Silodosin msn

Package leaflet: Information for the patient

Silodosin MSN, 4 mg, hard capsules
Silodosin MSN, 8 mg, hard capsules
Silodosinum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

What Silodosin MSN is
Silodosin MSN belongs to a group of medicines called alpha-adrenergic receptor blockers.
Silodosin MSN 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 facilitates urination and relieves symptoms of the disease.
What Silodosin MSN is used for
Silodosin MSN is used in adult men to treat lower urinary tract symptoms associated with benign enlargement of the prostate gland (prostate enlargement), such as:

• difficulty starting urination,
• sensation of incomplete bladder emptying,
• increased frequency of urination, including at night.

2. Important information before using Silodosin MSN

When not to use Silodosin MSN

• 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 MSN, 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 MSN, as some patients treated with this type of medicine have experienced loss of muscular tension 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 stop taking Silodosin MSN prior to undergoing cataract surgery.

• If the patient has ever fainted or experienced dizziness upon standing up quickly, they should inform their doctor before taking Silodosin MSN. Dizziness upon standing and occasionally fainting may occur during treatment with Silodosin MSN, especially at the beginning of treatment or when taking other medicines that lower blood pressure. If these symptoms occur, the patient should sit or lie down immediately until symptoms resolve and inform their doctor as soon as possible (see also section "Driving and operating machinery").

• If the patient has severe liver disease, they should not take Silodosin MSN, as this medicine has not been studied in such conditions.

• If the patient has kidney disease, they should consult their doctor. If the patient has moderately impaired kidney function, the doctor will initiate treatment with Silodosin MSN with caution and may use a lower dose (see section 3 "How to use Silodosin MSN"). Silodosin MSN 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 MSN to exclude prostate cancer. Silodosin MSN does not treat prostate cancer.

• Treatment with Silodosin MSN may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. Inform your doctor if the patient plans 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 use of this medicine in this age group.
Silodosin MSN with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• Medicines that lower blood pressure (especially medicines known as alpha-blockers, such as prazosin or doxazosin), as there is a risk that the effect of these medicines may be enhanced when taking Silodosin MSN.
• Antifungal medicines (such as ketoconazole or itraconazole), medicines used to treat HIV/AIDS (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 MSN in the blood.
• Medicines used to treat difficulties in achieving or maintaining an erection (such as sildenafil or tadalafil), as concomitant use with Silodosin MSN may lead to a slight decrease in blood pressure.
• Medicines used to treat epilepsy or rifampicin (an anti-tuberculosis medicine), as the effect of Silodosin MSN may be reduced.
  Pregnancy and breastfeeding
  Silodosin MSN is not intended for use in women.
  Fertility
  Silodosin MSN may reduce semen volume and therefore may temporarily affect the ability to conceive a child. If the patient plans to have children, they should consult their doctor or pharmacist before using this medicine.
  Driving and operating machinery
  Do not drive or operate machinery if the patient feels they might faint, experience dizziness, feel sleepy, or have blurred vision.

3. How to use Silodosin MSN

This medicine should always be taken exactly as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The recommended dose is one 8 mg Silodosin MSN 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 the patient has moderately severe kidney disease, the physician may prescribe a different dose.
For this purpose, Silodosin MSN 4 mg hard capsules are available.

Taking more Silodosin MSN than prescribed
If more than one capsule has been taken, contact the physician immediately.
If the patient experiences dizziness or feels weak, they should inform the physician without delay.

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

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

If there are any further doubts concerning the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Seek immediate medical attention if the patient experiences the following allergic reactions:
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 MSN. 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 resolve. If dizziness upon standing or fainting occurs, the doctor should be informed as soon as possible.

Silodosin MSN 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 MSN.

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 (also see above in this section)
• Nasal congestion or runny nose
• Diarrhoea

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty in achieving or maintaining erection
• Rapid heartbeat
• 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 (so-called palpitations)
• Fainting and (or) 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 during cataract surgery (also see above in this section)

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

Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: (22) 49 21 301, Fax: (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 the medicine.

5. How to store Silodosin MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
after “EXP” or “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Silodosin MSN contains
The active substance is silodosin. Each hard capsule contains 4 mg or 8 mg of silodosin.
The other ingredients are:

• capsule contents: mannitol, pregelatinized starch (maize), magnesium stearate, polysorbate 80, magnesium aluminium metasilicate, butylated hydroxytoluene.
• capsule shell: gelatin, titanium dioxide (E 171).
• printing ink: shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

What Silodosin MSN looks like and contents of the pack
Silodosin MSN 4 mg capsules, size “3”, containing a white or almost white powder, consisting of a white, opaque, hard gelatin cap printed with “4 mg” and a white, opaque, hard gelatin body printed with “M”, in black ink.
Silodosin MSN 8 mg capsules, size “1”, containing a white or almost white powder, consisting of a white, opaque, hard gelatin cap printed with “8 mg” and a white, opaque, hard gelatin body printed with “M”, in black ink.
Silodosin MSN is available in blister packs containing 5, 10, 20, 30, 50, 90 and 100 hard capsules, packed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA3000
Malta

Importer:
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Silodosina MSN
Czech Republic: Silodosin MSN
Hungary: Silodosin MSN 4 mg/8 mg kemény kapszula
Poland: Silodosin MSN
Romania: Silodosin MSN 4 mg capsule
Silodosin MSN 4 mg capsule
Slovakia: Silodosin MSN 4 mg/8 mg
Bulgaria: Silodosin MSN 4 mg/8 mg