FLOMAX RELIEF MR

Active substance: TAMSULOSIN HYDROCHLORIDE

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Package Leaflet: Information for the User

140274

abcd
Read all of this leaflet carefully because it contains
important information for you. This medicine is
available from your pharmacist without
prescription. You will need to see your doctor
within 6 weeks of starting treatment, in order to
confirm that you can take FLOMAX RELIEF longterm from your pharmacist. You need to take
FLOMAX RELIEF as instructed in this leaflet to get
the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more
information or advice, or you do not understand
the instructions
• You must contact your pharmacist or doctor if
your symptoms worsen or do not improve after
2 weeks of treatment
• If a side effect occurs and gets troublesome, or
seems serious, or if you experience any side
effect not listed in this leaflet, tell your doctor or
pharmacist
In this leaflet
1. What FLOMAX RELIEF is and what it is used for
2. Before you take FLOMAX RELIEF
3. How to take FLOMAX RELIEF
4. Possible side effects
5. How to store FLOMAX RELIEF
6. Further information

1. What FLOMAX RELIEF is and what it is

used for


The name of your medicine is FLOMAX RELIEF MR.
FLOMAX RELIEF is a modified release capsule
which contains a medicine called tamsulosin. This
belongs to a group of medicines called ‘alpha
blockers’ (or alpha1A-adrenoceptor antagonists).
FLOMAX RELIEF is used to treat the lower urinary
tract symptoms (LUTS) of a common condition
called benign prostatic hyperplasia (BPH). This is
when the prostate gland gets bigger. The prostate
gland is found just below a man’s bladder. When
your prostate gland gets bigger, it can:
• Make it difficult for you to start urinating
(peeing)
• Mean you take longer or have to urinate more
often
• Lead to the feeling that you still need to urinate
again, even though you have just done so
• Cause you to get up several times in the night
to urinate
FLOMAX RELIEF relieves these problems by:
• Relaxing the muscles in the prostate gland
• Relaxing the muscles in the urethra (the tube
from the bladder to the outside of the body).
This lets urine pass more freely through the
urethra, making it easier to urinate.

• You think you have diabetes and it is not
properly controlled
• You have had prostate surgery
• You have recently had blurred or cloudy vision
and have not been examined by your doctor or
optician
• You are about to undergo eye surgery for cataract
or glaucoma (see Eye surgery below)
Do not take FLOMAX RELIEF if any of the above
apply to you, without first consulting your doctor.
If you are not sure, talk to your doctor or
pharmacist before taking these capsules.
Taking other medicines
Please tell your pharmacist or doctor if you are
taking or have recently taken any other medicines.
This includes medicines that you can buy without a
prescription, including herbal medicines. This is
because FLOMAX RELIEF can affect the way that
some other medicines work and some other
medicines can affect the way that FLOMAX RELIEF
works.
In particular, tell your pharmacist or doctor 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
ketoconazole or itraconazole
• Other alpha-blockers such as doxazosin,
indoramin, prazosin, or alfuzosin
• Erythromycin, an antibiotic used to treat
infections
Tell your doctor or dentist that you are on FLOMAX
RELIEF before any operation or dental procedure as
there is a potential that your medicine may
interfere with the effects of the anaesthetic.
Driving and using machines
If you feel weak or dizzy or have blurred vision
while taking this medicine, do not drive or use
machines.
Eye surgery
• Do not start taking FLOMAX RELIEF now if you
are about to have an operation on your eye for
cloudiness of the lens (cataract) or glaucoma
(high pressure inside the eye)
• Please tell your eye specialist if you have ever
taken tamsulosin. The operation may need to be
performed differently
• If you are currently taking FLOMAX RELIEF,
ask your doctor if you should stop taking it for a
short time

3. How to take FLOMAX RELIEF

2. Before you take FLOMAX RELIEF
FLOMAX RELIEF should be used only by men who
are 45 to 75 years of age.
Do not take these capsules if:
• You are allergic (hypersensitive) to tamsulosin or
any of the other ingredients of this medicine
(listed in Section 6 below)
• You are taking certain medicines prescribed by
your doctor (see “Taking other medicines”
below)
• You have problems with your heart, liver, or
kidneys
• You faint or get dizzy or weak when you sit or
stand up suddenly
• You have had your symptoms for less than three
months
• You have pain when you urinate, or your urine
was cloudy or bloody, at sometime in the last
three months
• You have a fever due to an infection of your
kidneys or bladder (urinary tract infection)
• You have leaking of your urine which you are
unable to control (incontinence)

Taking this medicine
• Take one capsule each day
• Take it at the same time each day, after a meal
• Swallow the capsule whole with water
• Do not crush, chew, or open the capsules
Make a note of the date you start taking
FLOMAX RELIEF.
After 2 weeks
If you are using FLOMAX RELIEF for the first time
and you have not got any better after 2 weeks, or if
you get worse, you must stop taking this medicine
and ask your pharmacist or doctor for further
advice.
Within 6 weeks
You should see your doctor within 6 weeks of
starting treatment to confirm that your symptoms
are due to BPH.
Every 12 months
You should see your doctor every 12 months to
check your prostate. See the doctor sooner if your
symptoms change or get worse.

