PATIENT INFORMATION LEAFLET

Flomaxtra® XL

400 micrograms, film-coated prolonged release tablet
Tamsulosin hydrochloride

What is Flomaxtra XL?

Flomaxtra XL contains 400 micrograms tamsulosin hydrochloride in each modified release tablet, equivalent to 367 micrograms tamsulosin. The tablets also contain macrogol, magnesium stearate, butylhydroxytoluene, hypromellose and yellow iron oxide E172.

Flomaxtra XL tablets are round, yellow tablets with '04' imprinted on them.

The tablets are supplied in blister packs of 30.

Tamsulosin hydrochloride, the active ingredient of Flomaxtra XL, is an alpha1A-adrenoceptor blocker. It relaxes the muscles in the prostate and urethra, and lets urine pass more readily through the urethra and aids urination.

What is Flomaxtra XL used for?

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

In the prostate gland, bladder and urethra there are specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Flomaxtra XL is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

Before using Flomaxtra XL

You should not use Flomaxtra XL if you are allergic to tamsulosin or any of the inactive ingredients, or if you have a severe liver condition.

If you have ever fainted or felt dizzy when suddenly sitting or standing up, you should not take Flomaxtra XL. 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. You should not drive or operate machinery if you feel faint, dizzy, drowsy or have blurred vision until the symptoms have passed. Make sure you tell your doctor about all other medicines you are taking particularly those that lower blood pressure as there maybe a theoretical risk of an enhanced effect whilst taking Flomaxtra XL.

If you are undergoing eye surgery because of cloudiness of the lens (cataract), please inform your eye specialist that you are using or have previously used tamsulosin hydrochloride. 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 postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

Taking Flomaxtra XL

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.

After taking Flomaxtra XL

A small number of people may show side-effects after taking Flomaxtra XL. The following have been reported: Dizziness, abnormal ejaculation (i.e. less, or no noticeable, semen ejaculated), weakness, headache.

The following side-effects have been reported less often: Runny or blocked nose, fainting, dizziness as you sit or stand up, palpitations (rapid or irregular heart beat), gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation and hypersensitivity reactions such as rash, itching, redness or local swelling. As with other medicines of this type, drowsiness, blurred vision, dry mouth or swelling of the hands and feet can occur.

Tell your doctor if any of these symptoms become troublesome. There have been very rare reports of angioedema (swelling of the face, throat or tongue linked to allergy) and priapism (persistent painful erection usually unrelated to sexual activity). Consult your doctor immediately if these occur. You should also tell your doctor or pharmacist if you have any other side-effects after taking Flomaxtra XL.

If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken tamsulosin hydrochloride, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. This only occurs during the operation and it is important for the eye specialist to be aware of this possibility as the operation may need to be performed differently.

General information

Keep all medicines out of the reach and sight of children.

Do not use the tablets after the expiry date printed on the pack.

There are no special precautions for storage.

Remember your medicines have been prescribed for you. Never give your medicines to others, even if it does seem that they have the same condition as you.