Silodosin aurovitas

Package leaflet: Information for the user

Silodosin Aurovitas, 4 mg, hard capsules
Silodosin Aurovitas, 8 mg, hard capsules
Silodosinum
Please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Silodosin Aurovitas is and what it is used for
2. What you need to know before taking 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 selectively acts 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 pass urine and relieves symptoms of the condition.

What is Silodosin Aurovitas used for?
Silodosin Aurovitas is used in adult men to treat urinary symptoms associated with benign enlargement of the prostate gland (prostate enlargement), such as:

• difficulty starting urination,
• feeling of incomplete bladder emptying,
• increased need to urinate, even during the night.

2. Important information before using Silodosin Aurovitas

When not to use Silodosin Aurovitas

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

Warnings and precautions
Before starting to take Silodosin Aurovitas, discuss this with your doctor or
pharmacist.

• If the patient is due to undergo eye surgery for cataract (cataract surgery), it is important to inform the ophthalmologist immediately about current or past use of Silodosin Aurovitas, as some patients treated with this type of medicine have experienced intraoperative floppy iris syndrome (loss of muscle tone in the iris, the coloured, circular part of the eye) during such surgery. The specialist doctor may take appropriate precautions regarding medications and surgical techniques. Ask your doctor whether the patient should delay or temporarily discontinue taking Silodosin Aurovitas if undergoing cataract surgery.

• If the patient has ever fainted or experienced dizziness upon standing up quickly, inform the doctor before taking Silodosin Aurovitas. Dizziness upon standing and occasionally fainting may occur while taking Silodosin Aurovitas, especially at the beginning of treatment or when taking other medicines that lower blood pressure. If such symptoms occur, the patient should sit or lie down immediately until symptoms subside and inform the doctor as soon as possible (see also section "Driving and using machines").

• The patient should not take Silodosin Aurovitas if they have severe liver disease, as the medicine has not been studied in such conditions.

• If the patient has kidney disease, consult the doctor for advice. If the patient has moderately severe kidney disease, the doctor will start treatment with Silodosin Aurovitas cautiously and may use a lower dose (see section 3 "How to take Silodosin Aurovitas"). Silodosin Aurovitas should not be taken if the patient has severe kidney disease.

• Since benign prostatic hyperplasia and prostate cancer may cause similar symptoms, the doctor will perform tests before starting treatment with Silodosin Aurovitas to rule out prostate cancer. Silodosin Aurovitas does not treat prostate cancer.

• Treatment with Silodosin Aurovitas may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. Inform the doctor if the patient plans to father children.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there are no indications for use of this medicine in this age group.
Silodosin Aurovitas and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Specifically inform the doctor if the patient is taking any of the following medicines:

• Medicines that lower blood pressure (especially medicines called alpha-blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be increased when taking Silodosin Aurovitas.
• Antifungal medicines (such as ketoconazole or itraconazole), medicines used in HIV/AIDS infections (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as cyclosporine), as these medicines may increase the concentration of Silodosin Aurovitas in the blood.
• Medicines used to treat difficulties in achieving or maintaining an erection (such as sildenafil or tadalafil), as concomitant use with Silodosin Aurovitas may lead to a slight decrease in blood pressure.
• Medicines used in 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.
Effect on fertility
Silodosin Aurovitas may reduce sperm volume and therefore may temporarily affect the ability to conceive a child. If the patient plans to father a child, he should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Do not drive or operate machinery if the patient feels they might faint, experience dizziness, feel sleepy, or have blurred vision.
This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e. the medicine is considered "sodium-free".

3. How to use Silodosin Aurovitas

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one 8 mg Silodosin Aurovitas 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; swallow it whole, preferably with a glass of water.

Patients with kidney disease
If a patient has moderate kidney impairment, the doctor may prescribe a different dose. For this
purpose, Silodosin Aurovitas 4 mg hard capsules are available.

Taking more Silodosin Aurovitas than recommended
If more than one capsule has been taken, inform the doctor as soon as possible.
If the patient experiences dizziness or feels unwell, they should immediately inform the doctor.

Missed dose of Silodosin Aurovitas
If the patient forgets to take a capsule, they may take it later the same day. If it is almost time for the
next dose, the missed dose should not be taken. Do not take a double dose to make up for a missed
capsule.

Stopping Silodosin Aurovitas
If treatment is stopped, symptoms of the disease may return.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences any of the following allergic reactions, medical advice should be sought immediately:
facial or throat swelling, difficulty breathing, fainting, itching or hives, due to the possibility of severe consequences.

The most common adverse reaction is reduced semen volume during ejaculation. This effect resolves after discontinuation of Silodosin Aurovitas. The patient should inform the doctor if planning to have children.

Dizziness, including dizziness upon standing, and occasionally fainting may occur. If the patient feels unwell or experiences dizziness, they should immediately sit or lie down and remain lying until symptoms subside. If dizziness upon standing or fainting occurs, the doctor should be informed as soon as possible.

Silodosin Aurovitas may cause complications during cataract surgery (eye surgery due to lens clouding; see section "Warnings and precautions").

It is important that the patient immediately informs the ophthalmologist about current or previous use of Silodosin Aurovitas.

Possible adverse reactions are listed below:

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

• Ejaculation disorder (reduced or absent semen during sexual intercourse; see section "Warnings and precautions").

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

• Dizziness, including dizziness upon standing (see also above in this section),
• Nasal congestion or stuffy nose sensation,
• Diarrhea.

Uncommon adverse reactions (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, urticaria, and drug eruption,
• Abnormal liver function test results,
• Low blood pressure.

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

• Fast or irregular heartbeat (palpitations),
• Fainting/loss of consciousness.

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

• Other allergic reactions with facial or throat swelling.

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

• Intraoperative floppy iris syndrome (IFIS) during cataract surgery (see also above in this section).

If the patient experiences any impact on sexual function, they should inform the doctor.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Silodosin Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer
carton after “EXP” or “Expiry date (EXP)”. The expiry date refers to the last day of the
specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 silodosine.
Each hard capsule, 4 mg, contains 4 mg of silodosine.
Each hard capsule, 8 mg, contains 8 mg of silodosine.
The other ingredients are:
Capsule contents: mannitol, pregelatinized starch (corn), sodium lauryl sulfate, hydrogenated vegetable oil.
Capsule shell: titanium dioxide (E 171), gelatin.
Ink components: shellac (E 904), black iron oxide (E 172), potassium hydroxide (E 525).

What Silodosin Aurovitas looks like and contents of the pack
Hard capsule.
Silodosin Aurovitas 4 mg hard capsules
Size "3" capsule containing a white or almost white powder, consisting of a white, opaque, hard gelatin cap printed with "SIL" and a white, opaque, hard gelatin body printed with "4 mg", in black ink.
Silodosin Aurovitas 8 mg hard capsules
Size "1" capsule containing a white or almost white powder, consisting of a white, opaque, hard gelatin cap printed with "SIL" and a white, opaque, hard gelatin body printed with "8 mg", in black ink.
Silodosin Aurovitas is available in blisters, packed in quantities of 5, 10, 20, 30, 50, 90 and 100 hard capsules per 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 Warsaw
e-mail: [email protected]

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 European Economic Area countries 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