SILODOSINA 4 mg Hard Capsules

Зміст інструкції

1. SILODOSINA DOC 4 mg hard capsules, 8 mg hard capsules
   1. What is SILODOSINA DOC and what is it used for
   2. What you need to know before taking SILODOSINA DOC
   3. How to take SILODOSINA DOC
   4. Possible side effects
   5. How to store SILODOSINA DOC
   6. Package contents and other information

SILODOSINA DOC 4 mg hard capsules, 8 mg hard capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 is SILODOSINA DOC and what it is used for

• 1. What you need to know before you take SILODOSINA DOC
• 2. How to take SILODOSINA DOC
• 3. Possible side effects
• 4. How to store SILODOSINA DOC
• 5. Contents of the pack and other information

1. What is SILODOSINA DOC and what is it used for

What is SILODOSINA DOC
SILODOSINA DOC belongs to a group of medicines called alpha 1A-adrenoceptor inhibitors.
SILODOSINA DOC 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 DOC used for
SILODOSINA DOC 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,
• frequent need to urinate, even at night.

2. What you need to know before taking SILODOSINA DOC

Do not take SILODOSINA DOC
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 SILODOSINA DOC

• If you are going to have eye surgery for a clouded lens (cataract surgery), it is important that you immediately inform your doctor that you are using or have used in the past SILODOSINA DOC. 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 to be used. Ask your doctor if it is necessary to postpone or temporarily interrupt
  treatment with SILODOSINA DOC in case of cataract surgery.

If you have previously fainted or felt dizzy when getting up suddenly, tell your doctor before taking SILODOSINA DOC. Taking SILODOSINA DOC 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”).

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

Other medicines and SILODOSINA DOC
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 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 DOC. -
• antifungal medicines(such as ketoconazole or itraconazole), medicines usedto treat HIV/AIDS(such as ritonavir) or medicines used after atransplant to prevent organ rejection(such as cyclosporine), because these medicines may increase the concentration of SILODOSINA DOC in the blood. -
• medicines used for erectile dysfunction or to maintain an erection(such as sildenafil or tadalafil), because concomitant use with SILODOSINA DOC may slightly reduce blood pressure. -
• medicines for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of SILODOSINA DOC may be reduced. -

Pregnancy and breastfeeding
Pregnancy
Since SILODOSINA DOC is used to treat men with an enlarged
benign prostate, it is not indicated for women. .
Fertility
SILODOSINA DOC may reduce the amount of semen, leading temporarily to a
reduced chance of having a child.

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

SILODOSINA DOC 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 DOC

Take 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 DOC 8mg capsule daily by oral route.
Always take the capsule with food, 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, it is
available SILODOSINA DOC 4mg hard capsules.

If you take more SILODOSINA DOC 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 DOC
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 forgotten dose. Do not take a double dose to
make up for the forgotten capsule.

If you stop taking SILODOSINA DOC
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 intercourse. This effect disappears after stopping treatment with SILODOSINA
DOC. 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, tell your
doctor as soon as possible.
SILODOSINA DOC 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
DOC previously.
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 stuffy nose
• Diarrhea

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

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• 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 heartbeats (so-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 (the 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, report it to your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store SILODOSINA DOC

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 package and on the 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 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 DOC contains
SILODOSINA DOC 4 mg hard capsules
The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.
The other ingredients are:

• Capsule content: 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 DOC 8 mg hard capsules
The active ingredient is silodosin. Each capsule contains 8 mg of silodosin.
The other ingredients are:

• Capsule content: 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 the appearance of SILODOSINA DOC and package contents
SILODOSINA DOC 4 mg hard capsules
Hard gelatin capsule, yellow, opaque, size 3, with "4" printed with black ink on the
cap.
SILODOSINA DOC 8 mg hard capsules
Hard gelatin capsule, white, opaque, size 0, with "8" printed with black ink
on the cap.
SILODOSINA DOC is available in packs containing 30 capsules.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
DOC Generici S.r.l. - Via Turati, 40 - 20121 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
with the following names:
Hungary: SILODOSIN DOC
Italy: SILODOSINA DOC