Omnicare

Package Leaflet: Information for the Patient

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

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

• Keep this 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Omnicare and what is it used for

The active substance of Omnicare is tamsulosin. Tamsulosin is a selective alpha-1A adrenergic receptor antagonist. Tamsulosin reduces the tension of the prostate and urethra, facilitating the flow of urine and urination. Additionally, tamsulosin reduces the feeling of urgency to urinate.
Tamsulosin is prescribed for the treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate). 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.
By relaxing the muscles of the prostate and urethra, it allows for easier urination.

2. Important information before taking Omnicare

When not to take Omnicare:

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include: facial and throat edema(angioedema);
• if you have experienced or are experiencing dizziness, fainting, or syncope related to low blood pressure when changing body position (from lying to sitting or standing);
• if you have severe liver disease.

Warnings and precautions

Before starting treatment with Omnicare, you should discuss it with your doctor:

• if you experience dizziness or fainting, especially when changing body position (from lying to sitting or standing). Tamsulosin may lower blood pressure, which can cause these symptoms. In such cases, you should sit or lie down and remain in that position until the symptoms subside;

if you have severe kidney disease. Administration of the usual dose of tamsulosin to a patient with impaired kidney function may not produce the expected effect.

• if you are scheduled to undergo eye surgery for cataracts or increased intraocular pressure (glaucoma). Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4. Possible side effects). You should inform your ophthalmologist if you have taken, are taking, or plan to take tamsulosin hydrochloride. The doctor 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 glaucoma.

Before starting treatment with tamsulosin, your doctor should examine you to confirm that the symptoms are indeed caused by an enlarged prostate. 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 and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Omnicare may affect other medicines, and other medicines may affect the efficacy of Omnicare.
In particular, you should inform your doctor about taking:

• other medicines from the same group (alpha-1 adrenergic receptor blockers), such as doxazosin, indoramin, terazosin, prazosin, or alfuzosin
• medicines that lower blood pressure, such as verapamil and diltiazem
• medicines used to treat 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)
• analgesic and anti-inflammatory medicines (e.g., diclofenac)
• medicines that prevent blood clotting (warfarin)
• medicines that reduce the immune system (e.g., cyclosporine)

You should inform your 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 the anesthetic.

Omnicare with food and drink

Tamsulosin should be taken after breakfast or after the first meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

Tamsulosin 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 there is a decrease in the volume of ejaculate or its absence (anejaculation). These symptoms do not pose a risk to the patient.

Driving and using machines

There is no data on the effect of tamsulosin on the ability to drive and use machines. However, you should remember that Omnicare may cause dizziness, blurred vision, fainting, or drowsiness. If you experience any of these symptoms, do not drive or operate machinery.

Omnicare contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Omnicare

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.
The recommended doseis one capsule once a day after breakfastor after the first meal.
The capsule should be taken with a glass of water, standing or sitting (not lying down), and swallowed whole. The capsules should not be crushed or chewed, as this may affect the efficacy of the medicine.
If you have mild to moderate kidney or liver disease, you may take the usual dose of tamsulosin.

Overdose of Omnicare

After taking a higher dose of Omnicare than recommended, a sudden drop in blood pressure may occur. The patient may experience dizziness, weakness, and fainting, vomiting, and diarrhea.
To reduce the symptoms of low blood pressure, you should lie down and then contact your doctor. The doctor may administer medicines that restore blood pressure to normal values and monitor the patient's vital functions. If necessary, the doctor may recommend gastric lavage and administer laxatives to remove the part of the medicine that has not yet been absorbed from the gastrointestinal tract into the bloodstream.

Missed 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, the symptoms of the disease may return. Therefore, you should take tamsulosin for as long as your doctor has prescribed, even if the symptoms of the disease have subsided.
Stopping treatment should always be consulted 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, Omnicare can cause side effects, although not everybody gets them.
You should stop taking the medicine and contact your doctor immediatelyif you experience:

• rare (occurs in less than 1 in 1,000 patients): severe allergic reaction (angioedema) with symptoms such as:
• facial and throat edema
• difficulty swallowing
• rash
• wheezing or difficulty breathing. If you experience such symptoms, you should not take tamsulosin again (see section 2 "When not to take Omnicare").
• very rare (occurs in less than 1 in 10,000 patients): prolonged and painful erection (usually not related to sexual activity). If such an erection occurs and lasts continuously for more than 4 hours, you should contact your doctor immediately. If left untreated, it may lead to tissue damage and permanent loss of potency.
• very rare: rapidly progressing severe rash with skin peeling and blistering on the skin, around the mouth, eyes, and genitals (Stevens-Johnson syndrome)
• severe skin rashes of unknown frequency (erythema multiforme - edematous, violaceous changes on the skin or mucous membranes of the mouth, sometimes with blisters on the surface, exfoliative dermatitis)
• heart symptoms (atrial fibrillation) of unknown frequency, including severe chest pain, irregular heartbeat, and fainting, as well as signs of stroke such as numbness of one part of the body and slurred speech.

Other side effects:

Common(occurs in less than 1 in 10 patients)

• dizziness, especially when sitting or standing
• abnormal ejaculation (ejaculation disorders)
• retrograde ejaculation (this means that semen does not flow out of the body through the urethra but instead flows back into the bladder)
• anejaculation (the volume of ejaculate is reduced or it is impossible to achieve ejaculation).

Uncommon(occurs in less than 1 in 100 patients)

• headache
• palpitations
• low blood pressure when standing up, which can cause dizziness, weakness, or fainting (orthostatic hypotension). If you experience symptoms of low blood pressure, you should first lie down or sit down and wait for the symptoms to subside. Drinking water, getting fresh air, or crossing your legs may also help.
• nasal congestion or irritation (rhinitis)
• constipation, diarrhea
• nausea, vomiting
• rash, urticaria, itching
• weakness (asthenia).

Rare(occurs in less than 1 in 1,000 patients)

• fainting.

Side effects of unknown frequency(frequency cannot be estimated from available data)

• blurred vision
• vision disturbances
• nasal bleeding
• dry mouth
• drowsiness
• edema
• irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), breathing difficulties (dyspnea).

During eye surgery for cataracts or increased intraocular pressure (glaucoma), Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate well, and the iris (the colored part of the eye) may become floppy. Before planned cataract or glaucoma surgery, you should inform your ophthalmologist about taking Omnicare. For more information, see section 2 "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Omnicare

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and container after: EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Omnicare contains

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

What Omnicare looks like and contents of the pack

Omnicare is an olive-green/orange capsule that contains white or almost white pellets.
PVC/PE/PVDC/Aluminum blisters or HDPE containers with a child-resistant closure, in a cardboard box.
The pack contains 30 capsules.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +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
Netherlands

Date of last revision of the leaflet: