Flomax

Flomax (tamsulosin) is an oral drug for the treatment of men who are having difficulty urinating because of enlarged prostates from benign prostatic hyperplasia (BPH).

• The recommended starting dose is 0.4 once daily about 30 minutes after the same meal time each day.
• When taken on an empty stomach, more of the medication is absorbed.
• This could cause a greater effect and potentially a drop in blood pressure.
• The dose may be increased to 0.8 mg once daily after 2 to 4 weeks if the response is not adequate.
• The capsules should not be crushed, chewed or opened.

Flomax is a prescription medication used to treat the symptoms of enlarged prostate, known medically as benign prostatic hyperplasia (BPH).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects can occur. See "Drug Precautions" section.

Common side effects of Flomax may include:

• headache
• dizziness
• runny nose
• abnormal ejaculation
• general weakness
• back pain
• diarrhea
• upper respiratory infection
• chest pain
• cough
• sleepiness
• nausea
• insomnia
• decreased libido
• tooth disorder
• blurred vision

These are not all the possible side effects with Flomax. 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. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. It is not known if Flomax will harm your unborn baby. This medication should not be taken during pregnancy. Tell your doctor if you become pregnant while taking Flomax.

Absorption

Bioavailability

Essentially completely absorbed following oral administration under fasting conditions; peak plasma concentrations attained within 4–5 hours.1

Food

Food delays time to peak plasma concentration by about 2 hours.1 When administered under fasting conditions, bioavailability and peak plasma concentration are increased by 30 and 40–70%, respectively, compared with fed state.1

Distribution

Extent

Appears to distribute into extracellular fluids in humans.1 In animals, distributed into kidney, prostate, liver, gallbladder, heart, aorta, and brown fat, with minimal distribution into brain, spinal cord, and testes.1

Plasma Protein Binding

94–99% (mainly to α1-acid glycoprotein).1

Special Populations

In patients with moderate hepatic impairment, protein binding is altered, resulting in changes in overall plasma concentrations; however, no substantial alterations in intrinsic clearance and concentrations of unbound drug.1 8 13

In patients with renal impairment, protein binding is altered, resulting in changes in overall plasma concentrations; however, no substantial alterations in intrinsic clearance and concentrations of unbound drug.1 8 13

Elimination

Metabolism

Extensively metabolized by CYP enzymes (specific isoenzyme[s] not identified) in the liver.1 Metabolites undergo further conjugation prior to excretion.1

Elimination Route

Excreted in urine (76%) and feces (21%).1

Half-life

Because of absorption rate-controlled pharmacokinetics of tamsulosin capsules, apparent half-life is about 9–13 hours in healthy individuals and 14–15 hours in patients with BPH.1

Special Populations

In males 55–75 years of age, intrinsic clearance is decreased and elimination half-life is prolonged, resulting in a 40% increase in AUC compared with males 20–32 years of age.1 34

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Change in sex ability.
• Back pain.
• Cough.
• Loose stools (diarrhea).
• Dizziness.
• Runny nose.
• Stuffy nose.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

  Mechanism of Action

The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic. The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in the human prostate. At least three discrete alpha1 adrenoceptor subtypes have been identified: alpha1A, alpha1B, and alpha1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1 receptors in the human prostate are of the alpha1A subtype.

Flomax capsules are not intended for use as an antihypertensive drug.

  Pharmacodynamics

Urologic pharmacodynamic effects have been evaluated in neurologically impaired pediatric patients and in adults with BPH [see Use in Specific Populations (8.4) and Clinical Studies (14)].

  Pharmacokinetics

The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg.

Absorption of tamsulosin hydrochloride from Flomax capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions. Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with achievement of steady-state concentrations by the fifth day of once-a-day dosing.

The time to maximum concentration (Tmax) is reached by 4 to 5 hours under fasting conditions and by 6 to 7 hours when Flomax capsules are administered with food. Taking Flomax capsules under fasted conditions results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations (Cmax) compared to fed conditions (Figure 1).

Figure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-Dose Administration of Flomax Capsules 0.4 mg Under Fasted and Fed Conditions (n=8)

The effects of food on the pharmacokinetics of tamsulosin hydrochloride are consistent regardless of whether a Flomax capsule is taken with a light breakfast or a high-fat breakfast (Table 2).

The mean steady-state apparent volume of distribution of tamsulosin hydrochloride after intravenous administration to 10 healthy male adults was 16 L, which is suggestive of distribution into extracellular fluids in the body.

