ALTACE® Capsules 17 PATIENT COUNSELING INFORMATION

(ramipril)

17 PATIENT COUNSELING INFORMATION

Angioedema

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.

Neutropenia

Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.

Symptomatic Hypotension

Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ALTACE if syncope (fainting) occurs, and to follow up with their health care providers.

Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ALTACE can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to Altace during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.

Hyperkalemia

Advise patients not to use salt substitutes containing potassium without consulting their physician.

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17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

Angioedema

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.

Neutropenia

Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.

Symptomatic Hypotension

Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ALTACE if syncope (fainting) occurs, and to follow up with their health care providers.

Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ALTACE can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to Altace during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.

Hyperkalemia

Advise patients not to use salt substitutes containing potassium without consulting their physician.
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