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warnings and cautions
WARNINGS If pain or fever persists, if new symptoms occur, or if redness or swelling is pre- sent, consult your physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age unless directed by a physician. Caution should be exercised when used in patients with pro-static hypertrophy, urinary retention, bladder neck obstruction, increased ocular pressure, and asthma. PRECAUTIONS Information for Patients: Patient consultation should include the following information regarding the proper use of NOREL® SR: • Do not exceed recommended dosage. • May be taken with food, water, or milk to lessen gastric irritation. • Do not drive or operate heavy machinery if drowsi- ness or dizziness occurs. • Concomitant use of alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers and anti- anxiety drugs) while tak ing NOREL® SR may have an additive effect on drowsiness. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Doses should not be doubled. • Swallow extended-release tablets whole; do not crush or chew tablets prior to swallowing.
ADVERSE REACTIONS The following adverse effects have been selected on the basis of their potential clinical significance (not necessarily inclusive): allergic reactions, anemia, blood dyscrasias (sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness), psychotic episodes (mood or mental changes) – usually associated with previous history of psychiatric illness, tightness in chest.