PAMSVAX XL 400 MICROGRAMS CAPSULES

Active substance: TAMSULOSIN HYDROCHLORIDE

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Package leaflet: Information for the user

Pamsvax XL 400 micrograms
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.
•   f you have any further questions, ask your doctor or
I
pharmacist.
•  his medicine has been prescribed for you only. Do not
T
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
•  f you get any side effects talk to your doctor or pharmacist.
I
This includes any possible side effects not listed in this
leaflet. See section 4.
•  he full name of this medicine is Pamsvax XL 400
T
micrograms Capsules, hard but within the leaflet it will be
referred to as Pamsvax XL.

Children and adolescents

What is in this leaflet:
1 What Pamsvax XL is and what it is used for
2 What you need to do 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

Driving and using machines

1 What Pamsvax XL is and what it is used for
Pamsvax XL is used to treat the symptoms of an enlarged prostate
- a condition technically known as benign prostatic hyperplasia or
BPH. If the gland becomes enlarged, it can squeeze the urethra,
interfering with the flow of urine. This can cause difficulty in
starting urination, a weak flow of urine, and the need to urinate
urgently or more frequently. Pamsvax XL doesn’t shrink the
prostate. Instead, it relaxes the muscle around it, freeing the flow of
urine and decreasing urinary symptoms.

2 Before you take Pamsvax XL

Do not give this medicine to children or adolescent under 18 years
because it does not work 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.
Ejaculation disorders have been observed.
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
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

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.

If you forget to take Pamsvax XL

Do not take Pamsvax XL

•  f you are allergic to tamsulosin hydrochloride or any of the other
I
ingredients of this medicine (listed in section 6).
• If you have severe liver insufficiency.
• If you feel dizzy when you stand up.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pamsvax XL if you
are suffering from any other disease, particularly from kidney and
liver disorders, heart and circulatory system diseases.

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.

If you stop taking Pamsvax XL

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.

If you are undergoing or have been scheduled for eye surgery
because of cloudiness of the lens (cataract), 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.
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AAAG7649

Continued over page

Tamsulosin (Pamsvax XL) 400 microgram PIL - UK
item no: AAAG7649

dimensions: 210 x 300

print proof no: 3

pharmacode:

origination date: 09.04.14

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 28.04.14

Technical Approval

revised by: S.Anson

date sent: 09.04.14

supplier: Gideon Richter

technically app. date: 17.04.14

Non Printing Colours
1.
2.
3.

4 Possible side effects

5 How to store Pamsvax XL

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
• retrograde ejaculation (ejaculation into the bladder)
• failure of ejaculation
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
•  welling of the lower layers of the skin, often around the mouth
s
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):
•  riapism (painful, persistent, involuntary erection of the penis),
p
in which case immediate medical aid is needed
•  severe inflammatory eruption of the skin and mucous
a
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)

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
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 330 mg
white to off-white film-coated 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:
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage,
Hertfordshire, SG1 4SZ, UK
Manufacturer
Gedeon Richter Plc., 1103 Budapest, Gyömrői út 19-21, Hungary
This leaflet was last revised in May 2014.

If you are undergoing eye surgery because of cloudiness of the
lens (cataract) 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
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.

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.

00000000, K-00000-0.0, GRRo 0000

Continued top of next column
AAAG7649

Tamsulosin (Pamsvax XL) 400 microgram PIL - UK
item no: AAAG7649

dimensions: 210 x 300

print proof no: 3

pharmacode:

origination date: 09.04.14

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: 28.04.14

Technical Approval

revised by: S.Anson

date sent: 09.04.14

supplier: Gideon Richter

technically app. date: 17.04.14

Non Printing Colours
1.
2.
3.

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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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