Tamsulosin hydrochloride is extensively bound to human plasma proteins (94% to 99%), primarily alpha1 acid glycoprotein (AAG), with linear binding over a wide concentration range (20 to 600 ng/mL). The results of two-way in vitro studies indicate that the binding of tamsulosin hydrochloride to human plasma proteins is not affected by amitriptyline, diclofenac, glyburide, simvastatin plus simvastatin-hydroxy acid metabolite, warfarin, diazepam, propranolol, trichlormethiazide, or chlormadinone. Likewise, tamsulosin hydrochloride had no effect on the extent of binding of these drugs.

There is no enantiomeric bioconversion from tamsulosin hydrochloride [R(-) isomer] to the S(+) isomer in humans. Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged. However, the pharmacokinetic profile of the metabolites in humans has not been established. Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6 as well as via some minor participation of other CYP isoenzymes. Inhibition of hepatic drug-metabolizing enzymes may lead to increased exposure to tamsulosin [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. The metabolites of tamsulosin hydrochloride undergo extensive conjugation to glucuronide or sulfate prior to renal excretion.

Incubations with human liver microsomes showed no evidence of clinically significant metabolic interactions between tamsulosin hydrochloride and amitriptyline, albuterol (beta agonist), glyburide (glibenclamide) and finasteride (5alpha-reductase inhibitor for treatment of BPH). However, results of the in vitro testing of the tamsulosin hydrochloride interaction with diclofenac and warfarin were equivocal.

On administration of the radiolabeled dose of tamsulosin hydrochloride to 4 healthy volunteers, 97% of the administered radioactivity was recovered, with urine (76%) representing the primary route of excretion compared to feces (21%) over 168 hours.

Following intravenous or oral administration of an immediate-release formulation, the elimination half-life of tamsulosin hydrochloride in plasma ranged from 5 to 7 hours. Because of absorption rate-controlled pharmacokinetics with Flomax capsules, the apparent half-life of tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin hydrochloride undergoes restrictive clearance in humans, with a relatively low systemic clearance (2.88 L/h).

Pediatric Use

Flomax capsules are not indicated for use in pediatric populations [see Use in Specific Populations (8.4)].

Geriatric (Age) Use

Cross-study comparison of Flomax capsules overall exposure (AUC) and half-life indicates that the pharmacokinetic disposition of tamsulosin hydrochloride may be slightly prolonged in geriatric males compared to young, healthy male volunteers. Intrinsic clearance is independent of tamsulosin hydrochloride binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects of age 55 to 75 years compared to subjects of age 20 to 32 years [see Use in Specific Populations (8.5)].

Renal Impairment

The pharmacokinetics of tamsulosin hydrochloride have been compared in 6 subjects with mild-moderate (30≤ CLcr <70 mL/min/1.73 m2) or moderate-severe (10≤ CLcr <30 mL/min/1.73 m2) renal impairment and 6 normal subjects (CLcr >90 mL/min/1.73 m2). While a change in the overall plasma concentration of tamsulosin hydrochloride was observed as the result of altered binding to AAG, the unbound (active) concentration of tamsulosin hydrochloride, as well as the intrinsic clearance, remained relatively constant. Therefore, patients with renal impairment do not require an adjustment in Flomax capsules dosing. However, patients with end-stage renal disease (CLcr <10 mL/min/1.73 m2) have not been studied [see Use in Specific Populations (8.6)].

Hepatic Impairment

The pharmacokinetics of tamsulosin hydrochloride have been compared in 8 subjects with moderate hepatic impairment (Child-Pugh’s classification: Grades A and B) and 8 normal subjects. While a change in the overall plasma concentration of tamsulosin hydrochloride was observed as the result of altered binding to AAG, the unbound (active) concentration of tamsulosin hydrochloride does not change significantly, with only a modest (32%) change in intrinsic clearance of unbound tamsulosin hydrochloride. Therefore, patients with moderate hepatic impairment do not require an adjustment in Flomax capsules dosage. Flomax has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

Drug Interactions
Cytochrome P450 Inhibition

Strong and Moderate Inhibitors of CYP3A4 or CYP2D6
The effects of ketoconazole (a strong inhibitor of CYP3A4) at 400 mg once daily for 5 days on the pharmacokinetics of a single Flomax capsule 0.4 mg dose was investigated in 24 healthy volunteers (age range 23 to 47 years). Concomitant treatment with ketoconazole resulted in an increase in the Cmax and AUC of tamsulosin by a factor of 2.2 and 2.8, respectively [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of Flomax have not been evaluated [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

