Package leaflet: Information for the user

Omnic 0.4, 0.4 mg, modified-release hard capsules
Tamsulosin hydrochloride
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 personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Omnic 0.4 is and what it is used for
Before you take Omnic 0.4
How to take Omnic 0.4
Possible side effects
How to store Omnic 0.4
Contents of the pack and other information

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

The active substance in Omnic 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. Additionally, tamsulosin reduces the sensation of urgency to urinate.
Omnic 0.4 is used in men to treat symptoms of lower urinary tract related to benign prostatic hyperplasia (enlarged prostate gland). These symptoms may include difficulty in passing urine (weak stream), dribbling of urine, urgency to urinate, and increased frequency of urination both during the day and at night.

2. Before you take Omnic 0.4

Do not take Omnic 0.4 if:

you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include sudden swelling of soft tissues (e.g. throat or tongue), difficulty in breathing, and/or itching and rash (angioedema).
you have severe liver impairment,
you have experienced fainting episodes associated with low blood pressure upon changing position (from lying down to sitting or standing).

Warnings and precautions
Before starting Omnic 0.4, discuss this with your doctor.

Regular medical check-ups are necessary to monitor the progression of the condition being treated.
Rarely, as with other medicines in the same class, fainting may occur. If you experience symptoms such as dizziness or feeling weak, sit or lie down until these symptoms subside.
If you have severe kidney disease, inform your doctor.
If you are scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), inform your ophthalmologist that you are currently taking, have previously taken, or plan to take Omnic 0.4. The specialist can then take appropriate precautions regarding treatment and surgical techniques. Ask your doctor whether you should stop or temporarily discontinue Omnic 0.4 before cataract surgery or surgical treatment of increased intraocular pressure (glaucoma).

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

Omnic 0.4 and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Omnic 0.4 with other medicines of the same class (alpha-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 0.4 from the body (e.g. ketoconazole, erythromycin).

Omnic 0.4 with food and drink
Omnic 0.4 should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
Omnic 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 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 using machines
The effect of Omnic 0.4 on the ability to drive and use machines has not been established. However, you should bear in mind the possibility of dizziness occurring. In such a case, do not perform tasks requiring concentration.

3. How to take Omnic 0.4

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is one capsule once daily. Omnic 0.4 should be taken after breakfast or after
the first meal of the day.
The capsule should be swallowed whole and must not be chewed or crushed.
Omnic 0.4 is usually prescribed for long-term use. The effect on the bladder and urination is maintained
during prolonged treatment with Omnic 0.4.
Taking more Omnic 0.4 than recommended
Taking too many Omnic 0.4 capsules may lead to unwanted lowering of blood pressure and increased
heart rate accompanied by a feeling of weakness. If you have taken too many Omnic 0.4 capsules,
you should contact your doctor immediately.
Missing a dose of Omnic 0.4
If you miss a dose of Omnic 0.4, you may take the capsule later on the same day.
If you did not take an Omnic 0.4 capsule on a given day, you should continue treatment according to
the previous dosing schedule.
Do not take a double dose to make up for a missed dose (capsule).
Stopping Omnic 0.4 treatment
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, you should
continue taking Omnic 0.4 for as long as your doctor has instructed, even if symptoms have improved.
Any decision to stop treatment should always be discussed with your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common (may occur in fewer than 1 in 10 patients):
dizziness, particularly when changing from a lying to a sitting or standing position,
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 occur in fewer than 1 in 100 patients):
headache, palpitations (noticeable, rapid heartbeat), low blood pressure felt for example when changing from a lying to a sitting or standing position, sometimes causing dizziness; nasal mucosal inflammation, diarrhoea, nausea, vomiting, constipation, feeling of weakness (asthenia), rash, itching, and urticaria.

Rare (may occur in fewer than 1 in 1,000 patients):
fainting, sudden localized swelling of soft tissues (e.g. throat or tongue), breathing difficulties and/or itching and rash, often resulting from an allergic reaction (angioedema).

Very rare (may occur in fewer than 1 in 10,000 patients):
priapism (an unwanted, painful and prolonged erection, requiring immediate treatment), rash, inflammatory condition and/or formation of blisters 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 – oedematous, cyanotic-red skin lesions or lesions on oral mucous membranes, sometimes with blistering; exfoliative dermatitis),
irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea),
if a patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), and the patient is currently or has previously taken Omnic 0.4, it should be considered that during the procedure the pupil may not dilate properly and the iris (the coloured, circular part of the eyeball) may become floppy.
dryness of the 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 to provide more information on the safety of the medicine.

5. How to store Omnic 0,4

Keep the medicine in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Omnic 0.4 contains

The active substance is tamsulosin hydrochloride in the amount of 0.4 mg.
The other ingredients are: microcrystalline cellulose (E460), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium lauryl sulfate, triacetin (E1518), stearic acid calcium salt (E470a), talc (E553b) in the capsule; gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172) in the capsule coating. Shellac (E904), propylene glycol (E1520), black iron oxide (E172) in the printing ink.

What Omnic 0.4 looks like and contents of the pack:
Omnic 0.4 capsules are orange/olive-green in colour, marked with the code 0.4, logo and 701.
Omnic 0.4 is packed in Al/PP foil blisters containing 10 capsules per blister.
One package contains 30 capsules (3 blisters) in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Astellas Pharma Sp. z o.o.
Żwirki i Wigury 16C
02-092 Warsaw
Tel.: (22) 545 11 11

Manufacturer:
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder.