Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Fokusin
0.4 mg, modified-release hard capsules
Tamsulosin hydrochloride
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Fokusin is and what it is used for

Fokusin contains the active substance tamsulosin, which reduces the tone of smooth muscles in the prostate and urethra. This results in improved urine flow through the urethra and consequently easier urination.
Fokusin is used in men for the treatment of symptoms associated with benign prostatic hyperplasia, such as difficulty in urinating, dribbling urination, strong sensation of sudden urge to urinate, and frequent urination both during the day and at night.

2. Important information before using Fokusin

When not to use Fokusin

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in case of angioedema (vascular swelling occurring during an allergic reaction) following the use of certain medicines,
in case of severe liver impairment,
in case of dizziness associated with changing position from lying down to standing or sitting,
if the patient has felt unwell during or after urination (micturition syncope).

Warnings and precautions
Before starting treatment with Fokusin, discuss it with your doctor or pharmacist.
Regular medical check-ups are necessary during long-term treatment.
Rarely, a decrease in blood pressure has been reported during treatment with Fokusin.
If dizziness occurs, the patient should sit or lie down until symptoms subside.
Caution is advised in patients with severe renal impairment due to insufficient clinical data in patients with severe kidney dysfunction.
Rarely, angioedema (vascular swelling occurring during an allergic reaction) has been reported during treatment with tamsulosin (the active substance in Fokusin). If angioedema occurs, seek immediate medical help and discontinue use of Fokusin. Do not restart the medication.
If cataract or glaucoma surgery is planned, inform the doctor about current or recent use of Fokusin. The specialist will then take appropriate precautions regarding treatment and surgical techniques. Ask your doctor whether you should temporarily stop taking Fokusin before cataract surgery or surgical treatment for increased intraocular pressure (glaucoma).

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 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tamsulosin may affect 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 body, thereby shortening the duration of tamsulosin’s effect.
warfarin, a medicine used to prevent blood clots. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the duration of tamsulosin’s effect.
other α-adrenergic receptor antagonists. The combination may lower the patient’s blood pressure, causing dizziness and a sensation 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
Take the capsule after breakfast or after the first meal of the day. Swallow the capsule whole while sitting or standing, 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 in men only; therefore, information regarding pregnancy and breastfeeding is not relevant.

Fertility
Ejaculation difficulties have been reported with the use of tamsulosin (see section 4).

Driving and operating machinery
Dizziness may occur during treatment. Therefore, activities requiring high concentration should only be performed after consulting with your doctor.

Fokusin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free."

3. How to use Fokusin

This medicine should always be taken exactly as directed by a doctor or pharmacist. In case of doubt,
consult a doctor or pharmacist.
The recommended dose is 1 capsule once daily. The capsule should be taken after breakfast or after the first
meal of the day. The capsule must be swallowed whole, while sitting or standing, with a glass of water. Do not open, crush, or chew the capsule.
Use of a higher than recommended dose of Fokusin
Overdose may result in a drop in blood pressure.
Blood pressure and heart rate should return to normal values after placing the patient in a lying position.
In case of accidental ingestion of more capsules or if a child accidentally takes the medicine, contact a doctor immediately.
Missed dose of Fokusin
If a dose of Fokusin is missed, take it as soon as possible during the day.
If the missed dose is noticed the following day, continue taking the medicine according to the usual schedule. Do not take a double dose to make up for the missed dose.
Stopping treatment with Fokusin
Do not discontinue treatment with Fokusin before the recommended treatment duration ends without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If dizziness or weakness occurs, sit or lie down until
the symptoms subside.
You should stop taking this medicine and seek immediate medical help if you experience:

hypersensitivity reactions with purple or red spots on the skin, skin blisters, skin peeling, (high) fever, joint pain and (or) eye inflammation (Stevens-Johnson syndrome)*
severe allergic reaction causing swelling of the face or larynx (angioedema)**

The adverse reactions that may occur are listed below, grouped by frequency of occurrence:
Common (may affect up to 1 in 10 patients): dizziness (especially when changing position suddenly – from lying down to sitting or standing), difficulty with ejaculation, low volume or absence of ejaculate, cloudy urine after intercourse.
Uncommon (may affect up to 1 in 100 patients): headache, awareness of heartbeat (palpitations), feeling of emptiness in the head or fainting (orthostatic hypotension), nasal congestion and irritation inside the nose (rhinitis), constipation, diarrhoea, nausea, vomiting, rash, itching, urticaria, feeling of weakness (asthenia).
Rare (may affect up to 1 in 1,000 patients): brief loss of consciousness (fainting), angioedema**.
Very rare (may affect up to 1 in 10,000 patients): painful, prolonged erection requiring immediate treatment (priapism), Stevens-Johnson syndrome*.
Not known (frequency cannot be estimated from available data): visual disturbances, blurred vision, nosebleeds (epistaxis), rash with red, irregular spots (erythema multiforme), redness and peeling of the skin (exfoliative dermatitis), irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea), dry mouth.

During eye surgery (for glaucoma or cataract), a condition called 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 further information, see section 2.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine 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 stated month.
Store below 25°C.
Medicines must 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 package and other information

What Fokusin contains
The active substance is tamsulosin hydrochloride, 0.4 mg in each capsule, corresponding to 0.367 mg of tamsulosin.
Other ingredients are: capsule contents: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate, polysorbate 80), dibutyl sebacate, colloidal anhydrous silica, 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), indigotine – FD&C Blue No. 2 (E 132).

What Fokusin looks like and contents of the pack
Modified-release hard capsules of Fokusin are hard gelatin capsules, size 3, with an orange body and olive-colored cap, containing white or almost white pellets.
Pack sizes: 30, 90 capsules.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation 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, Poland

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

Marketing Authorisation Number in the Czech Republic, the country of export: 87/087/05-C
Parallel Import Licence Number: 350/22

This medicinal product is authorised for sale in 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