SILODOSIN VIVANTA 8 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Silodosin Vivanta 8 mg Hard Capsules EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Silodosin Vivanta and what is it used for
2. What you need to know before you take 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 is Silodosin Vivanta and what is it used for

What is silodosin

Silodosin belongs to a group of medicines 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 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 you take Silodosin Vivanta

Do not take silodosin

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine:

• If you are going to have eye surgery for cataracts, it is important 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 medicine have suffered 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 used. 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 and, occasionally, fainting may occur when standing up, especially when starting treatment or if you are taking other medicines 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 "Dosage"). If your kidney problems are severe, you should not take this medicine.

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

Children and adolescents

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

Taking silodosin with other medicines

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

Tell your doctor in particular if you are taking:

• medicines 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 medicines will increase during the use of this medicine.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS (such as ritonavir), or medicines used after transplants to prevent organ rejection (such as cyclosporine), as these medicines may increase the blood levels of silodosin.
• medicines used to treat problems getting or maintaining an erection (such as sildenafil or tadalafil), as their use with silodosin may lead to a slight decrease in blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as the effect of this medicine may be reduced.

Driving and using machines

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

have blurred vision.

3. How to take Silodosin Vivanta

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

The recommended dose is one silodosin 8 mg capsule per day by oral administration.

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 hard capsules 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 medicine and the amount taken. 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, it is possible that the symptoms will reappear.

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.

Get in touch with 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 stopping 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 important 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 "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)

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty getting 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 the available data)

• Flaccid pupil during cataract surgery (see also above in this section)

Tell your doctor if you notice that your sexual intercourse is affected.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Vivanta

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

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

This medicine does not require any special storage conditions.

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

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 further information

Composition of Silodosin Vivanta

The active substance 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 8 mg are white to off-white powders in hard gelatin capsules of size "1" with a white opaque body with "8 mg" printed and a white opaque cap with "M" printed in black ink.

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

Not all pack sizes may be marketed.

Marketing authorisation 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 medicine by contacting the local representative of the marketing authorisation holder:

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

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

Portugal Silodosina Vivanta

France Silodosine Vivanta 8 mg gelule

Germany Silodosin Vivanta 8 mg Hartkapseln

Spain Silodosina Vivanta 8 mg hard capsules EFG

Italy Silodosina Vivanta

Date of last revision of this leaflet:August 2021

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/.