Package leaflet: Information for the patient

Tanyz ERAS, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Tanyz ERAS is and what it is used for

The active substance in Tanyz ERAS is tamsulosin, which is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, allowing easier urine flow through the urethra and facilitating urination. Additionally, it reduces the sudden urge to urinate.
Tanyz ERAS is used in men to relieve lower urinary tract symptoms caused by an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak urine stream), dribbling after urination, sudden urge to urinate, and frequent urination both during the day and at night.

2. Important information before using Tanyz ERAS

When not to use Tanyz ERAS:

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, localized swelling of soft tissues (e.g. throat or tongue), difficulty in breathing and/or itching and rash (angioedema).
If the patient has severe impairment of liver function.
If the patient has experienced fainting associated with a drop in blood pressure upon changing body position (when sitting or standing up).

Warnings and precautions
Before starting treatment with Tanyz ERAS, discuss this with your doctor or pharmacist.

Periodic medical check-ups are necessary to monitor the progression of the disease being treated.
As with other similar medicines, in rare cases, treatment with Tanyz ERAS may lead to fainting. If the patient experiences dizziness or weakness, they should sit or lie down until symptoms subside.
If the patient has severe impairment of kidney function, the doctor should be informed.
Patients undergoing eye surgery or those scheduled for eye surgery due to lens opacity (cataract) should inform their ophthalmologist about current or recent use of tamsulosin hydrochloride. The ophthalmologist may then take appropriate precautions by selecting suitable medications or surgical techniques. Please ask your doctor whether it is necessary to reschedule or temporarily discontinue the medication due to cataract surgery.

Remnants of the tablet may be visible in the stool. Since the active substance has already been released from the tablet, there is no risk of reduced efficacy of the medicine.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as it is not effective in this patient group.
Tanyz ERAS and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Concomitant use of Tanyz ERAS with medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended reduction in blood pressure.
It is especially important to inform the doctor about concomitant use of medicines (e.g. ketoconazole, erythromycin) that may reduce the elimination of Tanyz ERAS from the body.
Tanyz ERAS with food and drink
Tamsulosin can be taken regardless of meals.
Pregnancy and breastfeeding
This section does not apply, as Tanyz ERAS is intended for use in men only.
Driving and operating machinery
There is no data available on the effect of tamsulosin on the ability to drive or operate machinery. However, it should be noted that tamsulosin may cause dizziness and fainting. Patients should only drive or operate machinery if they feel well.

3. How to use Tanyz ERAS

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Tamsulosin may be taken with food or independently of meals, preferably at the same time each day.
Tablets should be swallowed whole. It is important not to chew or crush the tablets, as this may affect the efficacy of tamsulosin.
Tanyz ERAS is usually prescribed for long-term use. The effect on the urinary bladder and urination is maintained during prolonged treatment with Tanyz ERAS.
Taking more Tanyz ERAS than recommended
Taking too many tablets may lead to an unintended drop in blood pressure and increased heart rate, causing a feeling of faintness. If an overdose of Tanyz ERAS is taken, contact your doctor immediately.
Missing a dose of Tanyz ERAS
If a daily dose of tamsulosin is missed, the missed dose may be taken later on the same day. If the patient forgets to take the medicine during the day, the next dose should be taken the following day as directed by the doctor. Do not take a double dose to make up for a missed dose.
Stopping Tanyz ERAS treatment
If tamsulosin is stopped too early, previous symptoms may return. Therefore, tamsulosin should be taken for as long as prescribed by the doctor, even if symptoms have already resolved. 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 will experience them.
Severe adverse reactions are rare. You should contact your doctor immediately if severe allergic reactions occur, causing swelling of the face or throat (angioedema).

Common adverse reactions (may affect up to 1 in 10 patients)

Dizziness, especially when sitting down or standing up
Ejaculation disorders, such as retrograde ejaculation (semen enters the bladder instead of being expelled through the urethra) or inability to achieve ejaculation.

Uncommon adverse reactions (may affect up to 1 in 100 patients)

Headache
Palpitations (heart beats faster than usual and this is noticeable)
Drop in blood pressure, e.g. when quickly standing up from sitting or lying down, sometimes causing dizziness
Runny nose or nasal mucosal swelling (inflammation of the nasal mucosa)
Diarrhoea, nausea and vomiting, constipation
Weakness (asthenia)
Rash, itching and hives.

Rare adverse reactions (may affect up to 1 in 1,000 patients)

Fainting
Localized, sudden swelling of soft tissues (e.g. throat or tongue), breathing difficulties and (or) itching and rash, often as an allergic reaction (angioedema).

Very rare adverse reactions (may affect up to 1 in 10,000 patients)

Priapism (painful, prolonged, unintended erection requiring immediate medical attention)
Rash, inflammation and blistering of the skin and (or) mucous membranes in the mouth, eyes, nose or genital organs (Stevens-Johnson syndrome)
Irregular, abnormal heartbeats (atrial fibrillation, arrhythmia, tachycardia), breathing problems (shortness of breath).

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

Blurred vision, visual disturbances
Nosebleeds
Dryness of the oral mucosa
Severe forms of skin rash (erythema multiforme, exfoliative dermatitis).

If Tanyz ERAS has been or is currently being taken, during eye surgery for cataract (clouding of the lens), the pupil may dilate poorly and the iris (the coloured, circular part of the eye) may become floppy during the procedure.

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

5. How to store Tanyz ERAS

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store 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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tanyz ERAS contains

The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
Other ingredients are: Tablet core: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silicon dioxide, iron oxide red (E 172), magnesium stearate; Outer core coating: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silicon dioxide, magnesium stearate.

What Tanyz ERAS looks like and contents of the pack
White, round prolonged-release tablets marked with "T9SL" on one side and "0.4" on the other side.
Pack sizes: 28, 30, 60 or 90 prolonged-release tablets in blister packs, contained in a cardboard box.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
Synthon Hispania SL, Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain

For further information on product names available in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. +48 22 57 37 500