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FLOMAXTRA XL 400MICROGRAM FILM-COATED PROLONGED RELEASE TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOMAXTRA® XL 400 micrograms
film-coated prolonged release tablets
(tamsulosin hydrochloride)
Your medicine is available as the above name 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. 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

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).

4. Possible side effects

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

Rare (affects less than 1 in 1000 people)
 Swelling of the face, throat or tongue with breathing
problems linked to allergy

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

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 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).

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

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).




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.

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

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 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.
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.

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.



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.
 Store in the original package.
6. Contents of the pack and other information
What Flomaxtra XL contains
Flomaxtra XL contains the active ingredient, tamsulosin
hydrochloride.
Each film-coated prolonged release tablet contains 400
micrograms tamsulosin hydrochloride.
The other ingredients are macrogol 7000000, macrogol 8000,
magnesium stearate (E470B), butylated hydroxytoluene (E321),
colloidal anhydrous silica (E551), hypromellose (E464) and iron
oxide Yellow (E172).
What Flomaxtra XL looks like and contents of the pack
Flomaxtra XL tablets are round, bi-convex, yellow, film-coated
tablets debossed with the code '04' and plain on the reverse.
The tablets are supplied in blister packs of 30.
Manufacturer and Product Licence holder
Flomaxtra XL is 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: G-Pharma Ltd., Dakota Avenue, Salford M50
2PU.
PL 16369/1561

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.
5. How to store Flomaxtra XL



Keep out of the sight and reach of children.
Do not use Flomaxtra XL after the expiry date which is
stated on the blister and outer carton. The expiry date
refers to the last day of that month.
 If your doctor tells you to stop taking Flomaxtra XL, it is
important to return any which are left over to your
pharmacist.
 If your Flomaxtra XL becomes discolored or shows any
signs of deterioration, consult your pharmacist who will tell
you what to do.

POM

Date of revision of this leaflet: 27/08/2015
Flomaxtra is a Registered Trademark of Astellas Pharma
Europe B.V.

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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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