Flomax

INDICATIONS & USAGE

FLOMAX CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

PREGNANCY

GERIATRIC USE

NURSING MOTHERS

PEDIATRIC USE

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

FLOMAX ADVERSE REACTIONS

• ●     The adverse event occurred for the first time after initial dosing with double-blind study medication.

• ●     The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or

• ●     The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment.

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL PATIENT PACKAGE INSERT

• ●     FLOMAX is not for women.

• ●     FLOMAX is not for children.

• ●     Before taking FLOMAX, tell your doctor about all your medical conditions including:

• ●               any kidney or liver problems.

• ●               any history of low blood pressure.

• ●               any allergies to sulfa or any other medicines.

• ●               if you are planning to have cataract surgery.

• ●     Tell your doctor about all the medicines you take including:

• ●               any prescription medicines, including blood pressure medicines

• ●               any non-prescription medicines, including vitamins and herbal supplements.

• ●     Some of your other medicines may affect the way FLOMAX works. Especially tell your doctor if you take a medicine for high blood pressure. You should not take FLOMAX if you are already taking certain blood pressure medicines.

• ●Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

• ●How should I take FLOMAX?

• ●     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.

• ●     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:

• ●               fainting

• ●               dizziness

• ●               lightheadedness

• ●     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.

• ●               rash

• ●               itching

• ●               hives

• ●               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. If you need to have cataract surgery, be sure to tell your surgeon if you take or have taken FLOMAX.

• ●     runny nose

• ●     dizziness

• ●     decreased semen

• ●     Active Ingredient: tamsulosin hydrochloride

• ●     Inactive Ingredients: methacrylic acid copolymer dispersion NF, microcrystalline cellulose, triacetin, calcium stearate, talc, FD&C blue No. 2, titanium dioxide, ferric oxide, gelatin, and trace amounts of black edible ink.

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION