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FLOMAXTRA XL TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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S863 LEAFLET Flomaxtra 20150707

PATIENT INFORMATION LEAFLET

FLOMAXTRA XL TABLETS
(tamsulosin hydrochloride)
Your medicine is known as Flomaxtra XL Tablets but will be
referred to as Flomaxtra XL throughout the following patient
information leaflet.
Read all of this leaflet carefully before you start taking this
medicine because 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, pharmacist
or nurse.



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



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

Warnings and precautions
Talk to your doctor before using Flomaxtra XL


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. 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).
Children and adolescents
Do not give this medicine to children or adolescents under 18 years
because it does not work in this population.
Other medicines and Flomaxtra XL

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

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. 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.

2. What you need to know before you use Flomaxtra XL

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

3. How to use Flomaxtra XL



Medicines to lower your blood pressure such as verapamil and
diltiazem

5. How to store Flomaxtra XL



Medicines to treat HIV such as ritonavir or indinavir.

6. Contents of the pack and other information



Medicines to treat a fungal infection such as ketaconazole or
itraconazole



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

What is Flomaxtra XL



Erythromycin, an antibiotic used to treat infections

Flomaxtra XL contains the active substance 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.

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.

What is in this leaflet:

4. Possible side effects

1. WHAT FLOMAXTRA XL IS AND WHAT IT IS USED FOR

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.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FLOMAXTRA XL

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.
Driving and using machines
There is no information available on whether Flomaxtra XL affects
the ability to drive or to operate machinery or equipment. However,
it is known that Flomaxtra XL may cause drowsiness, blurred vision,
dizziness and fainting. If you suffer from these do not drive or
operate machinery.

Do not use Flomaxtra XL if you


are allergic to tamsulosin or any of the other ingredients of
Flomaxtra XL (listed in section 6)



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 alpha1blockers. If you do feel weak or dizzy make sure you sit or lie
down straight away until the symptoms have disappeared.

3. HOW TO USE FLOMAXTRA XL
Always take this medicine exactly as your doctor, pharmacist or
nurse has told you. Check with your doctor, pharmacist or nurse if
you are not sure. The recommended dose for adults and the elderly
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

Reporting of side effects

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 get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

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

By reporting side effects you can help provide more information on
the safety of this medicine.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE FLOMAXTRA XL

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store in the original package.

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



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Rare (affects less than 1 in 1000 people)


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

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


Persistent painful erection usually unrelated to sexual activity.



Rash, inflammation and blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal passages or genitals
(Stevens-Johnson syndrome).



Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia,
tachycardia), difficult breathing (dyspnoea).

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flomaxtra XL contains

The following side effects have also been reported:



Each film-coated prolonged release tablet contains
400 micrograms of tamsulosin hydrochloride (equivalent to
367 micrograms tamsulosin).



Flomaxtra XL Tablets also contain the following inactive
ingredients: macrogol 7000000, macrogol 8000, magnesium
stearate, butylated hydroxytoluene, colloidal anhydrous silica,
hypromellose, yellow iron oxide (E172).

Common (affects less than 1 in 10 people)


dizziness



abnormal ejaculation (ejaculation disorder). This means that
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.

What Flomaxtra XL looks like and contents of the pack
Uncommon (affects less than 1 in 100 people)


weakness



headache



runny or blocked nose



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



hypersensitivity reactions such as rash, itching, redness, local
swelling and breathing problems



The Flomaxtra XL tablets are round and yellow and marked ‘04’
on one side and plain on the other side.



Flomaxtra XL tablets are available as blister packs of 30 tablets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Astellas Pharma Europe B.V,
Sylviusweg 62, 2333 BE Leiden, The Netherlands.

Rare (affects less than 1 in 1000 people)


fainting

Not known (frequency cannot be estimated from the available
data):


blurred vision



impaired vision



nose bleeds (epistaxis)



serious skin rashes (erythema multiforme, dermatitis exfoliative)



dry mouth

As with other medicines of this type, drowsiness, blurred vision or
swelling of the hands and feet can occur.

POM

PL. 19488/0863

Leaflet revision date: 07 July 2015
Flomaxtra is a registered trade mark of Yamanouchi Europe BV,
The Netherlands.
S863 LEAFLET Flomaxtra 20150707

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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