Omsal 0,4 mg kapsuvki o pzhedvuzhonim uvalnianiu

Package Leaflet: Information for the User

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

Table of Contents of the Leaflet

• 1. What is Omsal 0.4 mg prolonged-release hard capsules (hereinafter referred to as Omsal) and what is it used for
• 2. Important information before taking Omsal
• 3. How to take Omsal
• 4. Possible side effects
• 5. How to store Omsal
• 6. Contents of the pack and other information

1. What is Omsal and what is it used for

The active substance of Omsal is tamsulosin hydrochloride. It is a selective alpha-1 adrenergic receptor antagonist. It reduces the tension of the smooth muscles of the prostate and urethra, making it easier for urine to flow through the urethra and facilitating its discharge. Additionally, it reduces the feeling of pressure on the bladder. Omsal is used in men for the treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate). These symptoms may include difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination both at night and during the day.

2. Important information before taking Omsal

When not to take Omsal:

• if you are allergic to tamsulosin hydrochloride or 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 you have severe liver impairment.
• if you experience fainting spells due to low blood pressure when changing position (from lying down to sitting or standing).

Warnings and precautions

Before starting to take Omsal, discuss it with your doctor or pharmacist.

• During treatment, it is necessary to perform periodic medical examinations to monitor the patient's condition.
• In rare cases, taking tamsulosin may lead to fainting, as with other medications in the same group. If you experience the first symptoms of dizziness or weakness, you should sit or lie down until the symptoms pass.

if you experience severe kidney problems, you should inform your doctor.

• If you are scheduled to undergo or are undergoing cataract surgery (lens clouding surgery) or have increased intraocular pressure (glaucoma), you should inform your ophthalmologist about taking Omsal, as Omsal may cause complications during the procedure. The specialist doctor may then take special precautions by selecting appropriate medications or surgical techniques. You should ask your doctor if it is necessary to postpone or temporarily stop taking the medication due to the cataract surgery (lens clouding) or surgery due to increased intraocular pressure (glaucoma).

Children and adolescents

Omsal should not be used in children and adolescents under 18 years of age, as there is no appropriate indication for the use of Omsal in this age group, and its efficacy has not been established.

Omsal 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. Some medicines (e.g., anticoagulant medications, such as warfarin, anti-inflammatory medications, such as diclofenac) may affect the action of tamsulosin. Therefore, other medications can only be taken with Omsal with the doctor's consent.

Pregnancy, breastfeeding, and fertility

Omsal is not indicated for use in women. In men, ejaculation disorders (ejaculation disorders) have been reported. This means that semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or ejaculation does not occur at all (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

Omsal may affect your ability to drive and use machines. You should consider that some patients may experience dizziness.

Omsal contains sodium

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

3. How to take Omsal

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist. If your doctor has not advised otherwise, the recommended dose is one capsule per day after breakfast or after the first meal of the day. The capsules should not be chewed or crushed, but swallowed whole.

Overdose of Omsal

Taking more than the recommended dose of Omsal may lead to an unexpected drop in blood pressure and rapid heartbeat, followed by dizziness. You should contact your doctor or go to the emergency room immediately, as the effects of accidental or intentional overdose may require medical intervention.

Missed dose of Omsal

You should take the missed capsule on the same day. The next day, do not take a double dose to make up for the missed dose, but continue treatment with one capsule per day.

Stopping treatment with Omsal

You should not stop treatment without consulting your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omsal can cause side effects, although not everybody gets them. Do not be concerned about the following list of possible side effects - you may not get any of them. Most patients do not experience any side effects. However, if side effects occur and bother you while taking the medicine, you should consult your doctor. If you feel dizzy or lightheaded, you should sit or lie down until the symptoms pass. Common(may affect up to 1 in 10 people)

• dizziness, especially when standing up from a chair or bed,
• ejaculation disorders,
• retrograde ejaculation (ejaculation into the bladder),
• absence of ejaculation.

Uncommon(may affect up to 1 in 100 people)

• headache,
• rapid heartbeat,
• low blood pressure, especially when changing position to standing,
• stuffy nose or rhinitis,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• rash,
• hives,
• itching,
• weakness.

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

• fainting,
• swelling of the lower skin, often around the mouth or mucous membrane of the mouth or throat, which can appear very quickly.

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

• priapism (painful, prolonged, and involuntary erection); if priapism occurs, immediate medical attention is required,
• acute skin and mucous membrane inflammation, which is an allergic reaction to the medicine or other substances, known as Stevens-Johnson syndrome.

Not known(frequency cannot be estimated from the available data)

• nosebleeds,
• blurred vision, vision disturbances,
• dry mouth,
• severe skin rash (erythema multiforme, exfoliative dermatitis).

In patients taking tamsulosin during or before cataract surgery (lens clouding surgery) or surgery due to increased intraocular pressure (glaucoma), there may be poor dilation of the pupil, and the iris (the colored part of the eye) may become floppy during surgery (see section 2 "Warnings and precautions"). Additionally, apart from the above-observed side effects, very rapid, uncoordinated heart muscle contractions, irregular heart rhythm, rapid heartbeat, and difficulty breathing have been reported in connection with the use of Omsal. Since these events are reported spontaneously after the marketing of the medicine, it is not possible to reliably determine their frequency or the role of Omsal in their occurrence.

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, 02-222 Warsaw, Tel.: +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 Omsal

Keep the medicine out of the sight and reach of children. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated. 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 Omsal contains

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are:

Filler: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) (contains: polysorbate 80, sodium lauryl sulfate), talc, triethyl citrate, calcium stearate. Capsule shell: yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin.

What Omsal looks like and contents of the pack

The capsules are size 2, matte, and have a light yellow and brown color. Each prolonged-release hard capsule is filled with 330 mg of white or off-white coated pellets. The carton pack contains 30 or 100 capsules packaged in PVC/PVDC/Aluminum blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more information about the medicine and its names in other EU countries, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, [email protected], fax: +48 (22) 755 96 24.

Date of last revision of the leaflet: April 2021