UROSTAD 0.4 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. UROSTAD 0.4 mg modified-release hard capsule
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is UROSTAD 0.4 mg modified-release hard capsule
4. Important information before taking UROSTAD 0.4 mg modified-release hard capsule
   1. When not to take UROSTAD
   2. Warnings and precautions
   3. Children and adolescents
   4. UROSTAD and other medicines
   5. UROSTAD with food and drink
   6. Driving and using machines
   7. UROSTAD contains sodium
5. How to take UROSTAD 0.4 mg modified-release hard capsule
   1. What to do if you take more UROSTAD than you should
   2. What to do if you forget to take UROSTAD
6. Possible side effects
   1. Common (may affect up to 1 in 10 people):
   2. Uncommon (may affect up to 1 in 100 people):
   3. Rare (may affect up to 1 in 1,000 people):
   4. Very rare (may affect up to 1 in 10,000 people):
   5. Not known (cannot be estimated from the available data)
7. How to store UROSTAD 0.4 mg modified-release hard capsule
8. Package contents and other information
   1. What UROSTAD contains
   2. What UROSTAD looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

UROSTAD 0.4 mg modified-release hard capsule

(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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 UROSTAD 0.4 mg modified-release hard capsule and what is it used for
• 2. Important information before taking UROSTAD 0.4 mg modified-release hard capsule
• 3. How to take UROSTAD 0.4 mg modified-release hard capsule
• 4. Possible side effects
• 5. How to store UROSTAD 0.4 mg modified-release hard capsule
• 6. Package contents and other information

1. What is UROSTAD 0.4 mg modified-release hard capsule

and what is it used for
UROSTAD is an alpha-adrenergic receptor blocker. The medicine causes relaxation of the smooth muscles of the prostate and urinary tract.
UROSTAD is used to alleviate the symptoms of benign prostatic hyperplasia (BPH).

2. Important information before taking UROSTAD 0.4 mg modified-release hard capsule

When not to take UROSTAD

• If the patient is allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6); symptoms may include swelling of the face or throat (angioedema).
• If the patient has experienced a drop in blood pressure when standing up, causing dizziness, fainting, or lightheadedness;
• If the patient has severe liver disease.

Warnings and precautions

Before starting to take UROSTAD, consult a doctor or pharmacist.

• If the patient experiences dizziness or lightheadedness, especially when standing up. UROSTAD may cause a decrease in blood pressure, which can cause these symptoms. In this case, the patient should sit or lie down and remain in this position until the symptoms subside.
• If the patient has severe kidney problems. Taking the usual dose of UROSTAD may not have the expected effect.
• If the patient experiences swelling of the face or throat. These are symptoms of angioedema (see section 2, When not to take UROSTAD). The patient should stop taking UROSTAD and consult a doctor immediately. The patient should not start taking tamsulosin again.
• If the patient is going to have cataract surgery. Patients taking tamsulosin may experience a condition called Intraoperative Floppy Iris Syndrome (IFIS) during surgery, which can increase the risk of complications. It is recommended to stop taking tamsulosin 1-2 weeks before the scheduled surgery. The patient should consult their doctor and surgeon before stopping the medicine.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

UROSTAD and other medicines

Tamsulosin may affect the action of other medicines or other medicines may affect the action of UROSTAD. UROSTAD may interact with:

• diclofenac, a painkiller and anti-inflammatory medicine. This medicine may increase the rate of elimination of tamsulosin from the body and consequently reduce its duration of action.
• warfarin, a medicine that prevents blood clotting. This medicine may increase the rate of elimination of tamsulosin from the body and consequently reduce its duration of action.
• medicines that lower blood pressure, such as verapamil and diltiazem.
• medicines used to treat HIV infection, such as ritonavir or indinavir.
• medicines used to treat fungal infections, such as ketoconazole or itraconazole.
• other alpha-blockers, such as doxazosin, indoramin, prazosin, or alfuzosin. Taking these medicines together may cause a decrease in blood pressure, leading to dizziness or lightheadedness.
• erythromycin, an antibiotic used to treat infections.

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

UROSTAD with food and drink

Take the medicine after breakfast or the first meal of the day, with a glass of water.