The effects of paroxetine (a strong inhibitor of CYP2D6) at 20 mg once daily for 9 days on the pharmacokinetics of a single Flomax capsule 0.4 mg dose was investigated in 24 healthy volunteers (age range 23 to 47 years). Concomitant treatment with paroxetine resulted in an increase in the Cmax and AUC of tamsulosin by a factor of 1.3 and 1.6, respectively [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. A similar increase in exposure is expected in CYP2D6 poor metabolizers (PM) as compared to extensive metabolizers (EM). A fraction of the population (about 7% of Caucasians and 2% of African Americans) are CYP2D6 PMs. Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when Flomax 0.4 mg is co-administered with strong CYP3A4 inhibitors in CYP2D6 PMs, Flomax 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g., terbinafine) on the pharmacokinetics of Flomax have not been evaluated [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

The effects of co-administration of both a CYP3A4 and a CYP2D6 inhibitor with Flomax capsules have not been evaluated. However, there is a potential for significant increase in tamsulosin exposure when Flomax 0.4 mg is co-administered with a combination of both CYP3A4 and CYP2D6 inhibitors [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

Cimetidine

The effects of cimetidine at the highest recommended dose (400 mg every 6 hours for 6 days) on the pharmacokinetics of a single Flomax capsule 0.4 mg dose was investigated in 10 healthy volunteers (age range 21 to 38 years). Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of tamsulosin hydrochloride, which resulted in a moderate increase in tamsulosin hydrochloride AUC (44%) [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].

Other Alpha Adrenergic Blocking Agents

The pharmacokinetic and pharmacodynamic interactions between Flomax capsules and other alpha adrenergic blocking agents have not been determined; however, interactions between Flomax capsules and other alpha adrenergic blocking agents may be expected [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].

PDE5 Inhibitors

Caution is advised when alpha adrenergic blocking agents, including Flomax, are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.2) and Drug Interactions (7.3)].

Warfarin

A definitive drug-drug interaction study between tamsulosin hydrochloride and warfarin was not conducted. Results from limited in vitro and in vivo studies are inconclusive. Therefore, caution should be exercised with concomitant administration of warfarin and Flomax capsules [see Warnings and Precautions (5.2) and Drug Interactions (7.4)].

Nifedipine, Atenolol, Enalapril

In three studies in hypertensive subjects (age range 47 to 79 years) whose blood pressure was controlled with stable doses of nifedipine, atenolol, or enalapril for at least 3 months, Flomax capsules 0.4 mg for 7 days followed by Flomax capsules 0.8 mg for another 7 days (n=8 per study) resulted in no clinically significant effects on blood pressure and pulse rate compared to placebo (n=4 per study). Therefore, dosage adjustments are not necessary when Flomax capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see Drug Interactions (7.5)].

Digoxin and Theophylline

In two studies in healthy volunteers (n=10 per study; age range 19 to 39 years) receiving Flomax capsules 0.4 mg/day for 2 days, followed by Flomax capsules 0.8 mg/day for 5 to 8 days, single intravenous doses of digoxin 0.5 mg or theophylline 5 mg/kg resulted in no change in the pharmacokinetics of digoxin or theophylline. Therefore, dosage adjustments are not necessary when a Flomax capsule is administered concomitantly with digoxin or theophylline [see Drug Interactions (7.6)].

Furosemide

The pharmacokinetic and pharmacodynamic interaction between Flomax capsules 0.8 mg/day (steady-state) and furosemide 20 mg intravenously (single dose) was evaluated in 10 healthy volunteers (age range 21 to 40 years). Flomax capsules had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in tamsulosin hydrochloride Cmax and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the Flomax capsules dosage [see Drug Interactions (7.7)].

Advise the patient to read the FDA-approved patient labeling (Patient Information)

• Hypotension
  Advise the patient about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking Flomax capsules, and they should be cautioned about driving, operating machinery, or performing hazardous tasks [see Warnings and Precautions (5.1)].
  
  
• Drug Interactions
  Advise the patient that Flomax should not be used in combination with strong inhibitors of CYP3A4 [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].
  
  
• Priapism
  Advise the patient about the possibility of priapism as a result of treatment with Flomax capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.3)].
  
  
• Screening for Prostate Cancer
  Prostate cancer and BPH frequently co-exist; therefore, screen patients for the presence of prostate cancer prior to treatment with Flomax capsules and at regular intervals afterwards [see Warnings and Precautions (5.4)].
  
• Intraoperative Floppy Iris Syndrome
  Advise the patient when considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken Flomax capsules [see Warnings and Precautions (5.5)].
  
  
• Administration
  Advise the patient that Flomax capsules should not be crushed, chewed or opened [see Dosage and Administration (2)].

