Silodosin Sandoz

Package leaflet: Information for the patient

Silodosin Sandoz 4 mg hard capsules, 8 mg hard capsules

Equivalent medicine
Please read all of 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Silodosina Sandoz is
Silodosina Sandoz belongs to a group of medicines called alpha-blockers.
Silodosina Sandoz 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 Sandoz is used for
Silodosina Sandoz 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,
• sensation of not having completely emptied the bladder,
• frequent need to urinate, including at night.

2. What you need to know before taking Silodosin Sandoz

Do not take Silodosin Sandoz
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 before taking Silodosin Sandoz:

• 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 taking or have previously taken Silodosin Sandoz. 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 is necessary to postpone or temporarily discontinue treatment with Silodosin Sandoz prior to cataract surgery.
• If you have previously fainted or experienced dizziness upon standing up suddenly, inform your doctor before taking Silodosin Sandoz.

Dizziness upon standing up and, occasionally, fainting may occur when taking Silodosin Sandoz,
particularly at the beginning of treatment or if you are taking other medicines that lower blood
pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• Do not take Silodosin Sandoz if you have severe liver problems, as the medicine has not been studied under these conditions.
• If you have kidney problems, consult your doctor.

If you have moderate kidney problems, your doctor will start treatment with Silodosin Sandoz cautiously and may prescribe a reduced dose (see section 3).
Do not take Silodosin Sandoz if you have severe kidney disease.

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

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 Sandoz
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 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 Silodosin Sandoz.
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 Sandoz in the blood.
Medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodosin Sandoz may slightly reduce blood pressure.
Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Sandoz may be reduced.

Fertility
Treatment with Silodosin Sandoz may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect reverses after discontinuation of Silodosin Sandoz treatment. Inform your doctor if you wish to have children.

Driving and use of machines
Do not drive or operate machinery if you feel faint, experience dizziness or drowsiness, or have blurred vision.

Silodosin 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 Silodosin Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Silodosin Sandoz 8 mg 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, but 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 Sandoz 4 mg hard capsules are available.

If you take more Silodosin 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, contact your doctor immediately.

If you forget to take Silodosin Sandoz
If you have forgotten 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 missed capsule.

If you stop taking Silodosin Sandoz
If you stop treatment, your symptoms may return.
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 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 Sandoz. Inform your doctor if you wish to have children.

Dizziness, even when standing up, and occasionally fainting, may occur.
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 Sandoz 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 Sandoz.

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 “Fertility”)

Common side effects (may affect up to 1 in 10 people)

• Dizziness, even when standing up (also see 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 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)

• 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

Not known (frequency cannot be estimated from the available data)

• Intraoperative floppy iris syndrome (IFIS) during cataract surgery (also see above in this section)

If you feel there are effects on your sexual life, report this to your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Silodosin Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton, following
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 above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Silodosina Sandoz contains
Silodosina Sandoz 4 mg hard capsules

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

Silodosina Sandoz 8 mg hard capsules

• The active substance is silodosin. Each hard capsule contains 8 mg of silodosin.
• The other components 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), iron oxide black (E172), potassium hydroxide (E525)

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

Silodosina Sandoz 8 mg hard capsules
White hard capsule, printed with ink with an "S" on the cap and an "8" on the body, containing a white or almost white fine powder.
Approximate length: 21.7 mm

Silodosina Sandoz is packaged in PVC/PVDC-aluminum blisters.
Pack sizes:
Blister packs: 30 hard capsules
Unit dose blister packs: 10x1 and 30x1 hard capsules
Not all pack sizes may be marketed.

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

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France SILODOSINE SANDOZ 4 mg, gélule
SILODOSINE SANDOZ 8 mg, gélule
Italy Silodosina Sandoz
Netherlands Silodosine Sandoz 4 mg, harde capsules
Silodosine Sandoz 8 mg, harde capsules
Portugal Silodosina Sandoz
Slovenia Silodozin Sandoz 4 mg trde kapsule
Silodozin Sandoz 8 mg trde kapsule
Spain Silodosina Sandoz 4 mg cápsulas duras EFG
Silodosina Sandoz 8 mg cápsulas duras EFG