This Drug Should Not Be Taken If

• you have had an allergic reaction to it previously.

• you have a currently active bone marrow or blood cell disorder.

Inform Your Physician Before Taking This Drug If

• you have a history of liver disease or impaired liver function.

• you have a history of any type of bone marrow or blood cell disorder,
especially one that is drug-induced.

• you are currently taking any anticoagulant medication, diazepam
(Valium) or phenytoin (Dilantin, etc.).

Possible Side-Effects

(natural, expected and unavoidable drug actions) None reported.

Possible Adverse Effects

(unusual, unexpected and infrequent reactions)

If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reactions: Skin rash (1.5%), itching. Headache (6.9%), dizziness (1.5%), drowsiness, weakness (1.1%).Indigestion (2.4%), nausea (2.2%), vomiting (1.5%), diarrhea (3%), con­stipation (1.1%). Serious Adverse Effects

Rare bone marrow depression: fatigue, weakness, fever, sore throat, infections, abnormal bleeding or bruising.

Rare liver damage with jaundice.

Urinary tract infection: painful urination, cloudy or bloody urine.

Possible Effects on Sexual Function

One case of drug-induced male breast enlargement and tenderness (gyne­comastia) has been reported; this occurred on two separate occasions in association with the use of this drug.

Adverse Effects That May Mimic Natural Diseases or Disorders

Persistent infection or bruising may reflect bone marrow depression;

blood counts advisable. Liver reactions may suggest viral hepatitis.

Possible Effects on Laboratory Tests

Complete blood cell counts: decreased red cells, hemoglobin, white cells

and platelets.

Blood glucose level: decreased. Liver function tests: increased liver enzymes (ALT/GPT, AST/GOT and

alkaline phosphatase), increased bilirubin.

CAUTION

1. Follow your physician's instructions exactly regarding the length of
time you take this drug. Do not extend its use without his guidance.

2. Report promptly any indications of infection.

3. Inform your physician if you plan to take any other medications
(prescription or over-the-counter) while taking omeprazole.

Precautions for Use

By Infants and Children

: Safety and effectiveness for use by those under 12 years of age have not

been established. By Those over 60 Years of Age: Slower elimination of this drug makes it

possible to achieve satisfactory response with smaller doses; this

reduces the risk of adverse effects. Limit the daily dose to 20 mg if

possible.