TAMISPRAS 0.4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. TamisPras Auro, 0.4 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet:
3. What is TamisPras Auro and what is it used for
4. Important information before taking TamisPras Auro
   1. When not to take TamisPras Auro:
   2. Warnings and precautions
   3. Children and adolescents
   4. TamisPras Auro and other medicines
   5. TamisPras Auro with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. TamisPras Auro contains lactose monohydrate
5. How to take TamisPras Auro
   1. If you take more TamisPras Auro than you should
   2. If you forget to take TamisPras Auro
   3. If you stop taking TamisPras Auro
6. Possible side effects
   1. Reporting side effects
7. How to store TamisPras Auro
8. Contents of the pack and other information
   1. What TamisPras Auro contains
   2. What TamisPras Auro looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet: 11/2023

Package Leaflet: Information for the User

TamisPras Auro, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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, or 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. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is TamisPras Auro and what is it used for

The active substance of TamisPras Auro is tamsulosin. It is a selective antagonist of α-adrenergic receptors. It reduces the tension of the prostate and urethra (urethra), allowing urine to flow through the urethra and facilitating urination. Additionally, it reduces the feeling of pressure on the bladder. TamisPras Auro is used in men for the treatment of symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia (BPH). These symptoms include: difficulty urinating (weak urine stream), urinating in drops or interrupted streams, sudden urge to urinate and frequent urination both at night and during the day.

2. Important information before taking TamisPras Auro

When not to take TamisPras Auro:

If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include sudden local swelling of soft tissues (throat or tongue), difficulty breathing and (or) itching and rash (angioedema). If you have severe liver disease. If you have experienced fainting during a change in body position (sitting or standing) caused by decreased blood pressure.

Warnings and precautions

Before taking TamisPras Auro, consult your doctor or pharmacist. Periodic medical examinations are necessary to determine the degree of development of the disease for which you are being treated. Rarely, as with other medicines of this type, during treatment with TamisPras Auro, fainting may occur. If you experience the first symptoms such as dizziness or weakness, you should sit or lie down until these symptoms pass. If you have severe kidney disease, inform your doctor. If you are to undergo cataract surgery or glaucoma treatment, you should inform your ophthalmologist that you have taken, are taking, or plan to take TamisPras Auro. The ophthalmologist may take necessary precautions regarding the treatment and surgical technique used. You should ask your doctor if you should stop or temporarily discontinue taking this medicine if cataract surgery or glaucoma treatment is planned.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age, as it does not work in this population.

TamisPras Auro and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Taking TamisPras Auro at the same time as other medicines belonging to the same group (α-adrenergic receptor antagonists) may lead to undesirable blood pressure lowering. It is especially important to inform your doctor if you are being treated with medicines that may slow down the elimination of TamisPras Auro from your body (e.g., ketoconazole, erythromycin).

TamisPras Auro with food and drink

TamisPras Auro can be taken with or without food.

Pregnancy and breastfeeding

TamisPras Auro is not indicated for use in women. In men, ejaculation disorders (ejaculation disorders) have been reported. This means that semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin impairs the ability to drive and use machines. However, you should be aware of the possibility of dizziness, so if this applies to you, you should not perform tasks that require attention.

TamisPras Auro contains lactose monohydrate

If your doctor has informed you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take TamisPras Auro

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet per day. TamisPras Auro can be taken with or without food, preferably at the same time each day. Swallow the tablet whole, do not chew or crush it. TamisPras Auro is a specially designed tablet that releases the active substance slowly after swallowing. You may notice the remains of the tablet in your stool. Since the active substance has already been released, there is no risk that the tablet will be less effective. TamisPras Auro is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term treatment with TamisPras Auro.

If you take more TamisPras Auro than you should

If you take more TamisPras Auro than you should, you may experience a sudden drop in blood pressure and an increase in heart rate, with a feeling of fainting. If you take more of this medicine than you should, contact your doctor immediately.

If you forget to take TamisPras Auro

If you forget to take your daily dose of TamisPras Auro as directed, you can take it on the same day later. If you forget to take the medicine for one day, you should skip the missed dose and continue taking the prescribed dose the next day at the usual time. Do not take a double dose to make up for the missed tablet.

If you stop taking TamisPras Auro

If you stop taking TamisPras Auro too early, the original symptoms of the disease may return. Therefore, the medicine should be taken for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. Consult your doctor if you are considering stopping treatment. If you have any further questions on the use of this medicine, ask your 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, especially when sitting or standing, abnormal ejaculation (ejaculation disorder). This means that semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless. Uncommon(may affect up to 1 in 100 people): headache, palpitations (heartbeats are faster than usual and are noticeable), low blood pressure, for example when standing up quickly from a sitting or lying position, sometimes associated with dizziness, runny nose or stuffy nose (rhinitis), diarrhea, nausea and vomiting, constipation, weakness (asthenia), rash, itching and hives. Rare(may affect up to 1 in 1,000 people): fainting and sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing and (or) itching and rash, often as an allergic reaction (angioedema). Very rare(may affect up to 1 in 10,000 people): painful, prolonged, and unwanted erection (priapism), which requires immediate treatment, rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nose, or genitals (Stevens-Johnson syndrome). Not known(frequency cannot be estimated from the available data): blurred vision, vision disturbances, nosebleeds, severe skin rashes (erythema multiforme, exfoliative dermatitis), irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea), if you are undergoing eye surgery for cataracts or glaucoma and are already taking or have taken TamisPras Auro, the pupil may dilate poorly and the iris (colored round part of the eye) may become flaccid during the surgical procedure, dry mouth.

Reporting side effects

If you experience any side effects, or 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. 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 TamisPras Auro

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, blister, or container after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TamisPras Auro contains

The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.

• Other ingredients are: Tablet core: microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), hydroxypropylcellulose, lactose monohydrate, polyethylene oxide, hypromellose type 2280 (100000 mPa · s), colloidal silicon dioxide, anhydrous, and magnesium stearate Tablet coating: hypromellose 2910, macrogol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What TamisPras Auro looks like and contents of the pack

Prolonged-release tablets. TamisPras Auro is yellow, round (9.1 mm in diameter), biconvex with "T" embossed above and "04" embossed below on one side and smooth on the other. TamisPras Auro prolonged-release tablets are available in blisters of PA/Aluminum/PVC/Aluminum and collective packaging (i.e., HDPE container with PP closure, containing a desiccant), in a cardboard box. Blister: Pack sizes: 20, 30, 50, 90, 100, and 200 prolonged-release tablets Container: Pack sizes: 250 prolonged-release tablets Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected] Manufacturer/Importer:APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques SAS 26, Avenue Tony Garnier 69007 Lyon France

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

Belgium: Tamsulosin AB 0.4 mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten Cyprus: Tamsulosin Aurobindo 0.4 mg δισκία παρατεταμένης αποδέσμευσης Czech Republic: Tamsulosin Aurovitas France: TAMSULOSINE ARROW LP 0.4 mg, comprimé à libération prolongée Germany: Tamsulosin PUREN 0.4 mg Retardtabletten Netherlands: Tamsulosine HCl Aurobindo Retard 0.4 mg, tabletten met verlengde afgifte Poland: TamisPras Auro Portugal: Tansulosina Generis Spain: Tamsulosina Aurovitas 0.4 mg comprimidos de liberación prolongada EFG

Date of last revision of the package leaflet: 11/2023