Silodosin Krka

Package leaflet: Information for the patient

Silodosin Krka 4 mg hard capsules, 8 mg hard capsules

silodosin
Generic medicine
Please 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, pharmacist or nurse.
• 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Silodosina Krka is and what it is used for

Silodosina Krka belongs to a group of medicines called alpha-adrenoceptor antagonists.
Silodosina Krka is selective for receptors located in the prostate, bladder, and urethra. By blocking
these receptors, the medicine causes relaxation of the smooth muscle in these tissues. This makes
urination easier and relieves symptoms.
What Silodosina Krka is used for
Silodosina Krka is used in adult men for the treatment of urinary symptoms associated with
benign enlargement of the prostate (benign prostatic hyperplasia), such as:

• difficulty starting to urinate,
• sensation of not having completely emptied the bladder,
• frequent need to urinate, including at night.

2. What you need to know before taking Silodosin Krka

Do not take Silodosin Krka:

• 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 taking Silodosin Krka.

• If you are scheduled for eye surgery due to clouding of the lens (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken Silodosin Krka. 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 such surgery. The ophthalmologist will take appropriate precautions regarding the medicines and surgical techniques to be used. Ask your doctor whether it is necessary to postpone or temporarily discontinue treatment with Silodosin Krka prior to cataract surgery.
• If you have previously fainted or felt dizzy upon standing up suddenly, inform your doctor before taking Silodosin Krka. Dizziness upon standing may occur while taking Silodosin Krka, and occasionally fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and using machines”).
• Do not take Silodosin Krka if you have severe liver problems, as the medicine has not been studied in patients with these conditions.
• If you have kidney problems, consult your doctor. If you have moderate kidney impairment, your doctor will start treatment with Silodosin Krka cautiously and may prescribe a reduced dose (see section 3 “Dosage”). You must not take Silodosin Krka if you have severe kidney disease.
• Since benign enlargement of the prostate and prostate cancer may present with similar symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosin Krka. Silodosin Krka is not a treatment for prostate cancer.
• Treatment with Silodosin Krka may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect reverses after stopping treatment with Silodosin Krka. Inform your doctor if you intend to father children.

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

Other medicines and Silodosin Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially medicines called alpha1-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with Silodosin Krka.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used to treat HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), because these medicines may increase the concentration of Silodosin Krka in the blood.
• medicines used for erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodosin Krka may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Krka may be reduced.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Since Silodosin Krka is used to treat men with benign prostate enlargement, it is not intended for use in women.

Fertility
Silodosin Krka may reduce the amount of semen, resulting in a temporary reduction in the ability to father children.

Driving and using machines
Do not drive or operate machinery if you feel faint, dizzy, or sleepy, or if you have blurred vision.

Silodosin Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Silodosin Krka

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 8 mg Silodosin Krka capsule daily, taken orally.
Take the capsule always with a meal, preferably at the same time each day. Do not crush or
chew the capsule; swallow it whole, preferably with a glass of water.

Patients with kidney problems
If you have moderate kidney problems, your doctor may prescribe a different dose. For these cases,
Silodosin Krka 4 mg hard capsules are available.

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

If you forget to take Silodosin Krka
If you forget to take a capsule, you may take it later the same day. If it is almost time for the next dose,
skip the missed dose. Do not take a double dose to make up for the forgotten capsule.

If you stop taking Silodosin Krka
If you stop treatment, symptoms may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives, as these may become severe.

The most common side effect is a reduction in the amount of semen released during sexual intercourse. This effect disappears after stopping treatment with Silodosina Krka. Inform your doctor if you wish to have children.

Dizziness may occur, even when standing up, and occasionally fainting.
If you feel weak or dizzy, sit or lie down immediately until symptoms resolve. If you experience dizziness upon standing or episodes of fainting, inform your doctor as soon as possible.

Silodosina Krka may cause complications during cataract surgery (eye surgery performed to treat clouding of the lens; see section “Warnings and precautions”).
It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken Silodosina Krka.

The possible side effects are listed below:

Very common side effects (may affect more than 1 in 10 people)

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

Common side effects (may affect up to 1 in 10 people)

• Dizziness, even when standing up (also see above in this section)
• Runny or stuffy nose
• Diarrhoea

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

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty in achieving or maintaining an erection
• Increased heart rate
• Skin allergic reactions such as rash, itching, hives, and drug-induced skin eruptions
• Abnormal liver function tests
• Low blood pressure

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

• Rapid or irregular heartbeat (called palpitations)
• Fainting/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

Not known (frequency cannot be estimated from the available data)

• Intraoperative floppy iris syndrome (IFIS) during cataract surgery (also see above in this section)

If you think this medicine is affecting your sexual life, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silodosin Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date 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.
Keep the medicine in the original packaging to protect it from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Silodosina Krka contains

• The active substance is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
• The other components are mannitol (E421), sodium starch glycolate (type A), sodium lauryl sulfate, talc in the capsule content.
• The other components of the hard capsules (body and cap) are titanium dioxide (E171), yellow iron oxide (E172) ( for 4 mg capsules only ), gelatin in the capsule shell, and printing ink (shellac, black iron oxide (E172), potassium hydroxide) on the cap only. See section 2 “Silodosina Krka contains sodium”.

Description of the appearance of Silodosina Krka and package contents
Hard capsule (capsule).
4 mg hard capsules (capsules): Hard gelatin capsule, size 3. The body and cap of the capsule are light brownish yellow in colour. The cap is printed with the black mark "S 4 mg". The capsule content is a white powder.
8 mg hard capsules (capsules): Hard gelatin capsule, size 0. The body and cap of the capsule are white. The cap is printed with the black mark "S 8 mg". The capsule content is a white powder.
Silodosina Krka in all strengths is available in cardboard boxes containing:

• 30 or 90 hard capsules in non-perforated blisters.

Not all pack sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names