Skip to Content

UK Edition. Click here for US version.

FLOMAXTRA XL 400 MICROGRAMS TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Flomaxtra XL 400 micrograms Tablets
(tamsulosin hydrochloride)

Your medicine is available using the name Flomaxtra XL
400 micrograms Tablets but will be referred to as Flomaxtra
XL throughout this 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.

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

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 alpha1Aadrenoceptor 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

Do not use Flomaxtra XL if you

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.





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 (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

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.

Page 1 of 2

Flomaxtra XL is not indicated for use in women.

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

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)

5. How to store Flomaxtra XL










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 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: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.








Keep all medicines 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.
There are no special precautions for storage.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if
your doctor tells you to.
If the tablets appear discoloured or show any other
signs of deterioration, take them to your pharmacist
who will advise you.
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.

6. Contents of the pack and other
information
What Flomaxtra XL contains

Each film-coated tablet contains tamsulosin hydrochloride 400
micrograms equivalent to 367 micrograms tamsulosin, in a
prolonged-release formulation.
The tablets also contain macrogol 7000000, macrogol 8000,
magnesium stearate (E470b), butylhydroxytoluene (E321),
colloidal silicon dioxide anhydrous (E551),
hypromellose (E464) and yellow iron oxide (E172).

What Flomaxtra XL looks like and contents of the
pack

Flomaxtra XL are round, yellow tablets with ‘04’ imprinted on
them.
The tablets are supplied in blister packs of 30.

Manufacturer

Your medicine is manufactured by:
Astellas Pharma Europe B.V., Elisabethhof 19, Leiderdorp,
2353 EW, The Netherlands
or
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden,
The Netherlands.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0549

POM

Leaflet revision & issue date: 14.01.16
Flomaxtra® is a registered trademark of
Astellas Pharma Europe B.V.
Page 2 of 2

Expand view ⇕

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.

Hide