Prospect: information for the patient

Silodosina Viatris 4 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 should not be given 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 Viatris and for what it is used

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

3. How to take Silodosina Viatris

4. Possible adverse effects

5. Storage of Silodosina Viatris

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 Viatris

if you are allergic to silodosina or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Silodosina Viatris

• 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 Silodosina Viatris. This is because some patients treated with this type of medication have 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 you need to postpone or interrupt Silodosina Viatris treatment temporarily when undergoing cataract surgery.

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

When taking Silodosina Viatris, 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 Viatris, as it has not been evaluated in this situation.

• If you havekidney problems, consult your doctor.

If your kidney problems are moderate, your doctor will start Silodosina Viatris treatment with caution and possibly with a lower dose (see section3 “Doses”).

If your kidney problems are severe, you should not take Silodosina Viatris.

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

• Silodosina Viatris treatment may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which can temporarily affect male fertility. Inform your doctor if you are planning to have children.

Children and adolescents

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

Other medications and Silodosina Viatris

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

Inform your doctorin particular if you are taking:

• Medications that lower blood pressure(especially alpha blockers such as prazosin or doxazosin), as there may be an increased risk of these medications' effects during Silodosina Viatris use.
• 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 can increase Silodosina Viatris blood levels.
• Medications used to treat erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with Silodosina Viatris may lead to a slight decrease in blood pressure.
• Medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as it may reduce the effect of Silodosina Viatris.

Pregnancy and fertility

Pregnancy

This is not recommended, as Silodosina Viatris is used to treat men with benign prostatic hyperplasia. Its use is not indicated for women.

Fertility

Silodosina Viatris may reduce semen volume, leading to a temporary reduction in the ability to conceive a child.

Driving and operating machines

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

Silodosina Viatris contains sodium.

This medication contains less than 1mmol of sodium (23mg) 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 common side effect is a reduction in the amount of semen expelled during sexual intercourse. This side effect disappears after discontinuing 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,inform your doctor as soon as possible.

Silodosina may cause complications duringcataract surgery(eye surgery for cloudy lens; see "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 "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 (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 about the safety of this medicine.

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

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

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated improperly.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Silodosina Viatris Composition

The active ingredient is silodosina. Each capsule contains 4mg of silodosina.

The other components are:

• Capsule content:manitol (E421), pregelatinized corn starch, sodium lauryl sulfate, dibehenato of glycerol (E471).
• Capsule coating:gelatine, titanium dioxide (E171), yellow iron oxide (E172).
• Black printing ink:shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Appearance of Silodosina Viatris and packaging contents

Hard gelatin capsule, opaque, yellow, size 3, with a black ink imprint of a “4”.

Silodosina Viatris is available in packaging of 10, 30, and 100capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O Box 3012 Larisa Industrial Area 41004

Larisa, Greece

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain:Silodosina 4 mg Viatris hard capsules EFG

France:Silodosine Mylan 4 mg gélule

Italy:Silodosina Mylan

Portugal:Silodosina Mylan

Slovak Republic:Silodosin Mylan 4 mg

Last reviewed date of this leaflet:February 2019

For detailed information about this medication, please visit the website of the Spanish Agency of Medicaments and Health Products (AEMPS)https://www.aemps.gob.es/