Silodosin Zentiva

Package leaflet: Information for the patient

Silodosin Zentiva 4 mg hard capsules, 8 mg hard capsules

Equivalent medicine
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Silodosina Zentiva is
Silodosina Zentiva belongs to a group of medicines called alpha-adrenoceptor blockers.
Silodosina Zentiva 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 Zentiva is used for
Silodosina Zentiva 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,
• feeling of not having completely emptied the bladder,
• need to urinate more frequently, including at night.

2. What you need to know before taking Silodosin Zentiva

Do not take Silodosin Zentiva
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 Zentiva

• 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 using or have previously used Silodosin Zentiva. 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 may be necessary to postpone or temporarily discontinue treatment with Silodosin Zentiva prior to cataract surgery.
• If you have previously fainted or felt dizzy upon standing up suddenly, inform your doctor before taking Silodosin Zentiva. Dizziness upon standing may occur while taking Silodosin Zentiva, and occasionally fainting, especially 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 symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).
• If you have severe liver problems, do not take Silodosin Zentiva, as the medicine has not been studied in patients with this condition.
• If you have kidney problems, consult your doctor. If you have moderate kidney impairment, your doctor will start treatment with Silodosin Zentiva cautiously and possibly at a reduced dose (see section 3 “Dosage”). If you have severe kidney disease, you must not take Silodosin Zentiva.
• 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 Zentiva. Silodosin Zentiva is not a treatment for prostate cancer.
• Treatment with Silodosin Zentiva may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect disappears after stopping treatment with Silodosin Zentiva. Inform your doctor if you wish to have 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 Zentiva
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 alpha-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 Zentiva.
• 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 Zentiva in the blood.
• medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodosin Zentiva may cause a slight reduction in blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Zentiva may be reduced.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Since Silodosin Zentiva is used to treat men with benign enlargement of the prostate,
it is not intended for use in women.
Fertility
Silodosin Zentiva may reduce the amount of semen, temporarily reducing the ability
to father a child.
Driving and use of machines
Do not drive and do not operate machinery if you feel faint, dizzy or drowsy, or if
you have blurred vision.
Silodosin Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is essentially
"sodium-free".

3. How to take Silodosin Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 8 mg Silodosin Zentiva 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 you a different dose. For these
cases, Silodosin Zentiva 4 mg hard capsules are available.

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

If you stop taking Silodosin Zentiva
If you stop treatment, symptoms may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, 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 Silodosin Zentiva.
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 subside. If you experience dizziness upon standing or episodes of fainting, inform your doctor as soon as possible.

Silodosin Zentiva 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 Silodosin Zentiva.

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, including when standing up (see also 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

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

• Intraoperative floppy iris syndrome during cataract surgery (see also above in this section). If you feel that this medicine is affecting your sexual life, inform your doctor.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
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 Zentiva

Keep this medicine out of the 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 that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via 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 Zentiva contains
Silodosina Zentiva 4 mg hard capsules:
The active substance is silodosin. Each capsule contains 4 mg of silodosin.
The other components are:
Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Black printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Silodosina Zentiva 8 mg hard capsules:
The active substance is silodosin. Each capsule contains 8 mg of silodosin.
The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171).
• Black printing ink: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of Silodosina Zentiva and package contents
Silodosina Zentiva 4 mg hard capsules:
Yellow, opaque hard gelatin capsules with the number "4" printed in black ink on the capsule body.
Silodosina Zentiva 8 mg hard capsules:
White, opaque hard gelatin capsules with the number "8" printed in black ink on the capsule body.

4 mg:
Silodosina Zentiva is available in packs containing 10, 30, 50 and 100 capsules.
8 mg:
Silodosina Zentiva is available in packs containing 30, 50 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milan
Italy

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O Box 3012 Larisa Industrial Area, Larisa
41004 Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Hungary: Szilodoszin Zentiva 4 mg, 8 mg kemény kapszula
Germany: Silodosin Zentiva 4 mg, 8 mg Hartkapseln
France: SILODOSINE ZENTIVA 4 mg, gélule
    SILODOSINE ZENTIVA 8 mg, gélule
Italy: Silodosina Zentiva