SEBRANE 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Sebrane 0.4 mg prolonged-release hard capsules 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. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Sebrane and what is it used for

The active substance in Sebrane is tamsulosin hydrochloride. It is a selective antagonist of alpha-1A/1D adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Sebrane is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine flow), dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Sebrane

Do not take Sebrane:

• If you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local inflammation of the soft tissues of the body (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• If you have severe hepatic impairment.
• If you suffer from fainting when changing posture (standing up or sitting down) due to low blood pressure.

Warnings and precautions

Consult your doctor before starting to take Sebrane.

• Regular medical examinations are necessary to monitor the development of the disease being treated.
• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo or have been scheduled for eye surgery due to cataracts or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you are taking or have previously taken Sebrane. This is because Sebrane may cause complications during surgery. The specialist will then be able to take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no precise indication for the use of Sebrane in this age group and its efficacy in this population has not been established.

Other medicines and Sebrane

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines (e.g., blood clot-preventing medications such as warfarin, called anticoagulants, and anti-inflammatory medications such as diclofenac) may influence the effects of tamsulosin. Therefore, you may only take it with other medications if your doctor allows it.

Pregnancy, breastfeeding, and fertility

Sebrane is not indicated in women.

In men, there have been cases of abnormal ejaculation (ejaculation disorders). This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

Sebrane may negatively affect the ability to use machines. It should be noted that in some patients, dizziness appears.

Sebrane contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule, i.e., it is essentially "sodium-free".

3. How to take Sebrane

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If your doctor does not prescribe another regimen, the recommended dose is one capsule per day, which should be taken after breakfast or after the first meal of the day.

The capsule should be swallowed whole without breaking or chewing.

If you take more Sebrane than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested, as the consequences may require medical intervention.

Taking too much Sebrane may lead to an undesired decrease in blood pressure and an increase in heart rate, with a feeling of fainting.

If you forget to take Sebrane

Take the forgotten capsule on the same day. If it is not possible, the next day do not take a double dose to make up for the forgotten doses; simply take one capsule per day again.

If you stop taking Sebrane

Do not stop taking it without consulting your doctor first.

If you have any other 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. Do not be alarmed by this list of possible side effects. You may not get any of them. Most patients do not detect any side effects. However, if you detect any and they bother you, tell your doctor.

If you start to feel dizzy or faint, sit or lie down until you feel better.

Frequent(may affect up to 1 in 10 people):

• Dizziness, especially when standing up from a chair or bed.
• Ejaculation disorder
• Retrograde ejaculation (ejaculation in the bladder)
• Ejaculatory insufficiency

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

• Headache
• Tachycardia (faster than normal heartbeat)
• Sudden decrease in blood pressure, especially when standing up
• Stuffy or runny nose
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Rash
• Hives
• Itching
• Weakness

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

• Fainting
• Swelling of the deep layers of the skin, often around the mouth or mucous membranes of the mouth or throat, which can appear very quickly.

Very rare(may affect up to 1 in 10,000 people):

• Priapism (painful and persistent involuntary erection of the penis), in which case you should immediately consult your doctor.
• A severe inflammatory skin and mucous membrane eruption, which is an allergic reaction to medications or other substances called Stevens-Johnson syndrome.

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

• Nosebleeds
• Blurred vision, visual impairment
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have previously taken tamsulosin, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid (see also section 2 "Warnings and precautions").

In addition to the adverse events mentioned above, the following have been reported in relation to the use of Sebrane:

• Very rapid and uncoordinated heart contractions
• Irregular heartbeat
• An abnormally rapid heart rate and
• Difficulty breathing.

As these spontaneously reported events come from post-marketing experience worldwide, the frequency of the events and the causal role of tamsulosin cannot be reliably determined.

Reporting of side effects

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

5. Storage of Sebrane

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

Store in the original packaging to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sebrane

The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.

The other ingredients are:

• capsule content:

microcrystalline cellulose (E-460), methacrylic acid-ethyl acrylate copolymer 1:1 (which includes polysorbate and sodium lauryl sulfate), talc, triethyl citrate, calcium stearate

• capsule shell:

yellow iron oxide (E-172), black iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171), gelatin

Appearance of the product and pack contents

The capsules are opaque with one part beige and the other brown. Each capsule contains white or off-white granules.

30, 90, or 100 capsules are packaged in PVC/PVDC/Aluminum blisters and in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors, 22. Polígono Can Rubiol

07141 Marratxí, Spain

Manufacturer

Gedeon Richter Plc.

1103 Budapest, Gyömroi út 19-21

Hungary

or

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas, (Madrid)

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

Spain - Sebrane 0.4 mg prolonged-release hard capsules EFG

Hungary - Tamsulosin-Richter 0.4 mg retard kemény kapszula

Date of the last revision of this leaflet:November 2022

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