Fokusin

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Fokusin

0.4 mg, modified-release capsules, hard

Tamsulosin hydrochloride

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 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 improved urine flow through the urethra and, consequently, easier urination. Fokusin is used in men to treat symptoms associated with benign prostatic hyperplasia, such as: difficult urination, urination in drops, strong urge to urinate, frequent urination both during the day and at night.

2. Important information before taking Fokusin

When not to take Fokusin

• if the patient is 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) occurring after taking certain medicines,
• in case of severe liver failure,
• in case of dizziness associated with a change in position from lying to standing or sitting,
• in case the patient has felt unwell during or after urination (micturition syncope).

Warnings and precautions

Before starting to take Fokusin, discuss it with your doctor or pharmacist. During long-term treatment, regular medical check-ups are necessary. During the use of Fokusin, a rare decrease in blood pressure has been reported. If dizziness occurs, the patient should sit or lie down until the symptoms subside. 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 renal impairment. Rarely, during the use of tamsulosin (the active substance of Fokusin), angioedema (swelling due to an allergic reaction) has been reported. In case of angioedema, seek medical help immediately and stop taking Fokusin. Do not take the medicine again. In case of planned cataract surgery or glaucoma surgery, inform your doctor about the current or recent use of Fokusin. The doctor will then be able to take appropriate precautions regarding treatment and surgical techniques. 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).

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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Tamsulosin may affect other medicines, and they 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. The combination may lower the patient's 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, remaining in a sitting or standing position, 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 exclusively for the treatment of men; therefore, 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 tablet, which means 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, consult 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, remaining in a sitting or standing position, and washed down with a glass of water. Do not open, crush, or chew the capsule.

Overdose of Fokusin

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

Missing a dose of Fokusin

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

Stopping Fokusin treatment

Do not stop taking Fokusin before the end of the prescribed treatment period without consulting your doctor. If you have any further doubts about taking this medicine, consult 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, sit or lie down until the symptoms subside.

Stop taking this medicine and seek immediate medical attention if you experience:

• allergic reactions 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 serious allergic reaction that causes swelling of the face or throat (angioedema)**

Side effects that may occur are listed below in groups according to frequency of occurrence:
Common (may affect up to 1 in 10 people):dizziness (may occur especially when changing position - from lying 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 (syncope), angioedema**.
Very rare (may affect up to 1 in 10,000 people):painful, prolonged unwanted erection, which requires immediate treatment (priapism), Stevens-Johnson syndrome*.
Unknown (frequency cannot be estimated from available data):vision disturbances, blurred vision, nosebleeds (epistaxis), rash with red irregular spots (erythema multiforme), skin peeling and inflammation (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 the leaflet, inform your doctor, pharmacist, or nurse. 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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fokusin

Keep the medicine 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. 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 in each 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, 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 pack

Fokusin modified-release capsules, hard, are hard gelatin capsules, size 3, with an orange body and an olive green cap, containing white or almost white pellets. Pack size: 30, 90. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Zentiva, k.s. U Kabelovny 130 102 37 Prague 10 Czech Republic

Manufacturer:

S.C. Zentiva S.A. Bucharest, Romania

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Authorization number in the Czech Republic, the country of export: 87/087/05-C

Parallel import authorization number: 350/22

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 Germany: Tamsulosin Zentiva Italy: Tamsulosina Zentiva Portugal: Tamsulosina Sanofi United Kingdom (Northern Ireland): Tamsulosin hydrochloride Zentiva Date of leaflet approval: 23.09.2022
[Information about the trademark]