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SULATAMIN 0.4 MG PROLONGED-RELEASE CAPSULES HARD

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Package leaflet: Information for the user
Sulatamin 0.4 mg prolonged-release 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.
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.
What is in this leaflet
1.
What Sulatamin is and what it is used for
2.
What you need to know before you take Sulatamin
3.
How to take Sulatamin
4.
Possible side effects
5.
How to store Sulatamin
6.
Contents of the pack and other information

1.

What Sulatamin is and what it is used for

The active ingredient in Sulatamin is tamsulosin. 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.
Sulatamin 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. Sulatamin 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 know before you take Sulatamin

Do not take Sulatamin
If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine
(listed in section 6).
If you feel dizzy when you stand up.
If you have severe liver insufficiency.
Warnings and precautions
Before starting treatment you should tell your doctor if you are suffering from any other disease,
particularly from kidney and liver disorders, heart and circulatory system diseases.
Rarely, fainting can occur during the use of Sulatamin, 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.
Periodic medical examinations are necessary to monitor the development of the condition you are
being treated for.

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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 Sulatamin. This is because Sulatamin 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.
Other medicines and Sulatamin
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, anti-inflammatory
drugs such as diclofenac, some group of medicines to treat high blood pressure, anti-fungal medicines
like ketoconazole) can influence the effects of tamsulosin. Therefore, you can only take medicines
concomitantly with Sulatamin if your doctor allows it.
Pregnancy, breast-feeding and fertility
Sulatamin is intended for male patients only.
Ejaculation disorder may occur following treatment with tamsulosin and may consequently have an effect
on fertility.
Driving and using machines
Sulatamin 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 Sulatamin

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 usual 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 Sulatamin 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 Sulatamin
Take the forgotten capsule on the same day. However, on the next day do not take a double dose; just
resume treatment at one capsule a day.
If you stop taking Sulatamin
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):

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ejaculation disorders called retrograde ejaculation (ejaculation into the bladder)
dizziness, especially when you are getting up from a chair or bed

Uncommon (may affect up to 1 in 100 people):

dropping of blood pressure especially when standing up

feeling of rapid heartbeat

headache

constipation

diarrhea

nausea

vomiting

hives

rash

itching

weakness

obstructed or runny nose
Rare (may affect up to 1 in 1000 people):

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

fainting
Very rare (may affect up to 1 in 10 000 people):

a severe inflammatory eruption of the skin and mucous membranes, which is an allergic
reaction to drugs or other substances called Stevens-Johnson syndrome

priapism (painful, persistent, involuntary erection of the penis), in which case immediate
medical aid is needed
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 irregular heart beat, abnormal heart rhythm (atrial
fibrillation, arrhythmia), rapid heart beat (tachycardia) and shortness of breath (dyspnoea) have been
reported in association with Sulatamin use. Because these spontaneously reported events are from the
worldwide post-marketing experience, the frequency of events and the role of Sulatamin 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 Sulatamin

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date. 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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6.

Contents of the pack and other information

What Sulatamin contains
The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin
hydrochloride.
The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer
(1:1) dispersion 30 per cent (including polysorbate, sodium laurilsulfate), talc, triethyl citrate,
calcium stearate in capsule filling and yellow iron oxide (E172), black iron oxide (E172), red
iron oxide (E172), titanium dioxide (E171), gelatin in capsule shell.
What Sulatamin looks like and contents of the pack
White or off-white pellets are filled in the capsules which sizes are about 18 mm lengthwise and
6.3 mm in external diameter, the upper part is brown opaque, lower part is buff opaque.
30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters.
The blisters are packed into folding box with a package leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Vale Pharmaceuticals Ltd.
1B Gurtnafleur Business Park, Gurtnafleur, Co. Tipperary
Ireland

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

This medicinal product is authorised in the Member States of the EEA under the following
names:
Sweden: Tamsulosin Vale
United Kingdom: Sulatamin
This leaflet was last revised in {08/2012}.

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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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