TAMSULOSIN QUALIGEN 0.4 mg PROLONGED-RELEASE TABLETS

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

Do not take Tamsulosina Qualigen if:

• you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema);

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

• you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before taking Tamsulosina Qualigen

• if you experience dizziness or fainting, especially when standing up. Tamsulosin may lower your blood pressure, causing this. Lie down or sit until the symptoms have disappeared;

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

• if you are going to undergo 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 (colored part of the eye) may become floppy during surgery. Please inform your ophthalmologist if you are taking or have previously taken 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.

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

You may notice remains of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be 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 in this population group.

Taking Tamsulosina Qualigen with other medicines

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

Other medicines may be affected by tamsulosin. These medicines, in turn, may affect the proper functioning of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Otheralpha-1A adrenergic receptor blockers. The combination may cause a drop in blood pressure, causing dizziness.
• Ketoconazole, a medicine to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

Taking Tamsulosina Qualigen with food, drinks, and alcohol

Tamsulosin can be taken independently of meals.

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 semen is not released through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (failure to ejaculate). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive and use machines. However, you should keep in mind that tamsulosin can cause dizziness. Only drive or operate machines if you feel well.

3. How to take Tamsulosina Qualigen

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

The normal dose is 1 tablet per day. You can take tamsulosin with or without food, preferably at the same time every 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 tamsulosin.

Tamsulosin is not indicated 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

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 consult your doctor.

If you forget to take Tamsulosina Qualigen

If you have forgotten to take Tamsulosina Qualigen as recommended, you can take your dose later in the same day. If you have missed a dose for a day, 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 tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosina Qualigen 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.

It is rare for serious side effects to occur. Contact your doctor immediately if you experience a severe allergic reaction that causes swelling of the face or throat (angioedema).

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

Dizziness • Abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (failure to ejaculate). This phenomenon is harmless.

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

Headache • Heartbeat perceptible (palpitations) • Reduction of blood pressure when standing up, which causes dizziness or fainting (orthostatic hypotension) • Swelling and irritation in the nose (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):

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

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

Blurred vision • Vision changes • Nosebleeds • Dry mouth • Severe skin rash (erythema multiforme, exfoliative dermatitis).

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

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 (colored part of the eye) may become floppy during surgery. 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, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificarRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosina Qualigen

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are: Inner tablet: microcrystalline cellulose, hypromellose carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate. Outer tablet: microcrystalline cellulose, hypromellose carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance and packaging of the product

Tamsulosina Qualigen tablets are presented in the form of round, white tablets with the inscription “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.

Not all 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-Paises Bajos

SYNTHON HISPANIA, S.L. Castello 1, Polígono Las Salinas. (Sant Boi de Llobregat (Barcelona))- 08830 – España.

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

Netherlands Protam 0.4 mg, prolonged-release tablets

Spain Tamsulosina Qualigen 0.4 mg prolonged-release tablets EFG

Portugal Tiatab

This leaflet was last revised in February 2015

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.es/