TAMSULOSIN KERN PHARMA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosin Kern Pharma 0.4 mg prolonged-release hard capsules EFG

tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tamsulosin Kern Pharma and what is it used for
2. What you need to know before you take Tamsulosin Kern Pharma
3. How to take Tamsulosin Kern Pharma
4. Possible side effects
5. Storage of Tamsulosin Kern Pharma
6. Contents of the pack and further information

1. What is Tamsulosin Kern Pharma and what is it used for

The active substance of this medicine 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.

This medicine is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine stream), dripping, urgency, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Tamsulosin Kern Pharma

Do not take Tamsulosin Kern Pharma:

• If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• Hypersensitivity 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 (when 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 medications of this type.
• If you experience 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, inform your ophthalmologist if you have taken tamsulosin before, are taking it, or are thinking of taking it. The specialist can then take the appropriate 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.

Children and adolescents

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

Other medicines and Tamsulosin Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking tamsulosin with other medicines of the same group (alpha-1 adrenergic receptor antagonists) may cause an undesirable 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 can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

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

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 semen is not released from the body 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 tools or machines. However, you should keep in mind that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosin Kern Pharma

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

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

Taking too much tamsulosin may lead to an undesirable 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 medicine and the amount ingested.

If you forget to take Tamsulosin Kern Pharma

If you have forgotten to take tamsulosin as recommended, you can take your daily dose of tamsulosin later within the same day. In case you have missed the dose one day, you can simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Kern Pharma

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 questions 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.

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

• difficulty breathing
• swelling of the face, tongue, or throat (angioedema)
• itching and skin rash

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

• dizziness
• abnormal ejaculation (alteration of ejaculation). This means that semen is not released from the body 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 patients):

• headache
• the heartbeat is faster or irregular
• dizziness, especially when standing up (orthostatic hypotension)
• nasal dripping 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):

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

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

• nosebleeds
• blurred vision, altered vision
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are going to undergo eye surgery due to cataracts and are already taking or have taken tamsulosin hydrochloride, the pupil may not dilate properly 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 in association with the use of tamsulosin hydrochloride. Because these spontaneously reported events come 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Kern Pharma

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister, bottle, and carton after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tamsulosin Kern Pharma

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other ingredients are:

Pellets: Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%*, microcrystalline cellulose, dibutyl sebacate, polysorbate 80 (E433).

Coating material:Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%*, dibutyl sebacate, polysorbate 80 (E433), hydrated silica.

Calcium stearate

Hard 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% sodium lauryl sulfate Ph.Eur / NF and 2.3% polysorbate 80 Ph.Eur / NF in solid substance, as emulsifiers.

Appearance of the product and pack contents

Tamsulosin Kern Pharma are hard capsules, approximately 15.6 - 16.2 mm in length, with an opaque orange body and an olive green cap. Tamsulosin Kern Pharma is available in PVC/PVdC-Al blisters or HDPE bottles, which are marketed in cardboard boxes.

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

The precut unit-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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

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 under the following names:

Denmark - Tamsulosin "Liconsa", hårde kapsler med modificeret udløsning

France - TAMSULOSINE LICONSA LP 0,4 mg, gélule à libération prolongée

Romania - TAMSULOSIN LICONSA 0,4 mg caps

Spain – Tamsulosina Kern Pharma 0,4 mg cápsulas duras de liberación modificada EFG

Portugal – Tansulosina Pharmakern 0.4 mg cápsulas duras de libertação modificada

Ireland - Tamsulosin hydrochloride 0.4 mg modified release capsules, hard

Date of the last revision of this leaflet: May 2024

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