Prospect: information for the user

Sebrane 0.4 mg prolonged-release hard capsules EFG

Tamsulosin hydrochloride

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

- Keep this prospect as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Sebrane and how it is used

2. What you need to know before starting to take Sebrane

3. How to take Sebrane

4. Possible adverse effects

5. Storage of Sebrane

6. Contents of the package and additional information

The active ingredient 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 the 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 an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and the need to urinate frequently both at night and during the day.

Do not take Sebrane:

• If you are allergic to hydrochloride tamsulosin or to any of the other components of this medication (listed in section 6).The hypersensitivity may present as sudden local inflammation of soft body tissues (for example, the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).

• If you have severe liver disease.

• If you suffer from fainting spells when changing position (standing up or sitting down) due to low blood pressure.

Warnings and precautions

Consult your doctor before starting to take Sebrane.

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

Children and adolescents

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

Other medications and Sebrane

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications (e.g., blood thinners such as warfarin, known as anticoagulants, and anti-inflammatory drugs such as diclofenac) may affect the effects of tamsulosin. Therefore, you will only be able to take it with other medications if your doctor allows it.

Pregnancy, breastfeeding, and fertility

Sebrane is not indicated for women.

In men, there have been cases of abnormal ejaculation(ejaculation disorders).This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

Sebrane may negatively affect the ability to operate machines. Note that in some patients, dizziness may occur.

Sebrane contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release hard capsule, which is essentially “sodium-free”.

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

If your doctor does not prescribe another schedule, 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 and without 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 undesirable decrease in blood pressure and an increase in heart rate, with a sensation of dizziness.

If you forgot to take Sebrane

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

If you interrupt treatment with Sebrane

Do not stop taking it without consulting your doctor first.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Do not be alarmed by this list of possible side effects, you may not experience 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 feeling dizzy or lightheaded, sit or lie down until you feel better.

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

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

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

• Headache
• Tachycardia, (heart rate is faster than normal)
• Sharp drop in blood pressure, especially when getting up
• Blocked nose or continuous mucous
• Constipation
• Dysentery
• Nausea
• Vomiting
• Rash
• Urticaria
• 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, and this can appear very quickly.

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

• Priapism (involuntary and painful erection of the penis that is persistent), in which case you should seek immediate medical attention.
• A severe inflammatory rash of the skin and mucous membranes, which is an allergic reaction to medications or other substances called Stevens-Johnson syndrome.

Frequency not known(cannot be estimated from available data)

• Nasal bleeding
• Blurred vision, visual deterioration
• Dry mouth
• Severe skin eruptions (erythema multiforme, exfoliative dermatitis)

If you are to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma), and you are already taking or have taken tamsulosin previously, during the surgery, the pupil may dilate slightly 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, in relation to the use of Sebrane, the following have been reported:

• Very rapid and uncoordinated heart contractions,
• Irregular heart rhythm,
• Abnormally fast heart rate,
• Difficulty breathing.

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

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 for Pharmacovigilance of Medicines for Human Use: http;//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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “Cad.” The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Sebrane

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

The other components are:

• capsule content:

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

• capsule coating:

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 content of the container

The capsules are opaque with a part of beige color and another of brown color. 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.

Only some package sizes may be marketed.

Marketing authorization holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors, 22. Polígono Can Rubiol

07141 Marratxí, Espain

Responsible for manufacturing

Gedeon RichterPlc.

1103 Budapest, Gyömroi út 19-21

Hungary

Ó

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas, (Madrid)

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain - Sebrane 0.4 mg hard capsules of prolonged release EFG

Hungary - Tamsulosin-Richter 0.4 mg retard hard capsule

Last review date of this leaflet:November 2022

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