Silodosin Aurovitas

Package Leaflet: Information for the User

Silodosin Aurovitas, 4 mg, hard capsules

Silodosin Aurovitas, 8 mg, hard capsules

Silodosin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

What is Silodosin Aurovitas?

Silodosin Aurovitas belongs to a group of medicines called alpha-adrenergic receptor blockers.
Silodosin Aurovitas acts selectively on receptors located in the prostate gland, bladder, and urethra. By blocking these receptors, it causes relaxation of the smooth muscle in these tissues. This makes it easier for the patient to urinate and alleviates the symptoms of the disease.

What is Silodosin Aurovitas used for?

Silodosin Aurovitas is used in adult men to treat the symptoms of benign prostatic hyperplasia (enlargement of the prostate gland), such as:

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

2. What you need to know before you take Silodosin Aurovitas

When not to take Silodosin Aurovitas

• If you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Silodosin Aurovitas, discuss it with your doctor or pharmacist.

• If you are going to have eye surgery for cataracts (cataract surgery), it is essential to inform your ophthalmologist immediately about taking Silodosin Aurovitas now or in the past, as some patients treated with this type of medicine have experienced loss of muscle tone in the iris (the colored, round part of the eye) during such surgery. The specialist doctor may take appropriate precautions regarding medications and surgical techniques. You should ask your doctor if you should delay or temporarily stop taking Silodosin Aurovitas in case of cataract surgery.

Cataract surgeryis important, and you should inform your ophthalmologist about taking Silodosin Aurovitas now or in the past.

• If you have ever fainted or had dizziness when standing up, you should inform your doctor before taking Silodosin Aurovitas. During treatment with Silodosin Aurovitas, dizzinessmay occur when standing up, and occasionally faintingmay occur, especially at the beginning of treatment or when taking other medications that lower blood pressure. If such symptoms occur, you should sit or lie down immediately and inform your doctor as soon as possible (see also "Driving and using machines").
• If you have severe liver disease, you should not take Silodosin Aurovitas, as it has not been studied in such a condition.
• If you have kidney disease, you should ask your doctor for advice. If you have moderate kidney disease, your doctor may prescribe a different dose. For this purpose, Silodosin Aurovitas 4 mg hard capsules are available. If you have severe kidney disease, you should not take Silodosin Aurovitas.
• Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, before starting treatment with Silodosin Aurovitas, your doctor will perform tests to rule out prostate cancer. Silodosin Aurovitas does not treat prostate cancer.
• Taking Silodosin Aurovitas may lead to abnormal ejaculation (reduced or absent semen during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping Silodosin Aurovitas. You should inform your doctor if you plan to have children.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no indication for its use in this age group.

Silodosin Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Tell your doctor especially about taking the following medicines:

• medicines that lower blood pressure(especially alpha-blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be enhanced when taking Silodosin Aurovitas.
• antifungal medicines(such as ketoconazole or itraconazole), medicines used for HIV/AIDS(such as ritonavir), or medicines used after transplants to prevent organ rejection(such as cyclosporine), as these medicines may increase the level of Silodosin Aurovitas in the blood.
• medicines used to treat difficulties in achieving or maintaining an erection(such as sildenafil or tadalafil), as taking them with Silodosin Aurovitas may lead to a slight decrease in blood pressure.
• medicines used for epilepsy or rifampicin(an anti-tuberculosis medicine), as the effect of Silodosin Aurovitas may be reduced.

Pregnancy and breastfeeding

Silodosin Aurovitas is not indicated for use in women.

Fertility

Silodosin Aurovitas may cause a decrease in sperm count and may temporarily affect male fertility. If you plan to have children, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel that you might faint, have dizziness, feel sleepy, or have blurred vision.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, which means it is essentially "sodium-free".

3. How to take Silodosin Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one Silodosin Aurovitas 8 mg hard capsule per day, taken orally.
The capsule should always be taken with food, preferably at the same time each day.
Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
Patient with kidney disease
If you have moderate kidney disease, your doctor may prescribe a different dose. For this purpose, Silodosin Aurovitas 4 mg hard capsules are available.

If you take more Silodosin Aurovitas than you should

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

If you forget to take Silodosin Aurovitas

If you miss a dose, you may take it later that day. If it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Silodosin Aurovitas

If you stop treatment, the symptoms of the disease may return.
If you have any further questions on 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 everybody gets them.
You should immediately see a doctor if you notice any of the following allergic reactions:
swelling of the face or throat, difficulty breathing, fainting, itching, or hives, due to the possibility of serious consequences.
The most common side effect is abnormal ejaculation (reduced or absent semen during sexual intercourse). This effect disappears after stopping Silodosin Aurovitas. You should inform your doctor if you plan to have children.
Dizzinessmay occur, including dizziness when standing up, and occasionally fainting.
If you feel weak or dizzy, you should sit or lie down immediately and stay there until the symptoms disappear. If you experience dizziness when standing up or fainting, you should inform your doctor as soon as possible.
Silodosin Aurovitas may cause complications during cataract surgery(eye surgery due to cataracts, see "Warnings and precautions").
It is essential to inform your ophthalmologist immediately about taking Silodosin Aurovitas now or in the past.
Possible side effects are listed below:

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

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

• abnormal ejaculation (reduced or absent semen 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),
• runny nose or stuffy nose,
• diarrhea.

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

• decreased sexual desire,
• nausea,
• dry mouth,
• difficulty achieving or maintaining an erection,
• rapid heartbeat,
• allergic reactions on the skin, such as rash, itching, hives, and drug rash,
• abnormal liver function tests,
• low blood pressure.

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

• rapid or irregular heartbeat (so-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.

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

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

If you experience any effects on your sexual life, you should inform your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silodosin Aurovitas

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 blister and carton after "EXP" or "Expiry date". The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Silodosin Aurovitas contains

The active substance is silodosin.
Each hard capsule, 4 mg contains 4 mg silodosin.
Each hard capsule, 8 mg contains 8 mg silodosin.
The other ingredients are:
Contents of the capsule:mannitol, maize starch, sodium lauryl sulfate, hydrogenated vegetable oil.
Contents of the capsule shell:titanium dioxide (E 171), gelatin.
Contents of the printing ink:shellac (E 904), iron oxide black (E 172), potassium hydroxide (E 525).

What Silodosin Aurovitas looks like and contents of the pack

Hard capsule.
Silodosin Aurovitas, 4 mg, hard capsules
A size 3 capsule containing a white or almost white powder, consisting of a white, opaque, hard gelatin capsule cap with the imprint "SIL" and a white, opaque, hard gelatin capsule body with the imprint "4 mg" in black ink.
Silodosin Aurovitas, 8 mg, hard capsules
A size 1 capsule containing a white or almost white powder, consisting of a white, opaque, hard gelatin capsule cap with the imprint "SIL" and a white, opaque, hard gelatin capsule body with the imprint "8 mg" in black ink.
Silodosin Aurovitas is available in blisters, packaged in 5, 10, 20, 30, 50, 90, and 100 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
BBB 3000 Birzebbugia
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Generiques
26 avenue Tony Garnier
69007 Lyon, Rhone
France

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

Belgium:

Silodosin AB 4 mg/8 mg, hard capsules

France:

SILODOSINE ARROW 4 mg/8 mg, gélule

Italy:

Silodosina Aurobindo

Netherlands:

Silodosin Aurobindo 4 mg/8 mg, hard capsules

Poland:

Silodosin Aurovitas

Portugal:

Silodosina Aurovitas

Date of last revision of the leaflet: 11/2022