Flomax: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed FLOMAX because you have a medical condition called benign prostatic hyperplasia or BPH.

What it does:

FLOMAX acts by relaxing muscles in the prostate and bladder neck at the site of obstruction, resulting in improved urine flow, and reduced BPH symptoms.

BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:

$ frequent sleep interruption caused by a need to urinate; $ having a weak urinary stream;

$ a sensation of not emptying your bladder completely after you

finish urinating;

$ pushing or straining to begin urination;

$ stopping and starting again several times when urinating; $ urinating again less than 2 hours after you finish urinating; $ finding it difficult to postpone urination.

When it should not be used:

You should not use FLOMAX if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients in FLOMAX. Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).

What the medicinal ingredient is:

Tamsulosin Hydrochloride

What the important non-medicinal ingredients are: Calcium stearate Eudragit L30-55(contains methacrylic acid copolymer, polysorbate 80, and sodium lauryl sulphate), FD&C blue No.2, ferric oxide (red and yellow), gelatine, microcrystalline cellulose, talc, titanium dioxide, triacetin.

What dosage forms it comes in:

Sustained-release Capsules. Each capsule contains 0.4 mg tamsulosin hydrochloride.

WARNINGS AND PRECAUTIONS

Rarely, fainting can occur during the use of FLOMAX, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.

FLOMAX should not be used in women or children.

BEFORE you use FLOMAX talk to your doctor or pharmacist:

• if you suffer from severe liver problems;
• if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up); $ if you have kidney problems;

$ if you have previously taken FLOMAX and became unwell;

$ if you are going to drive, operate machinery or perform hazardous tasks.

You must see your doctor regularly. While taking FLOMAX, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.

If you are undergoing eye surgery because of cloudiness of the lens (cataract) please inform your eye specialist that you are using or have used FLOMAX. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

INTERACTIONS WITH THIS MEDICATION

Taking FLOMAX with other medicines from the same class (alpha₁- adrenoceptor blockers) may cause an unwanted decrease in blood pressure.

Please tell your doctor or pharmacist if you are taking or have recently taken cimetidine or any other medicines, including medicines obtained without a prescription.

PROPER USE OF THIS MEDICATION

Usual dose:

Follow your doctor’s advice about how to take FLOMAX. You should take one capsule (0.4 mg) following the same meal everyday.

Do not chew or open FLOMAX capsules. These capsules are specially formulated to control the delivery of tamsulosin hydrochloride to the blood stream.

Do not share FLOMAX with anyone else; it is prescribed only for you.

If you interrupt your treatment for several days or more, resume treatment after consulting with your physician.

Overdose:

Taking too many FLOMAX capsules may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much FLOMAX.

Missed Dose:

You may take your daily FLOMAX capsule later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Never take a double dose to make up for the forgotten capsule.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all prescription drugs, FLOMAX may cause side effects. Side effects due to FLOMAX may include:

Common (1-10%):

Dizziness, particularly when getting up from a seated or lying position

Some men may experience dizziness or fainting caused by a decrease in blood pressure after taking FLOMAX. Although these symptoms are unlikely, you should avoid driving or hazardous tasks for 12 hours after the initial dose.

Uncommon (0.1-1%):

Headache, palpitations (a feeling of rapid beating of the heart that may be more forceful), reduced blood pressure e.g. when getting up quickly from a seated or lying position sometimes associated with dizziness; runny or blocked nose (rhinitis), diarrhea, feeling sick and vomiting, constipation, weakness (asthenia), rashes, itching and hives (urticaria), abnormal ejaculation. The latter means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.

Rare (0.01-0.1%):

Rarely, fainting can occur during the use of FLOMAX, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.

Sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema). If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.

Very rare (<0.01%):

Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).

There have been reports that FLOMAX Capsules and similar medications have caused prolonged, painful erection of the penis, which is unrelieved by sexual intercourse or masturbation. This

condition, if untreated, can lead to permanent inability to have an erection. If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.

If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken FLOMAX, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

This is not a complete list of side effects. For any unexpected

* If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.

HOW TO STORE IT

Store at room temperature (15-30ºC).

Keep FLOMAX and all medicines out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 866-234-2345

Toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.boehringer-ingelheim.ca

or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, ext. 4633 (Medical Information).

Please visit our website to see if more up-to-date information has been posted.

Last revised: August 15, 2007

Licensed from and Manufactured by:

Astellas Pharma Inc.

Tokyo, Japan

Distributed by:

Boehringer Ingelheim (Canada) Ltd.

Burlington, Ont., Canada