September 21, 2014
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Teva-Fosinopril

(fosinopril)

DIN (Drug Identification Number)

02247802 TEVA-FOSINOPRIL 10MG TABLET
02247803 TEVA-FOSINOPRIL 20MG TABLET

What side effects are possible with Teva-Fosinopril?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cough (dry, persistent)
  • diarrhea
  • headache
  • loss of taste sensation
  • nausea
  • unusual tiredness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • chest pain
  • fever
  • joint pain
  • signs of impared liver function (e.g., abdominal pain, itching of skin, yellow eyes or skin, loss of appetite, nausea or vomiting)
  • signs of low blood pressure (e.g., dizziness, lightheadedness, or fainting)
  • signs of too much potassium in the body:
    • confusion
    • irregular heartbeat
    • nervousness
    • numbness or tingling in hands, feet, or lips
    • shortness of breath or difficulty breathing
    • weakness or heaviness of legs

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • fever and chills
  • hoarseness
  • itching of skin, or yellow eyes or skin
  • signs of angioedema (e.g., swelling of face, mouth, hands, or feet)
  • stomach pain
  • trouble swallowing or breathing (sudden)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Teva-Fosinopril?

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of fosinopril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angioedema: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with use of fosinopril. If you experience swelling of the face, tongue, or throat, stop taking fosinopril at once and get immediate medical attention. Other medications in the class of medications known as ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving an ACE inhibitor.

Cough: People taking fosinopril may develop a dry, persistent cough that usually disappears only after stopping or lowering the fosinopril dose. Be sure to tell your doctor of any cough that does not seem to be related to a usual cause.

Fluid and electrolyte balance: In very few cases, people who take fosinopril experience an increase in blood levels of potassium. This rarely causes problems, but potassium levels should be monitored by your doctor.

Kidney function: Changes in kidney function have been seen for certain people who take this medication (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills) or nonsteroidal anti-inflammatory drugs (NSAIDs) may further increase risk of kidney problems for people already at risk for this problem.

Liver function: This medication may worsen liver function. People with liver disease or poor liver function should be closely monitored by their doctor while taking this medication. If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking fosinopril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur for those who take water pills, have a salt restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Pregnancy: Fosinopril should not be taken by pregnant women. If you discover you are pregnant, stop taking fosinopril at once and contact your doctor.

Breast-feeding: Fosinopril passes into breast milk. This medication should not be taken by breast-feeding mothers.

Children: The safety and effectiveness of fosinopril for children have not been established. Its use by this age group is not recommended.

What other drugs could interact with Teva-Fosinopril?

There may be an interaction between fosinopril and any of the following:

  • alcohol
  • antacids
  • diuretics (water pills)
  • lithium
  • medications that increase potassium levels (e.g., potassium supplements, salt substitutes containing potassium)
  • medications that lower blood pressure (e.g., beta-blockers)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
  • other blood pressure medications known as angiotensin II receptor blockers (e.g., candesartan, losartan)
  • potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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