Taniz Eras

Leaflet attached to the packaging: patient information

Tanyz ERAS, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tanyz ERAS and what is it used for
• 2. Important information before taking Tanyz ERAS
• 3. How to take Tanyz ERAS
• 4. Possible side effects
• 5. How to store Tanyz ERAS
• 6. Contents of the packaging and other information

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

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

2. Important information before taking Tanyz ERAS

When not to take Tanyz ERAS:

• If the patient is allergic to tamsulosinor 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 breathing, and (or) itching and rash (angioedema).
• If the patient has severe liver function disorders.
• If the patient has experienced fainting associated with a drop in blood pressure when changing body position (when sitting or standing up).

Warnings and precautions

Before starting to take Tanyz ERAS, the patient should discuss it with their doctor or pharmacist.

• -To monitor the development of the disease for which the patient is being treated, regular check-ups with the doctor are necessary.
• -As with the use of similar medicines, the use of Tanyz ERAS may rarely lead to fainting. If the patient experiences dizziness or weakness, they should sit or lie down until the symptoms pass.
• If the patient has severekidney function disorders, they should inform their doctor.
• Patient undergoing eye surgery or planned eye surgery for cataracts should inform their ophthalmologist about taking tamsulosin hydrochloride. The ophthalmologist may then take appropriate precautions by selecting appropriate medications or surgical techniques. The patient should ask their doctor if it is necessary to postpone or temporarily discontinue the medicine due to the cataract surgery.

Tablet residues 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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Taking Tanyz ERAS with medicines from the same class (alpha-adrenergic receptor antagonists) may cause unintended lowering of 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 independently of meals.

Pregnancy and breastfeeding

This section does not apply, as Tanyz ERAS is used only in men.

Driving and using machines

There are no data on the effect of tamsulosin on the ability to drive and use machines. However, tamsulosin may cause dizziness and weakness. The patient should drive or operate machines only if they feel well.

3. How to take Tanyz ERAS

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Recommended doseis one tablet per day. Tamsulosin can be taken with or without food, preferably at the same time every day. The 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 long-term treatment with Tanyz ERAS.

Taking a higher dose of Tanyz ERAS than recommended

Taking too many tablets may lead to unintended lowering of blood pressure and rapid heartbeat, causing a feeling of fainting. The patient should contact their doctor immediately if they have taken too much Tanyz ERAS.

Missing a dose of Tanyz ERAS

If the patient misses a daily dose of tamsulosin, they can take the missed dose later that day. If the patient forgets to take the medicine during the day, they should take the next dose as directed by the doctor the next day. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Tanyz ERAS

If the patient stops taking tamsulosin too early, the previous symptoms may return. Therefore, tamsulosin should be taken for as long as directed by the doctor, even if the symptoms of the disease have already disappeared. Before stopping treatment, the patient should always consult their doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tanyz ERAS can cause side effects, although not everybody gets them. Serious side effects are rare. The patient should contact their doctor immediatelyif they experience severe allergic reactions, causing swelling of the face or throat(angioedema). Common side effects(may affect up to 1 in 10 patients)

• Dizziness, especially when sitting or standing up
• Ejaculation disorders, retrograde ejaculation (semen does not exit the body through the urethra but enters the bladder) or inability to ejaculate.

Uncommon side effects(may affect up to 1 in 100 patients)

• Headache
• Palpitations (heart beats faster than usual and is noticeable)
• Low blood pressure, e.g., when standing up quickly from a sitting or lying position, sometimes causing dizziness
• Rhinorrhea or swelling of the nasal mucosa (rhinitis)
• Diarrhea, nausea, and vomiting, constipation
• Weakness (asthenia)
• Rash, itching, and urticaria.

Rare side effects(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 side effects(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 genitals (Stevens-Johnson syndrome)
• Abnormal, irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnea).

Side effects of unknown frequency(frequency cannot be estimated from the available data)

• Blurred vision, vision disturbances
• Nosebleeds
• Dryness of the mucous membranes in the mouth
• Severe forms of rash (erythema multiforme, exfoliative dermatitis).

If Tanyz ERAS was or is being taken during cataract surgery, the pupil may not dilate properly, and the iris may become flaccid during the procedure.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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]. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tanyz ERAS

The medicine should be stored 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 specified month. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tanyz ERAS contains

• The active substance of Tanyz ERAS is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• Other ingredients are: Core of the tablet: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, red iron oxide (E 172), magnesium stearate; Outer layer of the core of the tablet:microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What Tanyz ERAS looks like and contents of the packaging

White, round, prolonged-release tablets with the inscription "T9SL" on one side and "0.4" on the other side. Packaging: 28, 30, 60, or 90 prolonged-release tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

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, Netherlands
Synthon Hispania SL, Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain
To obtain more detailed information on the names of medicinal products in other Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500

Date of last revision of the leaflet: