Package Insert: Information for the Patient

Tamsulosin Kern Pharma 0.4 mg Modified Release Hard Capsules EFG

tamsulosin hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 side 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 adrenergic receptors α1A/1D. 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.

This medication is used in men for the treatment of lower urinary tract discomfort associated with an enlarged prostate gland (benign prostatic hyperplasia). It is used to treat discomforts such as: difficulty urinating (weak urine stream), dripping, urgency, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Kern Pharma:

• If you are allergic to tamsulosina or any of the other components of this medication (listed in section 6).
• Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g., the 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 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.
• 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 about to undergo or have scheduled eye surgery due to a cataract, inform your ophthalmologist if you have taken tamsulosina previously, are taking it now, or are thinking of taking it. 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 about to undergo eye surgery due to a cataract.

Children and adolescents

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 Kern Pharma

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

The use of tamsulosina with other medications of the same group (alpha1 adrenergic 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 of tamsulosina from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Kern Pharma with food and drinks
Tamsulosina should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

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

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release from the body 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.

Driving and using machines

There is no evidence that tamsulosina affects the ability to drive or use tools or machines. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 capsule per day and it should be taken after breakfast or after the first meal of the day. The capsule should be swallowed whole and not broken or chewed. 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 Kern Pharma than you should

Taking too much tamsulosina may lead to an undesirable drop 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 take Tamsulosina Kern Pharma

If you have forgotten to take tamsulosina as recommended, you can take your daily dose of tamsulosina later in the same day. If you have missed a dose one day, you can simply continue taking your daily capsule as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Tamsulosina Kern Pharma

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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking your medicine and seek medical help immediately if you experience any of the following allergic reactions:

• Difficulty breathing
• Swelling of the face, tongue, or throat (angioedema)
• Itching and skin rash

Frequent (may affect up to 1 in 10 patients):

• Mild dizziness
• Abnormal ejaculation (ejaculation alteration). This means that semen does not release from the body through the urethra, but rather goes to the bladder
• Retarded ejaculation
• Or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Less frequent (may affect up to 1 in 100 patients):

• Headache
• Irregular or rapid heartbeat
• Dizziness, especially when standing up (orthostatic hypotension)
• Nasal discharge or obstruction
• Constipation
• Diarrhea
• Nausea (feeling of discomfort)
• Vomiting
• Skin rash
• Itching and hives (urticaria)
• Feeling of weakness

Rare (may affect up to 1 in 1,000 patients):

• Fainting

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

• Prolonged and painful erection (priapism)
• Severe inflammatory skin and/or mucous membrane eruption of the lips, eyes, mouth, nasal passages, or genitals, which is an allergic reaction to medications or other substances called Stevens-Johnson syndrome.

Frequency unknown (cannot be estimated from available data)

• Nasal bleeding
• Blurred vision, altered vision
• Dry mouth
• Severe skin eruptions (erythema multiforme, exfoliative dermatitis)

If you are undergoing eye surgery due to a cataract opacity and are taking or have taken tamsulosin hydrochloride, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the procedure (see section 2 "Warnings and precautions").

In addition to the side effects listed above,

• Very rapid and uncoordinated heart contractions
• Irregular heartbeat rhythm
• Abnormally rapid heart rate and
• Difficulty breathing associated with the use of tamsulosin hydrochloride. Since these reported events are from post-marketing experience worldwide, the frequency of the events and the role of tamsulosin hydrochloride in their causality cannot be reliably determined.

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:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the blister, bottle, and box after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tamsulosina Kern Pharma Composition

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

Pellets: Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30%*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E433).

Coating material:Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30%*, dibutyl sebacate, polysorbate 80 (E433), hydrated colloidal silica.

Calcium stearate

Durable gelatin capsule:Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), indigo carmine (E132), gelatin.

*The dispersion contains 0.7% of sodium lauryl sulfate Ph.Eur / NF and 2.3% Polysorbate 80 Ph.Eur / NF in solid substance, as emulsifiers.

Product appearance and packaging content

Tamsulosina Kern Pharma are hard, closed capsules, approximately 15.6 - 16.2 mm in size, with an opaque orange body and a green olive-colored cap. Tamsulosina Kern Pharma is presented in PVC/PVdC-Al blisters or HDPE bottles that are marketed in cardboard boxes.

The PVC/PVdC-aluminum blisters contain 10, 20, 30, 50, 90, or 100 capsules.

The pre-cut single-dose PVC/PVdC-aluminum blisters contain 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1, or 100 x 1 capsules.

The HDPE bottles contain 30, 35, 50, 60, 90, 100, 112, or 200 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark - Tamsulosin "Liconsa", hard capsules with modified release

France - TAMSULOSINE LICONSA LP 0.4 mg, prolonged-release gelatin capsule

Romania - TAMSULOSIN LICONSA 0.4 mg caps

Spain – Tamsulosina Kern Pharma 0.4 mg hard capsules with modified release EFG

Portugal – Tansulosina Pharmakern 0.4 mg hard-release capsules

Ireland -Tamsulosin hydrochloride 0.4 mg modified release capsules, hard

Last review date of this leaflet: May 2024

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