Prospect: information for the patient

Silodosina Sandoz 8 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Silodosina Sandoz

3. How to take Silodosina Sandoz

4. Possible adverse effects

5. Storage of Silodosina Sandoz

6. Contents of the package and additional information

What is silodosina

Silodosina belongs to a group of medications known as alpha 1A adrenergic receptor blockers.

Silodosina is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle in these tissues. This makes it easier for you to urinate and alleviates your symptoms.

What is silodosina used for

Silodosina is used in adult males to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination,

• feeling of not fully emptying the bladder,

• more frequent need to urinate, even at night.

Do not take Silodosina Sandoz:

• if you are allergic to silodosin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Silodosina Sandoz:

• If you are to undergo eye surgery for cataract (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used silodosin previously. This is because some patients treated with this type of medication experienced a loss of iris muscle tone (the circular colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions regarding medical and surgical techniques that may be necessary. Ask your doctor if it is necessary or not to postpone or interrupt temporarily the treatment with silodosin when you are to undergo cataract surgery.

• If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking silodosin.

When taking silodosin, you may experience dizziness and, occasionally, fainting, especially when starting treatment or taking other medications that lower blood pressure. If this occurs, sit or lie down immediately until the symptoms disappear and inform your doctor as soon as possible (see also the section “Driving and operating machines”).

• If you have severe liver problems, do not take silodosin, as it has not been evaluated in this situation.

• If you have kidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will start treatment with silodosin with caution and possibly with a lower dose (see section 3).

If your kidney problems are severe, do not take silodosin.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with silodosin. Silodosin does not treat prostate cancer.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Taking Silodosina Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor in particular if you take:

• blood pressure-lowering medications (especially alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk that the effect of these medications increases during the use of silodosin,
• antifungal medications (such as ketoconazole or itraconazole),medications used for HIV/AIDS infection(such as ritonavir) ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase silodosin blood concentrations,
• medications used in the treatment of erectile dysfunction (such as sildenafil or tadalafil), as their concomitant use with silodosin may lead to a slight decrease in blood pressure,
• epilepsy medications or rifampicin (a medication used to treat tuberculosis), as the effect of silodosin may be reduced

Fertility

Treatment with silodosin may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. This effect disappears after discontinuing silodosin treatment. Inform your doctor if you are planning to have children.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, dizziness, or somnolence or have blurred vision.

Silodosina Sandoz contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 8 mg silodosina capsule per day taken orally.

Take the capsule always with food, preferably at the same time every day. Do not break or chew the capsule; 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 this purpose, the 4 mg silodosina hard capsules are available.

If you take more silodosina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.If you experience dizziness or feel weak, inform your doctor immediately.

If you forget to take silodosina

You can take the capsule later the same day if you forget to take it earlier. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed capsule.

If you interrupt treatment with silodosina

If you interrupt treatment, it is possible that symptoms will reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be severe: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or urticaria.

The most frequent side effect is a reduction in the amount of semen expelled during sexual intercourse. This side effect disappears after discontinuation of treatment with silodosina. Inform your doctor if you are planning to have children.

You may experiencedizziness, including dizziness when standing up, and, occasionally,fainting.

If you notice weakness or dizziness,sit or lie downimmediately until the symptoms disappear. If you experience dizziness when standing up or fainting, pleaseinform your doctor as soon as possible.

Silodosina may cause complications duringcataract surgery(eye surgery for cloudy lens; see section “Warnings and precautions”).

It is essential thatyou inform your ophthalmologist immediatelyif you are using or have previously used silodosina.

The possible side effects are listed below:

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

• Abnormal ejaculation (a smaller or imperceptible amount of semen is expelled during sexual intercourse; see section “Fertility”)

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

• Dizziness, including dizziness when standing up (see also above, in this section)

• Nasal secretion or obstruction

• Diarrhea

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

• Loss of sexual appetite

• Nausea

• Dry mouth

• Difficulty achieving or maintaining an erection

• Increased heart rate

• Skin allergy symptoms, such as rash, itching, urticaria, and drug-induced rash

• Abnormal liver function test results

• Low blood pressure

Rare side effects (may affect up to 1 in 1,000 people)

• Rapid 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

Unknown frequency (the frequency cannot be estimated from available data)

• Flaccid pupil during cataract surgery (see also above, in this section)

Inform your doctor if you notice that your sexual relations are affected.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Store in the original packaging to protect it from light. Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Silodosina Sandoz

• The active ingredient is silodosina.
• 1. Silodosina Sandoz 8 mg: each hard capsule contains 8 mg of silodosina.
• The other components are:

Hard capsule content: mannitol (E421), pregelatinized cornstarch, sodium laurilsulfate (E487), magnesium stearate (E470b).

Hard capsule composition: titanium dioxide (E171), gelatin (E441).

Printing ink: shellac (E904), iron oxide black (E172), potassium hydroxide (E525).

Appearance of the product and contents of the package

Hard, white capsules printed 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.

Package size

Blister package: 30 hard capsules.

Unit dose blister package: 10x1 and 30x1 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Noucor Health S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Lek Pharmaceuticals d.d.

Verovskova Ulica 57,

1526 Ljubljana,

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Slovenia:Silodozin Sandoz 8 mg trde kapsule

France:SILODOSINE SANDOZ 8 mg, gélule

Italy:Silodosina Sandoz

Netherlands:Silodosine Sandoz 8 mg, harde capsules

Portugal:Silodosina Sandoz

Last review date of thisleaflet:April 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/