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TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS MR CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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TEVA UK Ref: 231-30-84170-ZE LEA TAMSULOSIN 400mcg CAPS TUK FrSYN

1

24 November 2015

Tamsulosin Hydrochloride
400 micrograms MR Capsules

• Rarely, fainting can occur during the use of Tamsulosin
Hydrochloride as with other medicinal products of this
type. At the first signs of dizziness or weakness you
should sit or lie down until they have disappeared
Tamsulosin Hydrochloride
• If you suffer from severe kidney problems, tell your doctor
PACKAGE LEAFLET: INFORMATION FOR THE USER
• If you are undergoing or have been scheduled for eye
surgery because of cloudiness of the lens (cataract) or
Read all of this leaflet carefully before you start taking this
increased pressure in the eye (glaucoma), please inform
medicine because it contains important information for you.
your eye specialist that you have previously used, are
• Keep this leaflet. You may need to read it again.
using, or are planning to use Tamsulosin Hydrochloride.
• If you have any further questions, ask your doctor or
The specialist can then take appropriate precautions with
pharmacist.
respect to medication and surgical techniques to be
• This medicine has been prescribed for you only. Do not
used. Ask your doctor whether or not you should
pass it on to others. It may harm them, even if their signs
postpone or temporarily stop taking this medicine when
of illness are the same as yours.
undergoing eye surgery because of a cloudy lens
• If you get any side effects, talk to your doctor or
(cataract) or increased pressure in the eye (glaucoma).
pharmacist. This includes any possible side effects not
Children and adolescents:
listed in this leaflet. See section 4.
Do not give this medicine to children or adolescents under
What Is in This Leaflet:
18 years because it does not work in this population.
1. What Tamsulosin Hydrochloride is and what it is used for Other medicines and Tamsulosin Hydrochloride
Tell your doctor or pharmacist if you are taking, have
2. What you need to know before you take Tamsulosin
recently taken or might take any other medicines.
Hydrochloride
Talk to your doctor if you are taking any of the following:
3. How to take Tamsulosin Hydrochloride
• any other alpha1-adrenoceptor antagonists (medicines
4. Possible side effects
used to treat prostatic disease) e.g. alfuzosin, doxazosin
5. How to store Tamsulosin Hydrochloride
or terazosin
6. Contents of the pack and other information
• diclofenac (an anti-inflammatory painkiller)
What Tamsulosin Hydrochloride is and what • warfarin (used to prevent blood clotting)
• ketoconazole (used to treat fungal infections).
it is used for
Pregnancy, breast-feeding and fertility
Tamsulosin Hydrochloride is not indicated in women.
Tamsulosin Hydrochloride is the brand name of your
In men, abnormal ejaculation has been reported (ejaculation
medicine. It is sometimes known by the name of the active
disorder).This means that the semen does not leave the
ingredient, tamsulosin hydrochloride.
body via the urethra, but instead goes into the bladder
The active ingredient in Tamsulosin Hydrochloride is
(retrograde ejaculation) or the ejaculation volume is
tamsulosin. This is a selective α 1A/1D-adrenoceptor
antagonist. It reduces tension of the smooth muscles in the reduced or absent (ejaculation failure). This phenomenon is
harmless.
prostate and the urethra, enabling urine to pass more
Driving and using machines
readily through the urethra and facilitating urination. In
There is no evidence that Tamsulosin Hydrochloride affect
addition, it diminishes sensations of urge.
the ability to drive or to operate machinery or equipment.
Tamsulosin Hydrochloride is used in men for the treatment
of the complaints of the lower urinary tract associated with However, you should bear in mind that dizziness can occur,
in which case you should not undertake activities that
an enlarged prostatic gland (benign prostatic hyperplasia).
require attentiveness.
These complaints may include difficulty urinating (poor
stream), dribbling, urgency and having to urinate frequently
HOW TO TAKE TAMSULOSIN
at night as well as during the day.

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HYDROCHLORIDE

What you need to know before you take
Tamsulosin Hydrochloride

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Adult males including older people
DO NOT take Tamsulosin Hydrochloride if you:
• The recommended dose is one capsule a day, which
• are allergic to tamsulosin hydrochloride or any of the
should be taken after breakfast or the first meal of the day
other ingredients of this medicine (listed in section 6).
Hypersensitivity may present as sudden local swelling of • The capsule should be swallowed whole and not be
crunched or chewed
the soft tissues of the body (e.g. the throat or tongue),
difficult breathing and / or itching and rash (angioedema). • Usually, Tamsulosin Hydrochloride is prescribed for long
periods of time. The effects on the bladder and on
• suffer from fainting due to reduced blood pressure when
urination are maintained during long-term treatment with
changing posture (e.g. when sitting up from lying down or
Tamsulosin Modified-Release Capsules.
when standing up)
If you take more Tamsulosin Hydrochloride than you should
• suffer from severe liver problems.
Taking too many Tamsulosin Hydrochloride may lead to an
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosin unwanted decrease in blood pressure and an increase in
heart rate, with feelings of faintness. Contact your doctor
Hydrochloride:
• Periodic medical examinations are necessary to monitor immediately if you have taken too many Tamsulosin
the development of the condition you are being treated for Modified-Release Capsules.

