Tamsudil

Leaflet accompanying the packaging: patient information

Tamsudil

0.4 mg, modified-release capsules, hard
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 Tamsudil and what is it used for
• 2. Important information before taking Tamsudil
• 3. How to take Tamsudil
• 4. Possible side effects
• 5. How to store Tamsudil
• 6. Contents of the pack and other information

1. What is Tamsudil and what is it used for

The active substance of Tamsudil, modified-release capsules, is tamsulosin hydrochloride. It is a selective alpha-1 adrenergic receptor antagonist. It reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, it reduces the feeling of pressure on the bladder.
Tamsudil is used in men for the treatment of symptoms of lower urinary tract disorders associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination at night and during the day.

2. Important information before taking Tamsudil

When not to take Tamsudil:

Warnings and precautions

Before starting to take Tamsudil, you should discuss it with your doctor or pharmacist:

• it is necessary to undergo regular medical examinations to determine the degree of development of the disease for which the patient is being treated,
• rarely, as with other medicines of the same group, fainting may occur. As soon as symptoms such as dizziness or weakness occur, you should sit or lie down until these symptoms pass. However, if you do not feel better, you should contact your doctor.

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

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is especially important in the case of:

• other alpha-1 adrenergic receptor antagonists (medicines used to treat prostate disorders) such as alfuzosin, doxazosin, prazosin, or indoramin, as concomitant use of tamsulosin may cause undesirable blood pressure lowering.
• diklofenak (an anti-inflammatory medicine with analgesic properties),
• warfarin (a medicine used to prevent blood clotting)
• it is especially important to inform your doctor or pharmacist if you are taking medicines that may reduce the excretion of tamsulosin from the body, such as ketokonazol (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.
There have been reports of ejaculation disorders 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 is harmless.

Driving and using machines:

Tamsudil should not affect your ability to drive or use machines.
However, you should be aware of the possibility of dizziness. In such cases, you should not perform tasks that require attention.

Tamsudil 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 Tamsudil

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose is: one capsule per day, taken after breakfast or the first meal of the day.

The capsule should be taken standing or sitting upright (not lying down) and swallowed whole, with a full glass of water. The capsules should not be crushed or chewed.

Tamsudil is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term use of Tamsudil.

Taking more than the recommended dose of Tamsudil

Taking too many Tamsudil capsules may lead to undesirable blood pressure lowering and increased heart rate, with a feeling of weakness. If you (or anyone else) take too many capsules at the same time or suspect that a child has swallowed any, you should contact the nearest hospital emergency department or immediately inform your doctor.

Missing a dose of Tamsudil

You should not take a double dose to make up for a missed dose. If you forget to take your medicine after the first meal of the day, you can take it later that day after a meal. If you forget to take your medicine for the entire day, you should skip the missed dose and take the next dose at the right time.

Stopping treatment with Tamsudil

Your doctor will prescribe the correct dose of Tamsudil for you and your condition and determine the correct duration of treatment. You should not change the dose of your medicine without consulting your doctor first.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsudil can cause side effects, although not everybody gets them.
You should stop taking Tamsudil and contact your doctor immediatelyif you experience any of the following symptoms:

• severe allergic reaction with sudden 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 people).
• a serious disease characterized by a rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, mouth, eyes, or genitals, known as Stevens-Johnson syndrome (very rare, may affect up to 1 in 10,000 people).

These are very serious but rare side effects. You may need urgent medical attention or hospitalization.

Common (may affect up to 1 in 10 people)

• dizziness, especially 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 people)

• headache
• rapid or irregular heartbeat (palpitations)
• low blood pressure, especially when sitting or standing up
• runny nose or stuffy nose (rhinitis)
• constipation, diarrhea, nausea (vomiting), vomiting
• rash, itching, and hives
• weakness (asthenia)

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

• fainting

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

• painful, prolonged, and involuntary erection (priapism)

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

• abnormal, irregular heartbeat (arrhythmia) and rapid heartbeat (atrial fibrillation, arrhythmia, tachycardia)
• breathing difficulties
• nosebleeds
• dry mouth
• blurred vision
• disturbed vision
• redness of the skin, severe skin rash (erythema multiforme, exfoliative dermatitis)

If you are scheduled to undergo eye surgery due to cataracts or increased eye pressure (glaucoma) and you are taking or have taken Tamsudil in the past, you should consider that during the surgery, the pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Tamsudil

The medicine should be stored out of 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 or blister after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should 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 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, modified-release capsules, hard, consisting of an orange body and an olive green cap. The capsule is filled with white to almost white pellets.

Pack sizes

10, 20, 30, 60, or 90 modified-release capsules, hard.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State Name of the medicinal product

Czech Republic
Tamsulosin HCL Actavis
Denmark
Tamsulosinhydrochlorid Actavis
Hungary
Tamsudil 0.4 mg modified-release hard capsules
Norway
Tamsulosin Actavis
Poland
Tamsudil
Slovakia
Tamsulosin Actavis

Date of last revision of the leaflet: May 2024