SILODOSINA 4 mg Hard Capsules

Зміст інструкції

1. Silodosina Krka 4 mg hard capsules, 8 mg hard capsules
   1. What is Silodosina Krka and what is it used for
   2. What you need to know before taking Silodosina Krka
   3. How to take Silodosina Krka
   4. Possible side effects
   5. How to store Silodosina Krka
   6. Package Contents and Other Information

Silodosina Krka 4 mg hard capsules, 8 mg hard capsules

silodosina

Generic medicine

Read 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Silodosina Krka belongs to a group of medicines called alpha-adrenoceptor inhibitors.
Silodosina Krka is selective for the receptors located in the prostate, bladder and urethra. Through the
blockade of these receptors, the medicine relaxes the smooth muscle of these tissues. This makes it easier to
urinate and relieves the symptoms.

What is Silodosina Krka used for
Silodosina Krka is used in adult men for the treatment of urinary symptoms associated
with benign prostatic enlargement (prostatic hyperplasia), such as:

• difficulty starting to urinate,
• feeling of not completely emptying the bladder,
• frequent need to urinate, even at night.

2. What you need to know before taking Silodosina Krka

Do not take Silodosina Krka:

• if you are allergic to silodosina 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 Silodosina Krka.

• If you are to undergo eye surgery for a cataract (cataract surgery), it is important that you immediately inform your ophthalmologist that you are using or have used Silodosina Krka in the past. This is because some patients treated with this type of medicine have experienced a 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 that will be used. Ask your doctor if it is necessary to postpone or temporarily interrupt treatment with Silodosina Krka in the event of cataract surgery.
• If you have previously fainted or felt dizzy when getting up suddenly, tell your doctor before taking Silodosina Krka. Taking Silodosina Krka may cause dizzinesswhen standing up and, occasionally, fainting, particularly at the beginning of treatment or if you are taking other medicines that lower blood pressure. In such cases, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also section “Driving and using machines”).
• If you have severe liver problems, you should not take Silodosina Krka, because the medicine has not been studied in patients with these conditions.
• If you have kidney problems, ask your doctor for advice. If you have moderate kidney problems, your doctor will start treatment with Silodosina Krka with caution and possibly with a reduced dose (see section 3 “Dose”). If you have a severe kidney disease, you should not take Silodosina Krka.
• Since an enlarged benign prostate and prostate cancer can present with the same symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosina Krka. Silodosina Krka is not a treatment for prostate cancer.
• Treatment with Silodosina Krka may lead to abnormal ejaculation (reduced amount of semen released during sexual intercourse), which may temporarily impair male fertility. This effect disappears after stopping treatment with Silodosina Krka. Tell your doctor if you wish to have children.

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

Other medicines and Silodosina Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 Silodosina Krka.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used againstHIV/AIDS infection(such as ritonavir) or medicines used after a transplant toprevent organ rejection(such as cyclosporine), because these medicines can increase the concentration of Silodosina Krka in the blood.
• medicines used if you have problems getting or maintaining an erection(such as sildenafil or tadalafil), because concomitant use with Silodosina Krka may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of Silodosina Krka may be reduced.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Since Silodosina Krka is used to treat men with benign prostatic enlargement,
it is not intended for use in women.
Fertility
Silodosina Krka may reduce the amount of semen, with a temporary reduction in the ability to have
children.

Driving and using machines
Do not drive or use machines if you feel faint, dizzy or sleepy, or if your vision is
blurred.

Silodosina Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Silodosina Krka

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one Silodosina Krka 8 mg capsule daily by oral route.
Always take the capsule with a meal, preferably at the same time each day. Do not crush or chew the capsule, but 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, Silodosina Krka 4 mg hard capsules are available.

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

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

If you stop taking Silodosina Krka
If you stop the treatment, the symptoms may return.
If you have any questions about 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.
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, because the
consequences can become serious.
The most common side effect is a reduction in the amount of semen emitted during sexual
intercourse. This effect disappears after stopping treatment with Silodosina Krka. Tell your
doctor if you wish to have children.
Dizzinessmay occur, even when getting up, and, occasionally, fainting.
If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear. If you feel dizzy when getting up or in case of fainting, tell your doctor as
soon as possible.
Silodosina Krka may cause complications during a cataract surgery(surgical
procedure on the eye performed to correct lens opacity, see the section “Warnings and
precautions”).
It is important that you immediately inform your ophthalmologist if you are using or have used Silodosina Krka in
the past.
The possible side effects are listed below:

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

• Abnormal ejaculation (reduction or absence of semen emission during sexual intercourse, see section “Warnings and precautions”)

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

• Dizziness, even when getting up (see also above, in this paragraph)
• Runny or blocked nose
• Diarrhea

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

• Decreased libido
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• Fast heartbeat
• Symptoms of an allergic skin reaction, such as rash, itching, hives and drug-induced rash
• Abnormal liver function tests
• Low blood pressure

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

• Fast 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 based on available data)

• Flag pupil during cataract surgery (see also above, in this paragraph)

If you think there are effects on your sex life, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through 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 Silodosina 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 blister and the package after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Silodosina Krka contains

• The active ingredient is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
• The other ingredients are mannitol (E421), sodium starch glycolate (type A), sodium lauryl sulfate, talc in the capsule content.
• The other ingredients of the hard capsules (body and cap) are titanium dioxide (E171), yellow iron oxide (E172) ( only for 4 mg capsules) gelatin in the capsule shell and printing ink (shellac, black iron oxide (E172), potassium hydroxide) only on the capsule cap. 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 brownish-yellow in color. The capsule 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 in color. The capsule cap is printed with the black mark S 8 mg. The content
of the capsule is a white powder.
Silodosina Krka in all dosages is available in boxes containing:

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

Not all pack sizes may be marketed.

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

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations