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TABPHYN MR 400MICROGRAM CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TabphynTM MR 400 microgram modified-release capsules, hard
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 or pharmacist.
− This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side-effects not listed in
this leaflet (see section 4).
What is in this leaflet
1. What TabphynTM MR 400 microgram Capsules are
and what they are used for
2. What you need to know before you take TabphynTM
MR 400 microgram Capsules
3. How to take TabphynTM MR 400 microgram
Capsules
4. Possible side-effects
5. How to store TabphynTM MR 400 microgram
Capsules
6. Contents of the pack and other information

1.What TabphynTM MR 400
microgram Capsules are and
what they are used for

Tamsulosin is an α1Aadrenoreceptor blocker. It
relaxes the muscles in the prostate and urinary
tract.
Tamsulosin is prescribed to alleviate urinary
symptoms caused by an enlarged prostrate (benign
prostatic hyperplasia). By relaxing the muscle it
enables urine to be passed more easily and helps
urination.

2.What you need to know before
you take TabphynTM MR 400
microgram Capsules
DO NOT take TabphynTM MR 400
microgram Capsules if you:
• are allergic to tamsulosin or any of the other
ingredients of this medicine listed in section 6
[symptoms may include: swelling of your face and
throat (angio-oedema)]
• have a history of a fall in blood pressure on
standing up, which causes dizziness, lightheadedness or fainting
• have severe liver problems.
TabphynTM MR 400 microgram Capsules
warnings and precautions
Talk to your doctor or pharmacist before taking
TabphynTM MR 400 microgram Capsules if you:
• experience dizziness or light-headedness,
especially after standing up. TabphynTM MR 400
microgram Capsules may lower your blood
pressure, causing these symptoms.You should sit
or lie down until the symptoms have gone
• suffer from severe kidney problems. The normal
dose of TabphynTM MR 400 microgram Capsules
may not have the expected effect when your
kidneys are not functioning normally
• experience swelling in your face or throat. These
are symptoms of angio-oedema (see section 2,
DO NOT take TabphynTM MR 400 microgram
Capsules).You must stop taking tamsulosin
immediately and contact your doctor.You should
not be restarted on tamsulosin
• are planning to undergo eye surgery for cataract
(vision loss, especially for blue colours). A
condition called Intraoperative Floppy Iris
Syndrome (IFIS) can occur during surgery if you
are taking, or have recently taken, tamsulosin.
IFIS can cause complications during surgery. It is
recommended you stop taking tamsulosin 1-2
weeks before surgery. Contact your doctor and
your surgeon before to discuss your situation.

Children
Do not give this medicine to children or adolescents
under 18 years because it does not work in this
population.
Other medicines and TabphynTM MR 400
microgram Capsules
Other medicines may be affected by tamsulosin.
They, in turn, may affect how well tamsulosin works.
Tamsulosin can interact with:
• Diclofenac, a pain killer and anti-inflammatory
medicine. This medicine can speed up the
removal of tamsulosin from your body, thereby
shortening the time tamsulosin is effective.
• Warfarin, a medicine to prevent blood clotting.
This medicine can speed up the removal of
tamsulosin from your body, thereby shortening
the time tamsulosin is effective.
• 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.
• Another α1Aadrenoreceptor blocker such as
doxazosin, indoramin, prazosin or alfuzosin. The
combination may lower your blood pressure,
causing dizziness or light-headedness.
• Erythromycin, an antibiotic used to treat
infections.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
TabphynTM MR 400 microgram Capsules
with food and drink
You should take tamsulosin with a glass of water
after breakfast or after your first meal of the day.
Driving and using machines
There is no information on the effects of tamsulosin
on the ability to drive and use machines.You should
take into account that tamsulosin may cause
dizziness and light-headedness. Only drive or use
machines if you feel well.

3.How to take TabphynTM MR 400
microgram Capsules
Always take this medicine exactly as your doctor has
told you to. Check with your doctor or pharmacist if
you are not sure.
The recommended dose is one capsule per day
taken after breakfast or after your first meal of the
day.
Swallow the capsule whole with a glass of water,
while standing or sitting (not while lying down). It is
important that you do not break or crush the
capsule as this may influence how well TabphynTM
MR 400 microgram Capsules work.
If you take more TabphynTM MR 400
microgram Capsules than you should
Your blood pressure may suddenly drop if you take
more TabphynTM MR 400 microgram Capsules than
you should.You may experience dizziness,
weakness and fainting. Lie down to minimise the
effects of low blood pressure and then contact your
doctor.Your doctor may give you medicines to
restore your blood pressure and monitor your body
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function. When necessary your doctor may empty
your stomach and give you a laxative to remove any
tamsulosin not yet taken up in the blood from your
body.
If you forget to take TabphynTM MR 400
microgram Capsules
Do not take a double dose to make up for a
forgotten dose. Just take the next dose at the usual
time. If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4.Possible side-effects
Like all medicines, this medicine can cause sideeffects, although not everybody gets them.
Common (may affect up to 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 (may affect up to 1 in 100 people):
headache • feeling your heartbeat (palpitations)
• a fall in blood pressure on standing up, which
causes dizziness, light-headedness or fainting
(orthostatic hypotension) • swelling and irritation
inside the nose (rhinitis) • constipation • diarrhoea
• feeling sick (nausea) • vomiting • rash • itching
• hives (urticaria) • feeling of weakness (asthenia).
Rare (may affect up to 1 in 1,000 people):
fainting (syncope) • serious allergic reaction which
causes swelling of the face or throat (angiooedoema): Contact your doctor immediately, you
should not be restarted on tamsulosin (see Section
2, DO NOT take TabphynTM MR 400 microgram
Capsules).
Very rare (may affect up to 1 in 10,000 people):
painful erection (priapism) • serious illness with
blistering of the skin, mouth, eyes and genitals
(Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from
the available data):
serious skin rashes (erythema multiforme, dermatitis
exfoliative) • nose bleeds (epistaxis) • blurred vision
or impaired vision.
During cataract surgery a small pupil situation,
known as Intraoperative Floppy Iris Syndrome
(IFIS), has been associated with therapy of
tamsulosin during post-marketing surveillance (See
also Section 2, TabphynTM MR 400 microgram
Capsules warnings and precautions) • dry mouth.
Additional side-effects (post-marketing
experience):
In addition to the side-effects listed above,
abnormal heart rhythm (atrial fibrillation), irregular
heartbeat (arrhythmia), faster heartbeat
(tachycardia) and shortness of breath (dyspnoea)
have been reported in association with
tamsulosin use.
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.

Store the blisters in the original package in order to
protect from moisture.
Keep the container tightly closed in order to protect
from moisture.
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 protect the environment.

6.Contents of the pack and other
information
What TabphynTM MR 400 microgram
Capsules contain
• The active substance is Tamsulosin hydrochloride
400 microgram.
• The other ingredients are:
Capsule: Microcrystalline cellulose, Methacrylic
acid-ethyl acrylate copolymer, Polysorbate 80,
Sodium laurilsulfate, Triethyl citrate, Talc.
Capsule body: Gelatin, Indigotine (E132),
Titanium dioxide (E171), Yellow iron oxide (E172),
Red iron oxide (E172), Black iron oxide (E172).
What TabphynTM MR 400 microgram
Capsules look like and contents of the
pack
Orange/olive-green modified-release capsules. The
capsules contain white to off-white pellets.
They are supplied in blister packs with 10, 14, 15,
20, 28, 30, 48, 50, 56, 60, 90, 98, 100 or 200
modified-release capsules or containers with 60 or
250 modified-release capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Genus Pharmaceuticals
Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer:
Genus Pharmaceuticals
Linthwaite, Huddersfield, HD7 5QH, UK.
STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Germany.
POM
PL 06831/0157
TabphynTM MR 400 microgram Capsules
This leaflet was last revised in November 2015

5.How to store TabphynTM MR 400
microgram Capsules
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 packaging after ‘EXP’. The first two
digits indicate the month and the last four digits
indicate the year. The expiry date refers to the last
day of that month.

Cod. XXXXX
* Trademark
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MHRA Header Box
Product
Title

Tabphyn MR 400 mcg Capsules
(Tamulsoin Hydrochloride) Genus

Component

Leaflet

Pack Size

30's

IG code

24967804

Dimensions

305 x 148mm

Proof No.

01

Date

27/10/2015

Colours used

Fonts used

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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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