Consumer Medicine Information

FLOMAX™ Capsules

tamsulosin hydrochloride
400 micrograms

This leaflet contains information about Flomax. Please read it carefully before you start to take your medicine. Keep it, as you may want to read it again. The information in this leaflet answers some common questions. Your doctor or pharmacist have more information. This leaflet is not intended to take the place of discussion with your doctor.

Talk to your doctor or pharmacist if there is anything that is worrying you or you do not understand.

WHAT IS Flomax

Flomax is a medicine for use by MEN only. Flomax is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). This is a noncancerous enlargement of the prostate gland.

WHAT IS Flomax USED FOR

Flomax belongs to a group of medicines called alpha-blockers.

Your doctor has prescribed Flomax for you because you have symptoms caused by an enlarged prostate gland. BPH occurs only in men. It is common in men over the age of 50 years.

The prostate gland is deep in your pelvis, below your bladder. Because your prostate has become bigger than it should be, it is affecting how well you are able to pass your urine. This causes some, or all of the following symptoms; they usually start gradually and increase in severity:

• Urine flow is slow, the stream is poor.
• The urine stream may become a trickle, or it may stop and start.
• You find a delay when you try to pass urine, and you have to strain to do so.
• You feel that you cannot empty your bladder completely.
• You may dribble at the end of passing urine.
• You need to pass urine often during the day.
• You need to get up often during the night to pass urine.
• You feel an urgency to pass urine as soon as you first feel the need to do so.

HOW DOES Flomax WORK

When you pass urine, the urine travels from the bladder through a channel in the tissues of the prostate. When the gland becomes large, it presses on this channel which then becomes narrow. The channel may even become effectively completely blocked. If this happens, no urine can be passed. This is a medical emergency.

Flomax is a medicine which relaxes the smooth muscle. It is particularly active at relaxing smooth muscle in the prostate. Flomax works with BPH by widening the channel through the prostate gland. This allows the urine to flow easily.

WHEN SHOULD I NOT TAKE Flomax

Flomax is for use by MEN only. If you are a woman or a child, do not take Flomax. If you are not sure whether you should start taking Flomax you should contact your doctor.

You should not take Flomax if:

• you are allergic to any of the ingredients in the capsule (see "WHAT DOES Flomax CONTAIN?").
• you become dizzy or light-headed or have low blood pressure when you stand up, after sitting or lying down. This is called orthostatic hypotension.
• you have serious liver problems.
• you have serious kidney function problems.
• you are taking other medication which relaxes the smooth muscle (some of the tradenames are Minipress, Prasig, Hytrin).

BEFORE YOU TAKE Flomax

Use Flomax only if your doctor has prescribed it for you.

All medicines have benefits and risks. In deciding to prescribe Flomax for you, your doctor has weighed the risk of taking Flomax against the benefit it is expected to have for you.

Your doctor has prescribed Flomax for BPH and not for prostate cancer. These two separate conditions may have similar symptoms. A man can have prostate cancer and BPH at the same time. You should be checked for prostate cancer before you start Flomax. It is recommended that men be checked for prostate cancer once a year, from 50 years of age onwards. These checks should continue while you are on Flomax.

Before you start taking Flomax capsules you should tell your doctor if:

• you are allergic to Flomax or any of its ingredients (see "WHAT DOES Flomax CONTAIN?").
• you are taking any other medicines and what they are. This includes medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular, tell your doctor if you are taking cimetidine, a medicine generally used to treat stomach ulcers or reflux.
• you have angina (severe pain in the chest, usually on exertion) or have had a heart attack during the last six months.
• your blood pressure is too high, or too low, or it is controlled by medication.
• you have had ejaculation problems.
• you are suffering from any other illness.

HOW MUCH Flomax SHOULD I TAKE

The dose is one capsule a day. Take it about thirty minutes after breakfast or first meal of the day. Swallow the capsule whole, preferably with a glass of water. Do not bite or chew the capsule, as this stops it being absorbed at the desired rate. Do not take Flomax on an empty stomach as the risk of feeling faint or dizzy on standing up (orthostatic hypotension) is increased.

Do not take Flomax if the packaging is torn or shows signs of tampering, or if the capsules show visible signs of deterioration.

If you forget to take it

• If you forget to take your daily Flomax after breakfast or first meal of the day, you can take it later the same day after another meal
• If you miss a whole day, just continue to take your normal daily dose the next day after breakfast or first meal of the day
• Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take Flomax, ask your pharmacist for some hints.

SIDE EFFECTS

Although most men prescribed Flomax benefit, but as with any medicines, some side effects may occur. Flomax does not usually cause any problems.

A few people may be allergic to some medicines. If you develop a skin rash, itchiness or swelling of the face, lips or tongue, tell your doctor immediately, as you may be having an allergic reaction to Flomax. Swelling of the face, lips or tongue may cause difficulty in swallowing or breathing.

One side effect of Flomax is known as "retrograde ejaculation". When this happens the ejaculation fluid is not squirted out, most of it runs back into the bladder. Retrograde ejaculation is painless.

Other side effects reported by people taking Flomax include dizziness, headache, itching, weakness, dizziness on standing, nausea, vomiting, diarrhoea, constipation, rash, fast heart beats, increase in coughing, blocked nose and infection.

Flomax can occasionally cause people to feel faint and dizzy. You should get up slowly from the sitting or lying position to reduce the risk of dizziness or light-headedness. If you do feel faint on standing up, you should lie down for a short while. If the dizziness persists you should contact your doctor. You must not drive a car or operate machinery if you feel dizzy.

This is not a complete listing. Other unwanted effects may occur in some men. Tell your doctor if you notice any other effects.

You should always tell your doctor about any problems you have whilst taking Flomax.

OVERDOSAGE

If you think that you or anyone else may have taken too much Flomax, contact your doctor or go to the emergency department of your nearest hospital, or call the New Zealand National Poison Centre on 0800 POISON or 0800 764 766. Do this even if there are no signs of discomfort or poisoning.

There have been no reported cases of overdose. The most likely effect of an overdose would be low blood pressure. This requires medical attention.

WHAT DOES Flomax CONTAIN

Each Flomax capsule contains 400 micrograms of tamsulosin hydrochloride. The capsule is specially designed to gradually release Flomax into the body.

The colours of the capsule are light orange and light brown. The colouring agents in the capsule shell are indigo carmine, titanium dioxide and red and yellow iron oxides.

The capsule is made of hard gelatin; it has a surface marking for identification purposes in black ink (Opacode S-1-8100 HV black).

The capsule also contains cellulose, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulphate, glycerol triacetate, calcium stearate and talc.

There are 30 capsules in each pack.

HOW TO STORE Flomax

Keep Flomax capsules in the original pack until you use them.

Store Flomax capsules below 30°C. Keep the pack in a cool dry place. Do not store Flomax in the bathroom or near the sink, or in a car on a hot day. Do not use after the expiry date on the package. Keep Flomax where children cannot reach it.

This is not all the information available on Flomax. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Flomax is distributed in Australia by:

CSL Limited ABN 99 051 588 348
45 Poplar Road
Parkville 3052
Victoria, Australia

Flomax is distributed in New Zealand by:

CSL (New Zealand) Limited
Level 4, Building 10
666 Great South Road
Penrose
Auckland 6, New Zealand.

Flomax is manufactured by:

Yamanouchi Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
The Netherlands

Date of preparation: 06 August 2003

Flomax™ is a trademark of Yamanouchi Europe B.V.