Urisax

Package leaflet: Information for the patient

URISAX 4 mg hard capsules, 8 mg hard capsules

Silodosin
Generic medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What URISAX is and what it is used for

What URISAX is
URISAX belongs to a group of medicines called alpha-adrenoceptor blockers.
URISAX is selective for receptors located in the prostate, bladder, and urethra. By blocking
these receptors, the medicine relaxes the smooth muscle in these tissues. This makes urination
easier and relieves symptoms.
What URISAX is used for
URISAX is used in adult men for the treatment of urinary symptoms associated with
benign enlargement of the prostate (prostatic hyperplasia), such as:

• difficulty starting to urinate,
• feeling that the bladder has not emptied completely,
• frequent need to urinate, including during the night.

2. What you need to know before taking URISAX

Do not take URISAX
if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking URISAX

• If you are scheduled for eye surgery due to lens opacity (cataract surgery), it is important that you immediately inform your ophthalmologist
  that you are currently taking or have previously taken URISAX. This is because some patients treated with
  this type of medicine have experienced loss of iris muscle tone (the coloured circular part of the eye) during such surgery. The ophthalmologist will take appropriate
  precautions regarding the medicines and surgical techniques to be used. Ask your
  doctor whether it is necessary to postpone or temporarily interrupt treatment with
  URISAX in case of cataract surgery.

• If you have previously fainted or felt dizzy upon standing up suddenly, inform your doctor before taking URISAX. Dizziness upon standing may occur when taking URISAX, and occasionally fainting, especially at the beginning of treatment or if you are taking other medicines that lower blood pressure. In such cases, sit or lie down immediately until symptoms disappear and inform your doctor as soon as possible (see also section “Driving and use of machines”).

• If you have severe liver problems, do not take URISAX, as the medicine has not been studied in patients with this condition.

• If you have kidney problems, consult your doctor. If you have moderate kidney problems, your doctor will start treatment with URISAX cautiously and possibly at a reduced dose (see section 3 “Dosage”). If you have severe kidney disease, you must not take URISAX.

• Since benign prostate enlargement and prostate cancer may have similar symptoms, your doctor will check whether you have prostate cancer before starting treatment with URISAX. URISAX is not a treatment for prostate cancer.

• Treatment with URISAX may cause abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily affect male fertility. This effect disappears after stopping treatment with URISAX. Inform your doctor if you intend to have children.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age, as there is no indication for this age group.
Other medicines and URISAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor if you are taking:

• Medicines that lower blood pressure (especially medicines called alpha1-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with URISAX.
• Antifungal medicines (such as ketoconazole or itraconazolo), medicines used to treat HIV-AIDS infection (such as ritonavir), or medicines used after organ transplantation to prevent organ rejection (such as ciclosporina), because these medicines may increase the concentration of URISAX in the blood.
• Medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with URISAX may slightly reduce blood pressure.
• Medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of URISAX may be reduced.

Pregnancy and breastfeeding
Pregnancy
Since URISAX is used to treat men with enlarged prostate, it is not intended for use in women.
Fertility
URISAX may reduce the amount of sperm, temporarily reducing the ability to father children.
Driving and use of machines
Do not drive or operate machinery if you feel faint, dizzy or drowsy, or if you have blurred vision.
URISAX contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially
‘sodium-free’.

3. How to take URISAX

Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one capsule of URISAX 8 mg daily, taken orally.
Take the capsule with a meal, preferably at the same time each day. Do not crush 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 these cases, URISAX 4 mg hard capsules are available.

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

If you forget to take URISAX
If you forget to take a capsule, you may take it later the same day. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten capsule.

If you stop taking URISAX
If you stop treatment, symptoms may return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives, as these may lead to serious consequences.

The most common side effect is a reduction in the amount of semen released during sexual activity. This effect disappears after stopping treatment with URISAX. Inform your doctor if you intend to have children.

Dizziness may occur, even when standing up, and occasionally fainting. If you feel weak or dizzy, sit or lie down immediately until symptoms subside. If you experience dizziness upon standing or episodes of fainting, inform your doctor as soon as possible.

URISAX may cause complications during cataract surgery (eye surgery performed to treat clouding of the lens; see section “Warnings and precautions”). It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken URISAX.

The possible side effects are listed below:

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

• Abnormal ejaculation (reduced or absent semen emission during sexual activity; see section “Warnings and precautions”)

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

• Dizziness, even when standing up (also see above in this section)
• Runny or stuffy nose
• Diarrhoea

Uncommon side effects (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, hives, or drug-induced skin eruption
• Abnormal liver function test results
• Low blood pressure

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

• Rapid or irregular heartbeat (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

Not known (frequency cannot be estimated from the available data)

• Intraoperative floppy iris syndrome (IFIS) during cataract surgery (also see above in this section)
  If you feel this medicine is affecting your sexual life, inform your doctor.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store URISAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp.. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the packaging is damaged or shows signs of
tampering.
Do not dispose of any medicine 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 URISAX contains
URISAX 4 mg hard capsules
The active substance is silodosin. Each capsule contains 4 mg of silodosin.
The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

URISAX 8 mg hard capsules
The active substance is silodosin. Each capsule contains 8 mg of silodosin.
The other components are:

• Capsule contents: mannitol (E421), pregelatinized starch (maize), sodium lauryl sulfate, glyceryl dibehenate (E471).
• Capsule coating: gelatin, titanium dioxide (E171).
• Printing ink, black: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of URISAX and pack contents
URISAX 4 mg hard capsules
Yellow, opaque, size 3 hard gelatin capsule, printed with "4" in black ink on the cap.
URISAX 8 mg hard capsules
White, opaque, size 0 hard gelatin capsule, printed with "8" in black ink on the cap.
URISAX is available in packs containing 30 capsules.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy
Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area
P.O Box 3012, Larissa
41500 Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Hungary: URISAX
Italy: URISAX