Fokusin Sr

Package Leaflet: Information for the Patient

Fokusin SR, 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 of the Leaflet

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

1. What is Fokusin SR and what is it used for

Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra.
Tamsulosin, by reducing muscle tension, improves urine flow through the urethra
and, as a result, facilitates urination. Additionally, it reduces the sudden need to urinate.
Tamsulosin is prescribed to men to alleviate symptoms of urinary tract disorders,
caused by an enlarged prostate gland (benign prostatic hyperplasia). These symptoms
may include difficulty urinating (weak urine stream), urinating in drops, sudden need to urinate, and frequent urination both at night and during the day.

2. Important information before taking Fokusin SR

When not to take Fokusin SR:

• if the patient is allergic to the active substance or any of the other ingredientsof this medicine (listed in section 6). Hypersensitivity may manifest as sudden, localized swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash (angioedema),
• if the patient has experienced blood pressure drops associated with a change in body position to standing, causing dizziness, a feeling of "emptiness" in the head or fainting,
• if the patient has severe liver function disorders

Warnings and precautions

Before starting to take Fokusin SR, discuss it with your doctor or pharmacist.

• if the patient has experienced dizziness or a feeling of "emptiness" in the head, especially when changing body position to standing. Tamsulosin may cause a drop in blood pressure and lead to the occurrence of these symptoms. The patient should sit or lie down until the symptoms pass,
• if the patient has severe kidney function disorders, consult a doctor
• if the patient is to undergo eye surgery or is planned to undergo eye surgery due to cataracts or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS) may occur. The patient should inform the ophthalmologist about taking tamsulosin. The ophthalmologist may then take appropriate precautions by selecting appropriate medications or surgical techniques. The patient should ask the doctor if it is advisable to postpone or temporarily discontinue the medication in connection with the planned cataract or glaucoma surgery.

Periodic medical examinations are necessary to monitor the progress of the disease for which the patient is
being treated.
Remnants of the tablet may be visible in the stool. Since the active substance has been released
from the tablet, there is no risk of weakening the effectiveness of the medicine.

Children and adolescents

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

Fokusin SR and other medicines

Tamsulosin may affect other medicines. They, in turn, may affect the action of tamsulosin.
Tamsulosin may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the patient's body, thereby shortening the duration of action of tamsulosin,
• warfarin, a medicine that prevents blood clots. This medicine may accelerate the elimination of tamsulosin from the patient's body, thereby shortening the duration of action of tamsulosin,
• other alpha-adrenergic receptor antagonists. Concomitant use may cause a decrease in blood pressure and lead to dizziness and a feeling of "emptiness" in the head,
• ketokonazole, a medicine used to treat fungal infections. This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacistabout all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Fokusin SR with food, drink, and alcohol

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

There are no indications for the use of tamsulosin in women.
In men, ejaculation disorders (ejaculation disorders) have been reported. This means that
semen does not come out through the urethra and is transferred to the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or there is no ejaculation. This situation is harmful to the patient.

Driving and using machines

There are no data on the effect of tamsulosin on the ability to drive and use machines. The patient should remember the possibility of dizziness and a feeling of "emptiness" in the head. The patient can drive vehicles or operate machines only if they feel well

3. How to take Fokusin SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual doseis one tablet per day. Tamsulosin can be taken with or without food, best at the same time every day.
The tablet should be swallowed whole. It is important not to chewor crush the tablets, as this may affect the efficacy of tamsulosin.
Tamsulosin is not indicated for use in children.

Taking a higher dose of Fokusin SR than recommended

Blood pressure may drop sharply if a higher dose of tamsulosin is taken than recommended. The patient may experience dizziness, weakness, nausea, diarrhea, and fainting. The patient should lie down to minimize the effects of low blood pressure and then contact a doctor.

Missing a dose of Fokusin SR

If the patient forgets to take a dose of tamsulosin at the planned time of day, they can take the missed dose later that day. If the patient forgets to take the medicine during the entire day, they should take the next dose the next day at the planned time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Fokusin SR

If treatment with tamsulosin is stopped too early, previous symptoms may return. Therefore, tamsulosin should be taken for as long as the doctor has prescribed, even if the symptoms of the disease have already disappeared. Before stopping treatment, always consult a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects are rare. Seek medical attention immediatelyif you experience severe allergic reactions, causing swelling of the face or throat(angioedema).
Common side effects(may affect up to 1 in 10 people)
Dizziness
Ejaculation disorders (ejaculation disorders). This means that semen does not come out through the urethra and is transferred to the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or there is no ejaculation. This situation is harmful to the patient.
Uncommon side effects(may affect up to 1 in 100 people)
Headaches, feeling of heartbeat (palpitations), drop in blood pressure when changing body position to standing, causing dizziness, feeling of "emptiness" in the head or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhea, nausea, vomiting, rash, itching, hives, feeling of weakness (asthenia).
Rare side effects(may affect up to 1 in 1,000 people)
Transient loss of consciousness (fainting).
Very rare side effects(may affect up to 1 in 10,000 people)
Painful, prolonged unwanted erection (priapism), severe skin condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
Side effects with unknown frequency(frequency cannot be estimated from available data)
Visual disturbances, blurred vision, nosebleeds, dryness of the mucous membrane of the mouth.
Severe skin rash (erythema multiforme, exfoliative dermatitis).
Heart rhythm disorders, irregular heartbeat, rapid heartbeat, breathing difficulties.
During eye surgery performed due to cataracts or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid during the procedure. For more information, see section 2. "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, E-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fokusin SR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The first two digits indicate the month, and the last four digits indicate the year. The expiry date stated is the last day of the specified month.
Store the blisters in the original packaging to protect from light.
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 Fokusin SR contains

• The active substance is tamsulosin hydrochloride, 0.4 mg, equivalent to 0.367 mg of tamsulosin.
• The other ingredients are: Tablet core: hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, red iron oxide (E172), magnesium stearate Tablet coating: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What Fokusin SR 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.
The medicine is available in blisters in packs of 10, 28, 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.
U kabelovny 130, Dolni Mecholupy
102 37 Prague 10
Czech Republic

Manufacturer

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00

Date of last revision of the leaflet: