Virsil

Patient Information Leaflet

Virsil 4 mg Hard Capsules, 8 mg Hard Capsules

Silodosin
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Virsil is and what it is used for

What Virsil is
Virsil belongs to a group of medicines called alpha-adrenoceptor blockers.
Virsil 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 urinary symptoms.

What Virsil is used for
Virsil is used in adult men for the treatment of urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:

• difficulty starting to urinate,
• sensation of not having emptied the bladder completely,
• frequent need to urinate, including during the night.

2. What you need to know before taking Virsil

Do not take Virsil

• 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 Virsil.

• If you are scheduled to undergo eye surgery due to lens opacity (cataract surgery), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken Virsil. 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 may be necessary to postpone or temporarily discontinue treatment with Virsil
in case of cataract surgery.

• If you have previously fainted or felt dizzy upon standing up suddenly, inform your doctor before taking Virsil. Dizziness upon standing may occur while taking Virsil, and occasionally fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. In such cases, sit or lie down immediately until symptoms resolve 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 Virsil, as the medicine has not been studied in patients with this condition.
• If you have kidney problems, consult your doctor. If you have moderate kidney problems, your doctor will start treatment with Virsil cautiously and possibly at a reduced dose (see section 3 “Dosage”). You must not take Virsil 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 Virsil. Virsil is not a treatment for prostate cancer.
• Treatment with Virsil may lead to abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect resolves after discontinuation of Virsil treatment. Inform your doctor if you intend to father children.

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 Virsil
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 alpha-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with Virsil.
• 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 Virsil in the blood.
• medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Virsil may slightly reduce blood pressure.
• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Virsil may be reduced.

Pregnancy and breastfeeding
Virsil is not intended for use in women.
Fertility
Virsil may reduce the amount of semen and could therefore affect your ability to father children. If you are planning to have children, consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
Do not drive or operate machinery if you feel faint, dizzy or drowsy, or if you have blurred vision.
Virsil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Virsil

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Virsil 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; 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 these cases,
Virsil 4 mg hard capsules are available.
If you take more Virsil 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 Virsil
If you forget to take a capsule earlier, you may take it later the same day. If it is almost time for the next dose,
skip the missed dose. Do not take a double dose to make up for the forgotten capsule.
If you stop taking Virsil
If you stop treatment, symptoms may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 lead to serious consequences.

The most common side effect is a reduction in the amount of semen released during sexual activity. This effect disappears after stopping treatment with Virsil. Inform your doctor if you wish to have children.

Dizziness may occur, even when standing up, and occasionally fainting may happen.
If you feel weak or experience dizziness, 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.

Virsil may cause complications during cataract surgery (an eye procedure performed to correct 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 Virsil.

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 activity; see section “Warnings and precautions”)

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, or drug-induced skin eruption
• Abnormal liver function tests
• Low blood pressure

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

• Rapid 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 that this medicine is affecting your sexual life, inform 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Virsil

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 after
Exp. The expiry date refers to the last day of that month.
PVC/PE/PVdC-Aluminium blisters:
Do not store above 30°C.
OPA/Alu/PVC-Aluminium blisters:
This medicine does not require any special storage conditions.
Do not use this medicine if it appears damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Virsil contains
Virsil 4 mg

• The active substance is silodosin. Each capsule contains 4 mg of silodosin.
• The other components are mannitol, pregelatinized starch, sodium stearyl fumarate, gelatin, titanium dioxide (E171) and yellow iron oxide (E172). The capsules also contain shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

Virsil 8 mg

• The active substance is silodosin. Each capsule contains 8 mg of silodosin.
• The other components are mannitol, pregelatinized starch, sodium stearyl fumarate, gelatin, titanium dioxide (E171). The capsules also contain shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Virsil and contents of the pack
Virsil 4 mg hard capsules: hard gelatin capsule, ivory-colored, opaque, size 2, printed with '4' in black ink.
Virsil 8 mg hard capsules: hard gelatin capsule, white-colored, opaque, size 0, printed with '8' in black ink.
Virsil is available in packs containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina 1143
00156 Rome, Italy
Manufacturer
Teva Gyógyszergyár Zrt.
Pallagi út 13
Debrecen
4042 Hungary

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