Tamsulosin Pharmalab

Package Leaflet: Information for the Patient

Tamsulosin Pharmalab, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

Read the package 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 inform your doctor or pharmacist. See section 4.

Table of Contents

• 1. What is Tamsulosin Pharmalab and what is it used for
• 2. Important information before taking Tamsulosin Pharmalab
• 3. How to take Tamsulosin Pharmalab
• 4. Possible side effects
• 5. How to store Tamsulosin Pharmalab
• 6. Contents of the pack and other information

1. What is Tamsulosin Pharmalab and what is it used for

The active substance of Tamsulosin Pharmalab is tamsulosin hydrochloride. This is a substance belonging to the group of medicines called α-adrenolytics (or α-1A-adrenergic antagonists). Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of pressure on the bladder. Tamsulosin Pharmalab is used to treat the symptoms of lower urinary tract disorders associated with prostate enlargement (benign prostatic hyperplasia). These symptoms include difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination both at night and during the day.

2. Important information before taking Tamsulosin Pharmalab

When not to take Tamsulosin Pharmalab:

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash (angioedema).
• If you have severe liver failure.
• If you have fainting spells associated with low blood pressure when changing position (from lying down to sitting or standing).

Do not take Tamsulosin Pharmalab without consulting your doctor if any of the above applies to you.

In case of any doubts before taking the medicine, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Tamsulosin Pharmalab, discuss it with your doctor. It is necessary to perform periodic medical examinations to determine the degree of development of the disease being treated. Rarely, as with other medicines in the same group, a decrease in blood pressure and fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until they pass, If you have severe kidney disease, inform your doctor, If you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma), inform your ophthalmologist that you are taking, have taken, or plan to take Tamsulosin Pharmalab. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. Ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased eye pressure (glaucoma).

Children and adolescents

Do not use Tamsulosin Pharmalab in children and adolescents under 18 years of age, as the safety and efficacy of the medicine in this population have not been established.

Tamsulosin Pharmalab and other medicines

Taking Tamsulosin Pharmalab with other medicines in the same group (α1-adrenergic receptor antagonists) may cause unintended lowering of blood pressure. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. It is especially important to tell your doctor if you are taking medicines that may reduce the excretion of Tamsulosin Pharmalab from the body (e.g., ketoconazole, erythromycin).

Tamsulosin Pharmalab with food and drink

Tamsulosin Pharmalab can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin Pharmalab 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 does not pose a risk.

Driving and using machines

The effect of Tamsulosin Pharmalab on the ability to drive and use machines has not been proven. However, you should be aware of the possibility of dizziness - in such cases, do not perform tasks that require attention.

3. How to take Tamsulosin Pharmalab

Always take Tamsulosin Pharmalab exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet once a day. Tamsulosin Pharmalab should be taken regardless of meals, preferably at the same time every day. Swallow the tablet whole, do not chew or crush it. Tamsulosin Pharmalab is a tablet designed to release the active substance slowly and evenly after swallowing. The remains of the tablet may appear in the stool. There is no reason to suspect that the tablet is ineffective because the active substance has been released earlier. Usually, Tamsulosin Pharmalab is prescribed for long-term use. The effect on the bladder and urination persists during long-term use of Tamsulosin Pharmalab.

Taking a higher dose of Tamsulosin Pharmalab than recommended

Taking too many Tamsulosin Pharmalab tablets may lead to unintended lowering of blood pressure and increased heart rate with a feeling of weakness.

In case of taking a higher dose of Tamsulosin Pharmalab than recommended, consult your doctor or hospital.

Missing a dose of Tamsulosin Pharmalab

If you miss a dose, you can take the tablet later that day. If you do not take the tablet on a given day, continue treatment according to the previous dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Tamsulosin Pharmalab

If you stop treatment prematurely, the symptoms of the disease may return. Therefore, you should take Tamsulosin Pharmalab for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. Stopping treatment should always be discussed with your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosin Pharmalab can cause side effects, although not everybody gets them. The following side effects have been reported during treatment with Tamsulosin Pharmalab:
Common(may affect up to 1 in 10 people):

• dizziness, especially when changing position from lying down to sitting or standing,
• ejaculation disorders (retrograde ejaculation, absence of ejaculation). Ejaculation disorders mean 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 does not pose a risk.

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

• headache,
• palpitations (feeling of heart beating and faster than usual),
• low blood pressure felt, for example, when sitting or standing up from a lying position, associated with dizziness,
• nasal congestion,
• gastrointestinal reactions (constipation, diarrhea, nausea, vomiting),
• allergic reactions (rash, itching, hives),
• weakness.

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

• fainting,
• sudden local swelling of soft tissues, e.g., throat, tongue, difficulty breathing, and (or) itching and rash, often as a result of an allergic reaction (angioedema).

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

• persistent and painful erection of the penis (priapism), usually not during sexual activity, which requires immediate treatment,
• Stevens-Johnson syndrome (severe skin reactions that may manifest as rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genitals).

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

• blurred vision,
• vision disturbances,
• nasal bleeding,
• severe skin reactions (erythema multiforme, exfoliative dermatitis),
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnea),
• dry mouth.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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 Tamsulosin Pharmalab

Keep this medicine out of the sight and reach of children. Store the blisters in the original packaging to protect from light. Do not use this medicine after the expiry date which is stated on the carton and blister packaging (month/year). The expiry date is the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tamsulosin Pharmalab contains:

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: hypromellose, microcrystalline cellulose, carbomer (Carbopol 71G), colloidal anhydrous silica, red iron oxide (E 172), magnesium stearate.

What Tamsulosin Pharmalab looks like and contents of the pack

White, round tablets, without a dividing line, 9 mm in diameter, with the symbol "T9SL" embossed on one side and "0.4" on the other side. Tamsulosin Pharmalab is available in blisters in packs of 14 and 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Pharmalab Poland Sp. z o.o., ul. Siemianowicka 84, 41-902 Bytom, [email protected]

Manufacturer:

Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands, Synthon Hispania SL, Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain, Date of last revision of the leaflet:05/2025