Package leaflet: Information for the user

TamisPras Auro, 0.4 mg, prolonged-release tablets
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.
Please contact your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If any of the side effects worsens or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What TamisPras Auro is and what it is used for
What you need to know before taking TamisPras Auro
How to take TamisPras Auro
Possible side effects
How to store TamisPras Auro
Contents of the pack and other information

1. What TamisPras Auro is and what it is used for

The active substance in TamisPras Auro is tamsulosin. It is a selective antagonist of
α-adrenergic receptors. It reduces the tone of the muscles in the prostate gland and the urethra
(urinary tract), allowing urine to flow through the urethra and making urination easier. Additionally,
it reduces the sensation of bladder pressure.
TamisPras Auro is used in men to treat symptoms of lower urinary tract related to benign prostatic
hyperplasia (BPH).
These symptoms include: difficulty urinating (reduced urine stream), urination in drops or interrupted
streams, sudden urge to urinate, and frequent urination both during the night and during the day.

2. Important information before using TamisPras Auro

When not to use TamisPras Auro:
If the patient is allergic to tamsulosin or any of the other ingredients of this medicine
(listed in section 6).
Symptoms of hypersensitivity may include sudden localised swelling of soft tissues of the body
(throat or tongue), difficulty in breathing and (or) itching and rash (angioedema).
If the patient has severe liver disease.
If the patient has experienced fainting upon changing body position (sitting or standing up)
due to low blood pressure.

Warnings and precautions
Before starting treatment with TamisPras Auro, consult a doctor or pharmacist.
Regular medical check-ups are necessary to assess the progression of the condition for which
the patient is being treated.
Rarely, as with other medicines of this type, fainting may occur during treatment with TamisPras Auro.
If initial symptoms such as dizziness or weakness occur, the patient should sit or lie down until
these symptoms subside.
If the patient has severe kidney disease, this should be reported to the doctor.
If the patient is due to undergo surgery for removal of a cloudy lens of the eye (cataract) or
treatment of increased eye pressure (glaucoma), the patient must inform their ophthalmologist
before surgery that they are taking, have taken, or plan to take TamisPras Auro.
The ophthalmologist may take necessary precautions regarding the treatment and surgical technique.
Please ask your doctor whether you should discontinue or temporarily interrupt this medicine if
cataract surgery or treatment for increased eye pressure (glaucoma) is planned.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, as it is not effective in this population.

TamisPras Auro with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Taking TamisPras Auro together with other medicines of the same class (α-adrenergic receptor antagonists)
may lead to an undesirable decrease in blood pressure.
It is especially important to inform the doctor if the patient is being treated simultaneously with medicines
that may slow down the elimination of TamisPras Auro from the patient's body (e.g. ketoconazole, erythromycin).

TamisPras Auro with food and drink
TamisPras Auro can be taken with or without food.

Pregnancy and breastfeeding
TamisPras Auro is not indicated for use in women.
In men, ejaculation disorders (disorders of semen emission) 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 ejaculate is reduced, or ejaculation does not occur at all (absence of ejaculation). This phenomenon is harmless.

Driving and operating machinery
There is no evidence that tamsulosin impairs the ability to drive or operate machinery. However, the possibility of dizziness should be kept in mind; therefore, if this affects the patient, they should not perform activities requiring attention.

TamisPras Auro contains monohydrate lactose
If the doctor has informed the patient of an intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take TamisPras Auro

