Bazetham retard

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Bazetham Retard, 0.4 mg, prolonged-release tablets
tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Bazetham Retard is and what it is used for
2. What you need to know 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 Bazetham Retard is and what it is used for

The active substance in Bazetham Retard is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist that reduces the tone of smooth muscles in the prostate gland and urethra (the tube through which urine passes out of the body). As a result, the urethra, which runs through the prostate gland, becomes less constricted, making urination easier. In addition, tamsulosin reduces the sensation of urinary urgency.
Tamsulosin is intended for use in men to treat symptoms of the lower urinary tract associated with benign prostatic hyperplasia. These symptoms may include difficulty urinating (weak stream), dribbling after urination, urgency to urinate, and increased frequency of urination both during the day and at night.

2. Important information before using Bazetham Retard

When NOT to use Bazetham Retard

• if the patient is allergic 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. tongue or throat), difficulty in breathing and/or itching and rash (angioedema).
• if the patient has severe liver function disorders;
• if the patient has orthostatic hypotension (dizziness due to drop in blood pressure when sitting or standing up).

Warnings and precautions
Before starting treatment with Bazetham Retard, consult a doctor or pharmacist.

• in patients with severe kidney function disorders.
• In rare cases, treatment with Bazetham Retard may cause fainting during sitting or standing up. If the patient experiences dizziness or feeling weak, the patient should sit or lie down until symptoms subside.
• Before starting treatment with Bazetham Retard, the treating physician should examine whether the patient has other diseases that may cause symptoms similar to those of benign prostatic hyperplasia. Before starting treatment, and regularly during treatment, the treating physician should perform a manual examination of the patient's prostate gland to rule out abnormalities and order testing of the blood concentration of prostate-specific antigen (PSA) produced by the prostate gland.
• In rare cases, a severe allergic reaction may occur, characterized by swelling of the face, lips, tongue, and throat, which may impair breathing, speaking, or swallowing (angioedema). If such symptoms occur, treatment with Bazetham Retard must be stopped immediately and the treating physician should be contacted.
• If the patient is scheduled for surgery due to cataract or increased intraocular pressure (glaucoma), the patient should inform the ophthalmologist before surgery that he is currently taking or has taken Bazetham Retard. The ophthalmologist may take appropriate precautions regarding treatment and surgical techniques used. The patient should consult the physician whether treatment with Bazetham Retard should be discontinued or temporarily interrupted prior to cataract surgery or surgical treatment of increased intraocular pressure (glaucoma).

Patients should consult their treating physician if any of the above warnings apply or have applied in the past.

Children and adolescents
Bazetham Retard should not be given to children or adolescents under 18 years of age, as the medicine has not been shown to be effective in this patient group.

Other medicines and Bazetham Retard
Inform the doctor or pharmacist about all medicines currently taken or used recently, as well as any medicines the patient plans to take or use.
Inform the doctor if the patient is taking any of the following medicines:

• Any other alpha-1 adrenergic receptor antagonist (medicines used in the treatment of prostate disorders), e.g. alfuzosin, doxazosin, terazosin, because concomitant use with tamsulosin may cause undesirable lowering of blood pressure.
• Diclofenac (an anti-inflammatory medicine used to treat pain)
• Warfarin (used as an anticoagulant)
• Ketoconazole (used to treat fungal infections)

Bazetham Retard with food and drink
Bazetham Retard can be taken independently of meals.

Pregnancy and breastfeeding and effect on fertility
Bazetham Retard is not intended for use in women.
Cases of abnormal ejaculation have been reported in men (ejaculation disorders). This means that semen does not exit through the urethra but flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is not dangerous.

Driving and using machines
The effect of Bazetham Retard on the ability to drive and operate machinery has not been established. However, one should be aware of the possibility of dizziness occurring. If such symptoms occur, the patient should not drive or use tools or operate machinery requiring concentration.

3. How to use Bazetham Retard

Bazetham Retard must always be used according to the instructions given by the doctor or pharmacist.
If in doubt, please contact your doctor or pharmacist again.
The recommended dose of Bazetham Retard is one tablet per day. The patient may take Bazetham Retard
regardless of meals, preferably at the same time each day.
The tablet should be swallowed whole with a glass of water; do not chew or crush it.
Dose adjustment is not necessary in patients with renal impairment or mild to moderate hepatic
dysfunction (see also section 2, "When NOT to use Bazetham Retard").
Bazetham Retard is usually prescribed for long-term use. The effect on the bladder and urination is
maintained during prolonged treatment with Bazetham Retard.
Do not forget to take the medicine. Your doctor will inform you of the duration for which you should
take Bazetham Retard.

Taking more Bazetham Retard than recommended
Taking more extended-release tablets of Bazetham Retard than recommended may lead to unwanted
lowering of blood pressure, increased heart rate with a feeling of faintness, dizziness, and headache.
Seek immediate medical attention by contacting your doctor or going to the nearest hospital emergency
department. Bring this leaflet and any remaining tablets with you.

Missing a dose of Bazetham Retard
If the patient forgets to take a tablet of Bazetham Retard, they may take it later on the same day.
If the patient completely forgets to take the medicine for one day, they should 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 Bazetham Retard treatment
Stopping treatment with Bazetham Retard earlier than advised by the treating doctor may cause the
original symptoms of the disease to return. Therefore, continue taking Bazetham Retard for as long as
prescribed by your doctor, even if symptoms have subsided. Consult your doctor before considering
discontinuation of treatment.

If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Bazetham Retard is not intended for use in children.

4. Possible adverse reactions

Like all medicines, Bazetham Retard may cause adverse reactions, although not everyone experiences them.
The tablets must be discontinued immediately and the patient should contact a doctor or the nearest hospital if any of the following symptoms occur:

• Allergic reaction (skin rash or hives over the whole body with swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema) (may affect up to 1 in 1,000 people)
• Severe illness with blistering of the skin, mouth, eyes and genital organs, known as Stevens-Johnson syndrome (may affect up to 1 in 10,000 people).

These are very serious, but rare adverse reactions. The patient may require urgent medical attention or hospitalization.
The following adverse reactions have been reported during treatment with tamsulosin hydrochloride:
Common (may affect up to 1 in 10 patients):

• Dizziness,
• Abnormal ejaculation (ejaculation disorders). This means that semen does not pass through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is not dangerous.

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

• 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 blocked nose (nasal congestion),
• Nausea (feeling sick or vomiting), diarrhoea, constipation,
• Rash, itching and hives,
• Weakness (asthenia).

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

• Fainting,
• Skin rash or hives over the whole body, with swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).

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

• Severe skin rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genital organs, with flu-like symptoms (Stevens-Johnson syndrome),
• Priapism (prolonged, painful penile erection persisting despite absence of sexual stimulation; this adverse reaction requires immediate treatment).

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

• Blurred vision,
• Visual disturbances,
• Nosebleeds,
• Dry mouth,
• Itchy, red-pink spots on the limbs (erythema multiforme),
• Red, scaly skin (exfoliative dermatitis),
• Irregular, abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia),
• Breathing difficulties (dyspnoea).

If the patient is undergoing surgery for cataract or increased intraocular pressure (glaucoma) and is currently taking or has previously taken Bazetham Retard, the pupil may not dilate properly and the iris (the coloured part of the eye) may become floppy during surgery (see also section 2 "Warnings and precautions").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine. Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Bazetham Retard

Keep the medicine out of the sight and reach of children.
Do not use Bazetham Retard after the expiry date stated on the carton and
blister after the marking “Termin ważności (EXP):” or “EXP:”. The expiry date refers to the last day
of the specified month.
No special precautions for storage of the medicinal product are required.
Medicines must not be disposed of via sewage systems or household waste. Ask
your pharmacist what to do with medicines no longer required. Such measures 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.
• Other ingredients are: tablet core: microcrystalline cellulose, polyethylene oxide, anhydrous colloidal silicon dioxide, magnesium stearate; coating Opadry Yellow 03F32784: hypromellose 6cP, titanium dioxide (E171), polyethylene glycol 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 the imprint ‘T04’ on one side and blank on the other side.
• Pack sizes available: 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 Authorisation 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, The 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.