Package Insert: Information for the Patient

Urorec 8 mg Hard Capsules

Urorec 4 mg Hard Capsules

Silodosina

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Urorec

Urorec belongs to a group of medications known as alpha1A adrenergic receptor blockers.

Urorec is selective for receptors located in the prostate, 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 alleviates your symptoms.

What is Urorec used for

Urorec is used in adult males to treat urinary symptoms associated with benign prostatic hyperplasia (BPH), such as:

• difficulty starting urination
• sensation of not fully emptying the bladder
• more frequent need to urinate, even at night

Do not take Urorec

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Urorec

• If you are to undergo eye surgery for cataract (cataract surgery), it is essential thatyou inform your ophthalmologist immediatelythat you are using or have used Urorec previously. This is because some patients treated with this type of medication have suffered a loss of iris muscle tone (the circular colored part of the eye) during this type of surgery. Your ophthalmologist may then take appropriate precautions with regard to medical and surgical techniques that may be necessary. Ask your doctor if it is necessary or not to postpone or interrupt temporarily the treatment with Urorec when you are to undergo cataract surgery.

• If you have fainted or felt dizzy at any time when standing up suddenly, inform your doctor before taking Urorec.

When taking Urorec, you may experiencedizzinessand, occasionally, asyncope, especially when starting treatment or if you are taking other medications that lower blood pressure. If this occurs,sit or lie downimmediately until the symptoms disappear andinform your doctor as soon as possible(see also the section “Driving and operating machines”).

• If you havesevere liver problems, you should not take Urorec, as it has not been evaluated in this situation.

• If you havekidney problems, ask your doctor for advice.

If your kidney problems are moderate, your doctor will start treatment with Urorec with caution and possibly with a lower dose (see section 3 “Dose”).

If your kidney problems are severe, you should not take Urorec.

• Since benign prostatic hyperplasia and prostate cancer can cause the same symptoms, your doctor will examine you to rule out prostate cancer before starting treatment with Urorec. Urorec is not intended to treat prostate cancer.

• Treatment with Urorec may lead to abnormal ejaculation (reduced semen volume during sexual intercourse), which may temporarily affect male fertility. This effect disappears after stopping treatment with Urorec. Inform your doctor if you are planning to have children.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age, as there are no relevant indications for this age group.

Urorec with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Inform your doctorin particular if you take:

• blood pressure-lowering medications(especially alpha1 blockers, such as prazosin or doxazosin), as there may be a potential risk of increased effect of these medications during Urorec use.
• antifungal medications(such as ketoconazole or itraconazole),medications used to treat HIV/AIDS(such as ritonavir) ormedications used after organ transplants to prevent organ rejection(such as cyclosporine), as these medications may increase Urorec blood concentrations.
• medications used to treat erectile dysfunction(such as sildenafil or tadalafil), as their concurrent use with Urorec may lead to a slight decrease in blood pressure.
• medications for epilepsy or rifampicin(a medication used to treat tuberculosis), as the effect of Urorec may be reduced.

Pregnancy and breastfeeding

Urorec is not indicated for use by women.

Fertility

Urorec may reduce semen volume and temporarily affect your ability to conceive a child. If you intend to have a child, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Do not drive or operate machines if you feel dizziness, dizziness, or somnolence or have blurred vision.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Urorec 8 mg capsule per day taken orally.

Take the capsule always accompanied by food, preferably at the same time every day. Do not break or chew the capsule; 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 this purpose, the Urorec 4 mg hard capsules presentation is available.

If you take more Urorec than you should

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

If you forget to take Urorec

You can take the capsule later the same day if you forgot to take it earlier. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed capsule.

If you interrupt treatment with Urorec

If you interrupt treatment, it is possible that symptoms will reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you experience any of the following allergic reactions, as their consequences could be severe: swelling of the face or throat, difficulty breathing, feeling of fainting, itching on the skin or hives.

The most common side effect is a reduction in the amount of semen expelled during sexual intercourse. This side effect disappears after stopping treatment with Urorec. Inform your doctor if you are planning to have children.

You may experiencedizziness,including dizziness when standing up, and, occasionally,fainting.

If you feel weak or dizzy,sit or lie downimmediately until the symptoms disappear. If you experience dizziness when standing up or fainting,inform your doctor as soon as possible.

Urorec may cause complications duringcataract surgery(eye surgery for cloudy lens; see "Warnings and precautions").

It is essential thatyou inform your ophthalmologist immediatelyif you are using or have previously used Urorec.

The possible side effects are listed below:

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

• Abnormal ejaculation (less or negligible semen is expelled during sexual intercourse; see "Warnings and precautions")

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

• Dizziness, including dizziness when standing up (also see above, in this section)
• Nasal secretion or obstruction
• Diarrhea

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

• Loss of sexual appetite
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Allergic skin reactions, such as rash, itching, hives, and drug-induced rash
• Abnormal liver function test results
• Low blood pressure

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

• Fast or irregular heartbeats (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

Unknown frequency (frequency cannot be estimated from available data)

• Flaccid pupil during cataract surgery (also see above, in this section) Inform your doctor if you notice that your sexual relations are affected.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from light and moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been improperly handled.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Urorec

Urorec 8 mg

The active ingredient is silodosin. Each capsule contains 8 mg of silodosin.

The other components are pregelatinized cornstarch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171).

Urorec 4 mg

The active ingredient is silodosin. Each capsule contains 4 mg of silodosin.

The other components are pregelatinized cornstarch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the package

Urorec 8 mg are hard gelatin capsules, opaque and white, size 0 (21.7 x 7.6 mm, approximately).

Urorec 4 mg are hard gelatin capsules, opaque and yellow, size 3 (15.9 x 5.8 mm, approximately).

Urorec is available in packages of 5, 10, 20, 30, 50, 90, 100 capsules. Only some package sizes may be marketed.

Marketing Authorization Holder

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Irlanda

Responsible for manufacturing

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali 1

20148 Milán

Italia

Laboratoires Bouchara-Recordati

Parc Mécatronic

03410 Saint Victor

Francia

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.