SILODOSINA 4 mg Kapsułki Twarde

Treść ulotki

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

Silodosina Mylan 4 mg hard capsules, 8 mg hard capsules

Equivalent Medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any undesirable effect occurs, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is Silodosina Mylan
Silodosina Mylan belongs to a group of medicines called alpha-adrenoceptor inhibitors.
Silodosina Mylan 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 Mylan used for
Silodosina Mylan 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 you take Silodosina Mylan

Do not take Silodosina Mylan
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 Mylan

• 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 Mylan. This is because some patients treated

with this type of medicine have shown a loss of iris muscle tone (the
circular colored 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
Mylan in case of cataract surgery.

• If you have fainted or felt dizzy when getting up suddenly in the past, tell your doctor before taking Silodosina Mylan. Taking Silodosina Mylan 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 Mylan, 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 Mylan with caution and possibly with a reduced dose (see section 3 “Dose”). If you have a severe kidney disease, you should not take Silodosina Mylan.
• 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 Mylan. Silodosina Mylan is not a treatment for prostate cancer.
• Treatment with Silodosina Mylan may cause 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 Mylan. 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 Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
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 Mylan.
• 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 may increase the concentration of Silodosina Mylan in the blood.
• medicines used if you have problems getting or maintaining an erection(such as sildenafil or tadalafil), because concomitant use with Silodosina Mylan may slightly reduce blood pressure.
• medicines used for epilepsy or rifampicin(a medicine used to treat tuberculosis), because the effect of Silodosina Mylan may be reduced. Pregnancy and fertility

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

Driving and using machines
Do not drive and do not use machines if you feel faint, if you feel dizzy or drowsy, or if you have
blurred vision.

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

3. How to take Silodosina Mylan

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 Mylan 8 mg capsule daily by oral route.
Take the capsule always 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 Mylan 4 mg hard capsules are available.

If you take more Silodosina Mylan 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 Mylan
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 Mylan
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 Mylan. 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, inform your doctor as soon as possible.
Silodosina Mylan may cause complications during a cataract surgery(surgical
procedure on the eye performed to correct lens opacity, see the paragraph
“Warnings and precautions”).
It is important that you immediately inform the ophthalmologist if you are using or have used Silodosina Mylan
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 activity, see paragraph “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 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 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 (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, 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 http:// 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 Mylan

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
Expiry/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 eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Silodosina Mylan contains
Silodosina Mylan 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).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Silodosina Mylan 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).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of Silodosina Mylan and package contents
Silodosina Mylan 4 mg hard capsules
Hard gelatin capsule, yellow, opaque, size 3, with "4" printed in black ink on the cap.
.
Silodosina Mylan 8 mg hard capsules
Gelatin capsule, white, opaque, hard, size 0, with "8" printed in black ink on the cap.
.

4mg:
Silodosina Mylan is available in packs containing 10, 30 and 100 capsules.

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

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
Manufacturer
Rontis Hellas Medical and Pharmaceutical, Products S.A, P.O Box 3012 Larisa Industrial Area 41004,
Larisa, Greece

This medicinal product is authorised in the Member States of the EEA with the following denominations:
HU: Silodosin Mylan 4 mg, 8 mg kemény kapszula
ES: Silodosina Mylan cápsulas duras EFG
FR: Silodosine Mylan 4 mg et 8 mg, gélule
IT: Silodosina Mylan
PT: Silodosina Mylan
SK: Silodosin Mylan 4 mg
Silodosin Mylan 8 mg