete list, ask your doctor or pharmacist.

How do I store LOTREL?

• Store LOTREL at room temperature (59-86°F).
  
• Keep LOTREL in a closed container in a dry place.
  
• Keep LOTREL and all medicines out of the reach of children.

General Information about LOTREL

Doctors can also use medicine for a condition that is not in the patient information leaflet. Take LOTREL the way your doctor tells you. Do not share it with other people. It may harm them.

For more information, ask your doctor or pharmacist, visit www.LOTREL.com on the Internet, or call 1-888-669-6682.

What are the ingredients in LOTREL?

Active ingredients: amlodipine besylate (the active ingredient found in Norvasc®), benazepril hydrochloride (Lotensin®)

Inactive ingredients: calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg and 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.

Norvasc® is a registered trademark of Pfizer, Inc. Lotensin® is a registered trademark of Novartis Corp. Eskalith® and Lithobid® are registered trademarks of Noven Therapeutics, LLC.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2012-43/T2012-44
January 2012/January 2012

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146