Package leaflet: Information for the patient

TamisPRAS, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What TamisPRAS is and what it is used for
Important information before taking TamisPRAS
How to take TamisPRAS
Possible side effects
How to store TamisPRAS
Contents of the pack and other information

1. What TamisPRAS is and what it is used for

TamisPRAS reduces the tension of the muscles in the prostate gland and urinary tract, thereby facilitating urine flow and urination. Additionally, the medicine reduces the sensation of bladder pressure.
TamisPRAS is used in men to relieve symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia), such as: difficulty in urinating (reduced urine stream), dribbling when urinating, sudden urge to urinate, and frequent urination both during the day and at night.

2. Important information before taking TamisPRAS

When not to take TamisPRAS

if the patient is allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden local swelling of soft tissues (e.g. throat or tongue), breathing difficulties and/or itching and rash (angioedema).
if the patient experiences drops in blood pressure upon standing, which may cause dizziness, a sensation of "emptiness in the head" or fainting.
if the patient has severe hepatic impairment.

Warnings and precautions
Before starting treatment with TamisPRAS, discuss with your doctor or pharmacist:

if the patient experiences dizziness or a sensation of "emptiness in the head", especially when standing up. Tamsulosin may lower blood pressure, causing such symptoms. If symptoms of hypotension occur, the patient should sit or lie down until symptoms resolve.
if the patient has severe renal impairment, inform the doctor.
if the patient is undergoing or scheduled for eye surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma). During surgery, the

intraoperative floppy iris syndrome (IFIS) may occur (see section

Possible side effects). The patient should inform the ophthalmologist that they are currently taking, have recently taken, or plan to take tamsulosin hydrochloride. The ophthalmologist may take appropriate precautions regarding medications and surgical techniques. If preparing for cataract surgery or glaucoma treatment, the patient should consult their doctor whether to postpone or temporarily discontinue the medicine.

Regular medical check-ups are necessary to monitor the course of the disease.
The patient may notice remnants of the tablet in the stool. However, since the active substance has
already been released, there is no risk that the tablet will be less effective.
Children and adolescents
TamisPRAS must not be used in children and adolescents under 18 years of age, as it has not
been shown to be effective in this patient group.
TamisPRAS and other medicines
Tamsulosin may affect other medicines, and other medicines may affect the efficacy of
tamsulosin. Tamsulosin may interact with:

diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening its duration of action.
warfarin, a medicine used to prevent blood clots. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening its duration of action.
other medicines blocking alpha-adrenergic receptors. Their combination with tamsulosin may reduce blood pressure, causing dizziness or a sensation of "emptiness in the head".
ketoconazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

You should inform your doctor or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to take, including those available without a prescription.
TamisPRAS with food, drink and alcohol
TamisPRAS can be taken independently of meals.
Pregnancy, breastfeeding and effect on fertility
Tamsulosin is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorder) has been observed, characterized by semen not being expelled outside the body through the urethra but instead flowing backward into the bladder (retrograde ejaculation), or by reduced volume or absence of ejaculate (anejaculation). This phenomenon does not pose a health risk to the patient.
Driving and operating machinery
There are no data confirming the effect of tamsulosin on the ability to drive or operate machinery. However, it should be noted that TamisPRAS may cause dizziness or a sensation of "emptiness in the head"; therefore, driving and operating machinery should only be undertaken when the patient feels well.

3. How to take TamisPRAS

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The usual dose is one tablet per day. The medicine can be taken with or without food, preferably
at the same time each day.
The tablet should be swallowed whole. It is important not to crush or chew the tablet, as this
may affect the efficacy of tamsulosin.
TamisPRAS is not intended for use in children.
Taking more than the recommended dose of TamisPRAS
If more than the recommended dose of TamisPRAS is taken, a sudden drop in blood pressure may
occur. Symptoms may include: dizziness, weakness, vomiting, diarrhoea, and fainting. The patient
should lie down to reduce the effects of low blood pressure and then contact a doctor.
Missing a dose of TamisPRAS
If a patient forgets to take the medicine at the scheduled time, it can be taken later on the same day.
If a dose is missed for a given day, the next dose should be taken at the usual time. Do not take a
double dose to make up for the missed dose.
Stopping treatment with TamisPRAS
If treatment with TamisPRAS is stopped too early, symptoms of the disease may return. Therefore,
the medicine should be taken for as long as prescribed by the doctor, even if symptoms have
improved. Always consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions are rare. You must seek immediate medical help if the patient experiences a severe allergic reaction with swelling of the face or throat (angioedema).

Common adverse reactions (may occur in less than 1 in 10 people)

dizziness
ejaculation disorders. This means that semen does not exit the body through the urethra, but enters the urinary bladder (retrograde ejaculation), or only a small amount of semen is released during ejaculation, or ejaculation does not occur (inability to ejaculate). This phenomenon is not dangerous.

Uncommon adverse reactions (may occur in less than 1 in 100 people)

headache
palpitations
low blood pressure upon standing, which may cause dizziness, feeling faint, or fainting (orthostatic hypotension)
nasal mucosal swelling or irritation (rhinitis)
constipation
diarrhoea
nausea
vomiting
rash
itching
urticaria
weakness (asthenia)

Rare adverse reactions (may occur in less than 1 in 1,000 people)

fainting

Very rare adverse reactions (may occur in less than 1 in 10,000 people)

painful penile erection (priapism)
a serious condition characterised by blistering of the skin around the mouth, eyes, and genital organs (Stevens-Johnson syndrome)

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

blurred vision
loss of vision
nosebleeds
dry mouth
severe skin rashes (erythema multiforme, exfoliative dermatitis)
irregular heartbeat
cardiac arrhythmias
rapid heartbeat
breathing difficulties. During eye surgery due to lens clouding (cataract) or increased intraocular pressure (glaucoma), a condition known as Intraoperative Floppy Iris Syndrome (IFIS) may occur: during surgery, the pupil may dilate poorly and the iris (the coloured, circular part of the eye) may become floppy. For additional information, see section 2 "Warnings and precautions".

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the Marketing Authorisation Holder or its representative in Poland. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store TamisPRAS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the stated month.
The batch number follows the abbreviation "Lot".
Blister packs should be stored in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What TamisPRAS contains

The active substance is 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
Other ingredients are: Tablet core: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, iron(III) oxide red (E 172), magnesium stearate. Outer layer of the tablet core: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What TamisPRAS looks like and contents of the pack
White, round tablets marked with "T9SL" on one side and "0.4" on the other side.
TamisPRAS, prolonged-release tablets, is available in packs of 30 tablets, packed in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturers:
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania SL
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
Normon S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain