Leaflet: information for the user

Tamsulosina Vir 0.4 mg prolonged-release EFG tablets

Tamsulosina hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tamsulosina Vir is and what it is used for
2. What you need to know before you start taking Tamsulosina Vir
3. How to take Tamsulosina Vir
4. Possible side effects
5. Storage of Tamsulosina Vir
6. Contents of the pack and additional information

Tamsulosina relaxes the muscles in the prostate and the urinary tract. By relaxing the muscle, tamsulosina allows urine to pass more easily through the urethra and facilitates urination. Additionally, it reduces the sensation of urgency.

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

Do not take Tamsulosina Vir

• If you areallergic to tamsulosina or any of the other componentsof this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• If you experiencedizzinessdue to a drop in blood pressure when changing position (sitting or standing up).
• If you havesevere liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Vir:

• If you experience dizziness or fainting, especially after standing up. Tamsulosina may lower your blood pressure, causing these symptoms. Sit or lie down until these symptoms have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are undergoing or have scheduled eye surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma). You may experience an eye disorder called Intraoperative Floppy Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you have taken, are taking, or are planning to take tamsulosina. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.

You may observe a residue of the tablet in your stool. There is no risk of reduced efficacy as the active ingredient has already been released.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old as it is not effective in this population.

Other medications and Tamsulosina Vir

Some medications may be affected by tamsulosina. Conversely, these medications may interfere with the functioning of tamsulosina. Tamsulosina may interact with:

• Diclofenac,a pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from your body, thus shortening the time during which tamsulosina is effective.
• Warfarin, a medication to prevent blood clotting. This medication may accelerate the elimination of tamsulosina from your body, thus shortening the time during which tamsulosina is effective.
• Other alpha1-adrenergic receptor blockers,The combinationmay cause a drop in blood pressure, leading to dizziness or fainting.
• Ketoconazole, a medication to treat fungal infections on the skin. This medication may increase the effect of tamsulosina.

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Taking Tamsulosina Vir with food and drinks

You can take tamsulosina with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but rather into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

There is no evidence that tamsulosina affects your ability to drive or operate tools or machinery. However, you should be aware that dizziness or fainting may occur. Drive or operate machinery only if you feel well.

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

Theusual doseis 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time of day.

Swallow the tabletwhole. It is essential thatyou do not break or chew the tabletas this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated for use in children.

If you take more Tamsulosina Vir than you should

If you take more tamsulosina than you should, your blood pressure may drop suddenly. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and contact your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 tamsulosina as recommended, you can take your daily dose of tamsulosina later in the same day. If you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Tamsulosina Vir

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosina for the entire time your doctor prescribes, even if your symptoms have disappeared. Consult your doctor if you decide to discontinue treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects are rare.Contact your doctor immediatelyif you experience asevere allergic reaction that causes swelling of the face or throat(angioedema).

Frequent side effects(may affect up to 1 in 10 people):

Dizziness, abnormal ejaculation (ejaculation alteration). This means that semen is not released through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Infrequent side effects(may affect up to 1 in 100 people):

Headache, palpitations, decreased blood pressure when standing, which may cause dizziness, dizziness, fainting (orthostatic hypotension), nasal congestion or irritation (rhinitis), constipation, diarrhea, nausea, vomiting, skin rash, itching, and hives (urticaria), feeling of weakness (asthenia).

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

Fainting (syncope)

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

Painful erection (priapism), severe disorder with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Side effects of unknown frequency(frequency cannot be estimated from available data):

Blurred vision, loss of vision, nosebleed, dry mouth, severe skin eruptions (erythema multiforme, exfoliative dermatitis), irregular heart rhythm, irregular heartbeat, rapid heartbeat, difficulty breathing.

During eye surgery due to cataract opacity or increased eye pressure (glaucoma), a condition called Flaccid Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored circular part of the eye) may become flaccid. For more information, see section2, warnings and precautions.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Store the blisters in their original packaging to protect them from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tamsulosina Vir Composition

• The active ingredient is tamsulosin. Each tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other components (excipients) are:Tablet core: hypromellose, microcrystalline cellulose, carmelose, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate.Tablet coating: microcrystalline cellulose, hypromellose, carmelose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

White, round tablets with a diameter of 9 mm, engraved on one side with “T9SL” and “0.4” on the other.

The tablets are packaged in blisters containing 10, 30, 60, and 90 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

Synthon BV

Microweg, 22

P.O. Box 7071

NL-6545 (Nijmegen)

Netherlands

or

Synthon Hispania S.L.

Castello 1, Poligono Las Salinas.

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

GENERICON PHARMA GMBH

Hafnerstrasse, 211 A-8054 Graz

Austria

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

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

Netherlands Tamsulosine Synthon 0.4 mg tablets with prolonged release

Austria Tamsulosin Genericon 0.4 mg Retardtabletten

Spain Tamsulosina Vir 0.4 mg prolonged-release tablets EFG

Last review date of this leaflet:April 2016

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/