Leaflet: information for the patient

Silodosina Alter 4 mg hard capsules EFG

Silodosina Alter 8 mg hard capsules EFG

Read 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Silodosina Alter

4. Possible side effects

5. Storage of Silodosina Alter

6. Contents of the pack and additional information

whatisSilodosinaAlter

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

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 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
• sensation of not fully emptying the bladder
• more frequent need to urinate, even at night

Do not takeSSilodosinaAlter

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 Silodosina Alter.

• 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 Alter previously. This is because some patients treated with this type of medication 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 your treatment with this medication when undergoing cataract surgery.

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

When taking this medication, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

• If you havesevere liver problems, you should not take Silodosina Alter, as it has not been evaluated in this situation.

• If you haverenal problems, consult your doctor.

If your renal problems are moderate, your doctor will initiate treatment with Silodosina Alter with caution and possibly with a lower dose (see section 3 “Doses”).

If your renal problems are severe, you should not take Silodosina 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 Silodosina Alter. This medication does not treat prostate cancer.

• Treatment with Silodosina Alter may lead to abnormal ejaculation (reduced semen expulsion during sexual intercourse), which may temporarily affect male fertility. 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 Alter 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 are taking:

• blood pressure-lowering medications(especially alpha 1 blockers, such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during use of Silodosina Alter.

• antifungal medications(such as ketoconazole or itraconazole),medications used to treat HIV/AIDS(such as ritonavir) ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase Silodosina concentrations.
• medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concomitant 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 Alter is not indicated for use by women.

Fertility

This medication may reduce semen volume and temporarily affect your ability to conceive a child. If you plan 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, drowsiness, or blurred vision.

Silodosina Alter contains sodium

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. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Silodosina 8 mg capsule 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 Alter 4 mg hard capsules are available.

If you take more Silodosina Alter than you should

If you have taken more than one capsule, inform your doctor as soon as possible. If you experience dizziness or feel weak, notify 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 Silodosina Alter

You can take the capsule later the same day if you forget 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 treatment with Silodosina Alter

If you interrupt treatment, it is possible that 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 discontinuing 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 due to clouding of the lens; see "Warnings and precautions").

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

The possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or inappreciable 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 (also see above, in this section)
• Nasal discharge or obstruction
• Diarrhea

Uncommon side 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
• Allergic skin reactions, such as rash, itching, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

Rare side effects (may affect up to 1 in 1,000 people)

• Fast 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 the available data)

?Pupillary flaccidity during cataract surgery (also see above, in this section)

Informayour doctorifyounoticethatyoursexualintercourseisaffected

Reportingofadversereactions

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, 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 use this medication after 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.

Store in the original packaging to protect it from light.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated improperly.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

c omposition of S ilodosina A lter

Silodosina Alter 4 mg

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

The other components are pregelatinized cornstarch, mannitol (E421), dibehenato de glicerol, laurilsulfato de sodio, gelatina, dióxido de titanio (E171), óxido de hierro amarillo (E172) and components of the printing ink (gomas lacas, propilenglicol, disolución concentrada de amoniaco, óxido de hierro negro (E172), hidróxido de potasio).

Silodosina Alter 8 mg

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

The other components are pregelatinized cornstarch, mannitol (E421), dibehenato de glicerol (E471), laurilsulfato de sodio, gelatina, dióxido de titanio (E171) and components of the printing ink (gomas lacas, propilenglicol, disolución concentrada de amoniaco, óxido de hierro negro (E172), hidróxido de potasio).

Appearance of the product and content of the container

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

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

Silodosina Alter is available in PVC/PE/PVDC-aluminio blister packaging. Containers of 30 capsules.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Rontis Hellas Medical and Pharmaceutical Products, S.A.

Larisa Industrial Area, P.O. Box 3012,

Larisa, 41500, Greece

Last review date of this leaflet May 2024

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