TAMSULOSIN KRKA 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Tamsulosina Krka 0.4 mg prolonged-release tablets EFG

tamsulosin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tamsulosina Krka and what is it used for
2. What you need to know before taking Tamsulosina Krka
3. How to take Tamsulosina Krka
4. Possible side effects
5. Storage of Tamsulosina Krka
6. Package contents and additional information

1. What is Tamsulosina Krka and what is it used for

The active substance of this medication is tamsulosin. It is a selective antagonist of α1A/1D-adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulties in urination (weak urine stream), dripping, urgency, and frequent need to urinate both at night and during the day.

2. What you need to know before taking Tamsulosina Krka

Do not takeTamsulosina Krka

• if you are allergic to tamsulosin or any of the other componentsof this medication (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride may present as sudden local swelling of the body's soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• if you have severe liver problems.
• if you have dizziness due to a drop in blood pressure when changing position (sitting or standing).

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosin.

• Regular medical examinations are necessary to monitor the development of the disease being treated.
• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you have taken, are taking, or intend to take tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

It is possible to observe remains of the tablet in the stool. Since the active substance of the tablet has already been released, there is no risk that the tablet will be less effective.

Children

Do not administer this medication to children or adolescents under 18 years of age, as it does not work in this population.

Other medications and Tamsulosina Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking tamsulosin with other medications of the same group (α1-adrenergic receptor antagonists) may cause an undesired drop in blood pressure.

It is especially important that you inform your doctor if you are being treated at the same time with medications that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Krka with food and beverages

Tamsulosin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

This section is not relevant, as tamsulosin is intended only for male patients.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that the semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or use machines. However, you should keep in mind that tamsulosin can cause dizziness and drowsiness. Only drive or use machines if you feel well.

3. How to take Tamsulosina Krka

Follow the administration instructions of tamsulosin indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. You can take tamsulosin with or without food, preferably at the same time each day.

The tablet should be swallowed whole. It is important not to break or chew the tablet, as this can affect the proper functioning of tamsulosin.

Normally, tamsulosin is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you take more Tamsulosina Krka than you should

Taking too many tamsulosin tablets may lead to an undesired drop in blood pressure and an increase in heart rate, with a feeling of fainting. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tamsulosina Krka

You can take your daily tablet later on the same day if you have forgotten to take it as recommended. In case you have missed a dose one day, you can simply take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you stop taking Tamsulosina Krka

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosina Krka for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Severe reactions are rare. Contact your doctor immediatelyif you experience a severe allergic reaction that causes swelling of the face and throat(angioedema)

Common (may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing,
• abnormal ejaculation (alteration of ejaculation). This means that the semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• headache,
• palpitations (the heartbeat is faster than normal and also perceptible),
• reduced blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness,
• runny nose or nasal congestion (rhinitis),
• diarrhea, feeling of nausea and vomiting, constipation,
• weakness (asthenia),
• skin rash, itching, and hives (urticaria).

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

• fainting,
• sudden local swelling of the body's soft tissues (such as the throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).

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

• priapism (undesired, prolonged, and painful erection that requires immediate medical treatment),
• skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

Frequency not known (cannot be estimated from the available data):

• dry mouth,
• blurred vision, altered vision,
• nasal bleeding,
• severe skin reactions (erythema multiforme, exfoliative dermatitis),
• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).

If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have taken tamsulosin, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid during the operation.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tamsulosina Krka

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tamsulosina Krka

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other components are:

Tablet core: hypromellose (E464), microcrystalline cellulose (E460), carbomer, colloidal anhydrous silica (E551), red iron oxide (E172), magnesium stearate (E470b).

Tablet coating: hypromellose (E464), microcrystalline cellulose (E460), carbomer, colloidal anhydrous silica (E551), magnesium stearate (E470b).

Appearance of the product and package contents

Tamsulosina Krka 0.4 mg prolonged-release tablets are white, uncoated, round with a diameter of 9 mm, engraved on one side with "T9SL" and "0.4" on the other.

Tamsulosina Krka is available in boxes containing 30 and 90 prolonged-release tablets in blister packs.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Synthon Hispania, S.L.

C/ Castelló 1 Poligono Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

TAD Pharma GmbH

Heinz-Lohmann-Strabe 5

27472 Cuxhaven

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

This package leaflet was approved in: June 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/