Urostad 0.4 mg modified release capsule, hard

Package leaflet: Information for the patient

Caution! Keep this leaflet. Information on the immediate packaging in a foreign language.
UROSTAD 0.4 mg modified-release capsule, hard
(Tamsulosine HCl CF 0.4 mg, hard capsules with controlled release)
Tamsulosini hydrochloridum
UROSTAD 0.4 mg modified-release capsule, hard and Tamsulosine HCl CF 0.4 mg, hard capsules with controlled release are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

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 medicine causes relaxation of smooth muscles in 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 capsule, modified-release
When not to use UROSTAD

• If the patient is allergic to tamsulosin or to 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 cases, 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). The patient should immediately discontinue UROSTAD and contact a doctor. Re-initiation of tamsulosin therapy is not recommended.
• If the patient is scheduled for cataract surgery (loss of vision, particularly of the 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 to 2 weeks before planned surgery. The patient 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 it 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 medicines, such as doxazosin, indoramin, prazosin or alfuzosin. Concurrent use of these medicines may cause a decrease in blood pressure, which may lead to dizziness or lightheadedness.
• erythromycin, an antibiotic used to treat infections.

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

UROSTAD with food and drink
Take the capsule 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 if 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 prescribed by the doctor. 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.
Use of a higher than recommended dose of UROSTAD
If a higher than recommended dose of UROSTAD is taken, a sudden drop in blood pressure may occur. The patient may experience dizziness, weakness, and fainting. To reduce symptoms of low blood pressure, lie down and then contact your doctor. The doctor may administer medications to restore blood pressure to normal levels and monitor vital functions. If necessary, the doctor may recommend gastric lavage and administer laxatives to remove the portion of the drug that has not yet been absorbed from the gastrointestinal tract into the bloodstream.
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 doubts concerning 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 experiences them.

Common (may occur in 1 out of 10 people):
Dizziness • Ejaculation disorders (abnormal ejaculation). This means that semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or only a small amount of semen is released during ejaculation, or no semen is released (inability to ejaculate). These symptoms are harmless to the patient.

Uncommon (may occur in 1 out of 100 people):
Headache • Palpitations (awareness of heartbeat) • Decreased blood pressure, especially upon standing, causing dizziness, lightheadedness or fainting (orthostatic hypotension) • Nasal congestion and irritation (nasal mucositis)

• Constipation • Diarrhea • Nausea • Vomiting • Rash • Itching • Feeling of weakness (asthenia).

Rare (may occur in 1 out of 1,000 people):
Fainting • Severe allergic reactions causing swelling of the face and throat (angioedema). In such cases, contact a doctor immediately and do not restart treatment with UROSTAD (see section 2 Warnings and precautions).

Very rare (may occur in 1 out of 10,000 people):
Painful penile erection (priapism) • Severe illness causing blistering of the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from available data):
Severe skin rashes (erythema multiforme, exfoliative dermatitis) • Nosebleeds.

• After the medicine was placed on the market, during cataract surgery in patients treated with tamsulosin, a small pupil sign has been reported, known as intraoperative floppy iris syndrome (IFIS); (see also section 2 Warnings and precautions), dry mouth.

Additional adverse reactions (post-marketing experience): 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 with the use of tamsulosin.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

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

Keep this medicine out of the sight and reach of children.
Do not use UROSTAD after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store in the original packaging 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 required. Such measures help protect the environment.

6. Contents of the package and other information

What UROSTAD contains

• The active substance is tamsulosin hydrochloride 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

Orange-olive modified-release capsule. The capsules contain white or almost white pellets.

The capsules are packed in PVC/PE/PVDC/Al blisters and cardboard boxes containing 30 capsules.

For further information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten-Leur
The Netherlands

Manufacturer:
Centrafarm Services B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in the Netherlands, country of export: RVG 32582
Parallel Import Licence number: 781/12

This medicinal product is authorised in the European Economic Area (EEA) Member States 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 ilgstošas 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