TAMSULOSIN VIR 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosina Vir 0.4 mg prolonged-release tablets 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 Vir and what is it used for
2. What you need to know before you take Tamsulosina Vir
3. How to take Tamsulosina Vir
4. Possible side effects
5. Storing Tamsulosina Vir
6. Contents of the pack and other information

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

Tamsulosin relaxes the muscles in the prostate and the urinary tract. By relaxing the muscle, tamsulosin allows urine to flow more easily through the urethra and facilitates urination. It also decreases the sensation of urgency.

Tamsulosin 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 flow), dribbling, urgent need to urinate, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Tamsulosina Vir

Do not take tamsulosin Vir

• If you are allergic to tamsulosin or any of the other ingredientsof this medicine (listed in section 6). Hypersensitivity may occur as a sudden local 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 have dizzinessdue to a drop in blood pressure when changing position (sitting or standing up).
• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before taking Tamsulosina Vir:

• If you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should sit or lie down until these symptoms 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). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate sufficiently and the iris (the colored part of the eye) may become flaccid. For more information, see section 4, Possible side effects. Please inform your ophthalmologist if you have taken, are taking, or are planning to take tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

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

You may notice a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active ingredient has already been released.

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 Vir

Some medicines may be affected by tamsulosin. In turn, these medicines may interfere with the functioning of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from your body, shortening the time during which tamsulosin is effective.
• Warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from your body, shortening the time during which tamsulosin is effective.
• Other alpha-1 adrenergic receptor blockers, the combination may cause a drop in blood pressure, causing dizziness or fainting.
• Ketoconazole, a medicine to treat fungal infections of the skin. This medicine may increase the effect of tamsulosin.

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Tamsulosina Vir with food and drinks

You can take tamsulosin with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that the semen is not released 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 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 or fainting may occur. Drive or use machinery only if you feel well.

3. How to take Tamsulosina Vir

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

The usual doseis one tablet per day. You can take tamsulosin with or without food, preferably at the same time of day.

Swallow the tablet whole. It is important that you do not break or chew the tabletas this may affect the proper functioning of tamsulosin.

Tamsulosin is not indicated for use in children.

If you take more Tamsulosina Vir than you should

If you take more tamsulosin 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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. If you have missed a dose for one day, you can 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 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 further questions on 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.

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

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

Dizziness, abnormal ejaculation (alteration of ejaculation). This means that the semen is not released 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.

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

Headache, palpitations, drop in blood pressure when standing up, which can cause dizziness, fainting (orthostatic hypotension), swelling or irritation inside the nose (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 skin condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

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

Blurred vision, loss of vision, nosebleeds, dry mouth, severe skin rashes (erythema multiforme, exfoliative dermatitis), abnormal heart rhythm, irregular heartbeat, faster heartbeat, difficulty breathing.

During eye surgery due to cataracts or increased pressure in the eye (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate sufficiently and the iris (the colored part of the eye) may become flaccid. For more information, see section 2, Warnings and precautions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tamsulosina Vir

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Tamsulosina Vir

• The active substance is tamsulosin. Each tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other ingredients (excipients) are: Internal core of the tablet: hypromellose, microcrystalline cellulose, carbomer, colloidal anhydrous silica, red iron oxide (E172), magnesium stearate. External coating of the tablet: microcrystalline cellulose, hypromellose, carbomer, colloidal anhydrous silica, magnesium stearate.

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

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 authorised in the Member States of the European Economic Area under the following names:

Netherlands Tamsulosine Synthon 0.4 mg prolonged-release tablets

Austria Tamsulosin Genericon 0.4 mg prolonged-release tablets

Spain Tamsulosina Vir 0.4 mg prolonged-release tablets EFG

Date of last revision of this leaflet:April 2016

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