Package Insert: Information for the Patient

Tamsulosin Krka 0.4 mg Extended-Release Tablets EFG

tamsulosin hydrochloride

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

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Tamsulosina 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 with urination (weak urine stream), dripping, urgency, and the need to urinate frequently both at night and during the day.

Do not takeTamsulosina Krka

• if you areallergic to tamsulosina or any of the other componentsof this medication (listed in section 6).The hypersensitivity or allergy to hydrochloride tamsulosina may present as sudden swelling of the soft tissues of the body (for example, throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• if you have severe liver problems.
• if you havelightheadedness 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 tamsulosina.

• Regular medical check-ups are necessary to monitor the development of the disease you are being treated for.
• Rarely, dizziness may occur during the use of tamsulosina, as with other medications of this type. Sit or lie down until the symptoms have disappeared.
• If you haveserious kidney problems, consult your doctor.
• If you are to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken, are taking, or intend to take tamsulosina. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are to undergo said surgery due to a cloudy lens (cataract) or increased pressure in the eye (glaucoma).

It is possible to observe remnants of the tablet in the stool. Since the active principle 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 old because it does not work in this population.

Other medications and Tamsulosina Krka

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

The taking oftamsulosinawith other medications of the same group (α1-adrenérgic receptor antagonists)may produce an undesirable drop in blood pressure.

It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination oftamsulosinafrom the body (for example, ketoconazole, erythromycin).

Taking Tamsulosina Krka with food and drinks

Tamsulosina can be taken with or without food.

Pregnancy, breastfeeding and fertility

This section is not relevant, because tamsulosina is only intended for male patients.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive or operate machinery. You should be aware that tamsulosina may cause dizziness and drowsiness. Only drive or operate machinery if you feel well.

Follow exactly the administration instructions fortamsulosinaprescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablet must beswallowedwhole. It is importantnot to break or chew the tabletsince this can affect the proper functioning of tamsulosina.

Tamsulosina is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.

If you take more Tamsulosina Krka than you should

Taking too many tamsulosina tablets can lead to an unwanted drop in blood pressure and an increase in heart rate, with a feeling of dizziness. 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 medication and the amount ingested.

If you forget to takeTamsulosina Krka

You can take your daily tablet later in the same day if you have forgotten to take it as recommended. If 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 compensate for the missed doses.

If you interrupt treatment with Tamsulosina Krka

When treatment with tamsulosina is discontinued prematurely, your original discomforts may return. Therefore, take Tamsulosina Krka for the entire time your doctor prescribes it, even if your discomforts have disappeared. Consult your doctor at all times if you decide to discontinue treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing up,
• abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Possibly frequent (may affect up to 1 in 100 people)

• headache,
• palpitations (the heart rate is faster than normal and also perceptible),
• reduction in blood pressure, for example when standing up quickly after being seated or lying down, sometimes associated with dizziness,
• runny nose or nasal obstruction (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)

• syncope,
• sudden swelling of soft body 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 (unwanted, 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 available data):

• dry mouth,
• blurred vision, vision alteration,
• nosebleed,
• severe skin eruptions (erythema multiforme, exfoliative dermatitis),
• irregular and abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).

If you are to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma), and you are already taking or have taken tamsulosin previously, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the surgery.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. 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.

Medicines should not be throwndown the drains orinto the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubtask your pharmacist how to dispose ofthe packaging andthe medicines you no longer need. By doing so, you will help protect the environment.

Composition of Tamsulosina Krka

• The active ingredient ishydrochloride of tamsulosina. Each prolonged-release tablet contains 0.4 mg of hydrochloride of tamsulosina.
• The other components are:

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

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

Appearance of the product and contents of the package

Tamsulosina Krka 0.4 mg prolonged-release tablets are white, unnotched, rounded 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 blisters.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

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 Groden 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 leaflet was approved in: June 2019

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