Taniz

Leaflet attached to the packaging: patient information

Tanyz, 0.4 mg, modified-release hard capsules
tamsulosin hydrochloride

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tanyz and what is it used for

What is Tanyz

The active substance of Tanyz is tamsulosin hydrochloride, which causes relaxation of the prostate and urethra muscles (the tube that carries urine out of the body). Thanks to muscle relaxation, tamsulosin facilitates easier urine flow and makes it easier to urinate. The prostate, bladder, and urethra contain specialized cells with alpha-1 receptors that cause the urethra muscles to constrict. Tanyz is an alpha-1 adrenergic receptor antagonist - it inhibits the action of these specialized cells and relaxes the muscles, making it easier to urinate.

What is Tanyz used for

Tanyz is used to treat symptoms associated with benign prostatic hyperplasia (BPH), i.e., an enlarged prostate. These symptoms include difficulty starting to urinate, frequent urination, a feeling of incomplete bladder emptying, and frequent urination both at night and during the day.

2. Important information before taking Tanyz

When not to take Tanyz

• If you are allergic to tamsulosinor any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride may manifest as sudden swelling of the hands or feet, swelling of the lips, tongue, or throat causing breathing problems and (or) itching and rash (angioedema).
• If you have severe liver function disorders.
• If you have experienced dizziness associated with a drop in blood pressure when changing body position (when sitting or standing up) in the past.

Warnings and precautions

Before starting to take Tanyz, discuss it with your doctor or pharmacist.

• -As with the use of similar medicines, in rare cases, taking Tanyz may lead to fainting. If you experience dizziness or weakness, you should sit or lie down until the symptoms pass.
• -If you are taking certain medicines prescribed by your doctor (see section "Tanyz and other medicines").
• If you have kidney function disorders, you should inform your doctor.
• Patients undergoing eye surgery or who are scheduled to undergo eye surgery due to cataracts or increased eye pressure (glaucoma) should inform their ophthalmologist about taking tamsulosin hydrochloride. The ophthalmologist may then take appropriate precautions by choosing appropriate medicines or surgical techniques. You should ask your doctor if it is necessary to postpone or temporarily discontinue the medicine due to the cataract or glaucoma surgery.
• If you experience sudden swelling of the hands or feet, lips, tongue, or throat causing breathing problems and (or) itching and rash due to an allergic reaction (angioedema) while taking tamsulosin. In such a case, you should stop taking Tanyz and contact your doctor immediately.

Before starting treatment with Tanyz, your doctor will examine your prostate and then periodically perform check-ups during treatment.

Children

This medicine should not be given to children and adolescents under 18 years of age, as it is not effective in this population.

Tanyz and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Tanyz may affect the action of other medicines, and other medicines may affect the effectiveness of Tanyz, so it is essential to inform your doctor about taking the following medicines:

• blood pressure-lowering medicines (e.g., verapamil and diltiazem),
• medicines used to treat HIV infections (e.g., ritonavir or saquinavir),
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole, voriconazole, or fluconazole),
• medicines that prevent blood clot formation (warfarin),
• anti-inflammatory medicines (e.g., diclofenac),
• medicines used to treat infections (e.g., erythromycin, clarithromycin),
• medicines that suppress the immune system (e.g., cyclosporine).

In some patients taking alpha-adrenergic receptor blockers for high blood pressure or prostate enlargement, dizziness caused by low blood pressure may occur when sitting or standing up quickly. These symptoms occur in some patients during treatment for erectile dysfunction and when taking alpha-adrenergic receptor antagonists. To reduce the likelihood of these symptoms, you should take your daily dose of the alpha-receptor blocker regularly before starting treatment for erectile dysfunction. Before any surgical or dental procedure, you should inform your doctor about taking Tanyz, as there is a potential risk of affecting the action of anesthetics. Taking Tanyz with medicines from the same class (alpha-adrenergic receptor antagonists) may cause unintended low blood pressure.

Pregnancy, breastfeeding, and fertility

Tanyz is not intended for use by women. Abnormal ejaculation (ejaculation disorders) has been reported in men. This means that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon does not pose a risk.

