Tamsiger

Leaflet included in the packaging: patient information

Tamsiger, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

It is very important to read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tamsiger and what is it used for
• 2. Important information before taking Tamsiger
• 3. How to take Tamsiger
• 4. Possible side effects
• 5. How to store Tamsiger
• 6. Package contents and other information

1. What is Tamsiger and what is it used for

Tamsulosin reduces the tension of the prostate gland and urinary tract, facilitating urine flow and urination. Additionally, the medicine reduces the feeling of pressure on the urinary bladder. Tamsulosin is used in men to alleviate symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia), such as: difficulty urinating (reduced urine flow), urinating in drops, sudden urge to urinate, and frequent urination, both at night and during the day.

2. Important information before taking Tamsiger

When not to take Tamsiger

• if the patient is allergic to tamsulosin or any other ingredientof 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) dizziness and rash (anaphylactic shock).
• if the patient experiences severe blood pressure dropswhen changing body position to standing, causing dizziness, feeling of emptiness in the head, or fainting.
• if the patient has severe liver function disorders.

Warnings and precautions

Before starting to take Tamsiger, the patient should discuss it with their doctor or pharmacist:

• if the patient experiences dizzinessor feeling of emptiness in the head, especially when changing body position to standing. Tamsulosin may lower blood pressure, causing such symptoms. If they occur, the patient should sit or lie down until the symptoms pass.
• if the patient has severe kidney function disorders, they should inform their doctor.
• if the patient is undergoing or plans to undergo eye surgery due to cataracts or increased eye pressure (glaucoma). During the procedure, a condition called Intraoperative Floppy Iris Syndrome(IFIS) may occur (see section 4 "Possible side effects"). The patient should inform their eye doctor that they are taking or plan to take tamsulosin. The eye doctor may take appropriate precautions regarding the medications and surgical techniques used. When preparing for cataract surgery or increased eye pressure (glaucoma), the patient should ask their doctor if they should stop taking the medicine temporarily. Regular medical check-ups are necessary to monitor the disease.

The patient may notice remnants of the tablet in their stool. However, since the active substance has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Tamsiger should not be used in children and adolescents under 18 years of age, as it does not show efficacy in this patient group.

Tamsiger and other medicines

Tamsulosin may interact with other medicines, and other medicines may affect the efficacy of tamsulosin. Tamsulosin may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action.
• warfarin, a medicine that prevents blood clot formation. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action.
• other alpha-adrenergic receptor blockers. Their concurrent use with tamsulosin may lower blood pressure, causing dizziness or feeling of emptiness in the head.
• ketokonazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

The patient should inform their doctor or pharmacistabout all medicines they are currently taking or have recently taken, as well as those they plan to take, including over-the-counter medicines.

Tamsiger with food, drinks, and alcohol

Tamsiger can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.
In men, ejaculatory disorders (ejaculation disorders) have been reported, consisting of the semen not being released through the urethra but instead flowing back into the bladder (retrograde ejaculation) or being released in reduced quantity or not at all (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

There is no data confirming the effect of tamsulosin on the ability to drive vehicles and operate machines. However, it should be remembered that Tamsiger may cause dizziness or feeling of emptiness in the head, so the patient should only drive vehicles and operate machines when they feel well.

3. How to take Tamsiger

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The usual doseis one tablet per day. The medicine can be taken with or without food, preferably at the same time every day.
The tablet should be swallowed whole. It is essential not to crush or chew the tablets, as this may affect the efficacy of tamsulosin.
Tamsiger is not intended for use in children.

Taking a higher dose of Tamsiger than recommended

In case of taking a higher dose of Tamsiger than recommended, a sudden drop in blood pressure may occur. Symptoms such as dizziness, weakness, nausea, vomiting, diarrhea, and fainting may occur. The patient should lie down to reduce the effects of low blood pressure and then contact their doctor.

Missing a dose of Tamsiger

If the patient forgets to take the medicine at the scheduled time, they can take it later the same day. If the patient forgets to take the medicine on a given day, they should take the next dose the following day at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Tamsiger treatment

If the treatment with Tamsiger is stopped too early, the symptoms of the disease may return. Therefore, the medicine should be taken for as long as the doctor recommends, even if the symptoms of the disease have disappeared. Before stopping the treatment, the patient should always consult their doctor. In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsiger can cause side effects, although not everybody gets them. Serious side effects are rare. Medical help should be sought immediatelyif the patient experiences a severe allergic reaction with swelling of the face or throat(anaphylactic shock).
Common side effects(may affect up to 1 in 10 people)

• dizziness
• abnormal ejaculation (ejaculation disorder). This means that the semen does not come out through the urethra but instead flows back into the bladder (retrograde ejaculation) or is released in reduced quantity or not at all (absence of ejaculation). This phenomenon is harmless.

Uncommon side effects(may affect up to 1 in 100 people)

• headache
• heart palpitations
• low blood pressure when changing body position to standing, which may cause dizziness, feeling of emptiness in the head, or fainting (orthostatic hypotension)
• swelling or irritation of the nasal mucosa (rhinitis)
• constipation
• diarrhea
• nausea
• vomiting
• rash
• itching
• hives
• feeling of weakness (asthenia)

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

• fainting Very rare side effects(may affect up to 1 in 10,000 people)
• painful erection (priapism)
• a severe disease characterized by the formation of blisters on the skin, around the mouth, eyes, and genitals (Stevens-Johnson syndrome)

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

• blurred vision
• loss of vision
• nasal bleeding
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm
• irregular heartbeat
• rapid heartbeat
• breathing difficulties During eye surgery due to cataracts or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome(IFIS) may occur: during the procedure, the pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid. For more information, see section 2 "Warnings and precautions".

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist

Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tamsiger

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The first two digits indicate the month, and the last four digits indicate the year.
The expiry date indicates the last day of the specified month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tamsiger contains

• The active substance of the medicine is 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).
• Other ingredients are: tablet coreMicrocrystalline cellulose Hypromellose Carboxymethylcellulose silica, anhydrous Red iron oxide (E 172) Magnesium stearate

Coating
Microcrystalline cellulose
Hypromellose
Carboxymethylcellulose silica, anhydrous
Magnesium stearate

What Tamsiger looks like and contents of the pack

White, round tablets with "T9SL" embossed on one side and "0.4" on the other side.
The medicine is available in blisters containing 30 or 90 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Synthon Hispania SL
Calle Castelló 1
08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
Industria Química y Farmacéutica VIR, S.A.
Calle Laguna 66-68-70
Poligono Industrial Urtinsa II
28923 Alcorcón, Madrid
Spain

To obtain more detailed information and information on the names of the medicinal product in other EU Member States, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Jana Pawła II Avenue 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: