Silodosin Krka 8 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Silodosin Krka 4 mg hard capsules EFG

Silodosin Krka 8 mg hard capsules EFG

silodosin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse effects
5. How to store Silodosin Krka
6. Contents of the pack and other information

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

What silodosin is

Silodosin belongs to a group of medicines called alpha1A-adrenergic receptor blockers.

Silodosin is selective for 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 you to urinate and relieves your symptoms.

What silodosin is used for

Silodosin is used in adult men to treat urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia, BPH), such as:

• difficulty starting to urinate,
• sensation of not completely emptying the bladder,
• more frequent need to urinate, including during the night.

2. What you need to know before taking Silodosin Krka

Do not take silodosin

• 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 this medicine:

• 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. 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 this type of surgery. The ophthalmologist can then take appropriate precautions regarding the medical and surgical techniques to be used. Ask your doctor whether it is necessary to delay or temporarily interrupt silodosin treatment prior to cataract surgery.

• If you have ever fainted or felt dizzy upon standing suddenly, inform your doctor before taking silodosin.

When taking silodosin, dizziness and, occasionally, fainting may occur upon standing, especially when starting treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, you must not take silodosin, as it has not been evaluated in such cases.

• If you have kidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start silodosin treatment cautiously and possibly at a lower dose (see section 3 “Dosage”). If your kidney problems are severe, you must not take this medicine.

• Since benign prostatic enlargement and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting silodosin treatment. Silodosin is not effective for treating prostate cancer.

• Treatment with this medicine may lead to abnormal ejaculation (reduced amount of semen expelled during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping silodosin treatment. Inform your doctor if you are planning to have children.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as there are no relevant indications for this age group.

Other medicines and silodosin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially alpha-1 blockers such as prazosin or doxazosin), as there may be a potential risk that the effect of these medicines increases during treatment with silodosin.
• antifungal medicines (such as ketoconazole or itraconazol), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplants to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of silodosin.
• medicines used to treat difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), as their concomitant use with silodosin may lead to a slight decrease in blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as the effect of silodosin may be reduced.

Pregnancy, breastfeeding and fertility

Pregnancy and breastfeeding

Since silodosin is used for the treatment of benign prostatic enlargement in men, it is not intended for use in women.

Fertility

Silodosin may reduce the amount of semen, which may temporarily lead to reduced male fertility.

Driving and operating machinery

Do not drive or operate machinery if you experience dizziness, faintness, drowsiness, or blurred vision.

Silodosin Krka contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take/use Silodosin Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosin capsule per day, taken orally.

Always take the capsule with food, preferably at the same time each day. Do not break or chew the capsule; swallow it whole, preferably with a glass of water.

Patients with kidney problems

If you have moderate kidney impairment, your doctor may prescribe you a different dose. For this purpose, the 4 mg silodosin hard capsule formulation is available.

If you take more silodosin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. If you feel dizzy or weak, inform your doctor immediately.

If you forget to take silodosin

You may take the capsule later the same day if you forgot to take it earlier. 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 the forgotten capsule.

If you stop taking silodosin

If you stop treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following allergic reactions, as they could have serious consequences: swelling of the face or throat, difficulty breathing, feeling faint, skin itching, or hives.

The most common adverse effect is a reduction in the amount of semen ejaculated during sexual intercourse. This effect disappears after stopping treatment with silodosin. Inform your doctor if you are planning to have children.

Dizziness, including dizziness upon standing, and occasionally fainting, may occur.

If you feel weak or dizzy, sit or lie down immediately until symptoms subside. If you experience dizziness upon standing or fainting, inform your doctor as soon as possible.

Silodosin may cause complications during cataract surgery (eye surgery due to 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 silodosin.

The possible adverse effects are listed below:

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

• Abnormal ejaculation (a reduced or negligible amount of semen is expelled during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, including dizziness upon standing (see also above in this section)
• Nasal discharge or nasal congestion
• Diarrhea

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

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergic reactions such as rash, pruritus, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Fast or irregular heartbeat (called palpitations)
• Fainting/loss of consciousness

Very rare adverse 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 available data)

• Flaccid pupil during cataract surgery (see also above in this section)

Inform your doctor if you notice any changes in your sexual activity.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Krka

Keep this medicine out of 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 the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Krka

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

Appearance of the product and contents of the pack

Hard capsule (capsule)

4 mg hard capsules: Size 3 hard gelatin capsules. The body and cap of the capsule are yellowish-brown in colour. The cap is printed with a black mark "S 4 mg". The capsule contents are white powder.

8 mg hard capsules: Size 0 hard gelatin capsules. The body and cap of the capsule are white in colour. The cap is printed with a black mark "S 8 mg". The capsule contents are white powder.

All strengths of Silodosin Krka are available in packs containing:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information about this medicine is available from the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: April 2019.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).