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PAMSVAX XL 400 MICROGRAMS CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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Package leaflet: Information for the user

Pamsvax XL 400 micrograms
Capsules
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.
•  The full name of this medicine is Pamsvax XL 400
micrograms Capsules but within the leaflet it will be referred
to as Pamsvax XL.

What is in this leaflet:
1 What Pamsvax XL is and what it is used for
2 What you need to know before you take Pamsvax
XL
3 How to take Pamsvax XL
4 Possible side effects
5 How to store Pamsvax XL
6 Contents of the pack and other information
1 What Pamsvax XL is and what it is used for
The active ingredient in Pamsvax XL is tamsulosin hydrochloride.
This is a selective alpha1A/1D-adrenoceptor antagonist. It reduces
tension of the smooth muscles in the prostate and the urethra,
enabling urine to pass more readily through the urethra and
facilitating urination. In addition, it diminishes sensations of urge.
Pamsvax XL is used in men for the treatment of the complaints
of the lower urinary tract associated with an enlarged prostate
(benign prostatic hyperplasia). These complaints may include
difficulty urinating (poor stream), dribbling, urgency and having to
urinate frequently at night as well as during the day.

2 What you need to know before you take Pamsvax

XL

dizziness or weakness you should sit or lie down until they have
disappeared.
• If you suffer from severe kidney problems, tell your doctor.
• If you are undergoing or have been scheduled for eye surgery
because of cloudiness of the lens (cataract) or increased internal
pressure of the eye (glaucoma), please inform your eye specialist
that you are using or have previously used Pamsvax XL. This
is because Pamsvax XL may cause complications during the
surgery. 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 internal
pressure of the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescent under 18 years
because there is no relevant indication for use of Pamsvax XL in
this age group and its efficacy has not been established in this
population.

Other medicines and Pamsvax XL

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Certain medicines (e.g. medicines preventing blood clotting called
anticoagulants such as warfarin, anti-inflammatory drugs such as
diclofenac) can influence the effects of tamsulosin. Therefore, you
can only take medicines concomitantly with Pamsvax XL if your
doctor allows it.

Pregnancy breast-feeding and fertility

Pamsvax 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

Pamsvax XL can adversely affect the ability to drive or operate
machines. It should be taken into account that in some patients
dizziness may occur.

3 How to take Pamsvax XL

Do not take Pamsvax XL

• If you are allergic to tamsulosin hydrochloride or any of the other
ingredients of this medicine (listed in section 6). Hypersensitivity
may present as sudden local swelling of soft tissues of the body
(e.g. the throat or tongue), difficult breathing and/or itching and
rash (angioedema).
• If you have severe liver insufficiency.
• If you suffer from fainting due to reduced blood pressure when
changing posture (going to sit or stand up).

Warnings and precautions

Talk to your doctor or pharmacist before taking Pamsvax XL.
• Periodic medical examinations are necessary to monitor the
development of the condition you are being treated for.
• Rarely, fainting can occur during the use of tamsulosin, as
with other medicinal products of this type. At the first signs of

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
If it is not prescribed otherwise by your doctor the recommended
dose is one capsule daily, to be taken after breakfast or the first
meal of the day.
Do not crunch or chew the capsule, swallow it whole.

If you take more Pamsvax XL than you should

Taking more Pamsvax XL may lead to unexpected drop of blood
pressure and rapid heart beat, followed by dizziness. Contact your
doctor immediately or visit the emergency department of the
nearest hospital as the consequences of accidental or deliberate
overdose may require medical intervention.

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AAAH2830

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Tamsulosin (Pamsvax XL) 400mcg Capsules PIL - UK
item no: AAAH2830

dimensions: 210 x 300

print proof no: 2

pharmacode:

origination date: 26.09.14

min pt size: 9

1. Black
2.
3.
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5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 21.10.14

Technical Approval

revised by: S.Anson

date sent: 26.09.14

supplier: Gideon Richter

technically app. date: 02.10.14

Non Printing Colours
1.
2.
3.

