Omsal 0.4 mg prolonged release capsules

Package leaflet: Information for the user

Omsal 0.4 mg prolonged-release capsules, hard
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Omsal 0.4 mg prolonged-release hard capsules (referred to as Omsal in the rest of this leaflet) is and what it is 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 Omsal is and what it is used for
The active substance in Omsal is tamsulosin hydrochloride. It is a selective alpha-adrenergic receptor antagonist. It reduces the tone of smooth muscles in the prostate gland and urethra, allowing easier passage of urine through the urethra and facilitating urination. Additionally, it reduces the sensation of urgency to urinate.
Omsal is used in men to treat lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia).
These symptoms may include difficulty urinating (weak stream), dribbling after urination, urgency to urinate, and increased frequency of urination both during the day and at night.

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). Allergic reactions may present as sudden local swelling of soft tissues of the body (e.g. throat or tongue), breathing difficulties and/or itching and rash (angioedema).
• if you have severe liver impairment.
• if you suffer from fainting caused by low blood pressure upon changing position (from lying down to sitting or standing).

Warnings and precautions
Talk to your doctor or pharmacist before taking Omsal.

• Regular medical check-ups are necessary during treatment to monitor your condition.

• In rare cases, the use of tamsulosin may lead to fainting, as with other medicines in the same class. If you experience the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.

• If you have severe kidney problems, inform your doctor.

• If you are scheduled for or undergoing cataract surgery (lens opacity surgery), or if you have elevated intraocular pressure (glaucoma), you must inform your ophthalmologist that you are currently or recently taking Omsal, as Omsal may cause complications during the procedure. The specialist may then take special precautions by selecting appropriate medications or surgical techniques. Ask your doctor whether it is necessary to reschedule or temporarily discontinue treatment due to planned cataract surgery (lens opacity surgery) or surgery for elevated intraocular pressure (glaucoma).

Children and adolescents
Omsal must 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 with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines (e.g. anticoagulants such as warfarin, nonsteroidal anti-inflammatory drugs such as diclofenac) may affect the action of tamsulosin. Therefore, other medicines should only be taken together with Omsal under the advice of a doctor.

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

Driving and using machines
Omsal may affect the ability to drive and operate machinery. Consider that dizziness may occur in some patients.

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

3. How to use Omsal

This medicine should always be used according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
Unless otherwise advised by your doctor, the recommended dose is one capsule daily, taken after breakfast or after the first meal of the day.
Do not chew or crush the capsules; swallow them whole.
Use of a higher than recommended dose of Omsal
Taking a higher than recommended dose of Omsal may lead to an unexpected drop in blood pressure and rapid heartbeat, followed by dizziness. Contact your doctor immediately or go to the emergency department of the nearest hospital, as the consequences of accidental or intentional overdose may require medical intervention.
Missed dose of Omsal
If you miss a dose, take it as soon as you remember on the same day. Do not take a double dose the next day to make up for the missed dose; continue treatment with one capsule per day.
Stopping Omsal treatment
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
There is no need to be alarmed by the list of possible adverse reactions below – the patient may not experience any of them. Most patients do not experience any adverse reactions. However, if adverse reactions do occur and concern the patient during treatment, medical advice should be sought.
If the patient experiences a sensation of emptiness in the head or dizziness, they should sit or lie down until symptoms subside.

Common (may occur in up to 1 in 10 people)

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

Uncommon (may occur in up to 1 in 100 people)

• headache,
• rapid heartbeat,
• drop in blood pressure, especially when changing to an upright position,
• nasal congestion or rhinitis,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• rash,
• urticaria,
• itching,
• weakness.

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

• fainting,
• swelling of the lower skin layers, often around the mouth or the mucous membranes of the mouth or throat, which may appear very quickly.

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

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

Unknown (frequency cannot be estimated from available data)

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

In patients taking tamsulosin during or prior to cataract surgery (lens opacity surgery) or surgery due to elevated intraocular pressure (glaucoma), poor pupil dilation may occur, and the iris (the coloured circular part of the eye) may become floppy during surgery (see section 2 "Warnings and precautions").

Additionally, apart from the above-observed adverse reactions,

• very rapid, uncoordinated contractions of the heart muscle,
• irregular heart rhythm,
• rapid heartbeat,
• breathing difficulties, have been reported in association with the use of the medicine Omsal. Since these events are reported spontaneously following the medicine's release onto the market, their frequency of occurrence and the role of Omsal in causing them cannot be reliably determined.

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 at 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Omsal

Keep the medicine out of sight and reach of children.
Store in the original packaging 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 stated month.
Medicines must 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 package 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:

Capsule filling: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) (containing: 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
Size 2 capsules are matte, with yellowish and brown parts. Each extended-release hard capsule is filled with 330 mg of white or almost white coated pellets.
The cardboard pack contains 30 or 100 capsules packed in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about the medicinal product and its names in other European Economic Area 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