Fokusin

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, the information on the immediate packaging in a foreign language.

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Fokusin and what is it used for
• 2. Important information before taking Fokusin
• 3. How to take Fokusin
• 4. Possible side effects
• 5. How to store Fokusin
• 6. Contents of the packaging 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 improved 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 feeling of sudden pressure on the bladder, frequent urination both during the day and at night.

2. Important information before taking 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,
• if you have felt unwell while urinating or after urinating (micturition syncope).

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 occasionally observed.
In case of dizziness, you should sit down or lie down until the symptoms disappear.
You should be cautious 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, you should inform your doctor about the current or recent use of Fokusin.

Children and adolescents

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

Fokusin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as about medicines you plan to take.
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 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 body, thereby shortening the duration of action of tamsulosin. other alpha-adrenergic receptor antagonists.The combination may lower blood pressure, causing dizziness and a feeling of "emptiness" in the head. medicines that may delay the elimination 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 the treatment of men only, 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.

3. How to take Fokusin

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is 1 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.

Taking a higher dose of Fokusin than recommended

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

Missing a dose of Fokusin

In case of missing 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 according to the previous schedule. Do not take a double dose to make up for the missed dose.

Stopping the use of Fokusin

You should not stop taking Fokusin before the end of the prescribed treatment period without consulting a doctor.
In case of any further doubts about the use of this medicine, you should consult a 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 down or lie down until the symptoms disappear.

You should stop taking Fokusin and seek immediate medical attention in case of:

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

Side effects that may occur are listed below in groups according to frequency:
Common (may affect up to 1 in 10 patients): dizziness (may occur especially when changing position 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 patients): headaches, feeling of palpitations (heart pounding), feeling of "emptiness" in the head or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhea, nausea (nausea), vomiting, rash, itching, hives, feeling of weakness (asthenia).
Rare (may affect up to 1 in 1000 patients): short-term loss of consciousness (syncope), angioedema**.
Very rare (may affect up to 1 in 10,000 patients): painful, prolonged unwanted erection, which requires immediate treatment (priapism), Stevens-Johnson syndrome*.
Unknown (frequency cannot be estimated from the available data): vision disturbances, blurred vision, nosebleeds (epistaxis), rash with red irregular spots (erythema multiforme), redness and peeling of the skin (exfoliative dermatitis), irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea), dryness in the mouth.
During eye 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 those not listed in the 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.
Reporting side effects will help to gather more information on the safety of the 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 packaging and other information

What Fokusin contains

The active substance of Fokusin is tamsulosin hydrochloride, 0.4 mg in each capsule, which corresponds to 0.367 mg of tamsulosin.
The other ingredients are: capsule contents:microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium lauryl sulfate, polysorbate 80), dibutyl sebacate, colloidal silicon dioxide, polysorbate 80, calcium stearate. capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), indigo carmine – FD&C Blue 2 (E 132).

What Fokusin looks like and contents of the packaging

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 size: 10, 20, 30, 50, 90, 100.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

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

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Company Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Authorization number in Lithuania, the country of export:LT/1/ 06/0480/004
LT/1/ 06/0480/005
LT/1/ 06/0480/001
LT/1/ 06/0480/006
LT/1/ 06/0480/002
LT/1/ 06/0480/003

Parallel import authorization number: 88/22 Date of leaflet approval: 16.02.2022

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