SEBRANE NEO 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sebrane Neo 0.4 mg, prolonged-release tablets EFG

Tamsulosin 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience 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 package leaflet:

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

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

Tamsulosin relaxes the muscles of the prostate and the urinary tract. By relaxing the muscle, tamsulosin facilitates the passage of urine and helps with urination. It also reduces the feeling of urgency.

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

2. What you need to know before you take SEBRANE NEO

Do not takeSebrane Neo

• if you are allergic (hypersensitive) to tamsulosin or any of the other ingredientsof this medicine (listed in section 6). Hypersensitivity may occur as a sudden local swelling of the soft tissues of the body (e.g., the throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• if you have a history of low blood pressure when standing up, which causes dizziness,lightheadedness, or fainting.
• if you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sebrane Neo

• if you have dizziness orlightheadedness, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. It is advisable to sit or lie down until the symptoms have disappeared.
• if you have severe kidney problems, in which case you should inform your doctor.
• if you are going to have eye surgery due to cataracts. A condition called intraoperative floppy iris syndrome (IFIS) may occur (see section 4 Possible side effects). Inform your ophthalmologist if you are taking or have taken Sebrane Neo before.

The specialist can then take the necessary precautions regarding the medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily stop taking this medicine if you are going to have eye surgery due to cataracts or increased eye pressure (glaucoma).

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

You may notice remains of the tablet in your stool. The active substance of the tablet has already been released, so there is no risk of it being less effective.

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age because it is not indicated in this population.

Other medicines and SEBRANE NEO

Tamsulosin may affect other medicines. These may affect the efficacy of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thus shortening the time during which tamsulosin is effective.
• Warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, thus shortening the time during which tamsulosin is effective.
• Other alpha-1A adrenergic receptor antagonist. The combination may reduce your blood pressure, causing dizziness or lightheadedness.
• Ketoconazole, a medicine to treat fungal skin infections. This medicine may increase the effect of tamsulosin.

Tell your doctor or pharmacistif you are using or have recently used any of the above-mentioned medicines or others, even those obtained without a prescription.

Taking Sebrane Neo with food and drinks

Tamsulosin can be taken with or without food.

Driving and using machines

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

Pregnancy, breastfeeding, and fertilityTamsulosin is not indicated for use in women. In men, abnormal ejaculation (ejaculation disorders) has been described. This means that the semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation) or the volume of the ejaculation is reduced or absent (ejaculation failure). This phenomenon is harmless.

3. How to take SEBRANE NEO

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

The recommended doseis one tablet per day. You can take tamsulosin with or without food, preferably at the same time every day.

Swallow the wholetablet. It is important that you do not crush or chewit, as this may affect the efficacy of tamsulosin.

Tamsulosin is not indicated in children.

If you take more Sebrane Neo than you should

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

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 taken.

If you forget to take Sebrane Neo

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

If you stop taking Sebrane Neo

When treatment with tamsulosin is stopped prematurely, the original symptoms may reappear. Therefore, you should take tamsulosin for the time indicated by your doctor, even if your symptoms have disappeared. Always consult your doctor if you are thinking of stopping treatment.

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

4. Possible side effects

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

Serious reactions are rare. Consult your doctor immediatelyif you suffer from a severe allergic reaction that causes swelling of the face or throat(angioedema).

Common(may affect up to 1 in 10 people)

Dizziness, especially when sitting or standing up.

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

Uncommon(may affect up to 1 in 100 people)

Headache • Heartbeat awareness (palpitations) • Low blood pressure when standing up, which causes dizziness, lightheadedness, or fainting (postural hypotension) • Nasal congestion and irritation (rhinitis) • Constipation • Diarrhea • Nausea • Vomiting • Skin rash • Hives • Itching • Feeling of weakness (asthenia)

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

Fainting (syncope) and sudden local swelling of the 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) • Severe skin condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)

Frequency not known(cannot be estimated from the available data)

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

If you are going to have eye surgery due to cataracts and are already taking or have taken Sebrane Neo before, the pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during and after the procedure. This only occurs during surgery, and it is essential that the eye specialist is aware of this possibility, as it may be necessary to perform the operation differently.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SEBRANE NEO

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

Do not use tamsulosin after the expiry date stated on the pack after “EXP”. The first two digits indicate the month, and the last four digits indicate the year. The expiry date is the last day of the month indicated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further 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 ingredients 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 pack contents

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

Blisters of PVC/PVDC/Al containing 30 prolonged-release tablets

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Netherlands

or

LABORATORIOS FRANCISCO DURBAN, S.A.

Calle IX nº 2. Pol. Ind. La Redonda

04710 El Ejido ALMERIA, Spain

This medicine is authorised 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 last revision of this leaflet:07/2022

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