VIRSIL 4 mg Hard Capsules

Зміст інструкції

1. Virsil 4 mg hard capsules, 8 mg hard capsules
   1. What is Virsil and what is it 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

Virsil 4 mg hard capsules, 8 mg hard capsules

Silodosin
Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Virsil and what is it used for

What is Virsil
Virsil belongs to a group of medicines called alpha-adrenoceptor inhibitors.
Virsil is selective for the receptors located in the prostate, bladder and urethra. By blocking
these receptors, the medicine relaxes the smooth muscle of these tissues. This makes it easier
to urinate and relieves its symptoms.

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

• difficulty starting to urinate,
• feeling of not completely emptying the bladder,
• frequent need to urinate, even at night.

2. What you need to know before taking Virsil

Do not take Virsil

• if you are allergic to silodosin or 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 to have eye surgery for cataracts (cataract surgery), it is important to immediately inform your ophthalmologist that you are using or have used Virsil in the past. This is because some patients treated with this type of medicine have experienced a loss of iris muscle tone (the colored part of the eye) during such surgery. The ophthalmologist will take appropriate

precautions regarding the medicines and surgical techniques that will be used. Ask your
doctor if it is necessary to postpone or temporarily interrupt treatment with Virsil
in case of cataract surgery.

• If you have fainted or felt dizzy when getting up suddenly in the past, tell your doctor before taking Virsil. Taking Virsil may cause dizzinesswhen standing up and, occasionally, fainting, particularly 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 the symptoms disappear and inform your doctor as soon as possible (see also section “Driving and operating machinery”).
• If you have severe liver problems, you should not take Virsil, because the medicine has not been studied in patients with these conditions.
• If you have kidney problems, ask your doctor for advice. If you have moderate kidney problems, your doctor will start treatment with Virsil with caution and possibly with a reduced dose (see section 3 “Dosage”). If you have a severe kidney disease, you should not take Virsil.
• Since benign prostatic enlargement and prostate cancer can present with the same 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 (reduction in the amount of semen released during sexual intercourse), which may temporarily impair male fertility. This effect disappears after stopping treatment with Virsil. Tell your doctor if you wish to have children.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is no
indication for this age group.

Other medicines and Virsil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 againstHIV/AIDS infection(such as ritonavir) or medicines used after a transplant toprevent organ rejection(such as cyclosporine), because these medicines can increase the concentration of Virsil in the blood.
• medicines used for erectile dysfunction(such as sildenafil or tadalafil), because concomitant use with Virsil may slightly lower 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 sperm and could therefore affect your ability to conceive. If
you are planning to have children, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and operating machinery
Do not drive or operate machinery if you feel faint, dizzy or sleepy or if your
vision is blurred.

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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is one Virsil 8 mg capsule daily by oral route.
Take the capsule always with a meal, preferably at the same time each day. Do not crush or
chew the capsule, but 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 is
available Virsil 4 mg hard capsules.

If you take more Virsilthan you should
If you have taken more than one capsule, inform your doctor as soon as possible. If you feel dizzy or weak,
inform your doctor immediately.

If you forget to take Virsil
If you have forgotten to take a capsule before, you can take it later, on the same day. If it is almost
time for the next dose, skip the forgotten dose. Do not take a double dose to make up for the
forgotten capsule.

If you stop taking Virsil
If you stop the treatment, the symptoms may reappear.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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,
because the consequences can become serious.
The most common side effect is a reduction in the amount of semen emitted during sexual
activity. This effect disappears after stopping treatment with Virsil. Tell your doctor if
you wish to have children.
Dizziness, even when getting up, and occasionally fainting, may occur.
If you feel weak or dizzy, sit or lie down immediately until the symptoms disappear. If you feel dizzy when getting up or in case of fainting, tell your doctor as
soon as possible.
Virsil can cause complications during a cataract surgery(surgical procedure on the eye
performed to correct lens opacity, see section “Warnings and precautions”).
It is important that you immediately inform the ophthalmologist if you are using or have used Virsil previously.
Possible side effects are listed below:

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

• Abnormal ejaculation (reduction or absence of semen emission during sexual activity, see section “Warnings and precautions”)

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

• Dizziness, even when getting up (see also above, in this paragraph)
• Runny or blocked nose
• Diarrhea

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

• Decreased libido
• Nausea
• Dry mouth
• Difficulty getting or maintaining an erection
• Fast heart rate
• Symptoms of an allergic skin reaction, such as rash, itching, hives and drug-induced rash
• Abnormal liver function tests
• Low blood pressure

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

• Fast 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 based on the available data)

• Flag pupil during cataract surgery (see also above, in this paragraph)

If you think there are effects on your sex life, tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and blister after
Exp. The expiry date refers to the last day of that month.
PVC/PE/PVdC-Aluminum blister:
Do not store at a temperature above 30°C.
OPA/Alu/PVC-Aluminum blister:
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that it is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Virsil contains
Virsil 4 mg

• The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.
• The other ingredients 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 ingredient is silodosin. Each capsule contains 8 mg of silodosin.
• The other ingredients 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, with ‘4’ printed in black ink.
Virsil 8 mg hard capsules: hard gelatin capsule, white-colored, opaque, size 0, with ‘8’ printed in black ink.
Virsil is available in packs containing 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following denominations:
IT: Virsil