Silodosin Viatris 4 mg hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Silodosin Viatris 4 mg hard capsules EFG

Read all of this leaflet carefully before you start 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Silodosin Viatris is and what it is used for

What silodosin is

Silodosin belongs to a group of medicines known as alpha-1A adrenergic receptor blockers.

Silodosin 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 relieves your symptoms.

What silodosin is used for

Silodosin is used in adult men to treat urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia (BPH)), such as:

• difficulty starting urination,
• feeling of not completely emptying the bladder,
• need to urinate more frequently, including at night.

2. What you need to know before starting Silodosin Viatris

Do not take Silodosin Viatris

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 or pharmacist before taking Silodosin Viatris

• 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 taking or have taken Silodosin Viatris. 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 this type of surgery. The ophthalmologist can then take appropriate precautions regarding the medical and surgical techniques to be used. Ask your doctor whether you need to delay or temporarily interrupt treatment with Silodosin Viatris prior to undergoing cataract surgery.

• If you have ever fainted or felt dizzy upon suddenly standing up, inform your doctor before taking Silodosin Viatris.

When taking Silodosin Viatris, dizziness and occasionally fainting may occur upon standing, especially when starting treatment or if you are also taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms subside and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, you must not take Silodosin Viatris, as it has not been evaluated in this condition.

• If you have kidney problems, consult your doctor.

If you have moderate kidney problems, your doctor will start treatment with Silodosin Viatris cautiously and possibly at a lower dose (see section 3 “Dosage”).

If you have severe kidney problems, you must not take Silodosin Viatris.

• Since benign enlargement of the prostate gland and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with Silodosin Viatris. Silodosin Viatris is not effective for treating prostate cancer.

• Treatment with Silodosin Viatris may lead to abnormal ejaculation (reduced amount of semen ejaculated during sexual intercourse), which may temporarily affect male fertility. This effect reverses after stopping treatment with Silodosin Viatris. Inform your doctor if you are planning to have children.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as there are no relevant indications for this age group.

Other medicines and Silodosin Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking:

• Medicines that lower blood pressure (especially alpha1-blockers such as prazosin or doxazosin), as there may be an increased risk that the effect of these medicines will be enhanced during treatment with Silodosin Viatris.
• Antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase blood levels of Silodosin Viatris.
• Medicines used to treat difficulty in achieving or maintaining an erection (such as sildenafil or tadalafil), as their concomitant use with Silodosin Viatris may lead to a slight decrease in blood pressure.
• Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), as they may reduce the effect of Silodosin Viatris.

Pregnancy and fertility

Pregnancy

Not applicable, since Silodosin Viatris is used to treat men with benign enlargement of the prostate. It is not indicated for use in women.

Fertility

Silodosin Viatris may reduce the amount of semen, which may result in a temporary reduction in the ability to father a child.

Driving and use of machines

Do not drive or operate machinery if you experience weakness, dizziness, drowsiness, or blurred vision.

Silodosin Viatris contains sodium.

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

3. How to take/use Silodosin Viatris

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

The recommended dose is one 8 mg silodosin capsule daily, taken orally.

Take the capsule always with food, preferably at the same time each 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 impairment, your doctor may prescribe you a different dose. For this purpose, the 4 mg silodosin hard capsule formulation is available.

If you take more silodosin than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. If you feel dizzy or weak, inform your doctor immediately.

If you forget to take silodosin

You may take the capsule later the same day if you forgot 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 forgotten capsule.

If you stop taking silodosin

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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following allergic reactions, as they may have serious consequences: swelling of the face or throat, difficulty breathing, feeling faint, skin itching, or hives.

The most common adverse effect is a reduction in the amount of semen ejaculated during sexual intercourse. This effect resolves after stopping treatment with silodosin. Inform your doctor if you are planning to have children.

Dizziness, including dizziness upon standing, 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 fainting, inform your doctor as soon as possible.

Silodosin may cause complications during cataract surgery (eye surgery for lens clouding; see section “Warnings and precautions”).

It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken silodosin.

The possible adverse effects are listed below:

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

• Abnormal ejaculation (a reduced or negligible amount of semen is ejaculated during sexual intercourse; see section “Warnings and precautions”)

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

• Dizziness, including dizziness upon standing (see also above in this section)
• Nasal discharge or nasal congestion
• Diarrhea

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

• Loss of sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergic reactions such as rash, pruritus, urticaria, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Rapid or irregular heartbeat (called palpitations)
• Fainting/loss of consciousness

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Other allergic reactions with swelling of the face or throat

Frequency not known (frequency cannot be estimated from available data)

• Floppy iris during cataract surgery (see also above in this section)

Inform your doctor if you notice any changes in your sexual activity.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silodosin Viatris

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

Do not use this medicine after the expiry date stated on the carton and blister pack after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original container to protect it from light.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silodosin Viatris

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

The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (corn), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Appearance of Silodosin Viatris and contents of the pack

Hard gelatin capsule, opaque, yellow, size 3, printed with a "4" in black ink.

Silodosin Viatris is available in packs of 10, 30 and 100 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O Box 3012 Larisa Industrial Area 41004
Larisa, Greece

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Silodosin 4 mg Viatris hard capsules EFG
France: Silodosine Mylan 4 mg capsule
Italy: Silodosin Mylan
Portugal: Silodosin Mylan
Slovak Republic: Silodosin Mylan 4 mg

Date of the most recent review of this leaflet: February 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/