Tamsugen 0,4mg, kapsuvki o zmodifikovanim uvalnianiu, tvarde

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tamsugen and what is it used for

Tamsugencontains the active substance tamsulosin hydrochloride, which belongs to a group of medicines called alpha-adrenergic receptor antagonists (alpha blockers), used to reduce the tension of the smooth muscles of the prostate and urethra. This leads to an improvement in urine flow through the urethra and, as a consequence, easier urination.
Tamsugenis used in men for the treatment of symptoms associated with benign prostatic hyperplasia (BPH).

2. Important information before taking Tamsugen

When not to take Tamsugen

If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). Allergy to tamsulosin may manifest as sudden swelling of the hands or feet, difficulty breathing, and/or itching and rash (anaphylactic reaction).
If the patient has previously experienced dizziness or fainting due to low blood pressure (e.g., when suddenly sitting or standing up).
If the patient has severe liver impairment.

Warnings and precautions

Before starting treatment with Tamsugen, the patient should discuss it with their doctor or pharmacist.
If the patient has severe kidney disease.
If the patient is undergoing or plans to undergo surgery related to cataract (clouding of the lens) or increased pressure in the eye (glaucoma).
A condition called intraoperative floppy iris syndrome (IFIS) may occur (see section 4 - Possible side effects). The patient should inform their ophthalmologist that they have taken, are taking, or plan to take tamsulosin. The doctor will then be able to take appropriate precautions regarding treatment and surgical techniques.
The patient should ask their doctor if they should stop taking the medicine or temporarily discontinue it in connection with planned cataract surgery or increased pressure in the eye (glaucoma).
During treatment
The patient should inform their doctor or pharmacist:
If they experience dizziness or fainting while taking tamsulosin.
If they experience symptoms of orthostatic hypotension, they should then sit or lie down until the symptoms disappear.
If the patient experiences sudden swelling of the hands or feet, swelling of the lips, tongue, or throat, difficulty breathing, and/or itching and rash (anaphylactic reaction)
Before taking Tamsugen, the doctor should perform an examination of the prostate and urinary system, and subsequent examinations should be performed at regular intervals.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as it is ineffective in this age group.

Other medicines and Tamsugen

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tamsulosin may lower blood pressure when taken with other alpha-adrenergic receptor antagonists, such as doxazosin, prazosin, and indoramin.
Diclofenac (an anti-inflammatory and analgesic medicine) and warfarin (used to thin the blood) may affect the elimination of tamsulosin from the body.
Medicines that lower blood pressure, such as verapamil and diltiazem.
Medicines that suppress the immune system, such as cyclosporin.
Antibiotics used to treat infections, such as erythromycin, clarithromycin.
Medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole, voriconazole.
Medicines used to treat HIV infection, such as ritonavir, saquinavir.
The above statements may also apply to medicines taken previously and those that will be taken in the future.

Pregnancy and breastfeeding

Tamsulosin is not indicated for use in women.
Tamsulosin may cause ejaculation disorders, including inability to ejaculate or retrograde ejaculation (ejaculation into the bladder).

Driving and using machines

No studies have been conducted on the effects of tamsulosin on the ability to drive or operate machinery. However, patients should be aware that dizziness may occur.

3. How to take Tamsugen

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dose is one capsule after breakfast or after the first meal of the day.
The capsule should be swallowed whole.
The capsules should not be chewed or crushed, as this may affect the modified release of the active substance

Taking a higher dose of Tamsugen than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.
The patient may experience symptoms of low blood pressure, such as dizziness, feeling of emptiness in the head, fainting, vision disturbances, irregular heartbeat, dizziness, or weakness. If any of these symptoms occur, the patient should sit or lie down.

Missing a dose of Tamsugen

If the patient forgets to take the medicine after the first meal of the day, they can take it on the same day after a meal. If the patient forgets to take the medicine for the entire day, they should skip the missed dose and take the next dose at the right time.
The patient should not take a double dose to make up for the missed dose.
In case of any doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects:

If any of the following symptoms occur, the patient should stop taking the medicine and immediately inform their doctor or go to the emergency room of the nearest hospital:

Rare(may occur in less than 1 in 1000 patients):
sudden swelling of the hands and feet, difficulty breathing, and/or itching and rash, swelling of the lips, tongue, or throat (anaphylactic reaction)
Very rare(may occur in less than 1 in 10,000 patients):
widespread rash with numerous blisters, skin peeling, and bleeding in the area of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome).
Frequency not known(frequency cannot be estimated from the available data):
irregular or very rapid heartbeat (atrial fibrillation)

Other possible side effects:

Common(may occur in less than 1 in 10 patients):

• dizziness
• ejection disorders, including inability to ejaculate or retrograde ejaculation

Uncommon(may occur in less than 1 in 100 patients):

• headache
• feeling of abnormal heart rhythm (palpitations)
• dizziness, especially when changing position from lying down to sitting or standing (orthostatic hypotension)
• runny nose or stuffy nose (rhinitis)
• constipation
• diarrhea
• nausea
• vomiting
• rash
• itching
• feeling of weakness

Rare(may occur in less than 1 in 1000 patients):

• fainting

Very rare(may occur in less than 1 in 10,000 patients):

• painful, prolonged, unwanted erection (priapism)

Frequency not known(frequency cannot be estimated from the available data):
widespread skin rash with red spots with a pale center (erythema multiforme)
heart rhythm disorders (arrhythmia)
rapid heartbeat (tachycardia)
shortness of breath (dyspnea)
blurred or decreased vision (vision disturbances)
nosebleeds
skin rash with peeling (exfoliative dermatitis)
dry mouth
In some cases, the possibility of complications related to cataract surgery or glaucoma has been observed. During eye surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris may become floppy during surgery. For more information, see section 2 "Warnings and precautions"

Reporting side effects

If any undesirable effects occur, including any undesirable effects not mentioned in the 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
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 to gather more information on the safety of the medicine.

5. How to store Tamsugen

The medicine should be stored out of sight and reach of children.
Store in the original packaging.
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.
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. Contents of the pack and other information

What Tamsugen contains

The active substance of the medicine is tamsulosin hydrochloride.
One prolonged-release capsule contains 0.4 mg of tamsulosin hydrochloride.
The other ingredients are: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Cap capsule: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Tamsugen looks like and contents of the pack

Tamsugen capsules have an orange body and an olive green cap. The capsules contain white or almost white pellets.
The capsules are available in blisters containing 30 or 60 prolonged-release, hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer

McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Synthon Hispania S.L.
Castelló, 1
Polígono las Salinas
08830 Sant Boi de Llobregat
Spain
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: March 2023