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AMLOBENZ capsule


  1. Patient Information
  2. Pregnancy:
  3. What Is The Most Important Information I Should Know About Amlodipine Besylate And Benazepril Hydrochloride Capsules?
  4. What Is Amlodipine Besylate And Benazepril Hydrochloride Capsules?
  5. Who Should Not Take Amlodipine Besylate And Benazepril Hydrochloride Capsules?
  6. Tell Your Doctor About All Your Medical Conditions, Including If:
  7. 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 Amlodipine Besylate And Benazepril Hydrochloride Capsules Could Affect Each Other, Causing Serious Side Effects. Tell Your Doctor About All Your Medicines, Especially:
  8. How Do I Take Amlodipine Besylate And Benazepril Hydrochloride Capsules?
  9. Tell All Your Doctors Or Dentist You Are Taking Amlodipine Besylate And Benazepril Hydrochloride Capsules If You:
  10. Amlodipine Besylate And Benazepril Hydrochloride Capsules Can Cause Serious Side Effects Including:
  11. Stop Amlodipine Besylate And Benazepril Hydrochloride Capsules And Get Emergency Help Right Away If You Get:
  12. The More Common Side Effects Of Amlodipine Besylate And Benazepril Hydrochloride Capsules Are:
  13. How Do I Store Amlodipine Besylate And Benazepril Hydrochloride Capsules?
  14. Manufactured By:
  15. Repackaged By:

Patient Information 

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17.1 Information for Patients

Pregnancy: 

Tell female patients of childbearing age that use of drugs like benazepril that act on the renin-angiotensin system can cause serious problems in the fetus and infant including: low blood pressure, poor development of skull bones, kidney failure and death. Discuss other treatment options with female patients planning to become pregnant. Tell women using amlodipine besylate and benazepril hydrochloride who become pregnant to notify their physicians as soon as possible.

17.2 FDA-Approved Patient Labeling

Patient Information

Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg

Read this Patient Information leaflet before you start taking amlodipine besylate and benazepril hydrochloride capsules 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.

What Is The Most Important Information I Should Know About Amlodipine Besylate And Benazepril Hydrochloride Capsules? 

Amlodipine besylate and benazepril hydrochloride capsules can harm an unborn baby and even cause death. If you get pregnant, stop taking amlodipine besylate and benazepril hydrochloride capsules. Call your doctor right away.Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.

What Is Amlodipine Besylate And Benazepril Hydrochloride Capsules? 

Amlodipine besylate and benazepril hydrochloride capsules 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 amlodipine besylate and benazepril hydrochloride capsules 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. Amlodipine besylate and benazepril hydrochloride capsules can help your blood vessels relax so your blood pressure is lower.

Amlodipine besylate and benazepril hydrochloride capsules has not been studied in children.

Who Should Not Take Amlodipine Besylate And Benazepril Hydrochloride Capsules? 

Don t take amlodipine besylate and benazepril hydrochloride capsules if you are allergic to any of the ingredients.There is a complete list at the end of this leaflet.

Tell Your Doctor About All Your Medical Conditions, Including If: 

you are pregnant or plan to become pregnant.

you are breastfeeding.Amlodipine besylate and benazepril hydrochloride capsules may pass into your milk. Don t breastfeed while you are taking amlodipine besylate and benazepril hydrochloride capsules.

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 Amlodipine Besylate And Benazepril Hydrochloride Capsules 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 Amlodipine Besylate And Benazepril Hydrochloride Capsules? 

Take amlodipine besylate and benazepril hydrochloride capsules exactly as your doctor tells you.

Take amlodipine besylate and benazepril hydrochloride capsules 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 amlodipine besylate and benazepril hydrochloride capsules, call your doctor or Poison Control Center, or go to the emergency room.

Tell All Your Doctors Or Dentist You Are Taking Amlodipine Besylate And Benazepril Hydrochloride Capsules If You: 

- are going to have surgery

- are getting allergy shots for bee stings

- go for kidney dialysis

Amlodipine Besylate And Benazepril Hydrochloride Capsules Can Cause Serious Side Effects Including: 

serious allergic reactions that can be life threatening.

Stop Amlodipine Besylate And Benazepril Hydrochloride Capsules 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 amlodipine besylate and benazepril hydrochloride capsules. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.

more chest pain and heart attacksin 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 Amlodipine Besylate And Benazepril Hydrochloride Capsules Are: 

Cough

Dizziness

Headache

Swelling of the feet, ankles, and hands

These are not all of the side effects of amlodipine besylate and benazepril hydrochloride capsules. For a complete list, ask your doctor or pharmacist.

How Do I Store Amlodipine Besylate And Benazepril Hydrochloride Capsules? 

Store amlodipine besylate and benazepril hydrochloride capsules at 20 -25 C (68 -77 F); [

Active ingredients: amlodipine besylate, benazepril hydrochloride USP.

Inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate. Each hard-gelatin capsule contains gelatin, titanium dioxide and D&C yellow # 10, D&C red # 28 (5 mg/20 mg), FD&C blue # 1(5 mg/20 mg), FD&C green # 3(2.5 mg/10 mg), FD&C red # 40 (5 mg/20 mg) , iron oxide black (10 mg/20 mg) and iron oxide red (5 mg/20 mg and 10 mg/20 mg ) as coloring agents.

Norvascis a registered trademark of Pfizer, Inc..

Lotensinis a registered trademark of Novartis Corp.

Eskalithand Lithobidare registered trademarks of Noven Therapeutics, LLC..

To reorder additional Patient Information Leaflets, please contact Dr. Reddy s Customer Service at1-866-733-3952.

RXOnly

Manufactured By: 

Dr. Reddy s Laboratories Limited

Bachepalli 502 325 INDIA

Issued: 0410

Repackaged By: 

Rebel Distributors Corp

Thousand Oaks, CA 91320



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