How does it work?

Flomaxtra XL tablets contain the active ingredient tamsulosinhydrochloride, which is a type of medicine called an alpha blocker. It works byblocking alpha receptors that are found in the muscle in the prostate gland.

The prostate gland, which is found only in men, lies at the topof the tube connecting the bladder to the outside (urethra). The prostate glandoften enlarges with advancing age (benign prostatic hyperplasia), pressing onthe urethra and obstructing the flow of urine from the bladder. This can causevarious urinary symptoms, such as difficulty passing urine.

Tamsulosin blocks alpha receptors in the muscle of the prostategland, which causes the muscle in the prostate to relax. This allows urine toflow freely past the prostate and relieves the urinary symptoms.

Flomaxtra XL are 'prolonged-release'tablets. They are designed to release the tamsulosin gradually as they passthrough the stomach and intestine, so that a steady amount of medicine isabsorbed into the bloodstream throughout the day. The tablets must be swallowedwhole and must not be chewed, broken or crushed, as this would stop the prolonged-release action from working.

What is it used for?

• Enlarged prostate gland (benign prostatic hyperplasia).

Warning!

• This medicine may cause dizziness, light-headedness and on rare occasions fainting. Take care when moving from a lying down or sitting position to sitting or standing, particularly if you wake up in the night, until you know how this medicine affects you. If you feel dizzy or light-headed at any time during treatment, sit or lie down until the symptoms pass.
• This medicine may cause drowsiness, dizziness or blurred vision and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• This medicine does not cause prostate cancer, but prostate cancer can be another cause of an enlarged prostate gland. For this reason, tests for prostate cancer should be carried out before you start treatment with this medicine, and at regular intervals thereafter. One test that can be carried out is a digital rectal examination (DRE), to check if the prostate gland is enlarged. The other is to measure the level of prostate specific antigen (PSA) in the blood. An increase in the PSA levels may mean that the prostate gland is enlarged.
• If you are scheduled to have eye surgery for cataracts it is important to let your eye specialist know if you are or have been taking this medicine. This is because tamsulosin can make your pupil dilate poorly and the iris (the coloured circular part of the eye) become floppy during the procedure. The specialist needs to know if you have been taking this medicine so they can take appropriate precautions with the medicines and techniques they use during the surgery. You may be asked to stop taking this medicine for a period of time before cataract surgery. Check with your doctor.

Use with caution in

• Severely decreased kidney function.

Not to be used in

• History of drops in blood pressure when moving from a sitting or lying position to standing, which causes dizziness (postural hypotension).
• Severely decreased liver function.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.

If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Label warnings

• This medication is to be swallowed whole, not chewed.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Dizziness.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Headache.
• Awareness of your heartbeat (palpitations).
• A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
• Inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose.
• Disturbances of the gut such as diarrhoea, constipation, nausea or vomiting.
• Skin reactions such as rash and itch.
• Abnormal ejaculation.
• Weakness or loss of strength (asthenia).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Fainting (syncope).
• Swelling due to fluid retention (oedema).

Very rare (affect less than 1 in 10,000 people)

• Persistent painful erection of the penis (priapism).

Unknown frequency

• Drowsiness.
• Blurred vision.
• Dry mouth.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.

For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

If this medicine is taken with other medicines that can reduceblood pressure, this effect may be enhanced, with an increased chance ofdizziness or fainting. Other medicines that may reduce blood pressure includethe following:

• anaesthetics
• medicines for high blood pressure
• other alpha blockers
• phosphodiesterase type 5 inhibitors for impotence, eg sildenafil, vardenafil, tadalafil.

Other medicines containing the same active ingredient