SILODOSIN TECNIGEN 8 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Silodosin TecniGen 4 mg Hard Capsules EFG

Silodosin TecniGen 8 mg Hard Capsules EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Silodosin TecniGen and what is it used for
2. What you need to know before taking Silodosin TecniGen
3. How to take Silodosin TecniGen
4. Possible side effects
5. Storage of Silodosin TecniGen
6. Package Contents and Additional Information

1. What is Silodosin TecniGen and what is it used for

What is silodosin

Silodosin belongs to a group of medications called alpha1A adrenergic receptor blockers.

Silodosin is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle of these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What is silodosin used for

Silodosin is used in adult men to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination,
• feeling of not emptying the bladder completely,
• need to urinate more frequently, even at night.

2. What you need to know before taking Silodosin TecniGen

Do not take Silodosin

• if you are allergic to silodosin or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take silodosin.

• If you are going to undergo eye surgery for cataracts, it is essential that you inform your ophthalmologist immediately that you are using or have previously used silodosin. This is because some patients treated with this type of medication have experienced a loss of muscle tone in the iris (the colored part of the eye) during this type of surgery. The ophthalmologist may then take appropriate precautions regarding the medical and surgical techniques to be employed. Ask your doctor if it is necessary or not to postpone or temporarily interrupt treatment with silodosin when you are going to undergo cataract surgery.

• If you have ever fainted or felt dizzy when standing up, inform your doctor before taking silodosin.

When taking silodosin, dizziness may occur when standing up, and occasionally, fainting, especially when starting treatment or if you are taking other medications that lower blood pressure. If this happens, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also the section "Driving and Using Machines").

• If you have severe liver problems, you should not take silodosin, as it has not been evaluated in this situation.

• If you have kidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will start treatment with silodosin with caution and possibly with a lower dose (see section 3).

If your kidney problems are severe, you should not take silodosin.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not used to treat prostate cancer.

Children and Adolescents

Do not give this medication to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Other Medications and Silodosin TecniGen

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

Tell your doctor in particular if you are taking:

• medications that lower blood pressure(especially alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medications will increase during the use of silodosin,
• antifungal medications(such as ketoconazole or itraconazole), medications used for HIV/AIDS(such as ritonavir) or medications used after transplants to prevent organ rejection(such as cyclosporine), as these medications may increase the blood levels of silodosin,
• medications used to treat erection problems(such as sildenafil or tadalafil), as their concomitant use with silodosin may lead to a slight decrease in blood pressure,
• medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of silodosin may be reduced

Fertility

Treatment with silodosin may lead to abnormal ejaculation (reduced amount of semen expelled during sexual intercourse), which may temporarily affect male fertility. This effect disappears after discontinuation of treatment with silodosin. Inform your doctor if you are planning to have children.

Driving and Using Machines

Do not drive or operate machines if you feel faint, dizzy, or sleepy or have blurred vision.

Silodosin TecniGen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free.

3. How to take Silodosin TecniGen

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosin capsule per day, administered orally. Take the capsule always with food, preferably at the same time each day. Do not break or chew the capsule; swallow it whole, preferably with a glass of water.

Patient with kidney problems

If you have moderate kidney problems, your doctor may prescribe a different dose. For this purpose, the 4 mg silodosin capsule presentation is available.

If you take more silodosin than you should

If you feel dizzy or weak, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take silodosin

You can take the capsule later the same day if you forget to take it before. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed capsule.

If you stop taking silodosin

If you stop treatment, your symptoms may reappear.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following allergic reactions, as their consequences could be serious: swelling of the face or throat, difficulty breathing, feeling of fainting, itching of the skin, or hives.

The most common side effect is abnormal ejaculation (reduced amount of semen expelled during sexual intercourse). This effect disappears after discontinuation of treatment with silodosin. Inform your doctor if you are planning to have children.

Dizzinessmay occur, including dizziness when standing up, and occasionally fainting.

If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear. If you experience dizziness when standing up or fainting, please inform your doctor as soon as possible.

Silodosin may cause complications during cataract surgery(eye surgery for cataracts; see section "Warnings and Precautions").

It is essential that you inform your ophthalmologist immediately if you are using or have previously used silodosin.

The possible side effects are listed below:

Very common side effects (may affect more than 1 in 10 people)

• Abnormal ejaculation (a smaller or negligible amount of semen is expelled during sexual intercourse; see section "Fertility")

Common side effects (may affect up to 1 in 10 people)

• Dizziness, including dizziness when standing up (see also above in this section)
• Nasal congestion or obstruction
• Diarrhea

Uncommon side effects (may affect up to 1 in 100 people)

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Symptoms of an allergic reaction affecting the skin, such as rash, itching, hives, and drug-induced rash
• Abnormalities in liver function tests
• Low blood pressure

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

• Rapid or irregular heartbeats (called palpitations)
• Fainting/Loss of consciousness

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

• Other allergic reactions with swelling of the face or throat

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

• Flaccid pupil during cataract surgery (see also above in this section) Inform your doctor if you notice that your sexual intercourse is affected.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Silodosin TecniGen

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Silodosin TecniGen

• The active ingredient is silodosin:

Silodosin TecniGen 4 mg: each hard capsule contains 4 mg of silodosin

Silodosin TecniGen 8 mg: each hard capsule contains 8 mg of silodosin.

• The other ingredients (excipients) are:

Capsule content: mannitol (E-421), pregelatinized starch (from corn), sodium lauryl sulfate, magnesium stearate

Capsule composition: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172) (in 4 mg capsules).

Appearance of the Product and Package Contents

Silodosin TecniGen 4 mg

Hard capsule, with body and cap of opaque yellow color, 15.8 mm ± 0.3 mm in length.

Silodosin TecniGen 8 mg

Hard capsule, with body and cap of opaque white color, 21.8 mm ± 0.3 mm in length.

Blister pack of OPA complex (PA/ALU/PVC)-Aluminum, in packs of 30 capsules.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Date of the Last Revision of this Package Leaflet: June 2023

Other Sources of Information

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