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PROSURIN XL 400 MICROGRAMS CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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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.
TBC

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What is in this leaflet:
1. What Prosurin XL is and what it is used for.
2. What you need to know before you take Prosurin XL.
3. How to take Prosurin XL.
4. Possible side effects.
5. How to store Prosurin XL.
6. Contents of the pack and other information.
1. What Prosurin XL is and what it is used for
Prosurin XL is a modified release capsules. It contains
an active ingredient in the capsules which is a so‑called
alpha 1A‑blocker that reduces muscle contraction in the
prostate and urethra. This facilitates the flow of urine
through the urethra and aids urination.
Prosurin XL modified‑release capsules are used for the
treatment of urination symptoms caused by benign
prostatic hyperplasia (BPH ‑ enlarged prostate).
2. What you need to know before you take Prosurin XL
Do not take Prosurin XL:
• If you are allergic to tamsulosin hydrochloride or any
of the other ingredients of this medicine (listed in
section 6). Hypersensitivity or allergy to tamsulosin
hydrochloride can express itself as sudden swelling of
hands or feet, difficulties in breathing and/or itch and
rash, swollen lips, tongue or throat (angio‑oedema).
• If you have experienced dizziness or have fainted from
lowered blood pressure (e.g. when suddenly sitting or
standing up).
• If you have been found to suffer from severe
liver problems.
Warnings and precautions
Talk to your doctor before taking Prosurin XL:
• If you have been found to suffer from severe
kidney problems.
• If you experience dizziness or fainting during the use
of Prosurin XL. Please sit or lie down straight away until
the symptoms disappear.
• If you experience sudden swelling of hands or feet,
swollen lips, tongue or throat, difficulties in breathing
and/or itch and rash, caused by an allergic reaction
(angio‑oedema) during the use of Prosurin XL.
• If you are about to have an operation on your eye for
cloudiness of the lens (cataract).

You should have your prostate examined by a doctor
before taking Prosurin XL and at regular intervals
thereafter.
Children and adolescents
Prosurin XL is not indicated for use in the paediatric
population (patients below 18 years of age).
Other medicines and Prosurin XL
Tell your doctor if you are taking, have recently taken
or might take any other medicines:
• Prosurin XL may lower blood pressure when taken
with other alpha 1A‑blockers. e.g. doxazosin, prazosin
and indoramin.
• Diclofenac (an anti‑inflammatory painkiller) and
warfarin (used to prevent blood clotting) may have
an influence on how fast Prosurin XL is removed from
the body.
• Medicines which lower your blood pressure such as
verapamil and diltiazem.
• Medicines which are used to suppress your immune
system e.g. ciclosporin.
• Antibiotics to treat infection e.g. erythromycin,
clarithromycin.
• Medicines to treat fungal infections e.g.
ketoconazole, itraconazole, fluconazole, voriconazole.
• Medicines used to treat HIV e.g. ritonavir, saquinavir.
Please note that these statements may also apply
to products used some time ago or at some time in
the future.
Prosurin XL with food and drink
Prosurin XL should be taken after the first meal of the
day. Taking Prosurin XL on an empty stomach may
increase the number of side effects or increase the
severity of a side effect.
Pregnancy, breast‑feeding and fertility
Prosurin XL is not indicated for use in women.
Prosurin XL may cause ejaculation disorders including
inability to ejaculate.
Driving and using machines
Up until now, there is no evidence that Prosurin XL affects
the ability to drive or use machines.
Patients should nevertheless be aware that dizziness
may occur.
3. How to take Prosurin XL
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is one capsule a day after the
first meal of the day.
The capsule should be taken while standing or sitting
upright (not lying down) and should be swallowed whole
with a glass of water.
The capsule must not be chewed.
Your physician has prescribed a suitable dose for you
and your illness, and has specified the duration of
the treatment.
The dose should not be independently changed.

TBC

PROSURIN XL
400 MICROGRAM CAPSULES

Please consult your doctor, even if these statements were
applicable to you at any time in the past.

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Package Leaflet: Information for the user

If you forget to take Prosurin XL
If you have forgotten to take Prosurin XL after the first
meal of the day, it can be taken later the same day after
food. If you have missed a day, just continue to take your
daily capsule as prescribed.
Do not take a double dose to make up for forgotten
individual doses.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
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Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects:
If you have any of the following symptoms, stop taking
this medicine and tell your doctor immediately or go to
the casualty department at your nearest hospital:
Rare (may affect up to 1 in 1,000 people):
• sudden swelling of hands or feet, difficulties in
breathing and/or itch and rash, swollen lips, tongue or
throat (angio‑oedema).

5. How to store Prosurin XL
Keep this medicine out of the sight and reach
of children.
Store in the original package.
Keep the container tightly closed.
Do not use after the expiry date which is stated on the
label and carton after 'EXP'. 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.
6. Contents of the pack and other information
What Prosurin XL contains:
One modified‑release capsule contains 0.4 mg of
tamsulosin hydrochloride as the active substance.

Very rare (may affect up to 1 in 10,000 people):
• a widespread rash with severe blisters, peeling skin and
bleeding in the lips, eyes, mouth, nose and genitals
(Stevens‑Johnson syndrome).

The other ingredients are: microcrystalline cellulose,
methacrylic acid‑ethyl acrylate copolymer (1:1),
polysorbate 80, sodium laurilsulfate, triethyl citrate
and talc.

Not known (frequency cannot be estimated from
the available data):
• a severe inflammation of the skin with pale‑red, pale
centred blotches known as erythema multiforme.

The capsule body ingredients are gelatine, indigo
carmine (E 132), titanium dioxide (E 171), yellow iron
oxide (E 172), red iron oxide (E172) and black iron
oxide (E172).

The following other side effects may also occur:
Common (may affect up to 1 in 10 people):
dizziness, ejaculation disorders including inability
to ejaculate and ejaculation into the bladder
(retrograde ejaculation).

What Prosurin XL looks like and contents of the pack
The Prosurin XL modified‑release capsules are orange/
olive‑green in colour.

Uncommon (may affect up to 1 in 10 people):
headache, a sensation of abnormal heart beat
(palpitations), dizziness especially when sitting or
standing up, common cold, constipation, diarrhoea,
nausea, vomiting, rash, itching, hives, feeling
of weakness.
Rare (may affect up to 1 in 1,000 people):
fainting.
Very rare (may affect up to 1 in 10,000 people):
painful, prolonged, unwanted erection (priapism).
Not known (frequency cannot be estimated from the
available data):
an irregular heartbeat (atrial fibrillation), abnormal
heart rhythm (arrhythmia), accelerated heart beat
(tachycardia), shortness of breath (dyspnoea), blurred
vision, impaired vision, nose bleed, scaly skin rash
(dermatitis exfoliative), dry mouth.
In some occasions possible complications in connection
to cataract operations have been observed.

They are available in blister packaging or in containers
of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200
modified‑release capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Herts., EN6 1TL,
United Kingdom.
Manufacturer
Synthon Hispania S.L., Castelló, 1, Polígono las Salinas,
08830 Sant Boi de Llobregat - Spain
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Mylan Hungary Kft, H‑2900 Komarom, Mylan utca 1,
Hungary.

This leaflet was last revised in
February 2015

382138

TBC

If you take more Prosurin XL than you should
If you may have taken more Prosurin XL than you should,
talk to your doctor or pharmacist immediately.

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.

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If you have the impression that the effect of tamsulosin is
too strong or too weak, talk to your doctor or pharmacist.

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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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