Tamsulosin Vir 0.4 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tamsulosina Vir 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

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

Leaflet Contents

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

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

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing these muscles, tamsulosin allows urine to pass more easily through the urethra and facilitates urination. In addition, it reduces 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 are symptoms such as: difficulty urinating (weak urine stream), dribbling, urgent need to urinate, and frequent need to urinate both during the night and during the day.

2. What you need to know before taking Tamsulosina Vir

Do not take Tamsulosina Vir

• If you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of soft tissues in the body (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• If you suffer from dizziness due 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 the symptoms have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are scheduled for or undergoing eye surgery due to cataracts (clouding of the lens) or increased eye pressure (glaucoma). An eye disorder called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor on whether you should delay or temporarily stop taking this medicine 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 condition being treated.

You may notice a tablet shell residue in your stools. There is no risk of reduced efficacy, as the active ingredient has already been released.

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosina Vir

Some medicines may be affected by tamsulosin. Likewise, these medicines may interfere with the action of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a painkiller and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from your body, thereby shortening the time during which tamsulosin remains effective.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from your body, thereby shortening the time during which tamsulosin remains effective.
• Other alpha1-adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness or fainting.
• Ketoconazole, a medicine used to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

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

Taking Tamsulosina Vir with food and drinks

You may take tamsulosin with or without food.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness or fainting may occur. Drive or operate machinery only if you feel well.

3. How to take Tamsulosina Vir

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The usual dose is 1 tablet per day. You may take tamsulosina with or without food, preferably at the same time each day.

Swallow the tablet whole. It is important that you do not break or chew the tablet, as 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 prescribed, 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 immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tamsulosina Vir

If you forget to take tamsulosina as directed, you may take your daily dose later on the same day. If you have missed a day's dose, you may simply continue taking your daily tablet as prescribed.

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

If you stop taking Tamsulosina Vir

When treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, continue taking tamsulosina for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects are rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).

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

Dizziness, abnormal ejaculation (ejaculatory disorder). This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation), or the volume of ejaculated semen is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

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

Headache, noticeable heartbeat (palpitations), drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension), swelling or irritation inside the nose (rhinitis), constipation, diarrhea, feeling unwell (nausea), vomiting, skin rash, itching and hives (urticaria), feeling of weakness (asthenia).

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

Fainting (syncope)

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

Painful erection (priapism), serious disorder with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

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

During eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the circular colored part of the eye) may become floppy. For more information, see section 2, Warnings and precautions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Vir

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. 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 components (excipients) are: Inner core of the tablet: hypromellose, microcrystalline cellulose, carbomer, anhydrous colloidal silica, iron oxide red (E172), magnesium stearate. Outer tablet coating: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization 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)
The 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

The Netherlands: Tamsulosine Synthon 0.4 mg tabletten met verlengde afgifte
Austria: Tamsulosin Genericon 0.4 mg Retardtabletten
Spain: Tamsulosina Vir 0.4 mg prolonged-release tablets EFG

Date of the most recent revision of this leaflet: April 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/