Silodosin Msn

Package Leaflet: Information for the Patient

Silodosin MSN, 4 mg, hard capsules

Silodosin MSN, 8 mg, hard capsules

Silodosinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

What is Silodosin MSN

Silodosin MSN belongs to a group of medicines called alpha-adrenergic receptor blockers.
Silodosin MSN acts selectively on 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 the patient to urinate and alleviates symptoms of the disease.

What is Silodosin MSN used for

Silodosin MSN is used in adult men to treat symptoms of benign prostatic hyperplasia (enlargement of the prostate gland), such as:

• difficulty starting to urinate,
• feeling of incomplete emptying of the bladder,
• more frequent need to urinate, even at night.

2. Important information before taking Silodosin MSN

When not to take Silodosin MSN

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

Warnings and precautions

Before taking Silodosin MSN, discuss with your doctor or pharmacist:

• If you are going to have eye surgery for cataracts (cataract surgery), it is essential to inform your eye doctor about your current or past use of Silodosin MSN, as some patients taking this type of medicine have experienced a loss of muscle tone in the iris (the colored, round part of the eye) during such surgery. Your doctor may take appropriate precautions regarding medications and surgical techniques. You should ask your doctor if you should delay or temporarily stop taking Silodosin MSN in case of cataract surgery.

or if you have ever fainted or had dizziness when standing up, inform your doctor before taking Silodosin MSN. During treatment with Silodosin MSN, dizzinessmay occur when standing up, and occasionally faintingmay occur, especially at the beginning of treatment or when taking other medicines that lower blood pressure. If such symptoms occur, sit or lie down immediately and inform your doctor as soon as possible (see also "Driving and using machines").

• If you have severe liver disease, you should not take Silodosin MSN, as this medicine has not been studied in such a condition.
• If you have kidney disease, you should ask your doctor for advice. If you have moderate kidney disease, your doctor may start treatment with Silodosin MSN with caution and probably with a lower dose (see section 3 "How to take Silodosin MSN"). If you have severe kidney disease, you should not take Silodosin MSN.
• Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, before starting treatment with Silodosin MSN, your doctor will perform tests to rule out prostate cancer. Silodosin MSN does not treat prostate cancer.
• Taking Silodosin MSN may lead to abnormal ejaculation (reduced or absent semen during sexual intercourse), which may temporarily affect male fertility. If you plan to have children, you should consult your doctor or pharmacist before taking this medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no indication for its use in this age group.

Silodosin MSN and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Particularly, tell your doctor about taking the following medicines:

• medicines that lower blood pressure(especially alpha-blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be enhanced when taking Silodosin MSN.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used for HIV/AIDS(such as ritonavir), or medicines used after transplants to prevent organ rejection(such as cyclosporine), as these medicines may increase the level of Silodosin MSN in the blood.
• medicines used to treat difficulties in achieving or maintaining an erection(such as sildenafil or tadalafil), as taking Silodosin MSN at the same time may lead to a slight decrease in blood pressure.
• medicines used for epilepsy or rifampicin(an antituberculosis medicine), as the effect of Silodosin MSN may be reduced.

Pregnancy and breastfeeding

Silodosin MSN is not intended for use in women.

Fertility

Silodosin MSN may cause a decrease in semen volume and may temporarily affect the ability to father a child. If you plan to have children, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel that you might faint, have dizziness, feel sleepy, or have blurred vision.

3. How to take Silodosin MSN

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is one Silodosin MSN 8 mg capsule per day, taken orally.
The capsule should always be taken with food, preferably at the same time each day.
Do not crush or chew the capsule, but swallow it whole, preferably with a glass of water.
Patient with kidney disease
If you have moderate kidney disease, your doctor may prescribe a different dose. For this purpose, Silodosin MSN 4 mg hard capsules are available.

Taking a higher dose of Silodosin MSN than recommended

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.

Missing a dose of Silodosin MSN

If you forget to take a capsule, you can take it later that day. 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 a forgotten capsule.

Stopping treatment with Silodosin MSN

If you stop treatment, the symptoms of the disease may recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Silodosin MSN can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience any of the following allergic reactions:
swelling of the face or throat, difficulty breathing, fainting, itching, or hives, due to the risk of severe consequences.
The most common side effect is abnormal ejaculation (reduced or absent semen during sexual intercourse). This side effect disappears after stopping treatment with Silodosin MSN. If you plan to have children, inform your doctor.
Dizzinessmay occur, including dizziness when standing up, and occasionally fainting.
If you feel weak or dizzy, sit or lie down immediately and inform your doctor as soon as possible. If you experience dizziness when standing up or fainting, inform your doctor immediately.
Silodosin MSN may cause complications during cataract surgery(eye surgery due to cataracts, see "Warnings and precautions").
It is essential to inform your eye doctor about your current or past use of Silodosin MSN.
Possible side effects are listed below:
Very common side effects (may affect more than 1 in 10 people)

• abnormal ejaculation (less or no semen during sexual intercourse, see "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)
• runny nose or stuffy nose
• diarrhea

Uncommon side effects (may affect up to 1 in 100 people)

• decreased sexual desire
• nausea
• dry mouth
• difficulty achieving or maintaining an erection
• rapid heartbeat
• allergic reactions on the skin, such as rash, itching, hives, and drug rash
• abnormal liver function tests
• low blood pressure

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

• rapid or irregular heartbeat (so-called palpitations)
• fainting and (or) 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 (cannot be estimated from the available data)

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

If you experience any effects on your sexual life, you should inform your doctor.

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Silodosin MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP" or "Expiry date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if you notice that the packaging is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Silodosin MSN contains

The active substance is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
The other ingredients are:

• capsule content: mannitol, maize starch, magnesium stearate, polysorbate 80, magnesium aluminometasilicate, butylhydroxytoluene.
• capsule shell: gelatin, titanium dioxide (E 171).
• ink: shellac, propylene glycol, ammonia solution, concentrated iron oxide black (E 172), potassium hydroxide.

What Silodosin MSN looks like and contents of the pack

Silodosin MSN 4 mg capsules, size "3", containing white or almost white powder, consisting of a white, opaque, hard gelatin capsule with the imprint "4 mg" and a white, opaque, hard gelatin body with the imprint "M", printed with black ink.
Silodosin MSN 8 mg capsules, size "1", containing white or almost white powder, consisting of a white, opaque, hard gelatin capsule with the imprint "8 mg" and a white, opaque, hard gelatin body with the imprint "M", printed with black ink.
Silodosin MSN is available in blisters containing 5, 10, 20, 30, 50, 90, and 100 hard capsules, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA3000
Malta

Importer:

Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal:
Silodosina MSN
Czech Republic:
Silodosin MSN
Hungary:
Silodosin MSN 4 mg/8 mg hard capsule
Poland:
Silodosin MSN
Romania:
Silodosin MSN 4 mg capsule
Silodosin MSN 4 mg capsule
Slovakia:
Silodosin MSN 4 mg/8 mg
Bulgaria:
Silodosin MSN 4 mg/8 mg

Date of last revision of the leaflet: