Tamsulosin Qualigen 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamsulosina Qualigen 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

Leaflet contents:

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

1. What Tamsulosin Qualigen 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 and facilitates urination. It also reduces the sensation of urgency.

Tamsulosin is used in men to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

2. What you need to know before taking Tamsulosina Qualigen

Do not take Tamsulosina Qualigen 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 of the body (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema);

• you have a drop in blood pressure upon standing, which causes dizziness or fainting;

• you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting Tamsulosina Qualigen

• if you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should lie down or sit until symptoms have subsided;

• if you have severe kidney problems, consult your doctor;

• if you are scheduled for eye surgery due to cataracts (lens opacity) or increased eye pressure (glaucoma). An eye condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Please inform your ophthalmologist if you are currently taking or have previously taken tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue this medicine prior to such surgery.

Periodic medical examinations are necessary to monitor the progression of the condition for which you are being treated.

You may notice tablet remnants in your stools. Since the active ingredient of the tablet has already been released, there is no risk that the tablet is less effective.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as this medicine is not indicated for this population group.

Taking Tamsulosina Qualigen with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Other medicines may be affected by tamsulosin. In turn, these medicines may affect how well tamsulosin works. Tamsulosin may interact with:

• Diclofenac, an analgesic and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Other alpha1A-adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness.
• Ketoconazole, a medicine used to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

Taking Tamsulosina Qualigen with food, drinks and alcohol

Tamsulosin may be taken regardless of meals.

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 volume ejaculated is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Driving and use of machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness. Only drive or operate machinery if you feel well.

3. How to take Tamsulosina Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor. 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.

The tablet should be swallowed 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 Qualigen than you should

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

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

If you forget to take Tamsulosina Qualigen

If you have forgotten to take Tamsulosina Qualigen as recommended, you may take your dose later on the same day. If you have missed a day's dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Qualigen

When treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosina Qualigen for as long as your doctor has prescribed, 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 can cause adverse effects, although not everyone experiences them.

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

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

Dizziness • Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.

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

Headache • Noticeable heartbeat (palpitations) • Drop in blood pressure upon standing, causing dizziness or fainting (orthostatic hypotension) • Nasal swelling and irritation (rhinitis) • Constipation • Diarrhea • Nausea • Vomiting • Rash • Hives (urticaria) • Feeling of weakness (asthenia).

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

Fainting (syncope).

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

Pain during erection (priapism) • Serious illness with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from available data):

Blurred vision • Vision disturbance • Nosebleed • Dry mouth • Severe skin rashes (erythema multiforme, exfoliative dermatitis).

Abnormal heart rhythm • Irregular heartbeat • Faster heartbeat • Breathing difficulty.

During eye surgery due to clouding of the lens (cataract) 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 during surgery. For further 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificarRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Qualigen

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

Store in the original container to protect from light.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their containers, ask your pharmacist for guidance. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Qualigen 0.4 mg tablets

• The active substance is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
  • The other components are:
    Inner tablet: microcrystalline cellulose, hypromellose carbomer, anhydrous colloidal silica, iron oxide red (E172), magnesium stearate.
    Outer tablet: microcrystalline cellulose, hypromellose carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the medicine and contents of the pack

Tamsulosina Qualigen tablets are presented as round, white tablets, with the imprint “T9SL” on one side and “0.4” on the other.

They are available in packs of 10, 18, 20, 28, 30, 50, 60, 90, 98 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona
Spain

Manufacturer

SYNTHON BV Microweg, 22, P.O. Box 7071 (Nijmegen) - NL6545 - The Netherlands
SYNTHON HISPANIA, S.L. Castello 1, Polígono Las Salinas (Sant Boi de Llobregat (Barcelona)) - 08830 - Spain.

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

Netherlands: Protam 0.4 mg, tabletten met verlengde afgifte
Spain: Tamsulosina Qualigen 0.4 mg prolonged-release tablets EFG
Portugal: Tiatab

This leaflet was last reviewed in February 2015

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