FLOMAX is an alpha1 adrenoceptor antagonist indicated for treatment
of the signs and symptoms of benign prostatic hyperplasia (1)
• FLOMAX capsules are not indicated for the treatment of hypertension
Take FLOMAX exactly as prescribed by your doctor.
• Do not crush, chew, or open FLOMAX capsules.
• Take FLOMAX one time each day, about 30 minutes after the same meal each day. For example, you may take FLOMAX 30
minutes after dinner each day.
• If you miss a dose of FLOMAX, take it as soon as you remember. If you miss your dose for the whole day, continue with
your next dose on your regular schedule. Do not take two doses at the same time.
• If you stop or forget to take FLOMAX for several days, talk with your doctor before starting again.
• If you take more FLOMAX capsules than prescribed, call your doctor right away.
Possible side effects of FLOMAX may include:
• Decreased blood pressure when changing positions. FLOMAX capsules may cause a sudden drop in blood pressure upon
standing, especially after the first dose or when changing doses.
Symptoms may include:
Change positions slowly from lying down to sitting up or from a sitting to a standing position until you learn how you react
to FLOMAX capsules. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms are severe or do not
improve, call your doctor.
• Allergic reactions. Make your doctor aware of any allergic reactions you may experience while taking FLOMAX.
Allergic reactions may include:
Rare and more serious allergic reactions may also include:
• swelling of face, tongue, or throat
• difficulty breathing
Get medical help right away if you have swelling of the face, tongue or throat, or difficulty breathing.
• A painful erection that will not go away. FLOMAX capsules can cause a painful erection (priapism), which cannot be
relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an
erection in the future.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome
(IFIS) can happen if you take or have taken FLOMAX capsules. If you need to have cataract surgery, be sure to tell your
surgeon if you take or have taken FLOMAX capsules.
Common side effects of FLOMAX capsules may include:
• runny nose
• decreased semen
These are not all the possible side effects with FLOMAX capsules. Tell your doctor if you have any side effect that bothers you or
that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting
Store FLOMAX capsules at Room Temperature [77ºF (25ºC)]. Short-term exposure to higher or lower temperatures [from 59ºF
(15ºC) to 86ºF (30ºC)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules.
FLOMAX capsules 0.4 mg should not be used with strong inhibitors
of CYP3A4 (e.g., ketoconazole). FLOMAX capsules should be used
with caution in combination with moderate inhibitors of CYP3A4
(e.g., erythomycin), in combination with strong (e.g.,paroxetine) or
moderate (e.g.,terbinafine) inhibitors of CYP2D6, or in patients
known to be CYP2D6 poor metabolizers, particularly at a dose
higher than 0.4 mg (e.g., 0.8 mg) (5.2, 7.1, 12.3)
• Concomitant use of PDE5 inhibitors with tamsulosin can potentially
cause symptomatic hypotension (5.2, 7.3, 12.3)
Should overdosage of FLOMAX capsules lead to hypotension [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)], support
of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by
keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If
necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that
tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.