FOKUSIN 0.4 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the package leaflet:
2. What is Fokusin and what is it used for
3. Before you take Fokusin
   1. When not to take Fokusin
   2. Warnings and precautions
   3. Children and adolescents
   4. Fokusin and other medicines
   5. Fokusin with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Fokusin
   1. What to do if you take more Fokusin than you should
   2. What to do if you forget to take Fokusin
   3. What to do if you stop taking Fokusin
5. Possible side effects
   1. In case of dizziness or weakness, you should sit or lie down until the symptoms disappear.
   2. You should stop taking this medicine and seek immediate medical attention if you experience:
   3. Reporting side effects
6. How to store Fokusin
7. Contents of the pack and other information
   1. What Fokusin contains
   2. What Fokusin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about this medicine, please contact:

Package Leaflet: Information for the Patient

FOKUSIN, 0.4 mg, prolonged-release hard capsules
tamsulosin hydrochloride

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

• You should 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Fokusin and what is it used for

Fokusin contains the active substance tamsulosin, which reduces the tension of the smooth muscles of the prostate and urethra. This leads to an improvement in urine flow through the urethra and, as a result, easier urination.
Fokusin is used in men to treat symptoms associated with benign prostatic hyperplasia, such as: difficulty urinating, urinating in drops, strong urge to urinate, frequent urination both during the day and at night.

2. Before you take Fokusin

When not to take Fokusin

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in case of angioedema (swelling due to an allergic reaction) after taking certain medicines,
• in case of severe liver failure,
• in case of dizziness associated with a change in position from lying down to standing or sitting,

Warnings and precautions

Before starting to take Fokusin, you should discuss it with your doctor or pharmacist.
During long-term treatment, regular medical check-ups are necessary.
During the use of Fokusin, a decrease in blood pressure has been rarely observed.
In case of dizziness, the patient should sit or lie down until the symptoms disappear.
Caution should be exercised in case of severe kidney failure due to the insufficient number of data obtained during clinical trials in patients with severe kidney impairment.
Rarely, during the use of tamsulosin (the active substance of Fokusin), angioedema (swelling due to an allergic reaction) has been observed. In case of angioedema, you should immediately seek medical help and stop taking Fokusin. Do not take the medicine again.
In case of planned cataract surgery or glaucoma surgery, you should inform your doctor about the use of Fokusin. The doctor will then be able to take appropriate precautions regarding treatment and surgical techniques. You should ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased eye pressure (glaucoma).
Caution should be exercised if the patient has already experienced fainting during or after urination (syncope during micturition).

Children and adolescents

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

Fokusin and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Tamsulosin may affect other medicines. They may also affect the action of tamsulosin.
Tamsulosin may interact with:

• diclofenac,a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the removal 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 removal of tamsulosin from the patient's body, thereby shortening the duration of action of tamsulosin.
• other alpha-adrenergic receptor antagonists.The combination may lower the patient's blood pressure, causing dizziness and a feeling of "emptiness" in the head.
• medicines that may delay the excretion of Fokusin from the body (e.g., ketoconazole, erythromycin).

Fokusin with food and drink

The capsule should be taken after breakfast or after the first meal of the day. The capsule should be swallowed whole, while sitting or standing, and washed down with a glass of water. Do not open, crush, or chew the capsule.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding
Fokusin is intended for use only in men, so information on pregnancy and breastfeeding is not relevant.
Fertility
Difficulty with ejaculation has been reported in connection with the use of tamsulosin (see section 4).

Driving and using machines

Dizziness may occur during treatment. Therefore, activities that require increased concentration should only be performed after consulting a doctor.
Fokusin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that the medicine is considered "sodium-free).

3. How to take Fokusin

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose is one capsule once a day. The capsule should be taken after breakfast or after the first meal of the day. The capsule should be swallowed whole, while sitting or standing, and washed down with a glass of water. Do not open, crush, or chew the capsule.

What to do if you take more Fokusin than you should

In case of overdose, a decrease in blood pressure may occur. Blood pressure and heart rate should return to normal after the patient lies down.
In case of taking more capsules or accidental ingestion by a child, you should immediately contact a doctor.

What to do if you forget to take Fokusin

If you miss a dose of Fokusin, you should take it as soon as possible during the day.
If you realize you have missed a dose the next day, you should take the medicine as before. Do not take a double dose to make up for the missed dose.

What to do if you stop taking Fokusin

You should not stop taking Fokusin before the end of the prescribed treatment period without consulting your doctor.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

In case of dizziness or weakness, you should sit or lie down until the symptoms disappear.

You should stop taking this medicine and seek immediate medical attention if you experience:

• an allergic reaction with purple spots or patches on the skin, blisters on the skin, skin peeling, (high) fever, joint pain, and (or) eye inflammation (Stevens-Johnson syndrome)*
• a severe allergic reaction that causes swelling of the face or throat (angioedema)**

Side effects that may occur are listed below by frequency of occurrence:
Common (may affect up to 1 in 10 people): dizziness (may occur especially when changing position - changing from lying down to sitting or standing), difficulty with ejaculation, reduced or absent ejaculation, cloudy urine after intercourse.
Uncommon(may affect up to 1 in 100 people): headaches, palpitations (heart pounding), feeling of "emptiness" in the head or fainting (orthostatic hypotension), nasal congestion and irritation (rhinitis), constipation, diarrhea, nausea (nausea), vomiting, rash, itching, hives, feeling of weakness (asthenia).
Rare(may affect up to 1 in 1,000 people): short-term loss of consciousness (fainting), angioedema**.
Very rare (may affect up to 1 in 10,000 people): painful, prolonged unwanted erection, which requires immediate treatment (priapism), Stevens-Johnson syndrome*.
Not known (frequency cannot be estimated from the available data): vision disturbances, blurred vision, nosebleeds (epistaxis), rash with red irregular patches (erythema multiforme), rash and skin peeling (exfoliative dermatitis), irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnea), dry mouth.
During eye surgery (glaucoma or cataract surgery), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate well, and the iris (the colored, round part of the eye) may become floppy during the procedure. For more information, see section 2.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should 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.: 22 49-21-301, fax: 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 Fokusin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fokusin contains

The active substance of Fokusin is tamsulosin hydrochloride, 0.4 mg per capsule, which corresponds to 0.367 mg of tamsulosin.
The other ingredients are: capsule content:microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium lauryl sulfate, polysorbate 80), dibutyl sebacate, silica colloidal anhydrous, polysorbate 80, calcium stearate. capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), indigo carmine - FD&C Blue 2 (E132).

What Fokusin looks like and contents of the pack

Fokusin prolonged-release hard capsules are hard gelatin capsules, size 3, with an orange body and an olive green cap, containing white or almost white pellets.
Pack sizes: 10, 20, 30, 50, 90, 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, 032266 Bucharest, Romania
This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Czech Republic, Lithuania, Latvia, Poland, Slovakia: Fokusin
France: Tamsulosine Zentiva
Austria, Denmark, Norway, Germany: Tamsulosin Zentiva
Italy: Tamsulosina Zentiva
Portugal: Tansulosina Zentiva
United Kingdom (Northern Ireland): Tamsulosin hydrochloride Zentiva
Netherlands: Tamsulosine HCl Zentiva

For more information about this medicine, 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:August 2024