SILODOSINA 4 mg Kapsułki Twarde

Treść ulotki

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

Silodosina Zentiva 4 mg hard capsules

Silodosina Zentiva 8 mg hard capsules
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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

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

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

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

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

2. What you need to know before taking Silodosina Zentiva

Do not take Silodosina Zentiva
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 Zentiva

• 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 in the past Silodosina Zentiva. This is because some patients treated with this type of medicine have shown 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 Zentiva in case of cataract surgery.
• If you have previously fainted or felt dizzy when getting up suddenly, tell your doctor before taking Silodosina Zentiva. Taking Silodosina Zentiva may cause dizzinesswhen standing up and, occasionally, fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. In such a case, 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 Zentiva, 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 Zentiva with caution and possibly with a reduced dose (see section 3 “Dose”). If you have a severe kidney disease, you should not take Silodosina Zentiva.
• Since an enlarged benign prostate and prostate cancer can present the same symptoms, your doctor will check that you do not have prostate cancer before starting treatment with Silodosina Zentiva. Silodosina Zentiva is not a treatment for prostate cancer.
• Treatment with Silodosina Zentiva may lead to abnormal ejaculation (reduction in the amount of semen released during sexual intercourse), which may temporarily impair male fertility. This effect disappears after stopping treatment with Silodosina Zentiva. 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 Zentiva
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 take:

• 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 Silodosina Zentiva.
• antifungal medicines(such as ketoconazole or itraconazole), medicines usedagainst HIV/AIDS infection(such as ritonavir) or medicines used after atransplant to prevent organ rejection(such as cyclosporine), because these medicines may increase the concentration of Silodosina Zentiva in the blood.
• medicines used if you have problems getting or maintaining an erection(such as sildenafil or tadalafil), because concomitant use with Silodosina Zentiva may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of Silodosina Zentiva may be reduced.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Since Silodosina Zentiva is used to treat men with an enlarged benign prostate,
it is not indicated for women.
Fertility
Silodosina Zentiva may reduce the amount of semen, temporarily leading to a reduced ability
to conceive a child.

Driving and using machines
Do not drive and do not use machines if you feel faint, if you experience dizziness or drowsiness or if
your vision is blurred.

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

3. How to take Silodosina Zentiva

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

If you take more Silodosina 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, inform your doctor immediately.

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

If you stop taking Silodosina Zentiva
If you stop the treatment, the symptoms may reappear.
If you have any doubts 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
activity. This effect disappears after stopping treatment with Silodosina Zentiva.
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 standing up or in case of fainting, inform your doctor
as soon as possible.
Silodosina Zentiva 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 the ophthalmologist if you are using or have used Silodosina Zentiva in
the past.
The possible side effects are listed below:

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

• Abnormal ejaculation (reduced or unnoticeable semen emission during sexual activity, 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 stuffy nose
• Diarrhea

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

• Decreased libido
• Nausea
• Dry mouth
• Difficulty having or maintaining an erection
• Fast heart rate
• Symptoms of an allergic reaction affecting the skin, 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 1000 people)

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

Very rare side effects (may affect up to 1 in 10000 people)

• Other allergic reactions with swelling of the face or throat

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

• Small 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 or pharmacist. 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 Reporting side effects
can help provide more information on the safety of this
medicine.

5. How to store Silodosina Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister
after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice that the package is damaged or if it shows signs of tampering.
Do not dispose of any medicine in the 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 ingredient is silodosin. Each capsule contains 4 mg of silodosin.
The other ingredients are:

Capsule Contents: mannitol (E421), pregelatinized starch (corn), sodium lauryl sulfate,
glycerol 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 ingredient is silodosin. Each capsule contains 8 mg of silodosin.
The other ingredients are:

• Capsule Contents: mannitol (E421), pregelatinized starch (corn), sodium lauryl sulfate, glycerol 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 Silodosina Zentiva and Package Contents
Silodosina Zentiva 4 mg hard capsules:
Yellow, opaque hard gelatin capsules with "4" printed in black ink on the capsule.
Silodosina Zentiva 8 mg hard capsules:
White, opaque hard gelatin capsules with "8" printed in black ink on the capsule.
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milano
Italy

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

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