Prospect: information for the patient

Silodosina Krka 4 mg hard capsules EFG

Silodosina Krka 8 mg hard capsules EFG

silodosina

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Silodosina Krka

3. How to take Silodosina Krka

4. Possible adverse effects

5. Storage of Silodosina Krka

6. Contents of the package and additional information

What is silodosina

Silodosina belongs to a group of medications known as alpha 1A adrenergic receptor blockers.

Silodosina 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 alleviates your symptoms.

What is silodosina used for

Silodosina is used in adult males to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination,

• feeling of not fully emptying the bladder,

• more frequent need to urinate, even at night.

Do not take silodosina

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

Warnings and precautions

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

• If you are to undergo eye surgery for cataract (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used silodosina previously. This is because some patients treated with this type of medication have experienced a loss of iris muscle tone (the circular, colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions regarding medical and surgical techniques. Ask your doctor if you need to postpone or interrupt silodosina treatment temporarily when undergoing cataract surgery.

• If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking silodosina.

When taking silodosina, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

• If you havesevere liver problems, you should not take silodosina, as it has not been evaluated in this situation.

• If you havekidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start silodosina treatment with caution and possibly with a lower dose (see section 3 “Doses”). If your kidney problems are severe, you should not take this medication.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting silodosina treatment. Silodosina is not used to treat prostate cancer.

• Silodosina treatment may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping silodosina treatment. Inform your doctor if you are planning to have children.

Children and adolescents

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

Other medications and silodosina

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

Inform your doctor in particular if you take:

•blood pressure-lowering medications(especially alpha blockers such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during silodosina use.

•antifungal medications(such as ketoconazole or itraconazole),medications used to treat HIV/AIDS(such as ritonavir), ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase silodosina blood concentrations.

•medications used to treat erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with silodosina may lead to a slight decrease in blood pressure.

•medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of silodosina may be reduced.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

Since silodosina is used to treat benign prostatic hyperplasia in men, it is not intended for use in women.

Fertility

Silodosina may reduce semen volume, which may temporarily affect male fertility.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, drowsiness, or blurred vision.

Silodosina Krka contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule of silodosina 8 mg per day by oral administration.

Take the capsule always accompanied by food, preferably at the same time every 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 problems, your doctor may prescribe a different dose. For this purpose, the silodosina 4 mg hard capsules presentation is available.

If you take more silodosina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.If you feel dizzy or weak, inform your doctor immediately.

If you forgot to take silodosina

You can take the capsule later the same day if you forgot 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 compensate for the missed capsule.

If you interrupt the treatment with silodosina

If you interrupt the treatment, it is possible that the symptoms will reappear.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

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

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be severe: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or urticaria.

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

You may experiencedizziness, including dizziness when standing up, and, occasionally,fainting.

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

Silodosinamay cause complications duringcataract surgery(eye surgery for cloudy lens; see "Warnings and precautions").

It is essential that youinform your ophthalmologist immediatelyif you are using or have previously usedsilodosina.

The possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or imperceptible amount of semen is expelled 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)

• Nasal secretion or obstruction

• Diarrhea

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

• Loss of sexual appetite

• Nausea

• Dry mouth

• Difficulty achieving or maintaining an erection

• Increased heart rate

• Skin allergy symptoms, such as rash, itching, urticaria, and drug-induced rash

• Abnormal liver function test results

• Low blood pressure

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

Unknown frequency (frequency cannot be estimated from available data)

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

Inform your doctor if you notice that your sexual relations are affected.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Silodosina Krka

• The active ingredient is silodosina. Each hard capsule contains 4 mg or 8 mg of silodosina.
• The other components are mannitol (E421), carboxymethylcellulose sodium (type A) (from potato), 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) (only for 4 mg capsules) and gelatin in the capsule coating and black printing ink (shellac, black iron oxide (E172), potassium hydroxide) only on the capsule cap.See section 2 “Silodosina Krka contains sodium”.

Appearance of the product and contents of the package

Hard capsule (capsule)

4 mg hard capsules (capsules): Hard gelatin capsules size 3. The body and cap of the capsule are light brown. 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. The cap of the capsule is printed with black mark S 8 mg. The contents of the capsule are white powder.

Silodosina Krka of all doses is available in boxes containing:

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

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

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Last review date of this leaflet: April 2019.

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