Silodosin Normon 8 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Silodosin Normon 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. 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What silodosin is

Silodosin 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 is used for

Silodosin 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, even at night.

2. What you need to know before taking/using Silodosin Normon

Do not take silodosin

if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you are scheduled for eye surgery due to cataracts (clouding of the lens), 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 medicine have experienced loss of iris muscle tone (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 you need to delay or temporarily interrupt treatment with silodosin prior to cataract surgery.

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

When taking silodosin, 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 subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, you must not take silodosin, as it has not been evaluated in this condition.

• If you have kidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start treatment with silodosin cautiously and possibly at a lower dose (see section 3 “Dosage”). If your kidney problems are severe, you must not take this medicine.

• Since benign enlargement of the prostate and prostate cancer can cause similar symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not effective for treating prostate cancer.

• Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen expelled during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping treatment with silodosin. 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 silodosin with other medicines

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

Specifically 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 increases during treatment with silodosin.
• 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 difficulty in getting or maintaining an erection (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.

Driving and use of machines

Do not drive or operate machinery if you feel weak, dizzy, or drowsy, or if you have blurred vision.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

3. How to take/use Silodosin Normon

Follow exactly the instructions for use of this medicine as 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.

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.

Patients with kidney problems

If you have moderate kidney impairment, your doctor may prescribe a different dose. For this purpose, the 4 mg silodosin hard capsules formulation is available.

If you take more silodosin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. If you experience dizziness or feel weak, inform your doctor immediately.

If you forget to take silodosin

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

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 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 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 subside. If you experience dizziness upon standing or fainting, please 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 (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)

• Rapid or irregular heartbeats (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)

• Floppy iris during cataract surgery (see also above in this section)

Inform your doctor if you notice that your sexual activity is affected.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Normon

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 pack following "EXP". The expiry date refers to the last day of the month indicated.

Aluminum/Aluminum-Polyamide-PVC blister: This medicine requires no special storage temperature conditions.

Aluminum/PVC-PE-PVDC (90) white blister: Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

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. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Normon 8 mg

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

The other components are pregelatinized corn starch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, and titanium dioxide (E171).

Appearance of the medicine and contents of the pack

Silodosin Normon 8 mg are hard, opaque, white gelatin capsules. Each pack contains 30 or 90 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos - Madrid

Spain

Date of the most recent review of this leaflet: October 2019

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/84634/P_84634.html