Prospect: information for the patient

Silodosina Aristo 8 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as 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 to 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 Aristo and for what it is used

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

3. How to take Silodosina Aristo

4. Possible adverse effects

5. Storage of Silodosina Aristo

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 initiating urination,

• feeling of not fully emptying the bladder,

• more frequent need to urinate, even at night.

Do not take silodosina

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you are to undergo eye surgery for cataract turbidity (cataract surgery), it is essential that you inform your ophthalmologist immediately that you are using or have used silodosina 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. Ask your doctor if it is necessary or not to postpone or interrupt temporarily the treatment with silodosina 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 silodosina.

When taking silodosina, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

• If you havesevere liver problems, you should not take silodosina, as it has not been evaluated in this situation.

• If you havekidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will initiate treatment with silodosina with caution and possibly with a lower dose (see section 3 “Doses”). If your kidney problems are severe, you should not take this medication.

• 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 silodosina. Silodosina is not used to treat prostate cancer.

• Treatment with this medication may lead to abnormal ejaculation (reduced semen expulsion during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping silodosina treatment. Inform your doctor if you are planning to have children.

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 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 alpha blockers such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during use of this medication.

•antifungal medications(such as ketoconazole or itraconazole),medications used to treat HIV/AIDS(such as ritonavir), ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase silodosina blood concentrations.

•medications used in the treatment of erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with silodosina may lead to a slight decrease in blood pressure.

•epilepsy medications or rifampicin(a medication used to treat tuberculosis), as the effect of Silodyx may be reduced.

Driving and operating machines

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

Silodosina Aristo contains sodium

This medication contains less than 1 mmol (23 mg) of sodium 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 capsule of silodosina 8 mg per day taken orally.

Take the capsule always accompanied by 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 silodosina 4 mg hard capsules presentation is 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 compensate 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 common side effect is a reduction in the amount of semen expelled during sexual intercourse. This side effect disappears after discontinuation of treatment withsilodosina. Inform your doctor if you are planning to have children.

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

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

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

It is essential that youinform your ophthalmologist immediatelyif you are using or have previously usedsilodosina.

The possible side effects are listed below:

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

• Abnormal ejaculation (less semen is expelled or none at all during sexual intercourse; see section “Warnings and precautions”)

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 (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 about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Keep in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Silodosina Aristo

• The active principle is silodosina. Each capsule contains 8 mg of silodosina.

• The other components are:

Content of the capsule:manitol (E421), cornstarch pregelatinized, laurilsulfate of sodium, dibehenate of glycerol (E471).

Capsule coating:gelatine, titanium dioxide (E171).

Black Ink for Printing:shellac (E904), propylene glycol (E1520), concentrated solution of ammonia (E527), iron oxide black (E172), potassium hydroxide (E525).

Appearance of the product and contents of the package

Hard gelatin capsules, opaque, white, size 0, printed in black “8” on the cap.

Silodosina Aristo 8 mg is available in packages of 30, 50, and 100 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible Manufacturer

Rontis Hellas S.A.

Medical and Pharmaceutical Products

Larissa Industrial Area, P.O. Box 3012, Larissa, 41500

Greece

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Local Representative

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

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

Italy:Silodosina Aristo 8 mg hard capsule

Portugal:Silodosina Aristo 8 mg hard capsules

Spain:Silodosina Aristo 8 mg hard capsules EFG

GermanySilodosin Aristo 8 mg Hartkapseln Aristo Pharma GmbH

HungarySzilodoszin Aristo 8 mg hard capsule

Last review date of this leaflet:February 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/