Silodosine Alter 8 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Silodosin Alter 4 mg hard capsules EFG

Silodosin Alter 8 mg hard capsules EFG

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, consult 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 these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Silodosin Alter contains the active substance silodosin, which belongs to a group of medicines called alpha-blockers. It is used in adult men to treat the signs and symptoms of benign prostatic hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate gland, which can cause difficulty in urination. Silodosin Alter helps improve urination by relaxing the muscles in the prostate and the bladder neck.

What is Silodosin Alter

Silodosin Alter 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 in these tissues. This makes it easier for you to urinate and relieves your symptoms.

What Silodosin Alter is used for

This medicine 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
• feeling of not completely emptying the bladder
• more frequent need to urinate, even at night

2. What you need to know before taking Silodosin Alter

Do not take Silodosina Alter

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 Silodosina.

• 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 Silodosina. This is because some patients treated with this type of medication have experienced a loss of muscle 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 this medicine prior to undergoing cataract surgery.

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

When taking this medicine, 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 Silodosina, as it has not been evaluated in this condition.

• If you have kidney problems, consult your doctor.

If your kidney problems are of moderate severity, your doctor will start treatment with Silodosina Alter cautiously and possibly at a lower dose (see section 3 “Dosage”).

If your kidney problems are severe, you must not take Silodosina.

• 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 Silodosina. This medicine is not intended for the treatment of prostate cancer.

• Treatment with Silodosina may lead to abnormal ejaculation (reduced amount of semen ejaculated during sexual intercourse), which may temporarily affect male fertility. This effect resolves after discontinuation of Silodosina treatment. 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 Silodosina Alter 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 alpha-1 blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines may be increased during treatment with Silodosina Alter.

• 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 Silodosina.

• Medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), as concomitant use with Silodosina may lead to a slight decrease in blood pressure.

• Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as the effect of Silodosina may be reduced.

Pregnancy and breastfeeding

Silodosina Alter is not indicated for use in women.

Fertility

This medicine may reduce the amount of semen and temporarily affect your ability to father a child. If you intend to have a child, 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 experience blurred vision.

Silodosina Alter contains sodium

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

3. How to take Silodosin Alter

Follow exactly the instructions for use of 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 problems, your doctor may prescribe a different dose. For this purpose, Silodosin Alter 4 mg hard capsules are 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, tell your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Silodosin Alter

You may take the capsule later the same day if you forgot to take it earlier. If it is almost time for your 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 Alter

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 can 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 resolves after discontinuation of 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 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 (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 (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
• 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)

• Rapid or irregular heartbeats (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)

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

Inform your doctor if you notice that your sex life is affected

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Alter

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.

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Silodosin Alter

Silodosin Alter 4 mg

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

The other components are pregelatinized corn starch, mannitol (E421), glyceryl dibehenate, sodium lauryl sulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), and printing ink components (shellac gums, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Silodosin Alter 8 mg

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

The other components are pregelatinized corn starch, mannitol (E421), glyceryl dibehenate (E471), sodium lauryl sulfate, gelatin, titanium dioxide (E171), and printing ink components (shellac gums, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).

Presentation of the product and contents of the pack

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. Pack sizes 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 most recent review of this leaflet: May 2024

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