TAMSULOSIN KRKA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosina Krka 0.4 mg Hard Modified-Release Capsules EFG

hydrochloride of tamsulosin

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

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

• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 in this medicine is hydrochloride of 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 components of this medicine(listed in section 6). Hypersensitivity or allergy to hydrochloride of tamsulosin may present as sudden swelling of hands or feet, swollen lips, tongue, or throat, causing 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 up).

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 medicines of this type. At the first symptoms of dizziness or weakness, you should 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 to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

Children

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

Other Medicines and Tamsulosina Krka

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

Taking tamsulosin with other medicines 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 medicines that may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Krka with Food and Drinks

Tamsulosin should be taken after breakfast or the first meal of the day.

Pregnancy, Breastfeeding, and Fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen is not released through the urethra but instead 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 operate machines or tools.

However, you should keep in mind that dizziness may occur, in which case you should not perform activities that require attention.

Tamsulosina Krka Contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free."

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.

Dose

The dose is one capsule per day for adults or elderly patients. It should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole. It should not be broken or chewed.

Your doctor may want to examine you from time to time while you are taking this medicine.

If You Take More Tamsulosina Krka Than You Should

Taking too much tamsulosin 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget to Take Tamsulosina Krka

You can take your capsule later on the same day if you have forgotten to take it earlier. In case you have missed the dose for a day, you can simply continue taking your daily capsule the next day. 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 tamsulosin 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 doubts 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 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 up,
• abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra but instead 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),
• reduction of 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 swelling of the soft tissues of the body (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 rashes (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 Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosina Krka

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tamsulosina Krka

• The active substance is hydrochloride of tamsulosin. Each hard modified-release capsule contains 0.4 mg of hydrochloride of tamsulosin.
• The other components are: microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80 (E433), sodium lauryl sulfate, triethyl citrate (E1505), and talc (E553b) in the capsule core, and gelatin, carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172) in the capsule shell.

See section 2 "Tamsulosina Krka contains sodium".

Appearance of the Product and Package Contents

Tamsulosina Krka 0.4 mg hard modified-release capsules are orange/olive green in color. The capsules contain white or off-white pellets. The capsule size is 19.3 mm x 6.4 mm.

Tamsulosina Krka is available in cartons containing 20, 30, 90, and 100 hard modified-release capsules in blisters.

Not all pack 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/ Castello 1 Poligono Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

Tad Pharma GmbH

Heinz-Lohmann-Strabe 5

Groden Cuxhaven 27472, Germany

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

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

This medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/