SILODOSIN KRKA 8 mg HARD CAPSULES

2. What you need to know before you take Silodosin Krka

Do not take silodosin

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• If you are going to have eye surgery for cataracts, it is important that you inform your ophthalmologist immediately that you are using or have previously used silodosin. This is because some patients treated with this type of medicine have suffered a loss of muscle tone in the iris (the colored part of the eye) during this type of surgery. The ophthalmologist may then take appropriate precautions regarding the medical and surgical techniques to be employed. Ask your doctor if it is necessary or not to postpone or temporarily interrupt treatment with silodosin when you are going to undergo cataract surgery.

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

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

• If you have severe liver problems, you should not take silodosin, as it has not been evaluated in this situation.

• If you have kidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will start treatment with silodosin with caution and possibly with a lower dose (see section 3 "Dosage"). If your kidney problems are severe, you should not take this medicine.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin is not used to treat 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 treatment with silodosin. Inform your doctor if you are planning to have children.

Children and adolescents

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

Other medicines and silodosin

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

Tell your doctor in particular 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 will increase during the use of this medicine.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after transplants to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of silodosin.
• medicines used to treat problems 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 to treat benign prostatic hyperplasia in men, it is not for use in women.

Fertility

Silodosin may reduce the amount of semen, which may temporarily affect male fertility.

Driving and using machines

Do not drive or operate machines if you feel faint, dizzy, or sleepy, or

have 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 Silodosin Krka

Follow exactly the instructions of administration of this medicine indicated 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 by oral administration.

Take the capsule always 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.

Patient with kidney problems

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

If you take more Silodosin Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 Krka

You can take the capsule later the same day if you forget to take it before. 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 missed capsule.

If you stop taking Silodosin Krka

If you stop treatment, your symptoms may reappear.

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.

Get in touch with your doctor immediately if you experience any of the following allergic reactions, as their consequences could be serious: swelling of the face or throat, difficulty breathing, feeling of fainting, itching of the skin, or hives.

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

Dizziness, including dizziness when standing up, and, occasionally, fainting may occur.

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

Silodosin may cause complications during cataract surgery (eye surgery for cataracts; see section "Warnings and precautions").

It is important that you inform your ophthalmologist immediately if you are using or have previously used silodosin.

Possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or negligible amount of semen is expelled during sexual intercourse; see section "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)
• Nasal congestion or obstruction
• Diarrhea

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

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Allergic reactions affecting the skin, such as rash, itching, hives, and drug-induced rash

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

• Rapid or irregular heartbeats (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

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

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

Tell your doctor if you notice that your sexual intercourse is affected.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Krka

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 carton and blister after "EXP". The expiry date is the last day of the month shown.

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. These measures will help 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 ingredients are mannitol (E421), sodium carboxymethyl starch (type A) (from potato), sodium lauryl sulfate, talc in the capsule contents.
• The other ingredients 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 ink (shellac, black iron oxide (E172), potassium hydroxide) only on the capsule cap. See section 2 "Silodosin Krka contains sodium".

Appearance and packaging

Hard capsule (capsule)

4 mg hard capsules (capsules): Hard gelatin capsules size 3. The body and cap of the capsule are yellow-brown in color. The cap of the capsule is printed with black mark S 4 mg. The contents of the capsule are white powder.

8 mg hard capsules (capsules): Hard gelatin capsules size 0. The body and cap of the capsule are white in color. The cap of the capsule is printed with black mark S 8 mg. The contents of the capsule are white powder.

Silodosin Krka of all strengths is available in boxes containing:

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

Not all 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

You can obtain further information on this medicine 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 last revision of this leaflet: April 2019.

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