Omnic 0,4

Package Leaflet: Information for the User

Omnic 0.4, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Omnic 0.4 and what is it used for
• 2. Important information before taking Omnic 0.4
• 3. How to take Omnic 0.4
• 4. Possible side effects
• 5. How to store Omnic 0.4
• 6. Contents of the pack and other information

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

The active substance of Omnic 0.4 is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of urgency to urinate.
Omnic 0.4 is used in men for the treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include difficulty urinating (weak stream), urinating in drops, urgency to urinate, and increased frequency of urination both at night and during the day.

2. Important information before taking Omnic 0.4

When not to 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 appear as sudden swelling of the soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash (angioedema).
• if you have severe liver impairment,
• if you have fainting spells associated with low blood pressure when changing position from lying down to sitting or standing.

Warnings and precautions

Before starting treatment with Omnic 0.4, discuss it with your doctor.

• Regular medical check-ups are necessary to determine the progression of the disease being treated,
• Rarely, as with other medicines in the same group, fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until the symptoms pass,
• If you have severe kidney disease, inform your doctor,
• If you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma), inform your ophthalmologist that you have taken, are taking, or plan to take Omnic 0.4. The specialist 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

Omnic 0.4 should 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 about all medicines you are taking, have recently taken, or plan to take.
Taking Omnic 0.4 with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may cause unintended lowering of blood pressure.
It is especially important to tell 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.

Pregnancy, breastfeeding, and fertility

Omnic 0.4 is not indicated for use in women.
There have been reports of ejaculation disorders in men. This means that semen does not flow through the urethra, but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon does not pose a risk.

Driving and using machines

The effect of Omnic 0.4 on the ability to drive and use machines has not been proven. However, you should be aware of the possibility of dizziness - in such cases, do not perform tasks that require attention.

3. How to take Omnic 0.4

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one capsule once a day. Omnic 0.4 should be taken after breakfast or after the first meal.
Swallow the capsule whole, do not chew or crush it.
Omnic 0.4 is usually prescribed for long-term use. The effect on the bladder and urination persists during long-term use of Omnic 0.4.

If you take more Omnic 0.4 than you should

Taking too many Omnic 0.4 capsules may lead to unintended lowering of blood pressure and increased heart rate with a feeling of weakness. If you have taken too many Omnic 0.4 capsules, contact your doctor immediately.

If you forget to take Omnic 0.4

If you miss a dose of Omnic 0.4, you can take a capsule later that day.
If you do not take a capsule of Omnic 0.4 on a given day, continue treatment according to the previous dosing schedule.
Do not take a double dose to make up for a missed dose (capsule).

Stopping treatment with Omnic 0.4

If you stop treatment prematurely, the symptoms of the disease may return. Therefore, you should take Omnic 0.4 for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared.
Stopping treatment should always be discussed with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people)
dizziness, especially when changing position from lying down to sitting or standing,
ejaculation disorders; ejaculation disorders mean that semen does not flow through the urethra, but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon does not pose a risk.
Uncommon(may affect up to 1 in 100 people)
headache, palpitations (heart beating faster than usual), low blood pressure felt, for example, when changing position from lying down to sitting or standing, and sometimes causing dizziness; rhinitis, diarrhea, nausea, vomiting, constipation, feeling of weakness (asthenia), rash, itching, and urticaria.
Rare(may affect up to 1 in 1,000 people)
fainting, sudden localized swelling of the soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash, often as a result of an allergic reaction (angioedema).
Very rare(may affect up to 1 in 10,000 people)
priapism (unwanted, painful, and prolonged erection, in which case immediate treatment should be sought), rash, inflammatory condition, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).
Frequency not known(frequency cannot be estimated from the available data):

• blurred vision,
• vision disturbances,
• nasal bleeding,
• severe skin reactions (erythema multiforme - swollen, reddish-purple patches on the skin or mucous membranes of the mouth, sometimes with blisters on the surface; exfoliative dermatitis),
• irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea),
• if you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma), and you are taking or have taken Omnic 0.4, consider that during the surgery, the pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid.
• dry mouth.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301; Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omnic 0.4

Store the medicine in its original packaging.
Keep the medicine out of the 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 month stated.
Medicines should 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 pack and other information

What Omnic 0.4 contains

• The active substance is tamsulosin hydrochloride, 0.4 mg.
• The other ingredients are: microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium lauryl sulfate, triacetin (E1518), calcium stearate (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 shell. Shellac (E904), propylene glycol (E1520), black iron oxide (E172) in the ink for printing.

What Omnic 0.4 looks like and contents of the pack:

Omnic 0.4 capsules are orange/olive green in color, marked with the code 0.4 and the logo and 701.
Omnic 0.4 is packaged in Al/PP foil blisters of 10 capsules per blister.
One package contains 30 capsules (3 blisters) in a cardboard box

Marketing authorization holder and manufacturer

Marketing authorization holder:

Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw
phone: (22) 545 11 11

Manufacturer:

Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
Netherlands
To obtain more detailed information, contact the local representative of the marketing authorization holder.

Date of last revision of the package leaflet: 04/2024