SILODOSIN ALTER 4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Silodosin Alter 4 mg Hard Capsules EFG

Silodosin Alter 8 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 doubts, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Silodosin Alter and what is it used for
2. What you need to know before taking Silodosin Alter
3. How to take Silodosin Alter
4. Possible side effects
5. Storage of Silodosin Alter
6. Package Contents and Additional Information

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

WhatisSilodosinAlter

Silodosin Alter belongs to a group of medications called 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 of these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What is Silodosin Alter used for

This medication is used in adult males 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 Alter

DonottakeSilodosinAlter

If you are allergic to silodosin 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 Silodosin Alter

• If you are going to undergo eye surgery for cataracts, it is essential that you inform your ophthalmologist immediately that you are using or have previously used Silodosin Alter. This is because some patients treated with this type of medication 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 employed. Ask your doctor if it is necessary or not to postpone or temporarily interrupt treatment with this medication when undergoing cataract surgery.

• If you have ever fainted or felt dizzy when standing up, inform your doctor before taking Silodosin Alter.

When taking this medication, dizziness and, occasionally, fainting may occur, 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 Alter, 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 Alter with caution and possibly with a lower dose (see section 3 "Dosage").

If your kidney problems are severe, you should not take Silodosin Alter.

• 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 Alter. This medication is not intended to treat prostate cancer.

• Treatment with Silodosin Alter 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 Alter. 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.

Taking Silodosin Alter 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 alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medications increases during the use of Silodosin Alter.

• antifungal medications(such as ketoconazole or itraconazole), medications used for HIV/AIDS infection(such as ritonavir), or medications used after transplants to prevent organ rejection(such as cyclosporine), as these medications may increase the blood levels of Silodosin Alter.
• medications used to treat erection problems(such as sildenafil or tadalafil), as their concomitant use with Silodosin Alter may lead to a slight decrease in blood pressure.
• medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of Silodosin Alter may be reduced.

Pregnancy and Breastfeeding

Silodosin Alter is not indicated for use in women.

Fertility

This medication may reduce the amount of sperm 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 Using Machines

Do not drive or operate machines if you feel faint, dizzy, or sleepy, or have blurred vision.

Silodosin Alter contains Sodium

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

3. How to take Silodosin Alter

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

The recommended dose is one 8 mg Silodosin capsule per day, administered 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 Alter presentation is available.

If you take more Silodosin Alter than you should

If you have taken more than one capsule, inform your doctor as soon as possible. If you feel dizzy or weak, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Silodosin Alter

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 Alter

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

If you have any other doubts 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 Alter. 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, inform your doctor as soon as possible.

Silodosin Alter may cause complications during cataract surgery (eye surgery for cataracts; see also the section "Warnings and Precautions").

It is essential that you inform your ophthalmologist immediately if you are using or have previously used Silodosin Alter.

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
• Skin allergic reactions, such as rash, itching, hives, and drug-induced rash
• Abnormal liver function tests
• 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

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 relationships are affected

ReportingofSideEffects

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

5. Storage of Silodosin Alter

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 pack after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Do not use this medication if you notice that the packaging is damaged or shows signs of having been tampered with.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

CompositionofSilodosinAlter

Silodosin Alter 4 mg

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

The other ingredients are pregelatinized cornstarch, mannitol (E421), glycerol dibehenate, sodium lauryl sulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), and ink printing components (lacquers, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Silodosin Alter 8 mg

The active ingredient is silodosin. Each capsule contains 8 mg of silodosin.

The other ingredients are pregelatinized cornstarch, mannitol (E421), glycerol dibehenate (E471), sodium lauryl sulfate, gelatin, titanium dioxide (E171), and ink printing components (lacquers, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Appearance of the Product and Package Contents

Silodosin Alter 4 mg are hard gelatin capsules with an opaque yellow body, size 3, and a cap marked with "4" in black ink.

Silodosin Alter 8 mg are hard gelatin capsules with an opaque white body, size 0, and a cap marked with "8" in black ink.

Silodosin Alter is available in PVC/PE/PVDC-aluminum blisters. Packages of 30 capsules.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products, S.A.

Larisa Industrial Area, P.O. Box 3012,

Larisa, 41500, Greece

Date of the Last Revision of this Package Leaflet May 2024

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