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Package leaflet: Information for the user


146204 GBflomaxtra

Tab 0,4

United Kingdom

400 micrograms film-coated, prolonged-release tablet


tamsulosin hydrochloride
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.
What is in this leaflet:
1. What Flomaxtra XL is and what it is used for
2. What you need to know before you use Flomaxtra XL
3. How to use Flomaxtra XL
4. Possible side effects
5. How to store Flomaxtra XL
6. Contents of the pack and other information

1. What Flomaxtra XL is and what it is used for
What is Flomaxtra XL
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.
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
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. W
 hat you need to know before you use
Flomaxtra XL
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 alpha1- blockers. If you do feel weak or
dizzy make sure you sit or lie down straight away until the symptoms
have disappeared.
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
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

146204 GBflomaxtraLFT.indd 1

VTB 5424
surgery because of a cloudy lens (cataract) or increased pressure in the
eye (glaucoma).

Eq. to: N/A

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
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.
In particular tell your doctor or pharmacist if you are taking:
• Medicines to lower your blood pressure such as verapamil and
• Medicines to treat HIV such as ritonavir or indinavir
• Medicines to treat a fungal infection such as ketaconazole or
• Other alpha blockers such as doxazosin, indoramin, prazosin or
• Erythromycin, an antibiotic used to treat infections
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
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.

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

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4. Possible side effects
Like all medicines, this medicine can 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
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).
The following side effects have also been reported:
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.
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
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

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

5. How to store Flomaxtra XL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton (EXP). The expiry date refers to the last day of that month.
Store below 30°C in the original package.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Flomaxtra XL contains
The active substance is tamsulosin hydrochloride. Each prolongedrelease tablet contains 400 micrograms tamsulosin hydrochloride which
is equivalent to 367 micrograms of tamsulosin.
The other ingredients are macrogol, magnesium stearate,
butylhydroxytoluene, hypromellose and yellow iron oxide E172.
What Flomaxtra XL looks like and contents of the pack
Flomaxtra XL tablets are round, yellow tablets with `04´ imprinted on
The tablets are supplied in blister packs of 30.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS,
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden,
The Netherlands.
This leaflet was last revised in April 2015.

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


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