OMNIC 0.4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
2. What Omnic Ocas 0.4 is and what it is used for
3. Important information before taking Omnic Ocas 0.4
   1. When not to take Omnic Ocas 0.4
   2. Warnings and precautions
   3. Children and adolescents
   4. Omnic Ocas 0.4 and other medicines
   5. Omnic Ocas 0.4 with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Omnic Ocas 0.4
   1. Taking more than the recommended dose of Omnic Ocas 0.4
   2. Missing a dose of Omnic Ocas 0.4
   3. Stopping treatment with Omnic Ocas 0.4
5. Possible side effects
   1. Reporting side effects
6. How to store Omnic Ocas 0.4
7. Contents of the pack and other information What Omnic Ocas 0.4 contains
   1. What Omnic Ocas 0.4 looks like and contents of the pack
   2. Marketing authorization holder and manufacturer
   3. Date of last revision of the leaflet: 04/2024

Package Leaflet: Information for the User

Omnic Ocas 0.4; 0.4 mg, prolonged-release tablets
Tamsulosin hydrochloride

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

• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

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

The active substance of Omnic Ocas 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, making it easier for urine to flow through the urethra and urinate. Additionally, tamsulosin reduces the feeling of urgency to urinate.
Omnic Ocas 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 Ocas 0.4

When not to take Omnic Ocas 0.4

• if you are allergic to tamsulosin or any of the other ingredients of Omnic Ocas 0.4 (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 Ocas 0.4, you should discuss it with your doctor

• because regular medical check-ups are necessary to determine the progression of the disease being treated,
• because, as with other drugs in the same group, a decrease in blood pressure and fainting may occur. If symptoms such as dizziness or weakness occur, you should sit or lie down until they pass,
• if you have severe kidney disease,
• if you are scheduled for eye surgery for cataracts or increased pressure in the eye (glaucoma). You should inform the ophthalmologist that you are taking, have taken, or are planning to take Omnic Ocas 0.4. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. You should ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased pressure in the eye (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

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Taking Omnic Ocas 0.4 with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may cause unintended blood pressure lowering.
It is especially important to tell 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 with or without food.

Pregnancy, breastfeeding, and fertility

Omnic Ocas 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 is not a threat.

Driving and using machines

The effect of Omnic Ocas 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 Ocas 0.4

Omnic Ocas 0.4 should always be taken as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose is 1 tablet once a day. Omnic Ocas 0.4 should be taken regardless of meals, preferably at the same time.
The tablet should be swallowed whole and not chewed or crushed.
Omnic Ocas 0.4 is a tablet designed to release the active substance slowly and evenly after swallowing. The remains of the tablet may appear in the stool. There is no reason to suspect that the tablet is ineffective because the active substance has already been released from the tablet.
Omnic Ocas 0.4 is usually prescribed for long-term use. The effect on the bladder and urination persists during long-term use of Omnic Ocas 0.4.

Taking more than the recommended dose of Omnic Ocas 0.4

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

Missing a dose of Omnic Ocas 0.4

If you miss a dose of Omnic Ocas 0.4, you can take the tablet later that day. If you did not take the Omnic Ocas 0.4 tablet 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 (tablet).

Stopping treatment with Omnic Ocas 0.4

If treatment is stopped prematurely, the symptoms of the disease may return. Therefore, you should take Omnic Ocas 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, Omnic Ocas 0.4 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 is not a threat.

Uncommon (may affect up to 1 in 100 people)

• headache, palpitations (heartbeat felt and faster than usual), low blood pressure felt, e.g., when changing position from lying down to sitting or standing, and sometimes associated with dizziness; nasal congestion, diarrhea, nausea and vomiting, constipation, weakness (asthenia), rash, itching, and hives.

Rare (may affect up to 1 in 1,000 people)

• fainting and sudden local swelling of 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 (undesirable, painful, and prolonged erection, in which case immediate treatment should be sought),
• rash, inflammation, 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, exfoliative dermatitis),
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnea),
• if you are scheduled for eye surgery for cataracts or increased pressure in the eye (glaucoma), and you are taking or have taken Omnic Ocas 0.4, you should consider that the pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid during the procedure.
• dry mouth.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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 Ocas 0.4

Keep the 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 after "EXP" (date stated as month and year). The expiry date refers to the last day of the stated month.
Store the medicine in its original packaging.
There are no special storage precautions.
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 Ocas 0.4 contains

The active substance is tamsulosin hydrochloride, 0.4 mg.
The other ingredients are:
tablet core: macrogol 7,000,000, macrogol 8,000, magnesium stearate (E470b), butylhydroxytoluene (E321), colloidal silica (E551); coating: hypromellose (E464) and the colorant - yellow iron oxide (E172).

What Omnic Ocas 0.4 looks like and contents of the pack

Omnic Ocas 0.4 prolonged-release tablets are round, yellow, and marked with the code 0.4.
Omnic Ocas 0.4 prolonged-release tablets are packaged in aluminum foil blisters in a cardboard box.
One pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Astellas Pharma Sp. z o.o.
ul. Żwirki i Wigury 16C
02-092 Warsaw, tel. (+48 22) 545 11 11
Manufacturer:
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
Netherlands

Date of last revision of the leaflet: 04/2024