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should contact your doctor or pharmacist.
The recommended dose is one tablet daily. TamisPras Auro may be taken with or without food, preferably at the same time each day.
The tablet should be swallowed whole and must not be chewed or crushed.
TamisPras Auro is a specially designed tablet that gradually releases the active substance after ingestion. You may notice the tablet residue in your stool. Since the active substance has already been released, there is no risk that the tablet is less effective.
TamisPras Auro is usually prescribed for long-term use. The effect on the bladder and urination is maintained during prolonged treatment with TamisPr Auro.
Taking more TamisPras Auro than recommended
If you take more TamisPras Auro than recommended, you may experience a sudden drop in blood pressure and increased heart rate, accompanied by a feeling of fainting.
If you have taken more than the recommended dose of this medicine, you should contact your doctor immediately.
Missing a dose of TamisPras Auro
If you forget to take your daily dose of TamisPras Auro as prescribed, you may take the missed dose later the same day. If you forget to take the medicine for one day, you should skip the missed dose and continue taking your prescribed dose at the usual time the next day. Do not take a double dose to make up for the missed tablet.
Stopping TamisPras Auro treatment
If treatment with TamisPras Auro is stopped too early, the original symptoms of the disease may return. Therefore, the medicine should be taken for as long as your doctor has instructed, even if symptoms have improved. You should consult your doctor if you are considering stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Common (may occur in up to 1 in 10 patients):
dizziness, especially when sitting down or standing up,
abnormal ejaculation (ejaculation disorder). 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 (absence of ejaculation). This phenomenon
is harmless.
Uncommon (may occur in up to 1 in 100 patients):
headache,
palpitations (heartbeats that are faster than usual and are noticeable),
lowering of blood pressure, for example when quickly standing up from a sitting or lying
position, sometimes associated with dizziness,
nasal congestion or blocked nose (nasal mucosal inflammation),
diarrhea,
nausea and vomiting,
constipation,
weakness (asthenia),
rash,
itching and urticaria.
Rare (may occur in up to 1 in 1,000 patients):
fainting and sudden localized swelling of soft tissues of the body (e.g. throat or tongue),
difficulty breathing and (or) itching and rash, often as an allergic reaction (angioedema).
Very rare (may occur in up to 1 in 10,000 patients):
painful, prolonged and unwanted erection (priapism), which requires immediate treatment,
rash, inflammation and formation of blisters on the skin and (or) mucous membranes of the
lips, eyes, mouth, nasal passages or genital organs (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from the available data):
blurred vision,
visual disturbances,
nosebleeds,
severe skin rashes (erythema multiforme, exfoliative dermatitis),
irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing
(dyspnea),
if the patient is undergoing eye surgery due to cataract or increased intraocular pressure
(glaucoma) and is currently taking or has previously taken TamisPras Auro, the pupil may
dilate poorly and the iris (the colored circular part of the eye) may become flaccid during the
surgical procedure,
dry mouth.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform
your doctor or pharmacist. Adverse reactions can be reported directly to the Department of
Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be
collected.

5. How to store TamisPras Auro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or
container after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What TamisPras Auro contains
The active substance is tamsulosin hydrochloride.
Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.

Other ingredients are:
Tablet core: microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), hydroxypropylcellulose, monohydrate lactose, polyethylene oxide, hypromellose type 2280 (100000 mPa • s), colloidal silicon dioxide, anhydrous and magnesium stearate
Tablet coating: hypromellose 2910, macrogol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What TamisPras Auro looks like and contents of the pack
Prolonged-release tablets.
TamisPras Auro is yellow, round (9.1 mm in diameter), biconvex tablets, embossed with "T" above and "04" below on one side, and smooth on the other side.
TamisPras Auro prolonged-release tablets are available in blisters made of PA/Aluminium/PVC/Aluminium foil and in collective packaging (i.e. HDPE bottle with PP closure containing a desiccant), packed in a cardboard box.
Blister:
Pack sizes: 20, 30, 50, 90, 100 and 200 prolonged-release tablets
Bottle:
Pack size: 250 prolonged-release tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer / Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques SAS
26, Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Tamsulosin AB 0.4 mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten
Cyprus: Tamsulosin Aurobindo 0.4 mg δισκία παρατεταμένης αποδέσμευσης
Czech Republic: Tamsulosin Aurovitas
France: TAMSULOSINE ARROW LP 0.4 mg, comprimé à libération prolongée
Germany: Tamsulosin PUREN 0.4 mg Retardtabletten
Netherlands: Tamsulosine HCl Aurobindo Retard 0.4 mg, tabletten met verlengde afgifte
Poland: TamisPras Auro
Portugal: Tansulosina Generis
Spain: Tamsulosina Aurovitas 0.4 mg comprimidos de liberación prolongada EFG