TAMSULOSIN PENSA PHARMA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Tamsulosin Pensa Pharma

Do not take Tamsulosin Pensa Pharma

• if you are allergic to tamsulosin or any of the other components of this medicine (listed in section 6).

Hypersensitivity may manifest 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 (sitting or standing).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• 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 a cataract, please inform your ophthalmologist if you have taken, are taking, or are planning to take tamsulosin. 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 a cataract.

Children and adolescents

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 Tamsulosin Pensa Pharma

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

Taking tamsulosin with other medicines of the same group (alpha1 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 may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin Pensa Pharma with food and drinks

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

3. How to take Tamsulosin Pensa 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 one capsule per day and should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and should not be 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 Pensa 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 taken.

If you forget to take Tamsulosin Pensa Pharma

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

If you stop taking Tamsulosin Pensa 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 everyone gets them.

Stop taking your medicine and consult your doctor immediately if you have 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):

• 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 or being sick)
• 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):

• undesirable, prolonged, and painful 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 medicines or other substances called Stevens-Johnson syndrome

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

• Nosebleeds
• Blurred vision, vision changes
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are going to undergo eye surgery due to a cataract and are already taking or have taken tamsulosin hydrochloride, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid (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. Since 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Pensa Pharma

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

This medicine does not require special storage conditions.

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

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

6. Package contents and additional information

Composition of Tamsulosin Pensa Pharma

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

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

Coating material:Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 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 European Pharmacopoeia / NF and 2.3% Polysorbate 80 European Pharmacopoeia / NF in solid substance, as emulsifiers.

Appearance of the product and package contents

Tamsulosin Pensa Pharma are prolonged-release hard capsules, approximately 15.6 - 16.2 mm in length, closed, opaque, with an orange body and an olive-green cap. Tamsulosin Pensa Pharma is available in PVC/PVDC-Aluminum blisters or HDPE bottles, which are marketed in cardboard boxes.

PVC/PVDC-Aluminum blisters containing 10, 20, 30, 50, 90, or 100 capsules.

Unit-dose PVC/PVDC-Aluminum blisters containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 90 x 1, or 100 x 1 capsules.

HDPE bottles containing 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

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (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: Tamsuvilla 0.4 mg modified-release capsules, hard

Spain: Tamsulosina pensa pharma 0.4 mg prolonged-release hard capsules EFG

Portugal: Tansulosina Pensa

Date of the last revision of thisleaflet: May 2024

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