WHY IS IT PRESCRIBED?
For the treatment of depression,
obsessive compulsive disorders, and
panic disorders.
BEFORE USING THIS MEDICINE:
Tell your doctor:
If you are PREGNANT; If you are
BREAST FEEDING.
Tell your doctor if you are having
any of the following conditions:
LIVER PROBLEMS; KIDNEY DISEASE;
SEIZURES.
HOW MEDICINE IS ADMINISTERED?
Use this medicine exactly as
directed on the label, unless
instructed differently by your
doctor
* This medicine is usually taken as
a single daily dose in the morning.
* This medicine can be taken with or
without food, REGARDLESS of meal
times. If stomach upset occurs, take
with food.
* Use this medicine for the full
prescribed treatment period.
* Do not DISCONTINUE this medicine
ABRUPTLY after prolonged usage.
WHAT TO DO IF YOU MISS A DOSE?
If you miss a dose, take missed dose
if 12 hrs before next dose.
Otherwise omit and resume schedule.
No double doses.
HOW THIS MEDICINE SHOULD BE STORED?
Keep in original closed container in
a dark, cool, and dry place away
from children. Discard unneeded
medicine.
WARNINGS/PRECAUTIONS:
* Safety of use during pregnancy has
not been established. This medicine
SHOULD NOT BE USED DURING PREGNANCY
unless benefit justifies potential
risk to the fetus. CALL YOUR DOCTOR.
* Be alert to the emergence of
anxiety, panic attack, confusion,
irritability, worsening of
depression, and suicidal ideas.
* Contact your doctor right away if
you develop PSYCHIATRIC SYMPTOMS
(severe depression, anger, thoughts
of suicide).
* The risk of suicide attempt is
inherent in psychotic illnesses and
in patients with substance abuse.
Close supervision is necessary.
* Concomitant use with non-selective
NSAIDs, aspirin, or other drugs that
affect coagulation (warfarin, etc.)
may increase the risk of bleeding.
* Notify doctor if you are pregnant,
if pregnancy is suspected, or if you
intend to become pregnant.
* Notify your doctor if you are a
nursing mother before breast-feeding
your baby.
* Do not take for at least 14 days
following the discontinuation of an
MAOI. Also 14 days should be allowed
after stopping it before starting an
MAOI.
* This medicine may cause drowsiness,
dizziness, or blurred vision. DO
NOT drive or operate machines until
you know how you react to this
medicine.
* AVOID concurrent use of alcohol or
other CNS depressants as it may
intensify the drowsiness, dizziness,
or lightheadedness effect of this
medicine.
* This medicine may cause increased
sensitivity to the sun. You should
AVOID prolonged or excessive
exposure to direct and/or artificial
sunlight.
* Because of INTERACTIONS, report
the use of any other prescription or
nonprescription medicines, including
natural/herbal remedies, to your
doctor.
* It is important that you do not
stop taking your medications without
consulting your doctor.
* When discontinuing treatment,
gradual dose reduction rather than
abrupt cessation is recommended.
* SPECIAL POPULATIONS:
* Pediatric: The safety or efficacy
of this medicine in pediatric
patients below 18 years of age has
not been established.
* GERIATRIC (>65 years): No
differences in the safety or
efficacy were noted between the
elderly and younger patients. No
dose adjustment is needed.
Stop taking this medicine and notify
your doctor AS SOON AS POSSIBLE if
you experience:
Skin rash; Itching.
Other Common Side Effects:
Delayed ejaculation in males;
Decreased sexual desire; Unusual,
painful & prolonged erection;
Headache; Nausea; Muscle weakness;
Difficulty falling asleep;
Sleepiness; Sweating; Dry mouth;
Constipation; Diarrhea; Dizziness;
Decreased appetite.
If symptoms are mild but do not go
away or are bothersome, check with
your doctor. IF ANY OF THE ABOVE
SIDE EFFECTS IS SEVERE, CALL YOUR
DOCTOR IMMEDIATELY.
Call your doctor for medical advice
about side effects. You may report
side effects to FDA at
1-800-FDA-1088.
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