Silodosin Alter 4 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 the entire 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 others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 works by relaxing the muscles in the prostate and the bladder, making it easier to urinate.

Silodosin Alter is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is a condition in which the prostate gland is enlarged and not cancerous. Symptoms of BPH include difficulty starting urination, weak stream, or the need to urinate frequently or urgently.

What is Silodosin Alter

Silodosin Alter belongs to a group of medicines 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 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
• need to urinate more frequently, including at night

2. What you need to know before taking Silodosin Alter

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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 Silodosin.

• 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 a 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 to be used. Ask your doctor whether it is necessary to postpone 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 Silodosin.

When taking this medicine, dizziness and occasionally fainting may occur upon standing, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this happens, 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 this condition.

• If you have kidney problems, seek advice from your doctor.

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

If you have severe kidney problems, you must not take Silodosin.

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

• Treatment with Silodosin 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 Silodosin treatment. Inform your doctor if you are planning to have children.

Children and adolescents

Do not administer this medicine to children and 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 alpha1-blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines is 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 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

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 experience weakness, dizziness, drowsiness, or 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 given by your doctor or pharmacist for taking this medicine. 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 missed 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, 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 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 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 resolve. If you experience dizziness upon standing or fainting, inform your doctor as soon as possible.

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

It is important to 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 minimal semen emission 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 desire
• 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)

? 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 involves possible adverse reactions not listed in this leaflet. You can 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 tampering.

Medicines must not be disposed of via wastewater or household waste. Any unused medicines or waste materials should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other 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 maize 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 maize 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).

Appearance 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. Packs 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 revision of this leaflet: May 2024

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