PROSPECTO: INFORMATION FOR THE USER

Tamsulosina Qualigen0.4 mgprolonged-release EFG tablets

Tamsulosina hydrochloride

Read this prospectus carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

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

Do not take Tamsulosina Qualigen if:

• You are allergic to tamsulosina or any of the other components of 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);

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

• You have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Qualigen

• If you experience dizziness or fainting, especially after standing up. Tamsulosina may lower your blood pressure, causing this. You should lie down or sit until the symptoms have disappeared;

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

• If you are undergoing eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma). You may develop a condition called Intraoperative Floppy Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you are taking or have taken tamsulosina previously. 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 such surgery.

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

You may observe remnants 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 administer this medication to children or adolescents under 18 years old as this medication is not indicated in this population group.

Taking Tamsulosina Qualigen with other medications

Inform your doctor or pharmacistif you are using or have recently used other medications, including those purchased without a prescription.

Other medications may be affected by tamsulosina. These medications, in turn, may affect the proper functioning of tamsulosina. Tamsulosina may interact with:

• Diclofenac, an analgesic and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the effectiveness time of tamsulosina.
• Warfarin, a medication to prevent blood coagulation. This medication may accelerate the elimination of tamsulosina from the body, shortening the effectiveness time of tamsulosina.
• Otheralpha-1A adrenergic receptor blockers. The combination may produce a drop in blood pressure, causing dizziness.
• Ketoconazole,a medication to treat fungal skin infections. This medication may increase the effect of tamsulosina.

Taking Tamsulosina Qualigen with food, drinks, and alcohol

Tamsulosina can be taken regardless of meals.

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 goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory failure). This phenomenon is harmless.

Driving and operating machines

There is no evidence that tamsulosina affects the ability to drive and operate machines. However, tamsulosina may cause dizziness. Only drive or operate machines 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.

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

The tablet should be swallowed whole. It is essential that you do not break or chew the tablet, as this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated for children.

If you take moreTamsulosina Qualigenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 consult your doctor.

If you forgot to takeTamsulosina 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 one day, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withTamsulosina Qualigen

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Qualigen for the entire time your doctor prescribes, even if your symptoms have disappeared. Always 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 may cause side effects, although not everyone will experience them.

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

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

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

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

Headache • Perceptible heart palpitations • Reduction of blood pressure when standing, which causes dizziness or fainting (orthostatic hypotension) • Swelling and irritation in the nose (rhinitis) • Constipation • Diarrhea. Nausea • Vomiting • Rash • Itching (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) • Severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

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

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

Abnormal heart rhythm • Irregular heartbeat • Faster heartbeat • Difficulty breathing.

During eye surgery due to cataract opacity or increased eye pressure (glaucoma) a disease 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 during surgery. For more information see section 2, warnings and precautions.

Reporting of adverse effects

If you experience any type ofadverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificarRAM.es. By reporting adverse 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.

Store in the original packaging to protect from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofTamsulosina Qualigen 0.4 mg tablets

•The active ingredient is 0.400 mg of tamsulosina hydrochloride, equivalent to 0.367 mg of tamsulosina.

• The other components 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 of the product and content of the container

Tamsulosina Qualigen tablets are presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other.

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

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Responsible for manufacturing

SYNTHON BVMicroweg, 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 with the following names:

NetherlandsProtam 0.4 mg, tablets with prolonged release

SpainTamsulosina Qualigen 0.4 mg prolonged-release tablets EFG

PortugalTiatab

This leaflet has been reviewed in February 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/