Silodosin Accord

Leaflet accompanying the packaging: patient information

Silodosin Accord, 8 mg, hard capsules

Silodosin Accord, 4 mg, hard capsules

Silodosin

Read the 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 or pharmacist.
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What is Silodosin Accord

Silodosin Accord belongs to a group of medicines called alpha-adrenergic receptor blockers.
Silodosin Accord 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 the symptoms of the disease.

What is Silodosin Accord used for

Silodosin Accord 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 not fully emptying the bladder,
• more frequent need to urinate, even at night.

2. Important information before taking Silodosin Accord

When not to take Silodosin Accord

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

Warnings and precautions

Before starting treatment with Silodosin Accord, discuss it with your doctor or pharmacist.

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

Intraoperative Floppy Iris Syndrome
Your doctor may take appropriate precautions during cataract surgery.
If you have ever fainted or had dizziness when standing up, you should inform your doctor before starting Silodosin Accord. During treatment with Silodosin Accord, dizziness may occur when standing up, and occasionally fainting, especially at the beginning of treatment or when taking other medications that lower blood pressure. If such symptoms occur, you should 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 Accord, as this medicine has not been studied in this disease.
• 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 Accord with caution and probably with a lower dose (see section 3 "How to take Silodosin Accord"). If you have severe kidney disease, you should not take Silodosin Accord.
• Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, before starting treatment with Silodosin Accord, your doctor will perform tests to rule out prostate cancer. Silodosin Accord does not treat prostate cancer.
• Taking Silodosin Accord may lead to abnormal ejaculation (reduced or absent semen during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping Silodosin Accord. You should inform your doctor if you plan to have children.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

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 Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor especially about taking the following medicines:

• medicines that lower blood pressure(especially alpha-1 blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be enhanced when taking Silodosin Accord.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used to treat 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 Accord in the blood.
• medicines used to treat difficulties in achieving or maintaining an erection(such as sildenafil or tadalafil), as concurrent use with Silodosin Accord may lead to a slight decrease in blood pressure.
• medicines used to treat epilepsy, or rifampicin(an anti-tuberculosis medicine), as the effect of Silodosin Accord may be reduced.

Pregnancy, breastfeeding, and fertility

Silodosin Accord is not intended for use in women.

Fertility

Silodosin Accord may cause a decrease in semen volume and may temporarily affect male fertility. If you plan to have children, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

You should not drive or operate machinery if you feel that you may faint, have dizziness, feel sleepy, or have blurred vision.

3. How to take Silodosin Accord

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 8 mg Silodosin Accord capsule per day, taken orally.
The capsule should always be taken with food, preferably at the same time every 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 Accord 4 mg, hard capsules are available.

Taking more than the recommended dose of Silodosin Accord

If you have taken more than one capsule, inform your doctor as soon as possible. If you feel dizzy or weak, you should inform your doctor immediately.

Missing a dose of Silodosin Accord

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

Stopping treatment with Silodosin Accord

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

4. Possible side effects

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

• abnormal ejaculation (reduced or absent 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
• skin allergic reactions, 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 (frequency 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, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 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 Accord

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 that month.
Do not store above 30°C.
Store the blisters in the outer carton to protect from light.
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 Accord contains Silodosin Accord 4 mg

The active substance is silodosin. Each capsule contains 4 mg of silodosin.
The other ingredients are: maize starch, maize starch, mannitol, magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E 171), brilliant blue (E 133), erythrosine (E 127).
Silodosin Accord 8 mg
The active substance is silodosin. Each capsule contains 8 mg of silodosin.
The other ingredients are: maize starch, maize starch, mannitol, magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E 171).

What Silodosin Accord looks like and contents of the pack

Silodosin Accord 4 mg is a hard gelatin capsule with a white body and blue cap (size 3) containing a white powder. Each capsule is approximately 15.6 mm long.
Silodosin Accord 8 mg is a hard gelatin capsule with a white body and cap (size 1) containing a white powder. Each capsule is approximately 18.8 mm long.
Silodosin Accord is available in PVC/PVDC/Aluminum blisters, in cartons.
Pack sizes: 10, 30, 50, and 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain

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

Country Name

Bulgaria
Silodosin Accord 4/8 mg твърди капсули
France
SILODOSINE ACCORD 4/8 mg, gélule
Spain
Silodosina Accord 4/8 mg cápsulas duras EFG
Netherlands
Silodosin Accord 4/8 mg harde capsules
Ireland
Silodosin Accord 4/8 mg hard capsules
Germany
Silodosin Accord 4/8 mg Hartkapseln
Poland
Silodosin Accord
Portugal
Silodosin Accord 4/8 mg cápsulas
Romania
Silodosin Accord 4/8 mg capsule
Slovakia
Silodosin Accord 8 mg tvrdé kapsuly
Italy
Silodosin Accord

Date of last revision of the leaflet: