Tamsulosin Normon 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamsulosina Normon 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, 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Tamsulosin Normon and what is it 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. In addition, it 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 at night and during the day.

2. What you need to know before taking Tamsulosin Normon

Do not take Tamsulosin Normon 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 in the body (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema);
• you have a drop in blood pressure upon standing, causing dizziness or fainting;
• you have severe liver problems.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Tamsulosin Normon.

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

Regular medical check-ups are necessary to monitor the progression of the condition being treated.

You may notice tablet remnants in your stools. Since the active ingredient has already been released from the tablet, there is no risk of reduced effectiveness.

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as it is not indicated in this population.

Taking Tamsulosin Normon with other medicines

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 or lightheadedness.
• Ketoconazole, a medicine used to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

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

Tamsulosin Normon 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 is not expelled through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate 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 be aware that tamsulosin may cause dizziness or lightheadedness. Only drive or operate machinery if you feel well.

3. How to take Tamsulosin Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

The usual dose is 1 tablet per day. You may take tamsulosin with or without food, preferably at the same time each day.

The tablet must be swallowed whole. It is important not to break or chew the tablet, as this may affect the proper functioning of tamsulosin.

Tamsulosin is not indicated for use in children.

If you take more Tamsulosin Normon 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 tamsulosin 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 Tamsulosin Normon

If you have forgotten to take Tamsulosin Normon as recommended, you may take your dose later 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 Tamsulosin Normon

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosin Normon for as long as your doctor prescribes, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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).

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

Dizziness.

Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but goes into the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

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

Headache. Noticeable heartbeat (palpitations). Drop in blood pressure when standing up, causing dizziness, feeling faint, or fainting (orthostatic hypotension). Nasal swelling and irritation (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). Serious illness with blistering of 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).

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

During eye surgery due to clouding of the lens (cataracts) or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during surgery. For further 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 a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Normon

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

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.

Store in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Tamsulosin Normon

The active substance is 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

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

Appearance of the medicine and contents of the pack

Tamsulosin Normon is presented as round, white tablets, inscribed with “T9SL” on one side and “0.4” on the other. Each pack contains 30 tablets.

Marketing Authorization 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 – The 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

Tamsulosin Normon 0.4 mg modified-release hard capsules EFG.

Date of the most recent revision of this leaflet: February 2025

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.gob.es/

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

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