Package Insert: Information for the Patient

Tamsulosin Krka 0.4 mg Modified Release Hard Capsules 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 in this medication 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 the 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 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 components of this medication(listed in section 6).Hypersensitivity or allergy to tamsulosina hydrochloride may present as sudden swelling of the hands or feet, swollen lips, tongue, or throat, causing difficulty breathing and/or itching and skin rash (angioedema).
• if you havesevere liver problems.
• if you experiencedizziness 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 have severe kidney problems, consult your doctor.
• If you are scheduled to undergo or have scheduled eye surgery due to cataracts or increased eye pressure (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 scheduled to undergo surgery due to cataracts or increased eye pressure (glaucoma).

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.

Takingtamsulosinawith other medications of the same group (α1-adrenérgic receptor antagonists)may cause 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 should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume of semen 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 machines or tools.

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

Tamsulosina Krka contains sodium

This medication contains less than 23 mg of sodium (1mmol) per capsule; it is essentially “sodium-free”

Follow exactly the administration instructions fortamsulosinaprescribed by your doctor or pharmacist. If in 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 at regular intervals while taking this medication.

If you take more Tamsulosina Krka than you should

Taking too much tamsulosina may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation 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 forgot to takeTamsulosina Krka

You can take your capsule later in the same day if you forgot to take it earlier. If you have missed a dose one day, you can simply continue taking your daily capsule as scheduled for the next day. 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 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 medication, 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),
• abnormal irregular 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, 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 Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special conditions for conservation.

Medicines should not be throwndown the drain orinto the trash.Dispose of the packaging and medicines that you do not need at the SIGRE collection pointof the pharmacy.In case of doubtask your pharmacist how to dispose ofthe packaging andthe medicines that you do not need. In this way, you will help protect the environment.

Composition of Tamsulosina Krka

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

See section 2 “Tamsulosina Krka contains sodium”.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

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

Responsible 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 leaflet was approved in: June 2019

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