TAMSULOSIN STADAFARMA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosina Stadafarma 0.4 mg Modified Release Hard Capsules EFG

tamsulosine 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 Tamsulosina Stadafarma and what is it used for
2. What you need to know before you take Tamsulosina Stadafarma
3. How to take Tamsulosina Stadafarma
4. Possible side effects
5. Storage of Tamsulosina Stadafarma
6. Contents of the pack and other information

1. What is Tamsulosina Stadafarma and what is it used for

The active substance of Tamsulosina Stadafarma is tamsulosin. It is a selective antagonist of α 1A/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. It also decreases the sensation of urgency.

Tamsulosin 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 Tamsulosina Stadafarma

Do not take Tamsulosina Stadafarma

• 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 (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.
• 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 cataracts or increased pressure in the eye (glaucoma), please 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 medication if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

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 Tamsulosina Stadafarma

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 (α 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 Tamsulosina Stadafarma 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 keep in mind that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosina Stadafarma

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 after 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 Tamsulosina Stadafarma 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. Consult your doctor immediately if you have taken too many tamsulosin capsules.

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 Tamsulosina Stadafarma

If you have forgotten to take tamsulosin as recommended, you can take your daily dose of tamsulosin later that day. If you have forgotten 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 forgotten doses.

If you stop taking Tamsulosina Stadafarma

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 tamsulosin 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 people)

• 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 people)

• headache
• heartbeat is faster or irregular
• dizziness, especially when standing up (orthostatic hypotension)
• nasal dripping or obstruction
• constipation
• diarrhea
• nausea (feeling of discomfort)
• vomiting
• rash
• itching and hives (urticaria)
• feeling of weakness

Rare (may affect up to 1 in 1,000 people)

• fainting

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

• 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 medicines or other substances called Stevens-Johnson syndrome.

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

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

If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma) and are already taking or have taken tamsulosin hydrochloride, during the operation, the pupil may dilate poorly and the iris (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. Because these spontaneously reported events come from post-marketing experience worldwide, the frequency of 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, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosina Stadafarma

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 other information

Composition of Tamsulosina Stadafarma

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 European Pharmacopoeia / NF and 2.3% polysorbate 80 European Pharmacopoeia / NF in solid substance, as emulsifiers.

Appearance of the product and pack contents

Tamsulosina Stadafarma are approximately 15.6 - 16.2 mm long, closed, opaque, orange-colored body and greenish-olive-colored cap hard capsules.

They are presented in cardboard boxes containing PVC/PVdC-Al blisters or HDPE bottles.

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

Single-dose PVC/PVDC-aluminum blisters containing 10x1, 20x1, 30x1, 50x1, 90x1, or 100x1 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

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Limited

Waterford Road,

Clonmel, County Tipperary E91 D768

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Bladasin

France TAMSULOSINE EG LABO LP 0.4 mg, prolonged-release capsule

Germany Tamsulosin AL 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Ireland Tamsulosin Clonmel 400 micrograms modified-release capsules, hard

Portugal Tansulosina Ciclum Farma

Spain Tamsulosina STADAFARMA 0.4 mg modified-release hard capsules EFG

Date of last revision of this leaflet:March 2025

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/