BAZETHAM 0.4 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Bazetham Retard and what is it used for
3. Important information before taking Bazetham Retard
   1. When NOT to take Bazetham Retard
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Bazetham Retard
   5. Bazetham Retard with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Bazetham Retard
   1. Taking more than the recommended dose of Bazetham Retard
   2. Missing a dose of Bazetham Retard
   3. Stopping treatment with Bazetham Retard
5. Possible side effects
   1. Stop taking the tablets and contact your doctor or the nearest hospital immediately if you experience any of the following symptoms:
   2. Reporting side effects
6. How to store Bazetham Retard
7. Contents of the pack and other information
   1. What Bazetham Retard contains
   2. What Bazetham Retard looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: August 2022

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Bazetham Retard, 0.4 mg, prolonged-release tablets
tamsulosin hydrochloride

Read the 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Bazetham Retard and what is it used for

The active substance of Bazetham Retard is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist, which reduces the tension of the smooth muscles of the prostate and urethra (the tube that carries urine out of the body). As a result, the urethra, which passes through the prostate, is less constricted, making it easier to urinate. Additionally, tamsulosin reduces the feeling of urgency to urinate.
Tamsulosin is used in men to treat the symptoms of benign prostatic hyperplasia (enlargement of the prostate). These symptoms include difficulty urinating (weak stream), urinating in drops, urgency to urinate, and increased frequency of urination both at night and during the day.

2. Important information before taking Bazetham Retard

When NOT to take Bazetham Retard

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may appear as sudden swelling of the soft tissues (e.g. tongue or throat), difficulty breathing, and/or itching and rash (angioedema).
• if you have severe liver function disorders;
• if you have severe orthostatic hypotension (dizziness related to a drop in blood pressure when sitting or standing).

Warnings and precautions

Before starting treatment with Bazetham Retard, consult your doctor or pharmacist.

• in patients with severe kidney function disorders.
• Rarely, taking Bazetham Retard may lead to fainting when sitting or standing. If you experience dizziness or weakness, sit or lie down until the symptoms pass.
• Before taking Bazetham Retard, your doctor should check if you have any other conditions that may have similar symptoms to those of benign prostatic hyperplasia. Before starting treatment and then regularly during treatment, your doctor will manually examine your prostate and order a test to measure the level of prostate-specific antigen (PSA) in your blood.
• Rarely, a severe allergic reaction may occur, characterized by swelling of the face, lips, tongue, and throat, which can make breathing, speaking, or swallowing difficult (angioedema). If such symptoms occur, stop taking Bazetham Retard and contact your doctor immediately.
• If you are going to have cataract surgery or glaucoma surgery, tell your ophthalmologist that you have taken or are taking Bazetham Retard. The ophthalmologist may 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 glaucoma surgery.

Consult your doctor if any of the above warnings apply or have applied to you in the past.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this patient group.

Other medicines and Bazetham Retard

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:

• Any other alpha-1 adrenergic receptor antagonist (medicines used to treat prostate diseases), such as alfuzosin, doxazosin, terazosin, as concomitant use with tamsulosin may cause undesirable blood pressure lowering.
• Diclofenac (an anti-inflammatory medicine used to treat pain)
• Warfarin (used to prevent blood clots)
• Ketoconazole (used to treat fungal infections)

Bazetham Retard with food and drink

Bazetham Retard can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Bazetham Retard is not intended for use by women.
There have been reports of abnormal ejaculation in men (ejaculation disorders).
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 there is no ejaculation (absence of ejaculation). This phenomenon is not a threat.

Driving and using machines

The effect of Bazetham Retard on the ability to drive and use machines has not been proven. However, be aware of the possibility of dizziness. If you experience such symptoms, do not drive or operate tools or machines that require concentration.

3. How to take Bazetham Retard

Always take Bazetham Retard exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.
The recommended dose of Bazetham Retard is one tablet per day. You can take Bazetham Retard with or without food, preferably at the same time each day.
Swallow the tablet whole, with a glass of water, do not chew or crush it.
There is no need to adjust the dose in patients with kidney function disorders or mild to moderate liver function disorders (see also section 2 "When NOT to take Bazetham Retard").
Bazetham Retard is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term use of Bazetham Retard.
Do not forget to take your medicine. Your doctor will tell you how long to take Bazetham Retard.

