PAMSVAX XL 400 MICROGRAMS CAPSULES

Active substance: TAMSULOSIN HYDROCHLORIDE

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PIL-720UK_TAM_V4.qxp

25/02/2013

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PATIENT 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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
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. WHAT YOU NEED TO DO BEFORE YOU 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).
• If you have severe liver insufficiency.
• If you feel dizzy when you stand up.
Warnings and precautions
Talk to your doctor before taking Pamsvax XL if you are suffering from any other disease, particularly from kidney and liver disorders,
heart and circulatory system diseases.
If you are undergoing 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.
Children and adolescents
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.
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 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 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
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.

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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
• 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
• diarrhea
• nausea
• vomiting
• 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
• other skin disorders.
Not known (cannot be estimated from the available data)
• nose bleeding
• vision blurred, visual impairment
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.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 contains 0.4 milligram 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 capsules are opaque with buff-coloured and brown parts. Each capsule 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:
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, UK.
Manufacturer:
Gedeon Richter Plc, 1103 Budapest, Gyömröi út 19-21, Hungary.
This leaflet was last revised in 02/2013.

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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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