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 works by selectively blocking the alpha-adrenergic 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 you to urinate and helps to relieve symptoms of your condition.

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 being able to empty the bladder completely,
• needing 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, talk to your doctor or pharmacist.

• If you are going to have eye surgery for cataracts (cataract surgery), it is important that you tell your eye doctor that you are taking or have taken Silodosin Aurovitas, as it may cause a condition called floppy iris syndrome during this type of surgery. Your doctor may take appropriate precautions with regard to medicines and surgical techniques. You should ask your doctor if you should delay or temporarily stop taking Silodosin Aurovitas if you are going to have cataract surgery.

Cataract surgeryis an operation to remove the lens in the eye when it becomes cloudy, known as a cataract.

• If you have ever fainted or had dizziness when standing up, tell your doctor before taking Silodosin Aurovitas. When taking Silodosin Aurovitas, you may experience dizzinesswhen standing up and occasionally fainting, especially when you first start taking the medicine or when taking other medicines that lower your blood pressure. If you experience these symptoms, sit or lie down until they pass and tell your doctor as soon as possible (see also section “Driving and using machines”).
• If you have severe liver disease, do not take Silodosin Aurovitas, as it has not been studied in such conditions.
• If you have kidney disease, ask your doctor for advice. If you have moderate kidney disease, your doctor may start you on a lower dose of Silodosin Aurovitas (see section 3 “How to take Silodosin Aurovitas”). If you have severe kidney disease, do not take Silodosin Aurovitas.
• Because benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform tests to rule out prostate cancer before starting you on Silodosin Aurovitas. Silodosin Aurovitas does not treat prostate cancer.
• Taking Silodosin Aurovitas may cause abnormal ejaculation (decreased semen volume during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping Silodosin Aurovitas. If you are planning to have children, tell your doctor or pharmacist before taking this medicine.

Children and adolescents

Do not give Silodosin Aurovitas to children and adolescents under 18 years of age, as there are no indications for its use in this age group.

Silodosin Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tell your doctor about the following medicines in particular:

• medicines to lower blood pressure(especially alpha-blockers, such as prazosin or doxazosin), as there is a risk that the effects of these medicines may be increased when taking Silodosin Aurovitas.
• antifungal medicines(such as ketoconazole or itraconazole), HIV/AIDS medicines(such as ritonavir), or medicines to prevent organ rejection after a transplant(such as cyclosporine), as these medicines may increase the levels of Silodosin Aurovitas in your blood.
• medicines for erectile dysfunction(such as sildenafil or tadalafil), as taking Silodosin Aurovitas with these medicines may cause a slight decrease in blood pressure.
• medicines for epilepsy or rifampicin(an antibiotic), as they may decrease the effects of Silodosin Aurovitas.

Pregnancy and breastfeeding

Silodosin Aurovitas is not indicated for use in women.

Fertility

Silodosin Aurovitas may cause a decrease in semen volume, which may temporarily affect male fertility. If you are planning to have children, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, faint, sleepy, or have blurred vision.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, which 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 8 mg Silodosin Aurovitas capsule per day, taken orally.
Take the capsule with food, preferably at the same time each day.
Do not crush or chew the capsule; swallow it whole 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, tell your doctor immediately.
If you feel dizzy or weak, tell your doctor immediately.

If you forget to take Silodosin Aurovitas

If you miss a dose, you can 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 taking Silodosin Aurovitas, your symptoms may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Silodosin Aurovitas can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following allergic reactions:
swelling of the face or throat, difficulty breathing, fainting, itching, or hives, as these can be signs of a serious allergic reaction.
The most common side effect is abnormal ejaculation (decreased semen volume during sexual intercourse). This effect disappears after stopping Silodosin Aurovitas. If you are planning to have children, tell your doctor.
You may experience dizziness, including dizziness when standing up, and occasionally fainting.
If you feel weak or dizzy, sit or lie down and stay there until the symptoms pass. If you experience dizziness when standing up or fainting, tell your doctor immediately.
Silodosin Aurovitas may cause complications during cataract surgery(eye surgery to remove a cloudy lens).
It is important that you tell your eye doctor that you are taking or have taken Silodosin Aurovitas.
Other possible side effects are listed below:

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

• abnormal ejaculation (less or no semen during sexual intercourse, see section “Warnings and precautions”).

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

• dizziness, including dizziness when standing up (see also above),
• runny nose or stuffy nose,
• diarrhea.

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

• decreased sex drive,
• nausea,
• dry mouth,
• difficulty getting or maintaining an erection,
• fast heartbeat,
• skin allergic reactions, 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)

• fast or irregular heartbeat (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 (cannot be estimated from the available data)

• floppy iris syndrome during cataract surgery (see also above).

If you experience any effects on your sexual function, tell 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 details for reporting side effects” 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 (EXP)”. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 4 mg hard capsule contains 4 mg silodosin.
Each 8 mg hard capsule 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