FDA-approved Patient Labeling
Patient labeling is provided as a tear-off leaflet at the end of this prescribing information.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Flomax is a registered trademark of, and licensed from:
Astellas Pharma Inc.
Tokyo 103-8411, JAPAN

Copyright © 2016, ALL RIGHTS RESERVED

IT6314BA212016
2000007096

PATIENT INFORMATION

Flomax® (Flō-max)
(tamsulosin hydrochloride, USP)
Capsules, 0.4 mg

Read the Patient Information that comes with Flomax capsules before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.

What is Flomax?
Flomax is a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition your doctor may refer to as an enlarged prostate.

• Flomax is not for women.
• Flomax is not for children.

Who should not take Flomax?
Do not take Flomax capsules if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Flomax capsules.

What should I tell my doctor before using Flomax?

• 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 or glaucoma 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 capsules work. 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.

What are the possible side effects of Flomax capsules?
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:
  • 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.
  Allergic reactions may include:
  • rash
  • itching
  • hives
  Rare and more serious allergic reactions may also occur. Get medical help right away if you have any of the following reactions:
  • swelling of face, tongue, or throat
  • difficulty breathing
  • blistering of the skin
    
    
• 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 or glaucoma surgery. During cataract or glaucoma 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 or glaucoma 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
• dizziness
• 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 www.fda.gov/medwatch.

What should I avoid while taking Flomax capsules?
Avoid driving, operating machinery, or other dangerous activities, until you know how Flomax affects you. Flomax capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. See "What are the possible side effects of Flomax capsules?"

How do I store Flomax capsules?
Store Flomax capsules at Room Temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules.

Keep Flomax capsules and all medicines out of the reach of children.

General information
This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. Do not give Flomax to other people, even if they have the same symptoms that you have. It may harm them.

While taking Flomax, you must have regular checkups. Follow your doctor's advice about when to have these checkups.

BPH can occur with other more serious conditions, including prostate cancer. Therefore, ask your doctor about screening for prostate cancer prior to treatment with Flomax capsules and at regular intervals afterwards.

This patient information leaflet summarizes the most important information about Flomax. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Flomax that is written for health professionals. For current prescribing information scan the code below, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in Flomax capsules?

• Active Ingredient: tamsulosin hydrochloride, USP
• Inactive Ingredients: microcrystalline cellulose; methacrylic acid copolymer dispersion; triacetin; calcium stearate; talc; gelatin; iron oxide; FD&C blue No. 2; titanium dioxide; propylene glycol; and shellac.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Flomax is a registered trademark of, and licensed from:
Astellas Pharma Inc.
Tokyo 103-8411, JAPAN

Copyright © 2016, ALL RIGHTS RESERVED

IT6314BA212016
2000007096

Revised: January 2016

Flomax
(tamsulosin hydrochloride, USP)
0.4 mg
100 capsules
NDC: 0597-0058-01

Take Flomax exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Flomax is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day.

Do not crush, chew, or open the capsule. Swallow the capsule whole.

Flomax lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. You will also need to be checked for prostate cancer before and during treatment with Flomax.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking Flomax for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Applies to tamsulosin: oral capsule

Along with its needed effects, tamsulosin (the active ingredient contained in Flomax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tamsulosin:

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination

• Chest pain

• Dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of constant movement of self or surroundings
• painful or prolonged erection of the penis
• sensation of spinning

• Blistering, peeling, or loosening of the skin
• blurred vision
• confusion
• diarrhea
• difficult or labored breathing
• fast, pounding, or irregular heartbeat or pulse
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• tightness of the chest
• unusual tiredness or weakness

Some side effects of tamsulosin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal ejaculation
• back pain
• body aches or pain
• congestion
• headache
• lack or loss of strength
• sneezing
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

• Decreased interest in sexual intercourse
• decreased sexual drive or performance
• drowsiness
• inability to have or keep an erection
• increased cough
• loss in sexual ability, desire, drive, or performance
• nausea
• pain or tenderness around the eyes and cheekbones
• sleepiness or unusual drowsiness
• tooth disorder
• trouble sleeping

• Constipation
• hives or welts, skin rash
• redness of the skin
• vomiting

Flomax is a brand (trade) name for tamsulosin. Tamsulosin works on alpha receptors to relax muscles in the neck of the bladder and the prostate. This improves urine flow and reduces the symptoms of benign prostatic hyperplasia (BPH).

Flomax restores urine flow in men with BPH but may cause a drop in blood pressure when going from a sitting to a standing position.

Peak concentrations are reached within four to five hours when taken on an empty stomach or within six to seven hours when taken with food. May take up to five days before the full effects of Flomax on urine flow are achieved.

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