SILODOSINA 4 mg Kapsułki Twarde

Treść ulotki

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

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

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

What is Silodosina Sandoz
Silodosina Sandoz belongs to a group of medicines called alpha-adrenoceptor blockers.
Silodosina Sandoz is selective for the receptors located in the prostate, bladder and urethra. Through the
blockage 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 Sandoz used for
Silodosina Sandoz 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 Sandoz

Do not take Silodosina Sandoz
If you are allergic to silodosin or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor before taking Silodosina Sandoz

• 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 Sandoz. 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 Sandoz in the event of cataract surgery.
• If you have previously fainted or felt dizzy when getting up suddenly, tell your doctor before taking Silodosina Sandoz.

Dizziness may occur when standing up and,
occasionally, fainting, especially at the beginning of treatment or if you are taking other medicines
that lower blood pressure when taking Silodosina Sandoz. In this case, sit or lie down immediately until
the symptoms disappear and inform your doctor as soon as possible (see also the section “Driving and using machines”).

• If you have severe liver problems, you should not take Silodosina Sandoz, because the medicine has not been studied in 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 Sandoz with
caution and possibly with a reduced dose (see section 3).
If you have severe kidney disease, you should not take Silodosina Sandoz.

• 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 Sandoz. Silodosina Sandoz is not a treatment for prostate cancer.

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 Sandoz
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 Sandoz.

antifungal medicines(such as ketoconazole or itraconazole), medicines used to treat
HIV/AIDS(such as ritonavir) or medicines used after a transplant to
prevent organ rejection(such as cyclosporine), because these medicines can
increase the concentration of Silodosina Sandoz in the blood.

medicines used if you have problems getting or maintaining an erection(such as
sildenafil or tadalafil), because concomitant use with Silodosina Sandoz may slightly reduce
blood pressure.

medicines for epilepsy or rifampicin(a medicine used to treat
tuberculosis), because the effect of Silodosina Sandoz may be reduced.

Fertility
Treatment with Silodosina Sandoz may lead to abnormal ejaculation (reduction in the amount of
sperm released during sexual intercourse), which may temporarily impair male fertility.
This effect disappears after stopping treatment with Silodosina Sandoz. Tell your
doctor if you wish to have children.

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

Silodosina Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Silodosina Sandoz

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose is one Silodosina Sandoz 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 Sandoz 4 mg hard capsules are available.

If you take more Silodosina Sandoz 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 Sandoz
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 Sandoz
If you stop the treatment, the symptoms may reappear
If you have any further 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
activity. This effect disappears after stopping treatment with Silodosina Sandoz. 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 Sandoz can 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 your ophthalmologist if you are using or have used Silodosina Sandoz in
the past.
Possible side effects are listed below:

Very common side effects (may affect more than 1 in 10 people)
sexual, see paragraph “Fertility”)

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
• Fast heartbeat
• 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 1,000 people)

• Fast or irregular heartbeats (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 from 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
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 Sandoz

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 or the packaging, 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 store at
a temperature above 30°C.
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 Sandoz contains
Silodosina Sandoz 4 mg hard capsules

• The active ingredient is silodosin. Each hard capsule contains 4 mg of silodosin.

Silodosina Sandoz 8 mg hard capsules

• The active ingredient is silodosin. Each hard capsule contains 8 mg of silodosin.
• The other ingredients are Capsule contents: mannitol (E421), pregelatinized starch, sodium lauryl sulfate (E487), magnesium stearate (E470b)

Capsule shell: titanium dioxide (E171), gelatin (E441)
Printing ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525)

Description of Silodosina Sandoz and package contents
Silodosina Sandoz 4 mg hard capsules
White hard capsule, marked with ink with an “S” on the cap and a “4” on the body,
containing a fine white or almost white powder.
Approximate length: 29.2 mm

Silodosina Sandoz 8 mg hard capsules
White hard capsule, marked with ink with an “S” on the cap and an “8” on the body,
containing a fine white or almost white powder.
Approximate length: 21.7 mm
Silodosina Sandoz is packaged in PVC/PVDC-aluminum blisters
Pack sizes:
Blisters: 30 hard capsules
Unit dose blisters: 10x1 and 30x1 hard capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer

• J. Uriach y Compañía S.A. Av ingu da Camí Reial, 51-57 Palau Solità i Plegamans, 08184 Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France SILODOSINE SANDOZ 4 mg, capsule
SILODOSINE SANDOZ 8 mg, capsule
Italy Silodosina Sandoz
Netherlands Silodosine Sandoz 4 mg, hard capsules
Silodosine Sandoz 8 mg, hard capsules
Portugal Silodosina Sandoz
Slovenia Silodozin Sandoz 4 mg hard capsules
Silodozin Sandoz 8 mg hard capsules
Spain Silodosina Sandoz 4 mg hard capsules EFG
Silodosina Sandoz 8 mg hard capsules EFG