PACKAGE LEAFLET: INFORMATION FOR THE USER FLOMAXTRA® XL 400 micrograms film-coated prolonged release tablets

(tamsulosin hydrochloride)

Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye glaucoma).

Your medicine is available as the above name but will be

referred to as Flomaxtra XL throughout this leaflet.

Read all of this leaflet carefully before you start taking this

medicine. It contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Flomaxtra XL is and what it is used for

2.    Before you use Flomaxtra XL

3.    How to use Flomaxtra XL

4.    Possible side effects

5.    How to store Flomaxtra XL

6.    Further information

Children

Do not give this medicine to children or adolescents under 18 years because it does not work in this population.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Flomaxtra XL can affect the way that some other medicines work and some other medicines can affect the way that Flomaxtra XL works.

In particular tell your doctor or pharmacist if you are taking:

•    Medicines to lower your blood pressure such as verapamil and diltiazem

•    Medicines to treat HIV such as ritonavir or indinavir.

•    Medicines to treat a fungal infection such as ketaconazole or itraconazole

•    Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin

•    Erythromycin, an antibiotic used to treat infections

1. What Flomaxtra XL is and what it is used for

What is Flomaxtra XL

The active ingredient in Flomaxtra XL is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder and urethra there are specialised cells containing alpha_1A-receptors that cause the muscles in the urethra to tighten. Flomaxtra XL is an alpha_1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

What Flomaxtra XL is used for

Flomaxtra XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

Please inform your doctor that you are on Flomaxtra XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic'.

Pregnancy, breast-feeding and fertility

Flomaxtra XL is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

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3. How to use Flomaxtra XL

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2. Before you use Flomaxtra XL

Do not use Flomaxtra XL if you

•    are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Flomaxtra XL (see list in section 6 'Further information')

•    have a severe liver condition

•    have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Flomaxtra XL, particularly if you are also taking other alpha₁ - blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Dosage

For adults and the elderly, the dose is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crunch or chew.

Your doctor may want to examine you from time to time whilst you are taking this medicine.

If you take more Flomaxtra XL than you should

If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you.

If you forget to take Flomaxtra XL

You may take your tablet later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily tablet from the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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Take special care with Flomaxtra XL (and speak to your doctor)

•    If you have kidney problems

•    If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used.

4. Possible side effects

Like all medicines, Flomaxtra XL may cause side effects, although not everybody gets them.

Stop taking this medicine and consult your doctor immediately if any of the following occur - you may need medical treatment.

Rare (affects less than 1 in 1000 people)

• Swelling of the face, throat or tongue with breathing problems linked to allergy

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6. Further information

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5. How to store Flomaxtra XL