Sidarso

Package Leaflet: Information for the Patient

Sidarso, 4 mg, Hard Capsules

Sidarso, 8 mg, Hard Capsules

Silodosin

Read the Package Leaflet Carefully Before Taking the Medication, 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Sidarso and What is it Used For
• 2. Important Information 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 is Sidarso and What is it Used For

What is Sidarso

Sidarso belongs to a group of medicines called alpha-adrenergic receptor antagonists.
Sidarso works 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 makes it easier for the patient to urinate and alleviates the symptoms of the disease.

What is Sidarso Used For

Sidarso 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 Sidarso

When Not to Take Sidarso

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

Warnings and Precautions

Before taking Sidarso, discuss with your doctor or pharmacist:

• If you are going to have eye surgery for cataracts, it is important to inform your eye doctor about your current or past use of Sidarso, 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 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 Sidarso in case of cataract surgery.
• If you have ever fainted or had dizziness when standing up, you should inform your doctor before taking Sidarso. During treatment with Sidarso, dizziness when standing up and, rarely, fainting may occur, especially at the beginning of treatment or when taking other blood pressure-lowering medications. 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 Sidarso, as it 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 Sidarso with caution and probably use a lower dose (see section 3 "How to Take Sidarso"). If you have severe kidney disease, you should not take Sidarso.
• Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, before starting treatment with Sidarso, your doctor will perform tests to rule out prostate cancer. Sidarso does not treat prostate cancer.
• Taking Sidarso may lead to abnormal ejaculation (reduced or absent semen during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping Sidarso. You should inform your doctor if you plan to have children.

Children and Adolescents

Sidarso should not be given to children and adolescents under 18 years of age, as there are no indications for its use in this age group.

Sidarso 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:

• blood pressure-lowering medicines(especially alpha-adrenergic blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be enhanced when taking Sidarso.
• antifungal medicines(such as ketoconazole or itraconazole), HIV and/or AIDS medicines(such as ritonavir), or medicines used to prevent organ rejection after transplantation(such as cyclosporine), as these medicines may increase the levels of Sidarso in your blood.
• medicines used to treat difficulties in achieving or maintaining an erection(such as sildenafil or tadalafil), as taking them with Sidarso may lead to a slight decrease in blood pressure.
• medicines used to treat epilepsy or rifampicin(an anti-tuberculosis medicine), as the effect of Sidarso may be reduced.

Pregnancy, Breast-feeding, and Fertility

Pregnancy and breast-feeding
This does not apply, as Sidarso is used in men with benign prostatic hyperplasia and is not intended for use in women.
Fertility
Sidarso may reduce the amount of semen, leading to temporary reduced fertility in men.

Driving and Using Machines

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

Sidarso Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to Take Sidarso

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 Sidarso capsule per day, taken orally.
The capsule should always be taken with food, preferably at the same time every day. Do not break 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, 4 mg Sidarso hard capsules are available.

Taking More Than the Recommended Dose of Sidarso

If you take 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 Sidarso

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 Sidarso

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately contact your doctor if you notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, fainting, itching, or hives, as they can be serious.
The most common side effect is abnormal ejaculation (reduced or absent semen during sexual intercourse). This effect disappears after stopping Sidarso. You should inform your doctor if you plan to have children.
Dizziness, including dizziness when standing up, and rarely fainting, may occur. If you feel weak or dizzy, you should 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.
Sidarso may cause complications during cataract surgery (eye surgery due to lens clouding, see "Warnings and Precautions").
It is important that you inform your eye doctor about your current or past use of Sidarso.
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 sex drive
• 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 any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Sidarso

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package to protect from light and moisture.
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 Sidarso Contains

• The active substance is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
• The other ingredients are: mannitol, sodium carboxymethylcellulose (type A), sodium lauryl sulfate, talc inside the capsule.
• The other ingredients are (body and cap): titanium dioxide (E 171), yellow iron oxide (E 172) (only in the 4 mg capsule) and gelatin in the capsule shell, and ink (iron oxide black (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 (capsules): Hard, gelatin capsule, size 3. The body and cap of the capsule are brown-yellow in color. The cap is printed with a black mark "S 4 mg". The capsule is filled with a white powder.
8 mg, hard capsules (capsules): Hard, gelatin capsule, size 0. The body and cap of the capsule are white in color. The cap is printed with a black mark "S 8 mg". The capsule is filled with a white powder.
Sidarso for both strengths is available in packs containing:

• 30 hard capsules in non-perforated blisters.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, please contact your local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of Last Revision of the Leaflet: