SEBRANE NEO 0.4 MG PROLONGED-RELEASE TABLETS EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sebrane Neo 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What SEBRANE NEO is and what it is used for

Tamsulosin relaxes the muscles of the prostate and the urinary tract. By relaxing these muscles, tamsulosin facilitates the passage of urine and improves urination. It also reduces the sensation of urgency.

Tamsulosin is prescribed to male patients to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak urinary stream), post-micturition dribbling, urgency, and the need to urinate frequently both during the night and during the day.

2. What you need to know before taking SEBRANE NEO

Do not take Sebrane Neo

• if you are allergic (hypersensitive) 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 body tissues (e.g., throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• if you have a history of low blood pressure upon standing, causing dizziness, lightheadedness, or fainting.
• if you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting Sebrane Neo

• if you experience dizziness or lightheadedness, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. It is advisable to sit or lie down until symptoms subside.
• if you have severe kidney problems, in which case you should inform your doctor.
• if you are scheduled for eye surgery due to lens opacity (cataracts). An eye condition called intraoperative floppy iris syndrome may occur (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken Sebrane Neo.

The specialist may then take appropriate precautions regarding medication and surgical techniques to be used. Ask your doctor whether you should delay or temporarily stop taking this medicine if you are undergoing eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma).

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

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

Children and adolescents

This medicine must not be given to children or adolescents under 18 years of age, as it is not indicated for this population.

Other medicines and SEBRANE NEO

Tamsulosin may affect other medicines, and these may in turn affect the effectiveness of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a painkiller and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the time during which tamsulosin is effective.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening the time during which tamsulosin is effective.
• Another alpha-1A adrenergic receptor antagonist. The combination may reduce your blood pressure, causing 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 currently using or have recently used any of the medicines listed above or any other medicines, including those obtained without a prescription.

Taking Sebrane Neo with food and drinks

Tamsulosin may be taken regardless of meals.

Driving and using machines

Tamsulosin has not been shown to impair the ability to drive or use machines. However, you should be aware that tamsulosin may cause dizziness and lightheadedness. Only drive or operate machinery if you feel well.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women. In men, abnormal ejaculation (ejaculatory disorders) has been reported. This means that semen does not exit the body through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (anejaculation). This phenomenon is harmless.

3. How to take Sebrane Neo

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one tablet daily. You may take tamsulosin with or without food, preferably at the same time each day.

Swallow the tablet whole. It is important not to crush or chew it, as this may affect the effectiveness of tamsulosin.

Tamsulosin is not indicated for use in children.

If you take more Sebrane Neo than you should

Your blood pressure may drop suddenly if you take more tamsulosin than prescribed. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and then contact your doctor.

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 forget to take Sebrane Neo

If you forget to take your daily dose of tamsulosin at the recommended time, you may take it later the same day. If you have missed a day's dose, you may simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for missed doses.

If you stop taking Sebrane Neo

If treatment with tamsulosin is stopped prematurely, the original symptoms may return. Therefore, you should take tamsulosin for as long as your doctor recommends, even if your symptoms have disappeared. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious reactions are uncommon. Consult your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).

Frequent (may affect up to 1 in 10 people)

Dizziness, especially when sitting down or standing up.

Abnormal ejaculation (ejaculation disorders). This means that semen does not exit the body through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

Headache • Awareness of heartbeat (palpitations) • Drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting (postural hypotension) • Nasal congestion and irritation inside the nose (rhinitis) • Constipation • Diarrhea • Feeling unwell (nausea) • Vomiting • Skin rash • Hives • Itching • Feeling of weakness (asthenia)

Rare (may affect up to 1 in 1,000 people)

Fainting (syncope) and sudden localized swelling of soft tissues of the body (such as the throat or tongue), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema).

Very rare (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)

Frequency not known (cannot be estimated from available data)

Abnormal heart rhythm • Irregular heartbeat • Faster heartbeat • Difficulty breathing • Blurred vision • Loss of vision • Nosebleed • Urticaria • Scaling • Dry mouth

If you are undergoing eye surgery due to clouding of the lens (cataract), and you are currently taking or have previously taken Sebrane Neo, your pupil may not dilate properly and the iris (the colored circular part of the eye) may become floppy during and after the procedure. This only occurs during surgery, and it is important that the eye specialist is aware of this possibility, as the surgery may need to be performed differently.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SEBRANE NEO

Keep this medicine out of sight and reach of children.

Do not use tamsulosin after the expiry date stated on the packaging after "EXP". The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the mentioned month.

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 containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sebrane Neo 0.4 mg

• The active substance is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other components are:

Core of the tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, iron oxide red (E172), magnesium stearate

Coating of the tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate

Appearance of the product and contents of the pack

White, round tablets marked with “T9SL” on one side and “0.4” on the other.

Blister packs of PVC/PVDC/Al in cartons containing 30 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Francisco Durbán, S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido Almería

Spain

Manufacturer(s):

Synthon Hispania S.L.

Castelló 1, Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

SYNTHON BV

Microweg, 22, P.O. Box 7071

Nijmegen-NL-6545

The Netherlands

or

LABORATORIOS FRANCISCO DURBAN, S.A.

Calle IX nº 2. Pol. Ind. La Redonda

04710 El Ejido ALMERIA, Spain

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

Netherlands Sebrane 0.4 mg, tabletten met verlengde afgifte

Greece Sebrane MR 0.4 mg

Spain Sebrane Neo 0.4 mg prolonged-release tablets EFG

Portugal Sebrane XR

Date of the most recent review of this leaflet: 07/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/