Package leaflet: Information for the patient

Omnicare, 0.4 mg, modified-release capsules, hard
Tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
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. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Omnicare is and what it is used for
Important information before taking Omnicare
How to take Omnicare
Possible side effects
How to store Omnicare
Contents of the pack and other information

1. What Omnicare is and what it is used for

The active substance in Omnicare is tamsulosin. Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of the muscles in the prostate gland and urinary tract, thereby facilitating the flow of urine through the urethra and urination. In addition, tamsulosin reduces the sensation of urinary urgency.
Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty in urination (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the day and at night.
By relaxing the muscles of the prostate and urethra, it enables easier urination.

2. Information before taking Omnicare

When not to take Omnicare:

if the patient is allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include: swelling of the face and throat (angioedema);
if the patient currently has or has previously had dizziness, lightheadedness or fainting related to low blood pressure upon changing body position (from lying down to sitting or standing);
if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with Omnicare, discuss with a doctor:

if the patient experiences dizziness or lightheadedness, especially when changing body position (from lying down to sitting or standing). Tamsulosin may lower blood pressure,
which can cause these symptoms. In such a case, the patient should sit or lie down
and remain in this position until symptoms resolve;
if the patient has severe kidney disease. Administering the usual dose of tamsulosin to a patient with impaired kidney function may not provide the expected therapeutic effect.
if the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). An intraoperative floppy iris syndrome (IFIS) may occur (see section 4. Possible side effects). The ophthalmologist should be informed if tamsulosin hydrochloride has been used in the past, is currently being used, or is planned for use. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. The patient should ask the doctor whether treatment with Omnicare should be discontinued or temporarily interrupted before cataract surgery or surgical treatment of increased intraocular pressure (glaucoma).

Before starting treatment with tamsulosin, the doctor should examine the patient to confirm that
symptoms are indeed caused by benign prostatic hyperplasia. These examinations should be
repeated periodically.
Children and adolescents
Omnicare should not be used in children and adolescents under 18 years of age, as it is
not effective in this population.
Omnicare with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Omnicare may affect other medicines, and other medicines may affect the effectiveness of
Omnicare.
In particular, inform the doctor about taking:

other medicines from the same group (alpha-adrenergic receptor blockers), such as doxazosin, indoramin, terazosin, prazosin or alfuzosin;
medicines that lower blood pressure, such as verapamil and diltiazem;
medicines used in HIV infection, such as ritonavir or indinavir;
medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole or fluconazole;
medicines used to treat infections (e.g. erythromycin, clarithromycin);
painkillers and anti-inflammatory medicines (e.g. diclofenac);
medicines preventing blood clotting (warfarin);
medicines that suppress the immune system (e.g. cyclosporine).

Inform the doctor or dentist about taking Omnicare before any surgery or
dental procedure, as there is a risk that the medicine may interfere with the action of anaesthetics.
Omnicare with food and drink
Tamsulosin should be taken after breakfast or after the first meal of the day, with a glass of water.
Pregnancy, breastfeeding and fertility
Tamsulosin 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 there is reduced ejaculate volume or absence of ejaculation (anejaculation). These symptoms are not harmful to the patient.
Driving and using machines
There is no data available on the effect of tamsulosin on the ability to drive or operate machinery. However, it should be remembered that Omnicare may cause dizziness, blurred vision, fainting or drowsiness. If any of these symptoms occur, the patient should not drive or operate machinery.
Omnicare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Omnicare

This medicine should always be taken as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The usual recommended dose is one capsule once daily after breakfast or after the first meal.
The capsule should be taken with a glass of water, while standing or sitting (not lying down),
and swallowed whole. Capsules must not be crushed or chewed, as this may affect
the effectiveness of the medicine.
If a patient has mild to moderate kidney or liver disease, they may take the usual dose of tamsulosin.
Taking more Omnicare than prescribed
Taking a higher than recommended dose of Omnicare may cause a sudden drop in
blood pressure. The patient may experience dizziness, weakness, fainting, vomiting, and diarrhea.
To reduce symptoms of low blood pressure, lie down and then contact a doctor. The doctor
may administer medications to restore blood pressure to normal levels and monitor vital functions. If necessary, the doctor
may recommend gastric lavage and administer laxatives to remove the portion of the medicine that has not yet been absorbed from the gastrointestinal tract into the bloodstream.
Missing a dose of Omnicare
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping treatment with Omnicare
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, tamsulosin should be taken for as long as prescribed by the doctor, even if symptoms have improved.
Any decision to stop treatment should always be discussed with the doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The medicine must be discontinued immediately and medical advice sought if the patient experiences:

rarely (occurs in fewer than 1 in 1,000 patients): severe allergic reaction (called "angioedema") with symptoms such as:
- swelling of the face, tongue or throat
- difficulty swallowing
- rash
wheezing or difficulty breathing. If such symptoms occur in the patient, do not administer tamsulosin again (see section 2 "When not to take Omnicare").
- very rarely (occurs in fewer than 1 in 10,000 patients): prolonged and painful erection (usually unrelated to sexual activity). If such an erection occurs and lasts continuously for more than 4 hours, medical advice must be sought immediately. Without immediate treatment, tissue damage and permanent loss of potency may occur.
- very rarely: rapidly developing severe rash with skin peeling and blistering, affecting the area around the mouth, eyes and genital organs (Stevens-Johnson syndrome)
- severe skin rashes of unknown frequency (erythema multiforme – edematous, bluish-red skin or mucosal lesions sometimes with surface blisters, exfoliative dermatitis)
- cardiac symptoms (atrial fibrillation) of unknown frequency, including severe chest pain, irregular heartbeat, feeling of faintness, and signs of stroke such as numbness on one side of the body and slurred speech.

Other adverse reactions:
Common (occur in fewer than 1 in 10 patients)

dizziness, particularly when sitting down or standing up
abnormal ejaculation (ejaculation disorders)
retrograde ejaculation (this means semen does not exit the body through the urethra but instead flows back into the bladder)
absence of ejaculation (ejaculate volume is reduced or ejaculation cannot be achieved).

Uncommon (occur in fewer than 1 in 100 patients)

headache
sensation of rapid heartbeat (palpitations)
low blood pressure upon standing, which may cause dizziness, weakness or fainting (orthostatic hypotension). If symptoms of low blood pressure occur, the patient should lie down or sit until symptoms subside. Drinking water, getting fresh air or crossing the legs may also help.
nasal mucosal swelling or irritation (rhinitis)
constipation, diarrhoea
nausea, vomiting
rash, urticaria, itching
weakness (asthenia).

Rare (occur in fewer than 1 in 1,000 patients)

fainting.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data)

blurred vision
visual disturbances
nosebleeds
dry mouth
somnolence
oedema
irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), breathing difficulties (dyspnoea).

During eye surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy. Before planned cataract or glaucoma surgery, the patient should inform the ophthalmologist about taking Omnicare. For additional information, see section 2 "Warnings and precautions".

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Omnicare

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack,
and container following: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Omnicare contains

The active substance is 0.4 mg tamsulosin hydrochloride.
Excipients: Capsule contents: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion: polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc. Pellet coating: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion: polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc. Capsule shell - cap: indigo carmine (E 132), black iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin. Capsule shell - body: red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Omnicare looks like and contents of the pack
Omnicare is olive-green/orange capsules containing white or almost white pellets.
PVC/PE/PVDC/Aluminium blisters or HDPE bottle with child-resistant closure, in a cardboard box.
The pack contains 30 capsules.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Synthon Hispania S.L.
Calle Castelló no 1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands