Sidarso

Patient Information Leaflet

Sidarso, 4 mg, hard capsules
Sidarso, 8 mg, hard capsules
Silodosinum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Sidarso is and what it is used for

What Sidarso is
Sidarso belongs to a group of medicines called alpha-adrenergic receptor antagonists.
Sidarso acts selectively on receptors located in the prostate gland, urinary bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle in these tissues. This facilitates urination and alleviates symptoms of the disease.

What Sidarso is used for
Sidarso is used in adult men for the treatment of lower urinary tract symptoms associated with benign prostatic enlargement (benign prostatic hyperplasia), such as:

• difficulty starting urination,
• sensation of incomplete bladder emptying,
• increased frequency of urination, including during the night.

2. Important information before using Sidarso

When not to use Sidarso

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

Warnings and precautions
Before starting treatment with Sidarso, discuss the following with your doctor or pharmacist:

• If the patient is scheduled for cataract surgery (cataract operation), it is important to immediately inform the ophthalmologist about current or past use of Sidarso, as some patients treated with this type of medicine have experienced intraoperative floppy iris syndrome (loss of muscle tone in the iris, the coloured, circular part of the eye) during such surgery. The specialist doctor may take appropriate precautions regarding the medicines and surgical techniques used. Ask the doctor whether the patient should delay or temporarily stop taking Sidarso prior to cataract surgery.
• If the patient has ever fainted or experienced dizziness upon standing up quickly, they should inform the doctor before taking Sidarso. Dizziness upon standing and occasional fainting may occur while taking Sidarso, especially at the beginning of treatment or when taking other medicines that lower blood pressure. If such symptoms occur, the patient should immediately sit or lie down until symptoms subside and contact the doctor as soon as possible (see also section “Driving and using machines”).
• If the patient has severe liver disease, Sidarso should not be taken, as it has not been studied in such conditions.
• If the patient has kidney disease, consult the doctor. If the patient has moderately severe kidney disease, the doctor will initiate treatment with Sidarso cautiously and may prescribe a lower dose (see section 3 “How to use Sidarso”). Sidarso should not be used if the patient has severe kidney disease.
• Since benign prostatic hyperplasia and prostate cancer may cause similar symptoms, the doctor will perform tests before starting treatment with Sidarso to exclude prostate cancer. Sidarso does not treat prostate cancer.
• Use of Sidarso may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. Inform the doctor if the patient plans to have children.

Children and adolescents
Sidarso must not be given to children and adolescents under 18 years of age, as there is no indication for use of this medicine in this age group.

Sidarso with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Especially inform the doctor if the patient is taking any of the following medicines:

• Medicines that lower blood pressure (especially medicines called alpha-blockers, such as prazosin or doxazosin), as the effect of these medicines may be increased when taken with Sidarso.
• Antifungal medicines (such as ketoconazole or itraconazole), medicines used in HIV and (or) AIDS infections (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase the concentration of Sidarso in the blood.
• Medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), as concomitant use with Sidarso may lead to a slight decrease in blood pressure.
• Medicines used for epilepsy or rifampicin (an anti-tuberculosis medicine), as the effect of Sidarso may be reduced.

Pregnancy, breastfeeding and effects on fertility
Pregnancy and breastfeeding
Not applicable, as Sidarso is used in men with benign prostatic enlargement and is not intended for use in women.

Fertility
Sidarso may reduce semen volume, leading to a temporary reduction in fertility in men.

Driving and using machines
The patient should not drive or operate machinery if they feel they might faint, experience dizziness, feel sleepy, or have blurred vision.

Sidarso contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Sidarso

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one 8 mg Sidarso capsule taken orally once daily.
The capsule should always be taken with food, preferably at the same time each day. Do not
chew or crush the capsule; swallow it whole, preferably with a glass of water.

Patients with kidney disease
If a patient has moderate kidney impairment, the doctor may prescribe a different dose. For
this purpose, hard capsules of Sidarso 4 mg are available.

Taking more Sidarso than prescribed
If more than one capsule has been taken, inform a doctor as soon as possible. If the patient
experiences dizziness or feels unwell, medical advice should be sought immediately.

Missed dose of Sidarso
If the patient forgets to take a capsule, it may be taken later on the same day. However, if it is
almost time for the next dose, the missed dose should not be taken. Do not take a double dose
to make up for a missed capsule.

Stopping Sidarso treatment
If treatment is stopped, symptoms of the disease may return.

If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The patient should seek immediate medical advice if any of the following allergic reactions occur: facial or throat swelling, difficulty breathing, fainting, itching or hives, due to the possibility of serious consequences.

The most common adverse reaction is reduced semen volume during ejaculation. This effect resolves after discontinuation of Sidarso. Patients should inform their doctor if they are planning to have children.

Dizziness, including dizziness upon standing, and occasionally fainting may occur. If the patient feels unwell or experiences dizziness, they should immediately sit or lie down and remain lying until symptoms subside. If dizziness upon standing or fainting occurs, the doctor should be informed as soon as possible.

Sidarso may cause complications during cataract surgery (eye surgery due to lens clouding; see section "Warnings and precautions"). It is important that the patient immediately informs the ophthalmologist about current or past use of Sidarso.

Possible adverse reactions are listed below:

Very common adverse reactions (may affect more than 1 in 10 patients)

• Abnormal ejaculation (reduced or absent semen during sexual intercourse; see section "Warnings and precautions")

Common adverse reactions (may affect up to 1 in 10 patients)

• Dizziness, including dizziness upon standing (see also above in this section)
• Nasal congestion or sensation of a blocked nose
• Diarrhoea

Uncommon adverse reactions (may affect up to 1 in 100 patients)

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Faster heartbeat
• Skin allergic reactions such as rash, itching, urticaria, and drug eruption
• Abnormal liver function test results
• Low blood pressure

Rare adverse reactions (may affect up to 1 in 1,000 patients)

• Rapid or irregular heartbeat (so-called palpitations)
• Fainting and/or loss of consciousness

Very rare adverse reactions (may affect up to 1 in 10,000 patients)

• Other allergic reactions with facial or throat swelling

Frequency not known (frequency cannot be estimated from available data)

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

If the patient experiences any impact on sexual function, they should inform their doctor.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sidarso

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Sidarso contains

• The active substance is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
• Other ingredients are: mannitol, sodium carboxymethyl starch (type A), sodium lauryl sulfate, and talc inside the capsule.
• Other ingredients in the capsule shell (body and cap): titanium dioxide (E 171), yellow iron oxide (E 172) (only in the 4 mg capsule), and gelatin in the capsule coating, as well as printing ink (black iron oxide (E 172), shellac, potassium hydroxide). See section 2, "Sidarso contains sodium".

What Sidarso looks like and contents of the pack
Hard capsule (capsule)
4 mg hard capsules: Hard, gelatin capsule, size 3. The body and cap of the capsule are brown-yellow in colour. The cap is printed with the black marking "S 4 mg". The capsule is filled with white powder.
8 mg hard capsules: Hard, gelatin capsule, size 0. The body and cap of the capsule are white. The cap is printed with the black marking "S 8 mg". The capsule is filled with white powder.
Sidarso is available in both strengths in packs containing:

• 30 hard capsules in non-perforated blisters.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, please contact the local representative of the Marketing Authorisation Holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00