Silodosin Vivanta 4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Silodosin Vivanta 4 mg hard capsules EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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. How to store Silodosin Vivanta

6. Contents of the pack and other information

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

What is silodosin

Silodosin belongs to a group of medicines known as 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 in these tissues. This makes it easier for you to urinate and relieves your symptoms.

What silodosin is used for

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

• difficulty starting urination,
• sensation of not completely emptying the bladder,
• increased need to urinate, including during the night.

2. What you need to know before starting to take/use Silodosin Vivanta

Do not take silodosin

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you are scheduled for eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken silodosin. This is because some patients treated with this type of medication have experienced loss of muscular tone in the iris (the colored circular part of the eye) during this type of surgery. The ophthalmologist can then take appropriate precautions regarding the medical and surgical techniques required. Ask your doctor whether it is necessary to delay or temporarily interrupt treatment with silodosin prior to undergoing cataract surgery.

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

When taking silodosin, you may experience dizziness and, occasionally, fainting, especially when starting treatment or if you are taking other medications that lower blood pressure. If this occurs, sit or lie down immediately until symptoms subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).

If you have severe liver problems, you must not take silodosin, as it has not been evaluated in this condition.

• If you have kidney problems, consult your doctor.

If you have moderate kidney problems, your doctor will start treatment with silodosin cautiously and possibly at a lower dose (see section 3 “Dosage”). If you have severe kidney problems, you must not take this medicine.

• Since benign enlargement of the prostate 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 effective for treating 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

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

In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially alpha1-blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines increases during use of this medicine.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplants to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of silodosin.
• medicines used to treat difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), as their concomitant 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 use of machines

Do not drive or operate machinery if you feel faint, dizzy, or drowsy or
if you have blurred vision.

3. How to take/use Silodosin Vivanta

Follow exactly the administration instructions for this medicine given 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, taken orally.

Always take the capsule 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.

Patients with kidney problems

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

If you take more silodosin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. If you feel dizzy or weak, inform your doctor immediately.

If you forget to take silodosin

You may take the missed capsule later the same day if you forgot to take it earlier. 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 forgotten capsule.

If you stop taking silodosin

If you stop treatment, symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following allergic reactions, as they may have serious consequences: swelling of the face or throat, difficulty breathing, feeling faint, skin itching, or hives.

The most common adverse effect is a reduction in the amount of semen released during sexual intercourse. This effect disappears after stopping treatment with silodosin. Inform your doctor if you are planning to have children.

Dizziness, including dizziness upon standing, and occasionally fainting, may occur.

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

Silodosin may cause complications during cataract surgery (eye surgery for lens clouding; see section “Warnings and precautions”).

It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken silodosin.

The possible adverse effects are listed below:

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

• Abnormal ejaculation (reduced or negligible amount of semen released during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, including dizziness upon standing (also see above in this section)
• Nasal discharge or nasal congestion
• Diarrhea

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

• Loss of sexual appetite
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Symptoms of skin allergic reactions such as rash, pruritus, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Fast or irregular heartbeat (called palpitations)
• Fainting/Loss of consciousness

Very rare adverse 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)

• Floppy iris during cataract surgery (also see above in this section)

Inform your doctor if you notice any changes in your sexual activity.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Vivanta

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

The other components are:

• capsule contents: 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, iron oxide black (E172), potassium hydroxide.

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Appearance of the product and contents of the container

Silodosina Vivanta 4 mg are white to off-white powders in hard gelatin capsules of size “3” with an opaque white body printed with “4 mg” and an opaque white cap printed with “M” in black ink.

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

Only some 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area member states under the following names:

Portugal Silodosin Vivanta

France Silodosine Vivanta 4 mg hard capsules

Germany Silodosin Vivanta 4 mg hard capsules

Spain Silodosina Vivanta 4 mg hard capsules EFG

Italy Silodosina Vivanta

Date of latest review of this leaflet: August 2021

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