Taking more than the recommended dose of Bazetham Retard

Taking more than the recommended dose of Bazetham Retard may lead to undesirable blood pressure lowering, increased heart rate with a feeling of fainting, dizziness, and headache. Contact your doctor or go to the emergency room immediately. Bring this leaflet and any remaining tablets with you.

Missing a dose of Bazetham Retard

If you miss a dose of Bazetham Retard, you can take it later that day. If you miss a dose entirely, continue taking the prescribed dose the next day at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Bazetham Retard

Stopping treatment with Bazetham Retard earlier than your doctor recommended may cause the original symptoms to return. Therefore, take Bazetham Retard for as long as your doctor recommended, even if the symptoms have disappeared. Consult your doctor if you are considering stopping treatment.
If you have any doubts about taking the medicine, ask your doctor or pharmacist.
Bazetham Retard is not intended for use in children.

4. Possible side effects

Like all medicines, Bazetham Retard can cause side effects, although not everybody gets them.

Stop taking the tablets and contact your doctor or the nearest hospital immediately if you experience any of the following symptoms:

• allergic reaction (skin rash or hives all over the body with swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema) (may affect up to 1 in 1,000 people)
• severe skin condition with blisters on the skin, mouth, eyes, and genitals, similar to flu symptoms (Stevens-Johnson syndrome) (may affect up to 1 in 10,000 people).

These are very serious but rare side effects. You may need urgent medical attention or hospitalization.
The following side effects have been reported during treatment with tamsulosin hydrochloride:
Common(may affect up to 1 in 10 people):

• dizziness,
• abnormal ejaculation (ejaculation disorders). 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 there is no ejaculation (absence of ejaculation). This phenomenon is not a threat.

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

• headache,
• rapid heartbeat (palpitations),
• orthostatic hypotension (dizziness caused by a drop in blood pressure, especially when changing position from sitting or lying down to standing,
• runny or stuffy nose (rhinitis),
• nausea (nausea or vomiting), diarrhea, constipation,
• rash, itching, and hives
• weakness (asthenia).

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

• fainting,
• skin rash or hives all over the body, with swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema).

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

• severe skin condition with blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals, with flu-like symptoms (Stevens-Johnson syndrome),
• priapism (prolonged, painful erection of the penis, lasting despite the absence of sexual stimulation; this side effect requires immediate treatment).

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

• blurred vision,
• vision disorders
• nasal bleeding
• dry mouth
• itching, pink-red patches on the limbs (erythema multiforme)
• red and scaly skin (exfoliative dermatitis)
• irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia)
• breathing difficulties (dyspnea)

If you are going to have cataract surgery or glaucoma surgery and have taken or are taking Bazetham Retard, your pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during surgery (see also section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Bazetham Retard

Keep out of the sight and reach of children.
Do not take Bazetham Retard after the expiry date stated on the carton and blister after "Expiry date:" or "EXP:". The expiry date refers to the last day of that month.
There are no special precautions for storage of the medicinal product.
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 Bazetham Retard contains

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.40 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other ingredients are: tablet core: microcrystalline cellulose, polyethylene oxide, colloidal anhydrous silica, magnesium stearate; coating Opadry Yellow 03F32784: hypromellose 6cP, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172).

What Bazetham Retard looks like and contents of the pack

• Prolonged-release tablet
• Yellow, biconvex, oval, film-coated tablet, with "T04" engraved on one side and blank on the other.
• The pack sizes are 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200, and 50x1 (hospital pack) prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland
tel.: (22) 345 93 00

Manufacturer

1/ Pharmachemie B.V.,Swensweg 5, 2031 GA Haarlem, Netherlands;
2/ TEVA Pharmaceutical Works Private Limited Company,Pallagi út 13, 4042 Debrecen, Hungary;
3/ TEVA Pharma S.L.U.,C/C, nº4, Poligono Industrial Malpica 50016 Zaragoza, Spain;
4/ TEVA Czech Industries s.r.o.,Ostravská 29, č.p. 305, 747 70 Opava –Komárov, Czech Republic;
5/ Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland.

Date of last revision of the leaflet: August 2022