Omi-tam

Package Leaflet: Information for the User

OMI-TAM, 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.

What is in this leaflet

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

1. What OMI-TAM is and what it is used for

The active substance of OMI-TAM is tamsulosin. Tamsulosin is a selective alpha-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, the medicine reduces the feeling of pressure on the bladder.

OMI-TAM is used in men for the treatment of symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia (enlargement of the prostate gland), such as: difficulty urinating (reduced urine flow), urinating in drops, sudden urge to urinate, and frequent urination, both at night and during the day.

2. Important information before taking OMI-TAM

When not to take OMI-TAM

Warnings and precautions

• regular medical check-ups are necessary to determine the degree of development of the disease being treated
• rarely, as with other medicines 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 the symptoms pass

In this case, the doctor will take appropriate measures 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

OMI-TAM should not be used in children and adolescents under 18 years of age, as it is not effective in this population.

OMI-TAM and other medicines

Taking OMI-TAM with other medicines in the same group (alpha-adrenergic receptor antagonists) may cause unintended lowering of blood pressure.

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.

It is especially important to tell your doctor if you are taking medicines that may reduce the elimination of OMI-TAM from the body (e.g. ketoconazole, erythromycin).

OMI-TAM with food and drink

OMI-TAM can be taken with or without food.

Pregnancy, breastfeeding, and fertility

OMI-TAM 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

There is no data confirming the effect of OMI-TAM on the ability to drive and use machines. However, you should remember the possibility of dizziness - in such a case, do not perform tasks that require attention.

3. How to take OMI-TAM

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended doseis one tablet per day. The medicine can be taken with food or on an empty stomach, preferably at the same time every day.

The tablet should be swallowed whole, do not crush or chew.

OMI-TAM 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, as the active substance has already been released from the tablet.

OMI-TAM is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term use of OMI-TAM.

Taking more than the recommended dose of OMI-TAM

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

Missing a dose of OMI-TAM

If you forget to take OMI-TAM at the scheduled time, you can take it later that day. If you forget to take the medicine on a given day, you should continue treatment according to the previous dosage schedule.

Do not take a double dose to make up for a missed dose.

Stopping treatment with OMI-TAM

If treatment with OMI-TAM is stopped too early, the symptoms of the disease may return. Therefore, the medicine should be taken for as long as the doctor has prescribed, even if the symptoms of the disease have disappeared. Before stopping treatment, you should always consult 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, OMI-TAM 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, feeling of palpitations (heartbeat felt and faster than usual), low blood pressure, feeling of weakness, dry mouth, nasal congestion or runny nose, diarrhea, nausea and vomiting, constipation, weakness, 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 (angioedema), often as a result of an allergic reaction.

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

priapism (painful, prolonged, and unwanted erection, in which case immediate treatment should be sought); severe disease characterized by the formation of blisters on the skin, around the mouth, eyes, and genitals (Stevens-Johnson syndrome).

Unknown(frequency cannot be estimated from the available data):

• blurred vision
• vision disorders
• nasal bleeding
• severe skin reactions (erythema multiforme, exfoliative dermatitis)
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)
• dryness in the mouth

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.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 OMI-TAM

Keep this 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 first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month.

Store in the original package to protect from light.

Medicines should 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 OMI-TAM contains

• The active substance is 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: Core of the tablet:hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, red iron oxide (E 172), magnesium stearate. External layer of the core tablet: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What OMI-TAM looks like and contents of the pack

White, undivided, round tablets with a diameter of 9 mm, with the inscription "T9SL" on one side and "0.4" on the other side of the tablet.

OMI-TAM is available in packs of 30, 60, or 90 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh

Hafnerstraße 211

8054 Graz

Austria

Manufacturer

Genericon Pharma Gesellschaft m.b.H

Hafnerstraße 211

8054 Graz

Austria

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Synthon Hispania, S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

• G. L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria

To obtain detailed information on the medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

+pharma Polska sp. z o.o.

ul. Podgórska 34

31-536 Kraków

Poland

Tel.: +48 12 262 32 36

Date of last revision of the leaflet:March 2020