Urostad 0,4 mg kapsuvka o zmodifikovanim uvalnianiu, tvarda

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

UROSTAD 0.4 mg modified-release hard capsule

(Tamsulosine HCl CF 0.4 mg, hard capsules with regulated release)
Tamsulosini hydrochloridum
UROSTAD 0.4 mg modified-release hard capsule and Tamsulosine HCl CF 0.4 mg, hard capsules with regulated release are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Contents of the packaging and other information

1. What is UROSTAD 0.4 mg modified-release hard capsule and what is it used for

what it is used for
UROSTAD is a medicine that blocks alpha-adrenergic receptors. The medicine causes relaxation of the smooth muscles of the prostate and urinary system.
UROSTAD is used to alleviate symptoms of urinary disorders caused by an enlarged prostate (benign prostatic hyperplasia). UROSTAD, by causing relaxation of the smooth muscles, facilitates urine flow and urination.

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

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, you should 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 such a case, the patient should sit or lie down and remain in this position until the symptoms subside.
• If the patient has severe kidney problems. Administration of the usual dose of UROSTAD to a patient with impaired kidney function may not produce 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 immediately stop taking UROSTAD and consult a doctor. The patient should not restart treatment with tamsulosin.
• If the patient is to undergo cataract surgery (loss of vision, especially blue color). In patients currently or previously treated with tamsulosin, intraoperative floppy iris syndrome (IFIS) may occur during cataract surgery. This syndrome can cause an increased frequency of complications during surgery. It is recommended to discontinue tamsulosin 1-2 weeks before the planned surgery. The patient should consult their doctor and surgeon to discuss this situation.

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age, as it does not work in this population.

UROSTAD and 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 elimination of tamsulosin from the body and, as a result, reduce the duration of action of tamsulosin.
• warfarin, a medicine that prevents blood clotting. This medicine may increase the rate of elimination of tamsulosin from the body and, as a result, reduce the duration of action of tamsulosin.
• 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-blocker medicines, such as doxazosin, indoramin, prazosin, or alfuzosin. Concurrent use of these medicines may cause a decrease in blood pressure, which can cause dizziness or lightheadedness.
• erythromycin, an antibiotic used to treat infections.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 on the effect of tamsulosin on the ability to drive and operate machinery. However, patients should be aware that they may experience dizziness or lightheadedness. The patient 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, which means it is considered "sodium-free".

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

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dose is one capsule per day, taken after breakfast or after the first meal of the day.
The capsule should be taken 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.

Taking a higher dose of UROSTAD than recommended

After taking a higher dose of UROSTAD than recommended, a sudden drop in blood pressure may occur. The patient may experience dizziness, weakness, and fainting. To reduce the symptoms of low blood pressure, the patient should lie down and then consult a doctor. The doctor may administer medicines to restore blood pressure to normal values and monitor the patient's vital functions. If necessary, the doctor may recommend gastric lavage and administer laxatives to remove the part of the medicine that has not yet been absorbed from the digestive system into the blood.

Missing a dose of UROSTAD

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 semen does not come out of the body through the urethra, but enters the bladder (retrograde ejaculation) or that a small amount of semen or no semen is ejaculated (inability to ejaculate). These symptoms are harmless to the patient.

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

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

• 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). The patient should immediately consult a doctor and not restart treatment with UROSTAD (see section 2 Warnings and precautions).

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

Painful erection of the penis (priapism) • Severe disease 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 was placed on the market, during cataract surgery in patients treated with tamsulosin, there were reports of a condition known as intraoperative floppy iris syndrome (IFIS); (see also section 2 Warnings and precautions), dry mouth.

Additional side effects (post-marketing experience): In addition to the side effects listed above, the following side effects have been reported in connection with the use of tamsulosin: irregular heartbeat (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), and shortness of breath.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

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

modified release, hard capsule
The medicine should be stored out of sight and reach of children.
UROSTAD should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What UROSTAD contains

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

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

What UROSTAD looks like and what the packaging contains.

Orange-olive modified-release hard capsule. The capsules contain white or almost white pellets.
The capsules are packaged in PVC/PE/PVDC/Al blisters and a cardboard box, containing 30 capsules.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten-Leur
Netherlands

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 32582

Parallel import authorization number: 781/12

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, 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 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 leaflet approval: 31.10.2022
[Information about the trademark]