TAMSULOSIN VIR 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosina Vir 0.4 mg prolonged-release hard capsules EFG Hydrochloride of Tamsulosina

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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1 What is Tamsulosina Vir and what is it used for

1. What you need to know before taking Tamsulosina Vir
2. How to take Tamsulosina Vir
3. Possible side effects
4. Storage of Tamsulosina Vir
5. Package Contents and Additional Information

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

The active ingredient of this medication is tamsulosin. It is a selective antagonist of alpha1A/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.

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

2. Before taking Tamsulosina Vir

Do not take Tamsulosina Vir

• If you are allergic (hypersensitive) to tamsulosin or any of the other components of this medication. 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).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Vir

• 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 eye pressure (glaucoma), please inform your ophthalmologist if you have taken tamsulosin previously, are taking it, or are thinking of taking it. The specialist can then take the necessary 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 eye pressure (glaucoma).

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 Vir

Taking tamsulosin along with other medications of the same group (alpha-adrenergic receptor antagonists) may produce an undesired 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 may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Use of Tamsulosina Vir with Food and Beverages

Tamsulosin should be taken after breakfast or the first meal of the day.

Pregnancy, Breastfeeding, and Fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and Using Machines

There is no evidence that tamsulosin affects the ability to drive or operate 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 Tamsulosina Vir

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

The recommended dose is one capsule per day, and it should be taken after breakfast or 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 Tamsulosina Vir Than You Should

Taking too much tamsulosin may lead to an undesired 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 medication and the amount ingested.

If You Forget to Take Tamsulosina Vir

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 a dose one day, you can simply continue taking your daily capsule as prescribed.

Do not take a double dose to make up for missed doses.

If You Interrupt Treatment with Tamsulosina Vir

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 produce side effects, although not all people experience them.

• Frequent (may affect up to 1 in 10 patients)
  • Dizziness, especially when sitting or standing.
  • Abnormal ejaculation (altered ejaculation). This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

• Uncommon (may affect up to 1 in 100 patients)

Headache, palpitations (the heartbeat is faster than normal and also perceptible)

Decreased blood pressure, for example, when standing up quickly after being in a sitting or lying position, sometimes associated with dizziness, nasal congestion, or runny nose (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 patients)

Fainting and sudden local swelling of the body's soft tissues (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 patients)

Priapism (undesired, 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 (cannot be estimated from 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 eye pressure (glaucoma), and you are already taking or have taken tamsulosin previously, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 Vir

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

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition of Tamsulosina Vir

The active ingredient is tamsulosin hydrochloride.

Each prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

The other components (excipients) are: Capsule content:

Sodium alginate, methacrylic acid copolymer of ethyl acrylate, glycerol dibehenate, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone emulsion 30%, and anhydrous colloidal silica.

Capsule body:

Gelatin, red iron oxide (E-172), titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Tamsulosina Vir is presented in the form of orange, conical, prolonged-release hard capsules containing white-yellowish granules.

Each package contains 30 capsules.

Marketing Authorization HolderINDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A. C/ Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A. Carretera Cazoña-Adarzo s/n- 39011 Santander

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: July 2019

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