TAMSULOSIN NORMON 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamsulosina Normon 0.4 mg prolonged-release tablets EFG

tamsulosina hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Tamsulosina Normon and what is it used for

Tamsulosina relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosina allows urine to flow more easily and facilitates urination. It also decreases 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), dribbling, urgency, and the need to urinate frequently, both at night and during the day.

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

Do not take Tamsulosina Normon if:

• you are allergic to tamsulosina or any of the other ingredientsof 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 starting to take Tamsulosina Normon.

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;severe kidney problems, consult your doctor;

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 substance 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 because it is not indicated in this population.

Taking Tamsulosina Normon with other medicines

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

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

Tell your doctor or pharmacistif you are using, have recently used, or are going to use any other medicine, even those obtained without a prescription.

Tamsulosina Normon with food, drinks, and alcohol

Tamsulosina can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that the semen is not released through the urethra, but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculation failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosina affects the ability to drive and use machines. You should take into account that tamsulosina may cause dizziness or a feeling of dizziness. Only drive or operate machines if you feel well.

3. How to take Tamsulosina Normon

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal doseis 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 important that you do not break or chew the tabletas this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated in 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 on the same day. If you have missed a dose for one 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 Normon

When treatment with tamsulosina is abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosina Normon for as long as 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 immediatelyif you experience a severe 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 (altered ejaculation). This means that the semen is not released through the urethra, but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculation failure). This phenomenon is harmless.

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

Headache. Perceptible heartbeat (palpitations). Reduction of blood pressure when standing up, causing 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):

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

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

Blurred vision, loss of vision, nosebleeds, dry mouth, severe skin rashes (erythema multiforme, exfoliative dermatitis).

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

During eye surgery due to a cataract or glaucoma, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate sufficiently and the iris 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tamsulosina Normon

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

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

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. If you have any further questions on the use of this medicine, ask your pharmacist.

6. Contents of the pack and other information

Composition of Tamsulosina Normon

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

The other ingredients are: Tablet core: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate. Tablet coating: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance and packaging

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

Marketing authorisation holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

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, modified release EFG.

Date of last revision of this leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/74994/P_74994.html