Tamispras

Package Leaflet: Information for the Patient

TamisPRAS, 0.4 mg, prolonged-release tablets
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 those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is TamisPRAS and what is it used for

TamisPRAS reduces the tension of the prostate and urethra, making it easier to urinate and empty the bladder. Additionally, the medicine reduces the feeling of urgency to urinate.
TamisPRAS is used in men to alleviate symptoms associated with an enlarged prostate (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 TamisPRAS

When not to take TamisPRAS

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergy may manifest as sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• if you experience drops in blood pressure when standing up, which can cause dizziness, lightheadedness, or fainting.
• if you have severe liver impairment.

Warnings and precautions

Before taking TamisPRAS, discuss with your doctor or pharmacist:

• if you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower blood pressure, causing such symptoms. If you experience symptoms of low blood pressure, sit or lie down until they pass.
• if you have severe kidney impairment, inform your doctor.
• if you are having or plan to have eye surgery for cataracts or glaucoma. During surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4). You should inform your ophthalmologist that you have taken, are taking, or plan to take tamsulosin. The ophthalmologist may take appropriate precautions regarding the medications and surgical techniques used. If you are preparing for cataract or glaucoma surgery, ask your doctor if you should stop or temporarily discontinue taking the medicine.

Regular medical check-ups are necessary to monitor the course of the disease.
You may notice remnants of the tablet in your stool. However, since the active substance has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

TamisPRAS should not be used in children and adolescents under 18 years of age, as it is not effective in this patient group.

TamisPRAS 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 combination with tamsulosin may lower blood pressure, causing dizziness or lightheadedness.
• ketokonazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacistabout all the medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

TamisPRAS with food, drink, and alcohol

TamisPRAS can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorder) has been observed, where semen does not exit the body through the urethra but instead flows back into the bladder (retrograde ejaculation) or there is a reduced or absent ejaculate. This phenomenon does not pose a risk to the patient's health.

Driving and using machines

There is no data confirming the effect of tamsulosin on the ability to drive and use machines. However, remember that TamisPRAS may cause dizziness or lightheadedness, so you can drive and use machines only when you feel well.

3. How to take TamisPRAS

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual doseis one tablet per day. The medicine can be taken with or without food, preferably at the same time each day.
Swallow the tablet whole. It is important not to crush or chewthe tablets, as this may affect the efficacy of tamsulosin.
TamisPRAS is not intended for use in children.

Taking more than the recommended dose of TamisPRAS

If you take more than the recommended dose of TamisPRAS, you may experience a sudden drop in blood pressure. Symptoms such as dizziness, weakness, nausea, diarrhea, and fainting may occur. Lie down to reduce the effect of low blood pressure, and then contact your doctor.

Missing a dose of TamisPRAS

If you forget to take your dose at the scheduled time, you can take it later that day. If you forget to take your dose on a given day, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with TamisPRAS

If you stop treatment with TamisPRAS too early, your symptoms may return. Therefore, the medicine should be taken for as long as your doctor has prescribed, even if your symptoms have disappeared. Before stopping treatment, always consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects are rare. Seek medical attention immediatelyif you experience a severe allergic reaction with swelling of the face or throat(angioedema).
Common side effects(may affect up to 1 in 10 people)

• dizziness
• abnormal ejaculation (ejaculation disorder). This means that semen does not exit the body through the urethra but instead flows back into the bladder (retrograde ejaculation) or there is a reduced or absent ejaculate. This phenomenon does not pose a risk to the patient's health.

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

• headache
• palpitations
• low blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension)
• swelling or irritation of the nasal mucosa (rhinitis)
• constipation
• diarrhea
• nausea
• vomiting
• rash
• itching
• hives
• 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 skin condition characterized by blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

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

• blurred vision
• loss of vision
• nasal bleeding
• dry mouth
• severe skin rash (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm
• arrhythmia
• rapid heartbeat
• breathing difficulties. During eye surgery for cataracts or glaucoma, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: during surgery, the pupil may not dilate well, and the iris may become floppy. For more information, see section 2 "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, PL-02 222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TamisPRAS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the stated month.
The batch number is stated after the word "Lot".
Store the blisters in the original package to protect from light.
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 TamisPRAS contains

• The active substance is 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other ingredients are: Tablet core:microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, red iron oxide (E 172), magnesium stearate. Outer layer of the tablet core: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

What TamisPRAS looks like and contents of the pack

White, round tablets with the inscription "T9SL" on one side and "0.4" on the other side of the tablet.
TamisPRAS, prolonged-release tablets are available in packs of 30 tablets, packaged in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warszawa
Polska
Manufacturer:

Synthon B.V.

Microweg 22
6545 CM Nijmegen
Netherlands

Synthon Hispania SL

Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

Normon S.A.

Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

Date of last revision of the leaflet: