Package leaflet: Information for the patient

Fokusin SR, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read this entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Fokusin SR is and what it is used for
Important information before taking Fokusin SR
How to take Fokusin SR
Possible side effects
How to store Fokusin SR
Contents of the pack and other information

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

Tamsulosin reduces the tension of smooth muscles in the prostate gland and urethra.
By reducing muscle tension, tamsulosin improves urine flow through the urethra
and consequently facilitates urination. Furthermore, it reduces the sudden urge to urinate.
Tamsulosin is prescribed for men to relieve urinary symptoms
caused by an enlarged prostate gland (benign prostatic hyperplasia). These symptoms
may include difficulty urinating (weak urine stream), dribbling after urination, sudden urge to urinate, and frequent urination both during the day and at night.

2. Important information before using Fokusin SR

When not to use Fokusin SR:

if the patient is allergic to the active substance or to any of the other ingredients of 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 drops in blood pressure associated with changing body position to standing, causing dizziness, feeling of "emptiness" in the head or fainting,
if the patient has severe liver function disorders

Warnings and precautions

Before starting treatment with Fokusin SR, discuss this with your doctor or pharmacist.

if the patient experiences dizziness or a feeling of "emptiness" in the head, especially upon changing body position to standing. Tamsulosin may cause a drop in blood pressure and lead to the occurrence of the described symptoms. The patient should sit down or lie down until symptoms subside,
if the patient has severe kidney function disorders, consult a doctor,
if the patient is undergoing or scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS, Intraoperative Floppy Iris Syndrome) may occur. The patient should inform the ophthalmologist about current or recent use of tamsulosine hydrochloride. The ophthalmologist can then apply appropriate precautions by selecting suitable medications or surgical techniques. Ask your doctor whether postponing or temporarily discontinuing the medication is advisable in connection with planned cataract or glaucoma surgery.

Regular medical check-ups 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 reduced 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 is not effective in this population.

Fokusin SR and other medicines
Tamsulosin may interact with other medicines, and other medicines 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 tamsulosin's action,
warfarin, a medicine used to prevent blood clots. This medicine may accelerate the elimination of tamsulosin from the patient's body, thereby shortening the duration of tamsulosin's action,
other α-adrenergic receptor antagonists. Concurrent use may lead to a decrease in the patient's blood pressure and cause dizziness and a feeling of "emptiness" in the head,
ketoconazole, a medicine used in the treatment of fungal infections. This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to use.

Fokusin SR, food, drink, and alcohol
The medicine can be taken independently of meals.

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 exit externally through the urethra but is redirected into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent. This situation is not harmful to the patient.

Driving and operating machinery
There is a lack of data regarding the effect of tamsulosin on the ability to drive vehicles or operate machinery. The patient should be aware of the possibility of experiencing dizziness and a feeling of "emptiness" in the head. The patient may drive vehicles or operate machinery only if feeling well.

3. How to use Fokusin SR

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
The usual dose is one tablet per day. Tamsulosin may be taken with food
or independently of meals, preferably at the same time each day.
The tablet should be swallowed whole. It is important not to chew or crush the tablets, as this may
affect the effectiveness of tamsulosin.
Tamsulosin is not indicated for use in children.
Taking a higher than recommended dose of Fokusin SR
Blood pressure may drop sharply if more tamsulosin than recommended is taken. The patient may
experience dizziness, weakness, vomiting, diarrhea, and fainting. The patient should lie down to
minimize effects related to 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 scheduled time, the missed dose may be
taken later the same day. If the patient forgets to take the medicine for the entire day, the next dose
should be taken the following day at the scheduled time. A double dose should not be taken to make
up for a missed dose.
Stopping treatment with Fokusin SR
If tamsulosin is discontinued too early, previous symptoms may return. Therefore, tamsulosin should
be taken for as long as prescribed by the doctor, even if disease symptoms have already subsided.
Always consult a doctor before stopping treatment.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Severe adverse reactions are rare. You should contact your doctor immediately if severe allergic reactions occur, causing swelling of the face or throat (angioedema).

Common adverse reactions (may affect up to 1 in 10 patients)
Dizziness
Ejaculation disorders. This means that semen does not exit externally through the urethra but is redirected into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent. This condition is not harmful to the patient.

Uncommon adverse reactions (may affect up to 1 in 100 patients)
Headache, sensation of heart pounding (palpitations), drop in blood pressure upon changing to an upright position causing dizziness, feeling of "emptiness" in the head or fainting (orthostatic hypotension), nasal swelling and irritation (rhinitis), constipation, diarrhoea, nausea, vomiting, rash, itching, urticaria, feeling of weakness (asthenia).

Rare adverse reactions (may affect up to 1 in 1000 patients)
Brief loss of consciousness (fainting).

Very rare adverse reactions (may affect up to 1 in 10,000 patients)
Painful, prolonged unwanted erection (priapism), severe condition with blister formation on the skin, inside the mouth, eyes and genital organs (Stevens-Johnson syndrome).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)
Vision disturbances, blurred vision, nosebleeds, dryness of the oral mucosa.
Severe skin rash (erythema multiforme, exfoliative dermatitis).
Heart rhythm disorders, irregular heartbeat, rapid heartbeat, breathing difficulties.
During eye surgery performed due to lens clouding (cataract) or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly, and the iris (the coloured circular part of the eye) may become floppy during the procedure. For more information, see section 2. "Warnings and precautions".

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fokusin SR

Keep this medicine out of 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 refers to the last day of the stated month.
The blisters should be stored in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
Other ingredients:
Tablet core: hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, iron(III) oxide red (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 break line, 9 mm in diameter, embossed with
"T9SL" on one side and "0.4" on the other.
The medicine is available in blister packs containing 10, 28, 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130, Dolni Mecholupy
102 37 Prague 10
Czech Republic
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
For further information about this medicine and its trade names in the European Economic Area countries, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00