PATIENT INFORMATION LEAFLET

Sebrane Neo 0.4 mg, prolonged-release tablets EFG

Tamsulosin hydrochloride

Read this 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. 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.

1.What Sebrane Neo is and what it is used for

2.What you need to know before you start taking Sebrane Neo

3.How to take Sebrane Neo

4.Possible side effects

5.Storage of Sebrane Neo

6.Contents of the pack and additional information

Tamsulosin relaxes the muscles of the prostate and the urinary tract. By relaxing the muscle, tamsulosin facilitates the flow of urine and helps with urination. Additionally, it decreases the sensation of urgency.

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

Do not takeSebrane Neo

• if you areallergic (hypersensitive) to tamsulosin or any of the other componentsof this medication (listed in section 6). Hypersensitivity may present as sudden swelling of soft body tissues (e.g., the throat or tongue), difficulty breathing, and/or skin itching and rash (angioedema).
• if you have a history of low blood pressure when standing, which causesdizziness,lightheadedness, or fainting.
• if you havesevere liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take SebraneNeo

• if you experiencedizziness 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 havesevere kidney problems, in which case you should inform your doctor.
• if you are undergoing eye surgery due to cataracts. A condition called intraoperative floppy iris syndrome (see section 4 Possible side effects) may occur. Inform your ophthalmologist if you are taking or have taken Sebrane Neo previously.

The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily discontinue taking this medication if you are undergoing 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 receiving treatment.

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

Children and adolescents

This medication should not be administered to children or adolescents under 18 years old because it is not indicated in this population.

Other medications and SEBRANE NEO

Tamsulosin may affect other medications. These may in turn affect the efficacy of tamsulosin. Tamsulosin may interact with:

• Diclofenac, an analgesic and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosin from the body, thus shortening the time during which tamsulosin is effective.
• Warfarin, a medication to prevent blood coagulation. This medication may accelerate the elimination of tamsulosin from the body, thus 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 medication to treat fungal skin infections. This medication may increase the effect of tamsulosin.

Inform your doctor or pharmacistif you are using or have used any of the medications mentioned above or others, even those obtained without a prescription.

Sebrane Neo intake with food and beverages

Tamsulosin can be taken regardless of food.

Driving and operating machinery

It has not been demonstrated that tamsulosin affects the ability to drive and operate machinery. However, 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 inwomen.

In men, abnormal ejaculation (ejaculation disorders) has been described. 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

Swallow the tabletwhole. It is essential thatyou do not crush or chewit, as this may affect the efficacy of tamsulosin.

Tamsulosin is not indicated for 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 seek medical attention afterwards.

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 forget to take Sebrane Neo

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

If you interrupt treatment with Sebrane Neo

When treatment with tamsulosin is interrupted prematurely, the original symptoms may reappear. Therefore, you should take tamsulosin for the time indicated by your doctor, even if your symptoms have disappeared. Consult your doctor at all times if you are thinking of interrupting treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe reactions are rare.Consult your doctor immediatelyif you experiencea severe allergic reaction that causes swelling of the face or throat(angioedema).

Frequent(may affectup to 1 in 10 people)

Dizziness, especially when sitting 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.

Poorly frequent(may affectup to 1 in 100 people)

Headache • Perception of heartbeats (palpitations) • Decrease in blood pressure when standing, which causes dizziness, drowsiness, or fainting (postural hypotension) • Nasal congestion and irritation (rhinitis) • Constipation • Diarrhea • Uncomfortable feeling (nausea) • Vomiting • Skin rash • Itching • Pruritus • Feeling of weakness (asthenia)

Rare(may affectup to 1 in 1,000 people)

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

Very rare(may affectup to 1 in 10,000 people)

Painful erection (priapism) • Serious disease with blister formation on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)

Frequency unknown(cannot be estimated from available data)

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

If you are about to undergo eye surgery due to a cloudy lens (cataract), and you are taking or have taken Sebrane Neo, your pupil may not dilate properly and your iris (the colored part of the eye) may become flaccid during and after the procedure. This only occurs during the operation and it is essential that the eye specialist is aware of this possibility, as it may be necessary to perform the operation in a different way.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 tamsulosin after the expiration date that appears on the packaging after “CAD”. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Store in the original packaging to protect them from light.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Sebrane Neo 0.4 mg

• The active ingredient is0.400 mgof hydrochloride of tamsulosin, equivalent to0.367 mg oftamsulosin.
• The other components are:

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

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

Appearance of the product and contents of the package

Round white tablets with the inscription “T9SL” on one face and “0.4”on the other.

Boxes with PVC/PVDC/Al blisters containing 30 prolonged-release tablets

Only somepackage sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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 authorized in the member states of theEconomic European Spacewith the following names:

NetherlandsSebrane 0.4 mg, tablets with prolonged release

GreeceSebrane MR 0.4 mg

SpainSebrane Neo 0.4 mg prolonged-release tablets EFG

PortugalSebrane XR

Revision date of this prospectus: 07/2022

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