If you forget to take Pamsvax XL

Take the forgotten capsule on the same day. However, on the next
day do not take a double dose to make up for a forgotten dose;
just resume treatment at one capsule a day.

have been reported in association with Pamsvax XL use. Because
these spontaneously reported events are from the worldwide
post-marketing experience, the frequency of events and the role
of Pamsvax XL in their causation cannot be reliably determined.

If you stop taking Pamsvax XL

Reporting of side effects

You should not stop taking it without consulting your doctor
before.
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 side effects, although
not everybody gets them. Do not be alarmed by this list of
possible side effects, you may not have any of them. Most patients
do not notice any side effects. However if you do and they bother
you, talk to your doctor.
If you begin to feel light-headed or dizzy, sit or lie down until you
feel better.
Common (may affect up to 1 in 10 people):
• dizziness, especially when you are getting up from a chair or bed
• ejaculation disorders
Uncommon (may affect up to 1 in 100 people):
• headache
• rapid heartbeat
• dropping of blood pressure especially when standing up
• obstructed or runny nose
• constipation
• diarrhoea
• nausea
• vomiting
• rash
• nettle rash
• itching
• weakness
Rare (may affect up to 1 in 1,000 people):
• fainting
• swelling of the lower layers of the skin, often around the mouth
or of the mucosa of the mouth or throat which can appear very
quickly
Very rare (may affect up to 1 in 10,000 people):
• priapism (painful, persistent, involuntary erection of the penis), in
which case immediate medical aid is needed
• a severe inflammatory eruption of the skin and mucous
membranes, which is an allergic reaction to drugs or other
substances called Stevens-Johnson syndrome
Not known (frequency cannot be estimated from the available
data)
• nose bleeding
• vision blurred, visual impairment
• dry mouth
• serious skin rashes (erythema multiforme, dermatitis exfoliative)
• retrograde ejaculation (ejaculation into the bladder)
• failure of ejaculation

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 Pamsvax XL
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on
the 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 to protect the environment.

6 Contents of the pack and other information

What Pamsvax XL contains

The active substance is tamsulosin hydrochloride. Each capsule,
hard contains 400 micrograms of tamsulosin hydrochloride.
The other ingredients are:
capsule filling: microcrystalline cellulose (E460), methacrylic
acid-ethyl acrylate copolymer 1:1 (including polysorbate, sodium
laurilsulfate), talc, triethyl citrate, calcium stearate
capsule shell: yellow iron oxide (E172), black iron oxide (E172), red
iron oxide (E172), titanium dioxide (E171), gelatin.

What Pamsvax XL looks like and contents of the pack

The size No. 2 capsules are opaque with buff-coloured and brown
parts. Each prolonged-release capsule, hard is filled with white to
off-white pellets.
10, 20, 30, 50, 90 or 100 capsules are packed into PVC/PVDC/
Aluminium blisters and carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Gedeon Richter Plc., 1103 Budapest, Gyömrői út 19-21, Hungary
This leaflet was last revised in September 2014.

If you are undergoing eye surgery because of cloudiness of
the lens (cataract) or increased internal pressure of 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 (see also section 2 “Warnings and precautions”).
In addition to the adverse events listed above,
• very rapid uncoordinated contractions of the heart
• irregular rhythm of the heartbeat
• abnormally rapid heart rate and
• difficulty in breathing

00000000, K-00000-0.0, GRRo 0000

Continued top of next column
AAAH2830

Tamsulosin (Pamsvax XL) 400mcg Capsules PIL - UK
item no: AAAH2830

dimensions: 210 x 300

print proof no: 2

pharmacode:

origination date: 26.09.14

min pt size: 9

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

Actavis, Barnstaple, EX32 8NS, UK

revision date: 21.10.14

Technical Approval

revised by: S.Anson

date sent: 26.09.14

supplier: Gideon Richter

technically app. date: 02.10.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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