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FLOMAXTRA XL 400 MICROGRAM TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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Package leaflet: Information for the user

Flomaxtra® XL 400 micrograms Tablets
(tamsulosin hydrochloride)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

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

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.
The name of your medicine is Flomaxtra XL 400 micrograms Tablets but it
will be referred to as Flomaxtra XL throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Flomaxtra XL is and what it is used for
What you need to know before you use Flomaxtra XL
How to use Flomaxtra XL
Possible side effects
How to store Flomaxtra XL
Contents of the pack and other information

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
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
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.

1. What Flomaxtra XL is and what it is used for
Pregnancy, breast-feeding and fertility
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 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
Do not use Flomaxtra XL if you
are allergic (hypersensitive) to tamsulosin or any of the other
ingredients of Flomaxtra XL (listed in section 6)

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.

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.

have a severe liver condition

If you take more Flomaxtra XL than you should

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.

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.

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).

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, pharmacist or nurse.

4. Possible side effects
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).

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
As with other medicines of this type, drowsiness, blurred vision or swelling
of the hands and feet can occur.
Reporting 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:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Flomaxtra XL
There are no special precautions for storage.
Keep out of the sight and reach of children.
Do not use Flomaxtra XL after the expiry date printed on the pack. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any signs of deterioration, you
should seek the advice of your pharmacist (chemist).
If your doctor tells you to stop taking this medicine, take any unused tablets
back to your pharmacist for safe disposal.
Only keep them if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Flomaxtra XL contains
Flomaxtra XL contains the active ingredient, tamsulosin hydrochloride.
Each Flomaxtra XL tablet contains 400 micrograms of tamsulosin
hydrochloride, (equivalent to 367 micrograms tamsulosin) in a prolonged
release formulation.

The other ingredients are macrogol 8000, macrogol 7000000, magnesium
stearate (E470b), butylhydroxytoluene (E321), colloidal silica (E551),
hypromellose (E464) and yellow iron oxide (E172).
What Flomaxtra XL looks like and contents of the pack
Flomaxtra XL tablets are hard mustard yellow, round bi-convex film coated
tablets which are plain on one side and ‘04’ debossed on the other side.
The tablets are available in aluminium foil blister packs containing 30
tablets.
Manufactured by:
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Holland.
Procured from within the EU and repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Flomaxtra® XL 400 micrograms Tablets
PL 18799/1551
Leaflet date: 01.09.2015

POM

Flomaxtra is a registered trademark of Yamanouchi Pharma Ltd.

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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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