Omi-tam

Package leaflet: Information for the user

OMI-TAM, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the 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 in OMI-TAM is tamsulosin. Tamsulosin is a selective antagonist of
alpha-adrenergic receptors. Tamsulosin reduces the tone of smooth muscles in the prostate gland
and urethra, facilitating urine flow through the urethra and urination. Additionally, the medicine
reduces the sensation of urgency to urinate.
OMI-TAM is used in men to treat lower urinary tract symptoms associated with
enlargement of the prostate gland (benign prostatic hyperplasia), such as: difficulty urinating (reduced urine stream),
dribbling of urine, sensation of sudden urgency 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

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

Warnings and precautions

• Regular medical examinations are necessary to monitor the progression of the condition being treated.
• Rarely, as with other medicines in this class, a drop in blood pressure and fainting may occur. If symptoms such as dizziness or feeling weak occur, the patient should sit or lie down until symptoms subside.
• If the patient has severe renal impairment, this should be reported to the doctor.
• If the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), inform the ophthalmologist that the patient is currently using, has previously used, or plans to use OMI-TAM. The specialist will then be able to take appropriate precautions regarding suitable treatment and surgical techniques.
  Please ask your doctor whether you should temporarily stop taking OMI-TAM before cataract surgery or surgical treatment of increased intraocular pressure (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 with other medicines
Concomitant use of OMI-TAM with other medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended lowering of blood pressure. Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
It is particularly important to inform 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 independently of meals.

Pregnancy, breastfeeding and fertility
OMI-TAM 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
There are no data confirming the effect of OMI-TAM on the ability to drive or operate machinery. However, one should be aware of the possibility of dizziness; in such cases, activities requiring attention should not be performed.

3. How to take OMI-TAM
This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
Recommended dose: one tablet per day. The tablet may be taken with or without food, preferably at the same time each day.
The tablet should be swallowed whole, not crushed or chewed.
OMI-TAM is a tablet formulated to release the active substance gradually and evenly after swallowing. Residues of the tablet may appear in the stool. There is no reason to suspect that the tablet was 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 persists during prolonged treatment with OMI-TAM.

Overdose of OMI-TAM
Taking too many OMI-TAM tablets may lead to unwanted lowering of blood pressure and increased heart rate with a feeling of weakness. If an overdose occurs, contact your doctor immediately.

Missed dose of OMI-TAM
If the patient forgets to take OMI-TAM at the scheduled time, they may take it later the same day. If the patient forgets to take the medicine on a given day, they should continue treatment according to the previous dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping OMI-TAM treatment
Premature discontinuation of OMI-TAM treatment may lead to recurrence of symptoms. Therefore, the medicine should be taken for as long as prescribed by the doctor, even if symptoms have subsided. 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 side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.

Common (may occur in up to 1 in 10 patients):
dizziness, especially when changing position from lying to sitting or standing; ejaculation disorders. Ejaculation disorders mean 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.

Uncommon (may occur in up to 1 in 100 patients):
headache, sensation of palpitations (noticeable and faster heartbeat), low blood pressure felt, for example, upon rapid change from sitting or lying position, sometimes associated with dizziness, nasal mucosal inflammation or nasal congestion, diarrhoea, nausea and vomiting, constipation, fatigue, rash, itching and urticaria.

Rare (may occur in up to 1 in 1000 patients):
fainting and sudden local swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash, often occurring as a result of an allergic reaction (angioedema).

Very rare (may occur in up to 1 in 10,000 patients):
priapism (painful, prolonged and unwanted erection, which requires immediate treatment); a severe condition characterized by blister formation on the skin, around the mouth, eyes and genital organs (Stevens-Johnson syndrome).

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 the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma), and the patient is currently taking or has previously taken OMI-TAM, consider that the patient's pupil may dilate poorly and the iris may become flaccid during surgery
• dry mouth

If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of side effects
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store OMI-TAM
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 pack after "Expiry date" or "EXP". The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the specified month.
Keep the medicine in its original packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 tamsulosine hydrochloride.
• Other ingredients: Tablet core: hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, iron oxide red (E 172), magnesium stearate. Outer layer of tablet core: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What OMI-TAM looks like and contents of the pack
White, unmarked, round tablets, 9 mm in diameter, with the imprint "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
The 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

For detailed information about this medicine and its trade names in the European Economic Area countries, 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