Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Fokusin, 0.4 mg, modified-release capsules, hard
tamsulosini hydrochloridum
Please read this leaflet carefully before taking 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, 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 another person, even if their symptoms are the same.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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 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 for the treatment of symptoms associated with benign prostatic hyperplasia, such as difficulty urinating, urinating in drops, 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 (swelling due to allergic reaction) occurring during treatment with certain medicines,
in case of severe liver impairment,
in case of dizziness related to changing position from lying down to standing or sitting,

Warnings and precautions
Before starting treatment with Fokusin, discuss this with your doctor or pharmacist.
Regular medical check-ups are necessary during long-term treatment.
During treatment with Fokusin, a drop in blood pressure has been reported rarely.
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 severely impaired kidney function.
Rarely, angioedema (swelling due to allergic reaction) has been reported during treatment with tamsulosin (the active substance in Fokusin). If angioedema occurs, seek immediate medical help and discontinue treatment with Fokusin. Do not restart the medicine.
If cataract or glaucoma surgery is planned, inform your doctor that you are currently or have recently taken Fokusin. The specialist will then be able to take appropriate precautions regarding suitable treatment and surgical techniques. Ask your doctor whether you should delay starting or temporarily stop taking Fokusin before cataract removal or surgical treatment of increased intraocular pressure (glaucoma).
Exercise caution if the patient has previously experienced dizziness or fainting during or after urination (fainting during micturition).

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 with 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. 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 remaining in an upright (sitting or standing) position, 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 on pregnancy and breastfeeding is not relevant.

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

Driving and using machines
Dizziness may occur during treatment. Therefore, activities requiring high concentration should only be performed after obtaining approval from 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 your doctor or pharmacist. If you have any doubts,
consult your 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 remaining in a sitting or standing position,
and accompanied by a glass of water. Do not open, crush, or chew the capsule.
Taking more Fokusin than recommended
Overdose may result in a drop in blood pressure. Blood pressure and heart rate should return to normal
values when the patient lies down.
If more capsules have been taken than recommended, or if the medicine has been accidentally ingested by
a child, contact a doctor immediately.
Missing a dose of Fokusin
If a dose of Fokusin is missed, take it as soon as possible during the same day.
If the missed dose is realized the following day, continue taking the medicine according to the usual schedule.
Do not take a double dose to make up for a missed dose.
Stopping Fokusin treatment
Do not stop taking this medicine before the recommended treatment period is over, without consulting
your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If dizziness or weakness occurs, sit or lie down until
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 throat (angioedema)**

The possible side effects are listed below, grouped according to frequency of occurrence:
Common (may affect up to 1 in 10 patients): dizziness (may occur particularly with sudden change in body position – changing from lying to sitting or standing), difficulty with ejaculation, reduced or absent 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 swelling and irritation (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 patches (erythema multiforme), redness and peeling of the skin (exfoliative dermatitis), irregular heart rhythm (atrial fibrillation, cardiac arrhythmia, tachycardia), difficulty breathing (dyspnoea), dry mouth.

During eye surgery (glaucoma or cataract surgery), 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 more information, see section 2.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can 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, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps provide more information on the safe use of this medicine.

5. How to store Fokusin

Keep this 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Fokusin contains
The active substance 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-ethyl acrylate copolymer (1:1) dispersion 30%, 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. Fokusin modified-release hard capsules are hard gelatin capsules, size 3, with an orange body and olive cap, containing white or almost white pellets.
Pack sizes: 10, 20, 30, 50, 90, 100 capsules.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Lithuania, 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 no. 50, sector 3
032266 Bucharest
Romania

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation numbers in Lithuania, 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 Authorisation number: 257/20

This medicinal product is authorised for marketing 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
Austria, Denmark, Norway, Germany: Tamsulosin Zentiva
Italy: Tamsulosina Zentiva
Portugal: Tansulosina Zentiva
United Kingdom (Northern Ireland): Tamsulosin hydrochloride Zentiva
Netherlands: Tamsulosine HCl Zentiva