Package leaflet: Information for the user

Omnic Ocas 0.4; 0.4 mg prolonged-release coated tablets
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Omnic Ocas 0.4 is and what it is used for
What you need to know before taking Omnic Ocas 0.4
How to take Omnic Ocas 0.4
Possible side effects
How to store Omnic Ocas 0.4
Contents of the pack and other information

1. What Omnic Ocas 0.4 is and what it is used for

The active substance in Omnic Ocas 0.4 is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. In addition, tamsulosin reduces the sensation of urinary urgency.
Omnic Ocas 0.4 is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic enlargement (benign prostatic hyperplasia). These symptoms may include difficulty in urination (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the night and during the day.

2. Important information before taking Omnic Ocas 0.4

When not to take Omnic Ocas 0.4

if the patient is allergic to tamsulosin or any of the other ingredients of Omnic Ocas 0.4 (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema),
if the patient has severe liver impairment,
if the patient experiences fainting episodes associated with low blood pressure upon changing position (from lying down to sitting or standing).

Warnings and precautions
Before starting treatment with Omnic Ocas 0.4, please discuss with your doctor:

because periodic medical examinations are necessary to monitor the progression of the condition being treated,
because rarely, as with other drugs in the same class, a drop in blood pressure and fainting may occur. If symptoms such as dizziness or weakness occur,
the patient should sit or lie down until symptoms subside,
if the patient has severe kidney disease,
if the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). The ophthalmologist should be informed that the patient is currently using, has previously used, or plans to use Omnic Ocas 0.4. The specialist will then be able to take appropriate precautions regarding suitable treatment and surgical techniques. Please consult your doctor whether you should delay starting Omnic Ocas 0.4 or temporarily discontinue it prior to cataract removal or surgical treatment of increased intraocular pressure (glaucoma).

Children and adolescents
Omnic Ocas 0.4 should not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Omnic Ocas 0.4 and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of Omnic Ocas 0.4 with other medicines from the same class (alpha-1 adrenergic receptor antagonists) may lead to unintended lowering of blood pressure.
It is especially important to inform your doctor if you are taking medicines that may reduce the elimination of Omnic Ocas 0.4 from the body (e.g. ketoconazole, erythromycin).

Omnic Ocas 0.4 with food and drink
Omnic Ocas 0.4 can be taken regardless of meals.

Pregnancy, breastfeeding and fertility
Omnic Ocas 0.4 is not indicated for use in women.
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.

Driving and operating machinery
The effect of Omnic Ocas 0.4 on the ability to drive and operate machinery has not been established. However, one should remain aware of the possibility of dizziness occurring; in such a case, activities requiring attention should not be performed.

3. How to take Omnic Ocas 0.4

Omnic Ocas 0.4 should always be taken exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.

The recommended dose is one tablet once daily. Omnic Ocas 0.4 can be taken regardless of meals, preferably at the same time each day.
The tablet should be swallowed whole and must not be chewed or crushed.

Omnic Ocas 0.4 is a specially designed tablet that releases the active substance gradually and evenly after swallowing. Undissolved tablet residues may appear in the stool. This is normal and does not indicate that the tablet was ineffective, as the active substance has already been released earlier.

Omnic Ocas 0.4 is usually prescribed for long-term use. Its effect on the bladder and urination persists during prolonged treatment with Omnic Ocas 0.4.

Taking more Omnic Ocas 0.4 than recommended
Taking too many Omnic Ocas 0.4 tablets may cause an unwanted drop in blood pressure and increased heart rate accompanied by a feeling of weakness. If you have taken too many tablets, contact your doctor immediately.

If you forget to take Omnic Ocas 0.4
If you miss a dose of Omnic Ocas 0.4, you may take the tablet later the same day. If you did not take your Omnic Ocas 0.4 tablet on a given day, continue treatment according to your previous dosing schedule.
Do not take a double dose to make up for the missed dose.

Stopping Omnic Ocas 0.4 treatment
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, continue taking Omnic Ocas 0.4 for as long as your doctor has instructed, even if symptoms have improved. Always consult your doctor before stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Omnic Ocas 0.4 may cause adverse effects, although not everyone experiences them.

Common (may affect up to 1 in 10 patients):

Dizziness, particularly when changing position from lying down to sitting or standing,
Ejaculation disorders. Ejaculation disorders mean that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.

Uncommon (may affect up to 1 in 100 patients):

Headache, palpitations (awareness of heartbeat, faster than usual), low blood pressure felt, for example, when changing position from lying to sitting or standing, sometimes associated with dizziness; nasal mucosal inflammation, diarrhoea, nausea and vomiting, constipation, fatigue (asthenia), rash, itching, and urticaria.

Rare (may affect up to 1 in 1,000 patients):

Fainting and sudden localized swelling of soft tissues (e.g., throat or tongue), breathing difficulties and (or) itching and rash, often occurring as a result of an allergic reaction (angioedema).

Very rare (may affect up to 1 in 10,000 patients):

Priapism (an undesirable, painful, and prolonged erection, which requires immediate treatment),
Skin rash, inflammation, and blister formation on the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genital organs (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from available data):

Blurred vision,
Visual disturbances,
Nosebleeds,
Severe skin reactions (erythema multiforme, exfoliative dermatitis),
Irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea),
If a patient is scheduled for a surgical procedure due to cataract or elevated intraocular pressure (glaucoma), and the patient is currently taking or has previously taken Omnic Ocas 0.4, it should be considered that the patient's pupil may dilate poorly and the iris (the coloured, circular part of the eye) may become floppy during the procedure.
Dry mouth.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse 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 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Omnic Ocas 0.4

Keep this medicine out of the sight and reach of children.
Do not use Omnic Ocas 0.4 after the expiry date stated on the carton and blister pack following
"EXP" (the date refers to month and year). The expiry date refers to the last day of the stated
month.
Store the medicine in its original packaging.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the pack and other information What Omnic Ocas 0,4 contains

The active substance is tamsulosin hydrochloride 0.4 mg.
Other components of the medicine are:
tablet core: macrogol 7 000 000, macrogol 8 000, magnesium stearate (E470b),
butylated hydroxytoluene (E321), colloidal silicon dioxide (E551);
coating: hypromellose (E464) and a colourant – yellow iron oxide (E172).
What Omnic Ocas 0,4 looks like and contents of the pack
Omnic Ocas 0,4 coated tablets are round, yellow, marked with the code 0.4.
Omnic Ocas 0,4 coated tablets are packed in aluminium blisters contained in a cardboard box.
One pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw, Poland
tel. (+48 22) 545 11 11
Manufacturer:
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands