TAMSULOSIN Aurovitas 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosina Aurovitas 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tamsulosina Aurovitas and what is it used for
2. What you need to know before taking Tamsulosina Aurovitas
3. How to take Tamsulosina Aurovitas
4. Possible side effects
5. Storage of Tamsulosina Aurovitas
6. Package contents and additional information

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

The active substance of Tamsulosina Aurovitas is tamsulosin hydrochloride. It is a selective alpha-1A/1D adrenergic receptor antagonist. 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.

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 may include difficulty urinating (weak urine stream), dribbling, urgency, and frequent need to urinate both at night and during the day.

2. What you need to know before taking Tamsulosina Aurovitas

Do not take Tamsulosina Aurovitas

• If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medication (listed in section 6).
• Hypersensitivity may occur as a sudden local swelling of the soft tissues of the body (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 Tamsulosina Aurovitas.

• because periodic medical examinations are necessary to monitor the progression of the disease being treated.
• because, rarely, fainting can 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.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years of age, as it does not work in this population.

Other medications and Tamsulosina Aurovitas

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

Taking tamsulosin with other medications of the same group (alpha-1 adrenergic receptor blockers) 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 medications that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Aurovitas with food and beverages

You can take tamsulosin with or without food.

Pregnancy and breastfeeding

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen is not released through the urethra, but rather 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 operate machinery. However, you should be aware that dizziness can occur, in which case you should not perform activities that require attention.

Tamsulosina Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Tamsulosina Aurovitas

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

The recommended dose is 1 tablet per day. You can take tamsulosin with or without food, preferably at the same time every day.

The tablet should be swallowed whole and not crushed or chewed.

Tamsulosina Aurovitas is a tablet designed to release the active substance gradually after ingestion. You may observe a residue of the tablet in your stool. There is no risk of loss of efficacy, as the active substance has already been released.

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 Aurovitas than you should

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 medication and the amount ingested.

Taking too many tamsulosin tablets can lead to an undesirable drop in blood pressure and an increase in heart rate, with a sensation of fainting. Consult your doctor immediately if you have taken too many tamsulosin tablets.

If you forget to take Tamsulosina Aurovitas

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, simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Aurovitas

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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common(may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up.
• Abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra, but rather 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, palpitations (the heartbeat is faster than normal and also perceptible), drop in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal congestion (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)

• Fainting and sudden local swelling of the soft tissues of the body (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 (undesirable, prolonged, and painful erection that requires immediate medical treatment).
• Severe 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(the frequency cannot be estimated from the available data)

• Blurred vision.
• Visual disturbance.
• Nosebleeds (epistaxis).
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have taken tamsulosin, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid.
• Dry mouth.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tamsulosina Aurovitas

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

Do not use this medication after the expiration date stated on the packaging, blister, or bottle after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tamsulosina Aurovitas

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are:

Tablet core:microcrystalline cellulose (grades 101 and 102), hydroxypropylcellulose, lactose monohydrate, polyethylene oxide, hypromellose (type 2208), colloidal anhydrous silica, and magnesium stearate.

Tablet coating:hypromellose 2910, macrogol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and package contents

Prolonged-release tablet.

Yellow, round (9.1 mm in diameter), biconvex, film-coated tablets with the marks "T" above and "0 4" below on one side and smooth on the other.

Tamsulosina Aurovitas prolonged-release tablets are available in:

• Triple-layer cold-formed (Alu-Alu) blister packs and bottles (white opaque HDPE bottles with white opaque polypropylene caps containing silica gel as a desiccant).

Blister pack sizes:

20, 30, 50, 90, 100, and 200 prolonged-release tablets.

Bottle sizes:

250 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the member states of the European Economic Area under the following names:

Germany: Tamsulosin PUREN 0.4 mg Retardtabletten

Belgium: Tamsulosin AB 0.4 mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten

Spain: Tamsulosina Aurovitas 0.4 mg comprimidos de liberación prolongada EFG

France: TAMSULOSINE ARROW LP 0.4 mg, comprimé à libération prolongée

Netherlands: Tamsulosine HCl Aurobindo Retard 0.4 mg, tabletten met verlengde afgifte

Poland: Tamsulosin Aurovitas

Portugal: Tansulosina Generis

Czech Republic: Tamsulosin Aurovitas

Romania: Tamsulosin Aurobindo 0.4 mg comprimate cu eliberare prelungita

Date of the last revision of this package leaflet: November 2020

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