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TEVA UK Ref: 231-30-84170-ZE LEA TAMSULOSIN 400mcg CAPS TUK FrSYN

If you forget to take Tamsulosin Hydrochloride
You may take your daily Tamsulosin Hydrochloride later the
same day if you have forgotten to take it as recommended. If
you have missed a day, just continue to take your daily
capsule as prescribed. Never take a double dose to make up
for the forgotten capsule.
If you stop taking Tamsulosin Hydrochloride
When treatment with Tamsulosin Hydrochloride is stopped
prematurely, your original complaints may return. Therefore
use Tamsulosin Modified-Release Capsules as long as your
doctor prescribes, even if your complaints have
disappeared already. Always consult your doctor, if you
consider stopping this therapy.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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POSSIBLE SIDE EFFECTS

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24 November 2015

• retrograde ejaculation, ejaculation failure
• serious skin rashes (erythema multiform, dermatitis
exfoliative)
• dry mouth.
If you are undergoing eye surgery because of cloudiness of
the lens (cataract) or increased pressure in the eye
(glaucoma) and are already taking or have previously taken
Tamsulosin Hydrochloride, the pupil may dilate poorly and
the iris (the coloured circular part of the eye) may become
floppy during the procedure.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking the capsules and tell your doctor immediately
or go to the casualty department at your nearest hospital if
the following happens:
• an allergic reaction (swelling of the lips, face or neck
leading to severe difficulty in breathing; skin rash or
hives)
• a serious illness with blistering of the skin, mouth, eyes
and genitals called Stevens-Johnson syndrome (may
affect up to 1 in 10,000 people).
These are very serious but rare side effects. You may need
urgent medical attention or hospitalisation.
The following side effects have been reported.
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
• rapid heart beat
• dizziness (due to low blood pressure) especially when
sitting or standing up
• runny and itchy nose
• diarrhoea, constipation, nausea (feeling sick), vomiting
• itching, rash including nettle rash (hives)
• feeling of weakness.
Rare (may affect up to 1 in 1000 people):
• fainting
• serious allergic reaction which causes swelling of the
face or throat.
Very rare (may affect up to 1 in 10,000 people):
• prolonged and painful erection that can last from several
hours up to a few days.
Not known (frequency cannot be estimated from the
available data)
• abnormal irregular heart rhythm (atrial fibrillation,
arrhythmia, tachycardia)
• difficult breathing (dyspnoea)
• blurred vision
• impaired vision
• nose bleed (epistaxis)

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HOW TO STORE TAMSULOSIN
HYDROCHLORIDE

Keep this medicine out of the sight and reach of children.
Store in the original container and keep the container tightly
closed. Do not transfer to another container.
Do not use this medicine after the expiry date which is
stated on the outer packaging. The expiry date refers to the
last day of that month.
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.

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CONTENTS OF THE PACK AND OTHER
INFORMATION

What Tamsulosin Hydrochloride capsules contain:
• The active ingredient is tamsulosin hydrochloride 400
micrograms
The other ingredients are microcrystalline cellulose,
methacrylic acid-ethyl acrylate copolymer, polysorbate 80,
sodium laurilsulfate, triethyl citrate, talc, gelatin, indigotin
(E132), titanium dioxide (E171), yellow iron oxide (E172), red
iron oxide (E172), black iron oxide (E172).
What Tamsulosin Hydrochloride capsules look like and
contents of the pack:
• The Tamsulosin Hydrochloride Modified-Release
Capsules are Hard gelatin capsules with an orange
coloured body and olive coloured cap. The capsules are
filled with white to off-white pellets.
• The product is available in pack sizes of 10, 14, 20, 28, 30,
50, 56, 60, 90, 100, 180 or 200 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK Limited,
Eastbourne, BN22 9AG and the company responsible for
manufacture is Synthon B.V., CM Nijmegen, The
Netherlands.
This leaflet was last revised: 11/2015
PL 00289/0860

Approved

84170-ZE

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0860-petyme-400mcg-modified-release-capsules-tam
sulosin-hydrochloride

APPROVALS
Signed by
Kristina Mills

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Meaning of Signature
Regulatory Affairs Approval

Version 5.12

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Server Date
14-Dec-2015 05:40:36 PM

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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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