PATIENT INFORMATION LEAFLET

Tamsulosin NORMON 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 NORMON if:

• You areallergic to tamsulosina or any of the other componentsof 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 causesdizziness or fainting;
• You havesevere liver problems.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Tamsulosina NORMON.

• If you experiencedizziness or fainting, especially after getting up. Tamsulosina may lower your blood pressure, causing this. Lie down or sit until the symptoms have disappeared;
• If you havesevere kidney problems, consult your doctor;
• If you are about to undergo or have scheduled eye surgery due to a cloudy lens (cataract) or increased pressure in the eye (glaucoma). You may develop a condition called Intraoperative Floppy Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you have taken, are taking, or are thinking of taking hydrochloride tamsulosina. 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 suspend taking this medication if you are about to undergo such surgery due to a cloudy lens (cataract) or increased pressure in the eye (glaucoma).

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 because it is not indicated in this population.

Taking Tamsulosina NORMON with other medications

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

• Diclofenac, pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Warfarin, medication to prevent blood clotting. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Other alpha1A adrenergic receptor blockers. The combination may cause a drop in blood pressure, causing dizziness or a sensation of dizziness.
• Ketoconazole,medication to treat fungal skin infections. This medication may increase the effect of tamsulosina.

Inform your doctor or pharmacistif you are using, have used recently, or are about to use any other medication, including those acquired without a prescription.

Tamsulosina NORMON 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 or a sensation of dizziness. Only drive or operate machines if you feel well.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Theusual doseis 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time every day.

The tablet must be swallowedwhole. It is essentialnot to break or chew the tabletas this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated for children.

If you take more Tamsulosina NORMON than 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 forget to take Tamsulosina NORMON

If you have forgotten to take Tamsulosina NORMON 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 with Tamsulosina NORMON

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina NORMON 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 can cause side effects, although not everyone will experience them.

It is rare for serious adverse reactions to occur.Contact your doctor immediatelyif you experience asevere 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 (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 (ejaculatory failure). This phenomenon is harmless.

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

Headache. Perceptible heartbeats (palpitations). Reduction of blood pressure when standing, which causes dizziness, feeling of dizziness, or fainting (orthostatic hypotension). Swelling and irritation in the nose (rhinitis). Constipation. Diarrhea. Nausea. Vomiting. Rash. 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):

Penile pain (priapism). Severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

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

Blurred vision, loss of vision, nasal bleeding, dry mouth, severe skin eruptions (erythema multiforme, exfoliative dermatitis).

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

During eye surgery due to cataracts or increased eye pressure (glaucoma) may occur a disease called Iris Flaccid Syndrome (IFIS): the pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid during surgery. For more information, see section 2, Warnings and precautions).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaRAM.es. By reporting side 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.

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.

Store in its original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tamsulosina NORMON

The active ingredient contains 0.4 mg of hydrochloride of tamsulosina, equivalent to 0.367 mg of tamsulosina.

The other components are:Core of the tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate.Coating of the tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the packaging

Tamsulosina NORMON is presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other. Each package contains 30 tablets.

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible for manufacturing

SYNTHON BV

Microweg, 22, P.O. Box 7071 (Nijmegen) – NL-6545 – Netherlands

or

SYNTHON HISPANIA, S.L.

Castello 1, Polígono Las Salinas (Sant Boi de Llobregat (Barcelona)) – 08830 – Spain

or

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

TAMSULOSINA NORMON 0.4 mg hard capsules with modified release EFG.

This leaflet has been reviewed in February 2015

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