Driving and using machines

There is no data on the effect of tamsulosin on the ability to drive or use machines. However, patients should be aware that they may experience dizziness or lightheadedness. The patient may drive or use machines only if they feel well.

UROSTAD contains sodium

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

3. How to take UROSTAD 0.4 mg modified-release hard capsule

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one capsule per day, taken after breakfast or the first meal of the day.
Swallow the capsule whole with a glass of water, while standing or sitting (not lying down). Do not crush or chew the capsule, as this may affect the way the medicine works.

What to do if you take more UROSTAD than you should

If you take more UROSTAD than you should, you may experience a sudden drop in blood pressure. You may feel dizzy, weak, or faint. To reduce the symptoms of low blood pressure, lie down and then consult a doctor. The doctor may give you medicines to restore your blood pressure to normal and monitor your vital functions. If necessary, the doctor may recommend gastric lavage and give you laxatives to remove the part of the medicine that has not been absorbed from the digestive system into the bloodstream.

What to do if you forget to take UROSTAD

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):

Dizziness • Abnormal ejaculation (ejaculation disorders). This means that the semen does not come out of the body through the urethra, but enters the bladder (retrograde ejaculation) or that there is a small amount of semen or no semen at all (anejaculation). These symptoms are harmless to the patient.

Uncommon (may affect up to 1 in 100 people):

Headache • Heart palpitations (palpitations) • Decreased blood pressure, especially when standing up, which can cause dizziness, lightheadedness, or fainting (orthostatic hypotension) • Swelling and irritation inside the nose (nasal congestion)

• Constipation • Diarrhea • Nausea • Vomiting • Rash • Itching • Urticaria • Feeling weak (asthenia)

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

Fainting • Severe allergic reactions, causing swelling of the face and throat (angioedema):
Consult a doctor immediately and do not start taking UROSTAD again (see section 2, Warnings and precautions)

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

Painful erection (priapism) • Severe skin condition, causing blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)

Not known (cannot be estimated from the available data)

Severe skin rash (erythema multiforme, exfoliative dermatitis) • Nosebleeds • After the medicine has been on the market, the following side effects have been reported: abnormal heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), and shortness of breath in connection with the use of tamsulosin.
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store UROSTAD 0.4 mg modified-release hard capsule

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the month.
Store the blisters in the original packaging to protect from moisture.
Keep the container tightly closed to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What UROSTAD contains

• The active substance is tamsulosin hydrochloride in a dose of 0.4 mg.
• The other ingredients are: Capsule: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What UROSTAD looks like and contents of the pack

Orange-olive capsule with modified release. The capsules contain white or almost white pellets.
The capsules are packaged in blisters and a cardboard box, containing 30 capsules.

Marketing authorization holder and manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.
LAMP SAN PROSPERO S.p.A., Via della Pace, 25/A, 41030 San Prospero (Modena), Italy

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

Austria
Tamsulosin Stada retard 0.4 mg - Kapseln
Denmark
Omnistad
Estonia
Tamsulosin STADA
Lithuania
Tamsulosin STADA 0.4 mg modifikuoto atpalaidavimo kietos kapsulės
Germany
Tamsulosin STADA 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Ireland
Tamnic 400 micrograms Modified-release Capsule
Latvia
Tamsulosin STADA 0.4 mg ilgstošās darbības cietās kapsulas
Poland
UROSTAD, kapsułka o zmodyfikowanym uwalnianiu, twarda
Belgium
Tamsulosine EG 0,4 mg capsules met gereguleerde afgifte, hard
United Kingdom
Tabphyn MR Capsules 400 micrograms
Hungary
Urostad 0.4 mg módosított hatóanyagleadású kémeny kapszula
Italy
Tamsulosina EG 0.4 mg Capsule rigide a rilascio modificato
Netherlands
Tamsulosine HCI CF 0.4 mg, capsules met gereguleerde afgifte
Luxembourg
Tamsulosine EG 0.4 mg gélules à libération modifiée
Spain
TAMSULOSINA STADA 0.4 mg cápsulas duras de liberación modificada
Date of last revision of the leaflet:16.10.2020