Prospect: Information for the Patient

Silodosina Aurovitas 4 mg Hard Capsules EFG

silodosina

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Silodosina Aurovitas

3.How to take Silodosina Aurovitas

4.Adverse effects

5.Storage of Silodosina Aurovitas

6.Contents of the package and additional information

?What is silodosina?

Silodosina belongs to a group of medications known as alpha 1A adrenergic receptor blockers.1A.

Silodosina 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 is silodosina used for?

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

• difficulty starting urination,

• feeling of not fully emptying the bladder,

• increased need to urinate, even at night.

Do not takesilodosina

If you are allergic to silodosina or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

•If you are to undergo eye surgery for cataract (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used silodosina previously. This is because some patients treated with this type of medication have experienced a loss of iris muscle tone (the circular colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions regarding medical and surgical techniques. Ask your doctor if you need to postpone or interrupt temporarily the treatment with silodosina when undergoing cataract surgery.

•If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking silodosina.

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

•If you have severe liver problems, do not take silodosina, 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 silodosina with caution and possibly with a lower dose (see section 3 “How to take Silodosina Aurovitas”). If your kidney problems are severe, do 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 silodosina. Silodosina does not treat prostate cancer.

•Treatment with this medication may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping silodosina treatment. Inform your doctor if you are planning to have children.

Children and adolescents

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

Combination of silodosina with other medications

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

Inform your doctorin particular if you take:

•blood pressure-lowering medications(especially alpha blockers such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during use of this medication.

•antifungal medications(such as ketoconazole or itraconazole),medications used for HIV/AIDS infection(such as ritonavir) ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase silodosina blood concentrations.

•medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with silodosina may lead to a slight decrease in blood pressure.

•medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of silodosina may be reduced.

Pregnancy and breastfeeding

Silodosina Aurovitas is not indicated for use by women

Fertility

Silodosina Aurovitas may reduce semen volume and temporarily affect your ability to conceive a child. If you intend to have a child, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, dizziness, or somnolence or have blurred vision.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule of silodosina 8 mg per day taken orally.

Take the capsule always accompanied by food, preferably at the same time every 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 silodosina 4 mg hard capsules presentation is available.

If you take moresilodosinathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.If you experience dizziness or feel weak, inform your doctor immediately.

If you forgot to takesilodosina

You can 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 compensate for the missed capsule.

If you interrupt the treatment withsilodosina

If you interrupt the treatment, it is possible that the symptoms will reappear.

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

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

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be severe: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or urticaria.

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

You may experiencedizziness, including dizziness when standing up, and, occasionally,fainting.

If you feel weakness or dizziness,sit or lie downimmediately until the symptoms disappear. If you experience dizziness when standing up or fainting,inform your doctor as soon as possible.

Silodosina may cause complications duringcataract surgery(eye surgery for cloudy lens; see "Warnings and precautions").

It is essential thatyou inform your ophthalmologist immediatelyif you are using or have used silodosina previously.

The possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or imperceptible amount of semen is expelled during sexual intercourse; see "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 secretion or obstruction

• Diarrhea

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

• Loss of sexual appetite

• Nausea

• Dry mouth

• Difficulty following or maintaining an erection

• Increased heart rate

• Skin allergy symptoms, such as rash, itching, urticaria, and drug-induced rash

• Abnormalities in liver function

• 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

Unknown frequency (the 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 relationships are affected.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSilodosinaAurovitas

-The active ingredient is silodosina..Each hard capsule contains 4 mg ofsilodosina.

-The other components:

Hard capsule content:mannitol, pregelatinized cornstarch, sodium lauryl sulfate, hydrogenated vegetable oil.

Capsule coating:gelatin, titanium dioxide (E171).

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

Appearance of the product and content of the container

Hard gelatin capsule size “3”, with white opaque cap and white opaque body, with “SIL” printed on the cap and “4 mg” on the body with black ink, filled with a white or off-white powder.

Silodosina Aurovitasis available in blister packs with 10 and 30 hard capsules.

Only some container sizes may be marketed.

Marketing authorization holder and responsible 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

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Silodosina Aurovitas 4 mg hard capsules EFG

Portugal:Silodosina Generis

Last review date of this leaflet: November 2022

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