Silodosin Aurovitas 8 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Silodosina Aurovitas 8 mg hard capsules EFG

silodosin

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

• Keep this leaflet, as 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Silodosina Aurovitas is and what it is used for
2. What you need to know before taking Silodosina Aurovitas
3. How to take Silodosina Aurovitas
4. Possible side effects
5. How to store Silodosina Aurovitas
6. Contents of the pack and other information

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

What is silodosin?

Silodosin belongs to a group of medicines known as 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 relieves your symptoms.

What is silodosin 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,
• need to urinate more frequently, including at night.

2. What you need to know before taking Silodosin Aurovitas

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

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

• If you are scheduled for eye surgery due to cataracts (clouding of the lens), 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 medicine 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 you need to delay or temporarily interrupt treatment with silodosin prior to cataract surgery.

• If you have ever fainted or felt dizzy upon standing 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 medicines that lower blood pressure. If this occurs, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).

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

• If you have kidney problems, consult your doctor.

If you have moderate kidney problems, your doctor will start treatment with silodosin cautiously and may prescribe a lower dose (see section 3 “How to take Silodosin Aurovitas”). If you have severe kidney problems, you should not take this medicine.

• Since benign prostatic hyperplasia and prostate cancer may cause similar symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not intended for the treatment of prostate cancer.

• Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen ejaculated during sexual intercourse), which may temporarily affect male fertility. This effect reverses 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 or 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 concomitant use with silodosin.
• Antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of silodosin.
• Medicines used to treat erectile dysfunction (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 silodosin may be reduced.

Pregnancy and breastfeeding

Silodosin Aurovitas is not intended for use by women.

Fertility

Silodosin Aurovitas may reduce the amount of semen and temporarily affect your ability to father a child. If you intend to have children, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; essentially “sodium-free”.

3. How to take Silodosin Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosin capsule daily, 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.

Patients with kidney problems

If you have moderate kidney problems, 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 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, your 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 experiences them.

Contact your doctor immediately if you experience any of the following allergic reactions, as they could 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 ejaculated 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, 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 immediately inform your ophthalmologist 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 (a reduced or negligible amount of semen is ejaculated during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, including dizziness upon standing (see also 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
• Skin allergic reaction symptoms 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 (known as 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 (see also above in this section)

Inform your doctor if you notice that your sexual activity is affected.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Aurovitas

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and medicines you no longer need at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer require. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Aurovitas

• The active substance is silodosin. Each hard capsule contains 8 mg of silodosin.
• Other components:

Capsule contents: mannitol, pregelatinized corn starch, sodium lauryl sulfate, hydrogenated vegetable oil.

Capsule shell: gelatin, titanium dioxide (E171).

Printing ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525).

Appearance of the product and contents of the pack

Size "1" hard gelatin capsule with an opaque white cap and an opaque white body, printed with "SIL" on the cap and "8 mg" on the body in black ink, filled with white or almost white powder.

Silodosin Aurovitas is available in blister packs containing 10 and 30 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Silodosin Aurovitas 8 mg hard capsules EFG

Portugal: Silodosin Generis

Date of the most recent revision of this leaflet: November 2022

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/).