Driving and using machines

There is no data on the effect of tamsulosin on the ability to drive and use machines. However, you should keep in mind that tamsulosin may cause dizziness. You should drive or operate machines only if you feel well.

Tanyz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Tanyz

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The dose of Tanyz used in adults and elderly patients is one capsule taken every day. The capsules should be taken after breakfast or after the first meal of the day. The capsules should be swallowed whole, not chewed or crushed. During treatment with this medicine, your doctor may consider it necessary to perform periodic check-ups.

Taking a higher dose of Tanyz than recommended

Taking too many Tanyz capsules may lead to unintended low blood pressure and rapid heartbeat, causing a feeling of fainting. You should contact your doctor immediately if you have taken too much Tanyz.

Missing a dose of Tanyz

If you miss a daily dose of tamsulosin, you can take the missed dose later that day. If you forget to take the medicine during the day, you should take the next dose as directed by your doctor the next day. Do not take a double dose to make up for a missed dose. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tanyz can cause side effects, although not everybody gets them.

Stop taking Tanyz and contact your doctor immediately if you experience any of the following side effects:

• sudden swelling of the hands or feet, lips, tongue, or throat causing breathing problems and (or) itching and rash due to an allergic reaction (angioedema)
• rash, inflammation, and blistering of the skin and (or) mucous membranes of the mouth, eyes, nose, or genitals (Stevens-Johnson syndrome)
• severe skin inflammation and blistering (erythema multiforme)

Common side effects (may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing up
• abnormal ejaculation (ejaculation disorders): retrograde ejaculation of semen (semen is not expelled from the body through the urethra but instead flows back into the bladder) or inability to ejaculate (reduced volume of ejaculate or no ejaculation). This phenomenon does not pose a risk.

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

• headache
• palpitations (rapid or irregular heartbeat)
• low blood pressure, e.g., when standing up quickly from a sitting or lying position, sometimes causing dizziness
• runny nose or swelling of the nasal mucosa (rhinitis)
• gastrointestinal symptoms, such as nausea and vomiting, diarrhea, constipation
• weakness (asthenia)
• rash, itching, and urticaria

Rare side effects (may affect up to 1 in 1,000 people)

• fainting
• local, sudden swelling of soft tissues (e.g., throat or tongue), breathing problems, and (or) itching and rash, often as an allergic reaction (angioedema)

Very rare side effects may affect up to 1 in 10,000 people)

• priapism (painful, prolonged, unintended erection requiring immediate medical attention)
• rash, inflammation, and blistering of the skin and (or) mucous membranes of the mouth, eyes, nose, or genitals (Stevens-Johnson syndrome)

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

• -drowsiness, dry mouth, or swelling
• blurred vision, vision disturbances
• nasal bleeding
• severe skin rash (erythema multiforme, toxic epidermal necrolysis)
• irregular heartbeat, abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnea)

If you are taking or have recently taken Tanyz and are undergoing eye surgery due to cataracts or increased eye pressure (glaucoma), your pupils may not dilate properly, and your iris may become floppy during the procedure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can report side effects directly to the Department of Adverse Reaction Monitoring 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, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tanyz

Keep this medicine out of the 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 month. Store in the original packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tanyz contains

• The active substance is tamsulosin hydrochloride. Each modified-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc in the capsule core, and gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172) in the capsule shell. See section 2 "Tanyz contains sodium".

What Tanyz looks like and contents of the pack

The modified-release hard capsules are orange/olive. The capsules contain white to off-white pellets. Packs: 30, 60, or 90 modified-release hard capsules in blisters, in a cardboard box.

Marketing authorization holder

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

Manufacturer/Importer

Synthon Spain S.L, Castello, 1, Polígono Las Salinas, Sant Boi de Llobregat, Spain, Quinta-Analytica s.r.o., Pražská 1486/18c, 102 00 Praga 10, Czech Republic, KRKA, d.d, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, Date of last revision of the leaflet:15.11.2024