SILODOSIN VIVANTA 4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Silodosin Vivanta 4 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Silodosin Vivanta is and what it is used for
2. What you need to know before taking Silodosin Vivanta
3. How to take Silodosin Vivanta
4. Possible side effects
5. Storage of Silodosin Vivanta

1. Contents of the pack and further information

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

What is silodosin

Silodosin belongs to a group of medications called alpha-1A 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 in these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What silodosin is 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 Vivanta

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 this medication:

• If you are going to have 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 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 and, occasionally, fainting may occur when standing up, 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, consult your doctor.

If your kidney problems are moderate, your doctor will start treatment with silodosin with caution and possibly with a lower dose (see section 3 "Dosage"). If your kidney problems are severe, you should not take this medication.

• 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.

• Treatment with this medication 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.

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.

Taking silodosin with other medications

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

Inform your doctor in particular if you are taking:

• medications that lower blood pressure (especially alpha-1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medications will increase during use of this medication.
• 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 blood levels of silodosin.
• medications used to treat erection problems (such as sildenafil or tadalafil), as 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 this medication may be reduced.

Driving and using machines

Do not drive or operate machines if you feel faint, dizzy, or sleepy, or

have blurred vision.

3. How to take Silodosin Vivanta

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosin capsule per day, taken 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

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 feel dizzy or weak, inform your doctor immediately.

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 further 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 a reduction in the 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.

Dizziness, including dizziness when standing up, and, occasionally, fainting may occur.

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.

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 "Warnings and precautions")

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)

• Decreased 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

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 Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Silodosin Vivanta

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

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

This medication does not require special storage conditions.

Do not use this medication if you notice that it is damaged or shows signs of tampering.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, consult your pharmacist about how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Silodosin Vivanta

The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.

The other ingredients are:

• capsule content: pregelatinized corn starch, mannitol, magnesium stearate, polysorbate 80, magnesium aluminometasilicate, butylhydroxytoluene.
• capsule shell: gelatin, titanium dioxide (E171).
• printing ink: shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide.

Appearance of the product and contents of the pack

Silodosin Vivanta 4 mg are white to off-white powders in hard gelatin capsules, size "3", with a white opaque body with "4 mg" printed and a white opaque cap with "M" printed in black ink.

Silodosin Vivanta is available in blister packs in packs of 30, 50, 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

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

Portugal Silodosina Vivanta

France Silodosine Vivanta 4 mg gelule

Germany Silodosin Vivanta 4 mg Hartkapseln

Spain Silodosina Vivanta 4 mg hard capsules EFG

Italy Silodosina Vivanta

Date of last revision of this package leaflet:August 2021

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