Package leaflet: Information for the patient

Tanyz, 0.4 mg, modified-release capsules, hard
tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Leaflet contents

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

1. What Tanyz is and what it is used for

What Tanyz is
The active substance in Tanyz is tamsulosin hydrochloride, which causes relaxation of the muscles in the prostate gland and urethra (the tube through which urine passes out of the body). By relaxing these muscles, tamsulosin allows easier urine flow and facilitates urination.
In the prostate, bladder, and urethra, there are specialized cells containing alpha receptors, which cause constriction of the urethral muscles. Tanyz is an alpha-adrenergic receptor antagonist – it blocks the action of these specialized cells and relaxes the muscles, thus improving urine flow.

What Tanyz is used for
Tanyz is used in the treatment of symptoms associated with benign prostatic hyperplasia (BPH), i.e. an enlarged prostate gland.
These symptoms include difficulty starting urination, frequent urination, sensation of incomplete bladder emptying, and frequent urination both during the day and at night.

2. Important information before using Tanyz

When not to use Tanyz

If the patient is allergic to tamsulosin or to 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 difficulties and (or) itching and rash (angioedema).
If the patient has severe liver function impairment.
If the patient has previously experienced dizziness due to a drop in blood pressure upon changing body position (when sitting or standing up).

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

As with other similar medicines, in rare cases treatment with Tanyz may lead to fainting. If the patient experiences dizziness or a feeling of weakness, the patient should sit or lie down until symptoms subside.
If the patient is taking certain prescription medicines (see section "Tanyz and other medicines").
If the patient has kidney function disorders, inform the doctor.
Patients undergoing eye surgery or those scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma) should inform their ophthalmologist about current or recent use of tamsulosin hydrochloride. The ophthalmologist may then take appropriate precautions by selecting suitable drugs or surgical techniques. Ask your doctor whether it is necessary to reschedule or temporarily discontinue the medicine due to cataract surgery or increased intraocular pressure (glaucoma).
If the patient develops sudden swelling of the hands or feet, swelling of the lips, tongue or throat causing breathing difficulties and (or) itching and rash due to an allergic reaction (angioedema) while taking tamsulosin. In such a case, stop taking Tanyz immediately and contact a doctor without delay.

Before starting treatment with Tanyz, the doctor will examine the prostate gland and will perform periodic control examinations during treatment.
Children
This medicine must 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tanyz may affect the action of other medicines, and other medicines may also affect the efficacy of Tanyz. Therefore, it is important to inform the doctor if the patient is taking any of the following medicines:

Medicines that lower blood pressure (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 preventing 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 enlarged prostate, dizziness due to low blood pressure may occur when quickly sitting or standing up. These symptoms may occur in some patients during treatment for erectile dysfunction (impotence) who are also taking alpha-adrenergic receptor antagonists. To reduce the likelihood of these symptoms, the patient should be on a regular daily dose of an alpha-receptor blocking medicine before starting treatment for erectile dysfunction.
Before any surgical or dental procedure, inform the doctor about taking Tanyz, as there is a potential risk of interaction with anaesthetic medicines.
Taking Tanyz together with medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended lowering of blood pressure.
Pregnancy, breastfeeding and effects on fertility
Tanyz is not intended for use in women.
Abnormal ejaculation (ejaculation disorders) have been reported in men. This means that semen does not exit through the urethra but flows back into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.
Driving and operating machinery
There are no data on the effect of tamsulosin on the ability to drive or operate machinery. However, bear in mind that tamsulosin may cause dizziness. Driving or operating machinery should only be undertaken if the patient feels well.
Tanyz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Tanyz

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Dosage
The recommended dose for adults and elderly patients is one capsule taken daily. The capsule should be taken after breakfast or after the first meal of the day.
The capsules must be swallowed whole and should not be chewed or crushed.
During treatment with this medicine, the doctor may consider periodic monitoring of the patient appropriate.
Accidental overdose of Tanyz
Taking too many Tanyz capsules may lead to unintended lowering of blood pressure and increased heart rate, causing a feeling of faintness. If an overdose of Tanyz is taken, seek immediate medical advice.
Missed dose of Tanyz
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, according to the doctor's instructions. A double dose should not be taken to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop taking Tanyz and contact your doctor immediately if
any of the following adverse reactions occur:

sudden swelling of the hands or feet, lips, tongue or throat causing difficulty in breathing 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 genital organs (Stevens-Johnson syndrome)
severe inflammation and blistering of the skin, known as erythema multiforme

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

dizziness, especially when sitting down or standing up
ejaculation disorders: retrograde ejaculation (semen does not exit the body through the urethra but enters the bladder) or inability to achieve ejaculation (ejaculate volume is reduced or ejaculation does not occur). This phenomenon is not dangerous.

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

headache
palpitations (fast or irregular heartbeat)
drop in 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, vomiting, diarrhoea, constipation
weakness (asthenia)
skin rashes, itching and urticaria

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

fainting
localised, sudden swelling of soft tissues (e.g. throat or tongue), breathing difficulties and (or) itching and rash, often due to an allergic reaction (angioed ema)

Very rare adverse reactions (may occur in 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 of the mouth, eyes, nose or genital organs (Stevens-Johnson syndrome)

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

drowsiness, dry mouth or swelling
blurred vision, visual disturbances
nosebleeds
severe forms of skin rash (erythema multiforme, exfoliative dermatitis)
irregular heartbeat, abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea)

If Tanyz has been or is currently being taken by a patient undergoing eye surgery due to
cataract (clouding of the lens) or increased intraocular pressure (glaucoma), 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 adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Tanyz

Keep the 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.
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 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 coating. See section 2, "Tanyz contains sodium".

What Tanyz looks like and contents of the pack
Modified-release hard capsules are orange/olive in colour. The capsules contain white to off-white pellets.
Pack sizes: 30, 60 or 90 modified-release hard capsules in blisters, packed in a cardboard box.

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

Manufacturer/Importer
Synthon España S.L, Castello, 1, Polígono Las Salinas, Sant Boi de Llobregat, Spain
Quinta-Analytica s.r.o., Pražská 1486/18c, 102 00 Prague 10, Czech Republic
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia