Urostad 0.4 mg capsule with modified release, hard

Package leaflet: Information for the patient

UROSTAD 0.4 mg modified-release capsule, hard
( Tamsulosini hydrochloridum )
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

and what it is used for
UROSTAD is an alpha-adrenergic receptor blocking agent. The drug causes relaxation of smooth muscles of the prostate gland and urinary tract.
UROSTAD is used to relieve urinary symptoms caused by enlargement of the prostate (benign prostatic hyperplasia). By relaxing smooth muscles, UROSTAD facilitates urine flow and urination.

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

When not to use 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 upon standing, causing dizziness, lightheadedness, or fainting;
• If the patient has severe liver disease.

Warnings and precautions
Before starting treatment with UROSTAD, consult a doctor or pharmacist.

• If the patient experiences dizziness or lightheadedness, especially upon standing. UROSTAD may cause a decrease in blood pressure, which can lead to these symptoms. In such a case, the patient should sit or lie down and remain in that position until symptoms subside.
• If the patient has severe kidney function impairment. Administering the usual dose of UROSTAD in patients with impaired kidney function may not produce the expected therapeutic effect.
• If the patient develops swelling of the face or throat. These are symptoms of angioedema (see section 2, When not to use UROSTAD). Treatment with UROSTAD should be stopped immediately and medical advice sought. Re-initiation of tamsulosin therapy should not be attempted.
• If the patient is scheduled for cataract surgery (loss of vision, particularly of blue color). In patients currently or previously treated with tamsulosin, intraoperative floppy iris syndrome (IFIS) may occur during cataract surgery. This condition may increase the risk of surgical complications. It is recommended to discontinue tamsulosin 1–2 weeks prior to planned cataract surgery. Patients should discuss this with their treating physician and surgeon in advance.

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

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

• diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may increase the rate of tamsulosin elimination from the body, thereby shortening the duration of tamsulosin's effect.
• warfarin, a medicine used to prevent blood clotting. This medicine may increase the rate of tamsulosin elimination from the body, thereby shortening its duration of action.
• medicines that lower blood pressure, such as verapamil and diltiazem.
• medicines used in HIV infection, such as ritonavir or indinavir.
• medicines used to treat fungal infections, such as ketoconazole or itraconazole.
• other alpha-blocker receptor antagonists, such as doxazosin, indoramin, prazosin, or alfuzosin. Concomitant use of these medicines may cause a decrease in blood pressure, potentially leading to dizziness or lightheadedness.
• erythromycin, an antibiotic used to treat infections.

Inform 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.

UROSTAD with food and drink
The medicine should be taken after breakfast or after the first meal of the day, with a glass of water.

Driving and operating machinery
There are no data available on the influence of tamsulosin on the ability to drive or operate machinery. However, patients should be aware that dizziness or lightheadedness may occur. Patients may drive or operate machinery only when they feel well.

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

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

This medicine should always be taken exactly as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
The recommended dose is one capsule once daily, taken after breakfast or after the first meal of the day.
The capsule should be taken while standing or sitting (not lying down) and swallowed whole with a glass of water. It is important not to break or crush the capsule, as this may affect the proper functioning of UROSTAD.

Overdose of UROSTAD
Taking more than the recommended dose of UROSTAD may cause a sudden drop in blood pressure. The patient may experience dizziness, weakness, and fainting. To reduce symptoms of low blood pressure, the patient should lie down and then contact a doctor. The doctor may administer medications to restore blood pressure to normal levels and monitor vital functions. If necessary, the doctor may perform gastric lavage and administer laxatives to remove the portion of the medicine that has not yet been absorbed into the bloodstream from the gastrointestinal tract.

Missed dose of UROSTAD
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
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.
Common (may affect up to 1 in 10 people):
Dizziness • Abnormal ejaculation (ejaculation disorders). This means that semen does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or only a small amount of semen is expelled during ejaculation or there is no semen at all (inability to ejaculate). These symptoms are harmless to the patient.
Uncommon (may affect up to 1 in 100 people):
Headache • Awareness of heartbeat (palpitations) • Decrease in blood pressure, especially upon standing, causing dizziness, feeling faint or fainting (orthostatic hypotension) • Nasal congestion and irritation inside the nose (nasal mucositis)

• Constipation • Diarrhea • Nausea • Vomiting • Rash • Itching • Urticaria • Feeling of weakness (asthenia)
  Rare (may affect up to 1 in 1,000 people):
  Fainting • Severe allergic reactions causing swelling of the face and throat (angioedema): Immediate medical advice must be sought and treatment with UROSTAD must not be restarted (see section 2 Warnings and precautions)
  Very rare (may affect up to 1 in 10,000 people):
  Painful penile erection (priapism) • Severe illness causing blistering of the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome)
  Unknown (cannot be estimated from available data)
  Severe skin rashes (erythema multiforme, exfoliative dermatitis) • Nosebleeds • During cataract surgery in patients treated with tamsulosin, a small pupil phenomenon has been reported, known as intraoperative floppy iris syndrome (IFIS); (see also section 2 Warnings and precautions), dry mouth.
  Additional adverse reactions (reported after product marketing):
  In addition to the adverse reactions listed above, irregular heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), and shortness of breath have been reported in connection with the use of tamsulosin.
  If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
  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 for Monitoring Adverse Drug Reactions 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
  Reporting adverse reactions helps to provide more information on the safety of the medicine.
  Adverse reactions can also be reported to the marketing authorization holder.

5. How to store the medicine UROSTAD 0.4 mg modified-release capsule,

hard
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"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 specified month.
Store blisters in the original packaging to protect from moisture.
Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. Such measures will help protect the environment.

6. Contents of the pack and other information

What UROSTAD contains

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

Capsule shell: gelatin, indigotine (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
Urostad 0.4 mg modified-release hard capsule is orange-olive in colour and contains white or off-white pellets.
The capsules are packed in blisters and cardboard boxes containing 30 capsules.

Marketing Authorisation 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 authorised for sale in 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 0.4 mg modified-release hard capsule
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 kemény 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