Mandatory in

File information

TD

Printfile

Issue date of TD:

19.03.2013

Yes

Yes

PPM SKU:

P016073

No

Yes

PPM SKU version: 

005

No

Yes

Issue date of artwork:

10.05.2013

No

Yes

Print colors:

PAN Black

No

Yes

No

Yes

Mat. No. Pack. Site:

140274

Min. font size:



Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Additional information
Dimension

135 x 298 mm

Template Name

0041-TD-PI-LX-PX-135x298-V02

Gluepoints

Example
Technical information
control code

If you forget to take this medicine
• Take your capsule later the same day after food
• If you have missed a dose, just take your daily
capsule on the next day at the usual time
• Do not take two capsules to make up for a
forgotten capsule
If you take more of this medicine than you should,
talk to a doctor or pharmacist straight away.

4. Possible side effects
Like all medicines, FLOMAX RELIEF can cause side
effects, although not everybody gets them.
Serious side effects are rare or very rare. Stop
taking this medicine and see a doctor straight
away if you experience any of the following
symptoms - you may need medical treatment:
• Allergic reaction - (affects less than 1 in
1,000 people). The signs may include finding t
i
difficult to breathe, having an itchy rash, having a
swollen face, throat, or tongue
• Long-lasting and painful erection (usually not
during sexual activity) - affects less than 1 in
10,000 people
• A severe skin reaction with symptoms that could
include skin blistering and exfoliation (known as
Stevens-Johnson syndrome, erythema
multiforme, or exfoliative dermatitis). It is very
rare, affecting less than 1 in 10,000 people (or of
unknown frequency).
The following side effects have also been reported:
Especially when you sit or stand up
• Feeling dizzy (common - affects less than 1 in
10 people)
• Feeling weak (uncommon - affects less than 1 in
100 people)
If this happens, sit or lie down straight away until
you feel better.
Common (affects less than 1 in 10 people)
• Little or no semen during ejaculation. This
phenomenon is harmless.
Uncommon (affects less than 1 in 100 people)
• Headache
• Fast or uneven heart beat (palpitations)
• Runny or blocked nose
• Feeling sick or being sick
• Diarrhoea or constipation
• Itching or lumpy rash (urticaria)
Rare (affects less than 1 in 1,000 people)
• Feeling faint
Very rare (affects less than 1 in 10,000 people)
• During an operation on the eye for cloudiness
of the lens (cataract) or high pressure in the eye
(glaucoma), the pupil (the black circle in the
middle of your eye) may not increase in size as
needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery.
Not Known (frequency cannot be estimated from
the available data)
• Blurred vision or impaired vision
• Nose bleeds
Other possible side effects
• Drowsiness
• Dry mouth
• Swollen hands or feet
• Shortness of breath
• Heart rhythm disorders
If a side effect occurs and gets troublesome or seems
serious, or if you experience any side effect not
listed in this leaflet, tell your doctor or pharmacist.
You can also report any side effect you get to the
Medicines and Healthcare products Regulatory
Agency (MHRA), through the Yellow Card Scheme;
you can make a report by filling in a Yellow Card
(available from pharmacies), by phoning freephone
0808 100 3352, or on the web at
www.mhra.gov.uk/yellowcard
Alternatively, you can also report any side effect
you get to the marketing authorisation holder
Boehringer Ingelheim Limited, Consumer Safety,
Ellesfield Avenue, Bracknell, Berkshire,
RG12 8YS, UK, or by phoning free-of-charge on
0800 328 1627.
140274

5. How to store FLOMAX RELIEF
• Keep out of the reach and sight of children
• Do not use the capsules after the expiry date
which is stated on the base of the pack
• FLOMAX RELIEF does not require any special
storage conditions
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required.

6. Further information
What FLOMAX RELIEF contains
• The active substance is tamsulosin
hydrochloride. Each capsule contains 0.4 mg
• The other ingredients are microcrystalline
cellulose, methacrylic acid-ethyl acrylate
copolymer, polysorbate, sodium laurilsulfate,
triacetin, calcium stearate, and talc. These all
help to make the granules which are in the
capsule
• The capsule shell contains gelatin, and is
coloured with indigotin (E132), titanium dioxide
(E171), and yellow and red iron oxide
(E172); printing ink is shellac, propylene glycol,
and black iron oxide (E172)
What FLOMAX RELIEF looks like and contents of
the pack
FLOMAX RELIEF capsules have an orange body and
an olive-green cap. The capsules come in packs of
14 and 28 capsules, suitable for 14 and 28 days
treatment, respectively.
The marketing authorisation for
FLOMAX RELIEF is held by:
Boehringer Ingelheim Limited,
Consumer Healthcare,
Ellesfield Avenue,
Bracknell,
Berkshire,
RG12 8YS,
UK.
The capsules are manufactured by:
Astellas Pharma Europe B.V.,
Elisabethhof 19, 2353 EW Leiderdorp,
The Netherlands, at their site at
Hogemaat 2, 7942 JG Meppel, The Netherlands.
This leaflet was last revised in May 2013.
Assessing your symptoms
Your urinary symptoms can be assessed using a
questionnaire which you will be asked to complete
when you first purchase FLOMAX RELIEF.
To learn more about BPH visit www.1in4men.com
and call the helpline free-of-charge on
0800 731 9070

To request this leaflet free-ofcharge in formats such as audio,
Braille or large print, please call the
Royal National Institute of the Blind
(RNIB) freephone on 0800 198
5000. When prompted, please
provide the following information:
Product code number 00015/0280
and be ready to confirm the name
of this medicine (FLOMAX RELIEF).
©Boehringer Ingelheim Limited 2013

®

Registered trade mark.

Under licence from Astellas Pharma Europe 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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