Urorec 8 mg hard capsules

 

What is it and how is it used?

What Urorec is

Urorec belongs to a group of medicines called alpha 1A-adrenoreceptor blockers.Urorec is selective for the receptors located in the prostate, bladder and urethra. By blocking these receptors, it causes smooth muscle in these tissues to relax. This makes it easier for you to pass water and relieves your symptoms.

What Urorec is used for

Urorec is used in male patients to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:

  • difficulty in starting to pass water,
  • a feeling of not completely emptying the bladder,
  • a more frequent need to pass water, even at night.

What do you have to consider before using it?

Do NOT take Urorec

  • You must not take Urorec if you are allergic (hypersensitive) to silodosin or any of the other ingredients of this medicine.

Take special care with Urorec

  • If you are undergoing eye surgery because of cloudiness of the lens ( cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Urorec. This is because some patients treated with this kind of medicine experienced a loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery. The

specialist can take appropriate precautions with respect to medicine and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.

  • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec. Dizziness when standing up and occasionally fainting may occur when taking Urorec, particularly when starting treatment or if you are taking other medicines that lower blood pressure. If this occurs, make sure you sit or lie down straight away until the symptoms have disappeared and inform your doctor as soon as possible (see also section “Driving and using machines”).
  • If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
  • If you have problems with your kidneys, please ask your doctor for advice. If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”). If you have severe kidney problems, you should not take Urorec.
  • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec. Urorec does not treat prostate cancer.
  • The treatment with Urorec may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility. This effect disappears after discontinuation of Urorec. Please inform your doctor if you are planning to have children.
  • Urorec is not recommended for use in patients aged below 18 years since there is no relevant indication for this age group.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor in particular, if you take medicines which lower blood pressure in particular, medicines called alpha1-blockers, such as prazosin or doxazosin as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec. antifungal medicines such as ketoconazole or itraconazole, medicines used for HIV-AIDS such as ritonavir or medicines used after transplants to prevent organ rejection such as cyclosporin because these medicines can increase the blood concentration of Urorec. medicines used for treating problems in getting or keeping an erection such as sildenafil or tadalafil, since the concomitant use with Urorec might lead to a slight decrease in blood pressure. medicines for epilepsy or rifampicin a medicine to treat tubercolosis, since the effect of Urorec may be reduced.

Taking Urorec with food and drink

Take Urorec always with food (see section 3 “When and how to take Urorec”).

Driving and using machines

Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision.

How is it used?

Always use Urorec exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose

The usual dose is one capsule of Urorec 8 mg per day by oral administration.

Patients with kidney problems
If you have moderate kidney problems, your doctor may prescribe a different dose. For this purpose Urorec 4 mg hard capsules are available.

When and how to take Urorec

Take the capsule always with food, preferably at the same time every day. Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.

If you use more Urorec than you should

If you have taken more than one capsule, inform your doctor as soon as possible. If you become dizzy or feel weak, tell your doctor straight away.

If you forget to use Urorec

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

If you stop using Urorec

If you stop treatment, your symptoms may re-appear.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Urorec can cause side effects, although not everybody gets them.

The most common side effect is a decrease in the amount of semen released during sex. This effect disappears after discontinuation of Urorec. Please inform your doctor if you are planning to have children.

Dizziness, including dizziness when standing up, and occasionally fainting, may occur. If you do feel weak or dizzy, make sure you sit or lie down straight away until the symptoms have disappeared. If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.

Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Take special care with Urorec”).
It is important that you immediately inform your eye specialist if you are using or have previously used Urorec.

The frequency of possible side effects listed below is defined using the following convention:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Not known frequency cannot be estimated from the available data

Very common side effects

  • Abnormal ejaculation (less or no noticeable semen is released during sex, see section ‘Take special care with Urorec’)

Common side effects

  • Dizziness, including dizziness when standing up (see also above, in this section)
  • Runny or blocked nose
  • Diarrhoea

Uncommon side effects

  • Decreased sexual drive
  • Nausea
  • Dry mouth
  • Difficulties in getting or keeping an erection

Not known

  • Floppy pupil during cataract surgery (see also above, in this section)
  • Fainting

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you feel that your sexual life is affected, please tell your doctor.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Urorec after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.
Store in the original package in order to protect from light and moisture.

Do not use any Urorec pack that 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. These measures will help to protect the environment.

What is it?

Urorec is a medicine that contains the active substance silodosin. It is available as capsules (yellow: 4 mg; white: 8 mg).

What is it used for?

Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland). The prostate gland is an organ found at the base of the bladder in men. When enlarged, it can cause problems with the flow of urine.
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose is one 8-mg capsule once a day. For men with moderate kidney problems, the starting dose should be 4 mg once a day. This may be increased to 8 mg once a day after a week. Urorec is not recommended for patients with severe kidney problems.
The capsules should be taken with food, preferably at the same time every day. They should be swallowed whole, preferably with a glass of water.

How does it work?

The active substance in Urorec, silodosin, is an alpha-adrenoreceptor antagonist. It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body). When these receptors are activated, they cause the muscles controlling the flow of urine to contract. By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.

How has it been studied?

The effects of Urorec were first tested in experimental models before being studied in humans. Urorec has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH. One of these studies also compared Urorec with tamsulosin (another medicine used for BPH).
The main measure of effectiveness in all three studies was the improvement of the patients’ international prostate symptom score (IPSS) after 12 weeks of treatment. IPSS is a rating of the patient’s symptoms such as the inability to empty the bladder, and the urge to urinate repeatedly or to strain while urinating. The patients rated the severity of their symptoms themselves.

What benefits has it shown during the studies?

Urorec was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH. In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study. After 12 weeks, it had fallen by around 6.4 points in the men who took Urorec, and by around 3.5 points in the men who took placebo. In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Urorec after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.

What is the risk associated?

The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation. For the full list of all side effects reported with Urorec, see the Package Leaflet.
Urorec should not be used in people who may be hypersensitive (allergic) to silodosin or any of the other ingredients.
Intra-operative floppy iris syndrome (IFIS) occurs in some patients taking alpha-adrenoreceptor antagonists and may lead to complications during cataract surgery. IFIS is a condition that makes the iris floppy.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Urorec’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Urorec to Recordati Ireland Ltd. on 29 January 2010. The marketing authorisation is valid for five years, after which it can be renewed.