Package leaflet: Information for the patient

Tamsudil
0.4 mg, modified-release capsules, hard
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents:

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

1. What Tamsudil is and what it is used for

The active substance in Tamsudil modified-release capsules is tamsulosin hydrochloride. It is a selective α₁-adrenoceptor antagonist. It reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. Additionally, it reduces the sensation of urinary urgency.
Tamsudil is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the day and at night.

2. Important information before using Tamsudil

When not to use Tamsudil:

if the patient is allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Symptoms include sudden swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema)
if the patient has previously experienced dizziness or fainting upon sudden standing caused by low blood pressure (orthostatic hypotension)
if the patient has severe liver disease.

Warnings and precautions
Before starting Tamsudil, discuss the following with your doctor or pharmacist:

regular medical check-ups are necessary to monitor the progression of the condition being treated,
rarely, as with other medicines in this class, fainting may occur. If symptoms such as dizziness or feeling faint develop, sit or lie down until symptoms resolve. If the patient does not feel better, medical advice should be sought.
if the patient has severe kidney disease, or is undergoing or has planned eye surgery due to cataract or increased intraocular pressure (glaucoma). Inform the ophthalmologist about current or planned use of Tamsudil. The specialist may then take appropriate precautions regarding medications and surgical techniques used. Ask your doctor whether you need to postpone or temporarily discontinue Tamsudil before eye surgery for cataract or glaucoma.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as it is not indicated in this population and its safety and efficacy have not been established.

Tamsudil 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 planned for future use. This is particularly important in the case of:

other alpha1-adrenergic receptor antagonists (medicines used in the treatment of prostate gland disorders), e.g. alfuzosin, doxazosin, prazosin or indoramin, because concomitant use with tamsulosin may lead to undesirable lowering of blood pressure,
diclofenac (an anti-inflammatory pain-relieving medicine),
warfarin (a medicine used to prevent blood clotting),
it is especially important to inform your doctor or pharmacist if the patient is taking medicines that may reduce tamsulosin elimination from the body, e.g. ketoconazole (an antifungal medicine) or erythromycin.

Tamsudil with food and drink
Tamsudil should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding and fertility
Tamsudil is not indicated for use in women.
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is harmless.

Driving and using machines
Tamsudil is unlikely to affect the ability to drive or operate machinery. However, one should be aware of the possibility of dizziness. In such a case, activities requiring attention should not be performed.

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

3. How to use Tamsudil

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is: one capsule per day, taken after breakfast or the first meal of the day.
The medicine should be taken while standing or sitting upright (not lying down), swallowed whole,
and taken with a full glass of water. Capsules must not be crushed or chewed.
Tamsudil is usually prescribed for long-term use. Its effect on the bladder and urination is maintained
during prolonged treatment with Tamsudil.
Taking a higher than recommended dose of Tamsudil
Taking too many Tamsudil capsules may lead to undesirable lowering of blood pressure
and increased heart rate, accompanied by a feeling of weakness. If a patient (or anyone else)
takes many capsules at the same time, or if it is suspected that a child has swallowed any capsule,
immediately contact the nearest hospital emergency department or consult a doctor without delay.
Missing a dose of Tamsudil
Do not take a double dose to make up for a missed dose. If the patient forgets to take the medicine
after the first meal of the day, they may take it later the same day after a meal. If the patient
misses a dose for the entire day, they should skip the missed dose and take the next dose
at the usual time.
Stopping treatment with Tamsudil
The doctor will prescribe the appropriate dose of the medicine tailored to the patient and their condition,
and will determine the proper duration of treatment. Do not change the dose of the medicine without
first consulting the doctor.
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.
You should stop taking Tamsudil and contact your doctor immediately if any of the following symptoms occur:

severe allergic reaction with sudden, localized swelling of the lips, face, tongue or throat, leading to serious breathing difficulties and (or) itching and rash (angioedema) (rare, may affect up to 1 in 1,000 patients).
serious illness characterized by rash, inflammation, and formation of blisters on the skin and (or) mucous membranes of the lips, mouth, eyes or genital organs, known as Stevens-Johnson syndrome (very rare, may affect up to 1 in 10,000 patients).

These are very serious but rare adverse reactions. Urgent medical assistance or hospitalization may be required.
Common (may affect up to 1 in 10 patients)

dizziness, particularly when changing from a lying to a sitting or standing position
ejaculation disorders
retrograde ejaculation (ejaculation into the bladder)
absence of ejaculation

Uncommon (may affect up to 1 in 100 patients)

headache
rapid or irregular heartbeat (palpitations)
low blood pressure, especially felt when sitting or standing up
nasal congestion or runny nose (rhinitis)
constipation, diarrhoea, nausea, vomiting
skin rash, itching, urticaria
weakness (asthenia)

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

fainting

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

painful, prolonged and unintended erection (priapism)

Frequency not known (frequency cannot be estimated from available data)

irregular, abnormal heartbeat and increased heart rate (atrial fibrillation, arrhythmia, tachycardia)
difficulty breathing
nosebleeds
dry mouth
blurred vision
visual disturbances
skin redness, severe skin rashes (erythema multiforme, exfoliative dermatitis)

If a patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), and the patient is currently or has previously been taking Tamsudil, it should be considered that during the procedure the pupil may not dilate properly and the iris (the coloured, circular part of the eyeball) may become floppy (see section 2 "Warnings and precautions").
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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tamsudil

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton box or
blister pack following EXP. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Tamsudil contains

The active substance is tamsulosin hydrochloride. Each 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, and talc.
Capsule shell: 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).

What Tamsudil looks like and contents of the pack
Tamsudil is a modified-release hard capsule consisting of an orange body and an olive cap. The capsule is filled with white to almost white pellets.
Pack sizes available
10, 20, 30, 60, or 90 modified-release hard capsules.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel. (22) 345 93 00.
This medicinal product is authorised in the European Economic Area countries under the following names:
Member country Name of the medicinal product
Czech Republic Tamsulosin HCL Actavis
Denmark Tamsulosinhydrochlorid Actavis
Hungary Tamsudil 0.4 mg módosított hatóanyagleadású kemény kapszula
Norway Tamsulosin Actavis
Poland Tamsudil
Slovakia Tamsulosin Actavis