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URONNIDA XL 10 MG PROLONGED-RELEASE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Uronidda XL 10mg Prolonged-release Tablets
Active substance: Alfuzosin hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet.You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
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.
In this leaflet:
1. What Uronidda XL 10mg is and what it is used for
2. Before you take Uronidda XL 10mg
3. How to take Uronidda XL 10mg
4. Possible side-effects
5. How to store Uronidda XL 10mg
6. Further information
1. WHAT URONIDDA XL 10MG IS AND WHAT IT IS USED FOR
Uronidda XL 10mg belongs to a group of medicines called alpha-adrenoreceptor antagonists or
alpha-blockers.
It is used to treat moderate to severe symptoms caused by an enlarged prostate gland, a condition
that is also called benign prostatic hyperplasia. Enlarged prostate glands can cause urinary
problems such as frequent and difficult urination, especially at night. Alpha-blockers relax the
muscles in the prostate and bladder neck. This allows urine to flow out of the bladder more easily.
2. BEFORE YOU TAKE URONIDDA XL 10MG
Do not take Uronidda XL 10mg:
• if you are allergic (hypersensitive) to alfuzosin, other quinazolines (e.g. terazosin, prazosin,
doxazosin) or any of the other ingredients of Uronidda XL 10mg.
• if you suffer from conditions that cause a marked drop in blood pressure when standing up.
• if you have liver problems.
• if you take other medicines that belong to the group of alpha-blockers.
Take special care with Uronidda XL 10mg:
• if you have severe kidney problems, since the safety of Uronidda XL 10mg has not been
established here.
• if you take other medicines to treat high blood pressure. In this case your doctor will check
your blood pressure regularly, especially at the beginning of treatment.
• if you experience a sudden drop in blood pressure when you stand up shown by dizziness,
weakness or sweating within a few hours after you have taken Uronidda XL 10mg. If you
experience a drop in blood pressure you should lie down with your legs and feet up in the air
until the symptoms have totally disappeared. Usually, these effects last for only a short time and
occur at the start of the treatment. Normally, there is no need to stop treatment.
• if you have experienced a marked drop in blood pressure in the past after taking another
medicine belonging to the group of alpha-blockers. In this case your doctor will start treatment
with alfuzosin at low doses and will gradually increase the dose.
• if your heart is not working well (acute heart failure).
• if you suffer from chest pain (angina) and are treated with a nitrate, treatment with alfuzosin
may increase the risk of a drop in blood pressure. Your doctor will stop treating you with
alfuzosin when the angina recurs or worsens.
• your doctor will decide whether to continue treatment against chest pain or stop treatment with
Uronidda XL 10mg, especially when the chest pain recurs or worsens
• if you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform
your eye specialist before the operation that you are using or have previously used Uronidda
Tablets. This is because Uronidda Tablets may cause complications during the surgery which
can be managed if your specialist is prepared in advance.
Taking 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.
Uronidda XL 10mg must not be taken if you take other medicines that belong to the group of alphablockers.
Uronidda XL 10mg and some medicines may interfere with each other. These include:
- ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir
(medicine used to treat HIV).
If you are taking or have to take any of the following medicines, treatment with Uronidda XL 10mg
may cause your blood pressure to fall too low:
- medicines used to treat high blood pressure.
- medicines (nitrates) used to treat the symptoms of chest pain (angina).
- medicines you receive before an operation (general anaesthetics).Your blood pressure can
drop markedly. If you have to undergo an operation, please tell the doctor that you are taking
Uronidda XL 10mg.
Taking Uronidda XL 10mg with food and drink
Uronidda XL 10mg should be taken after a meal.
Pregancy and breast-feeding
This information is not relevant as Uronidda XL 10mg is only for men.
Driving and using machines
At the beginning of treatment with Uronidda XL 10mg you may feel lightheaded, dizzy or weak.
Do not drive or operate machinery or perform any hazardous tasks until you know how your body
responds to the treatment.
Important information about some of the ingredients of Uronidda XL 10mg
This medicinal product contains a small amount of lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
3. HOW TO TAKE URONIDDA XL 10MG
Always take Uronidda XL 10mg exactly as your doctor has told you to.You should check with your
doctor or pharmacist if you are not sure.
Swallow the tablets whole. Do not crush, powder or chew the tablets as too much of the active
substance alfuzosin may reach your body too quickly. This may raise the risk of unwanted effects.
Take the first tablet at bedtime. Take the tablets immediately after the same meal each day and
swallow them whole with a sufficient amount of fluid. Do not crush, chew or divide the tablets.
Please read the back of this leaflet.
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Adults:
The usual dose is 1 prolonged-release tablet (10mg alfuzosin) once daily.
For elderly patients:
The usual dose for elderly patients (over 65 years) is 1 prolonged-release tablet (10mg alfuzosin)
once daily if a lower dose of alfuzosin is well tolerated and a stronger effect is required.
For patients with impaired kidney function:
The usual dose for patients with mild to moderate kidney problems is 1 prolonged-release tablet
(10mg alfuzosin) if a lower dose was not sufficient and depending on how you respond to the
treatment.
If you take more Uronidda XL 10mg than you should
If you take large amounts of Uronidda XL 10mg contact your doctor or nearest hospital casualty
department immediately for advice.Your blood pressure may suddenly drop and you may feel dizzy
or even faint. If you begin to feel dizzy, sit or lie down until you feel better.
If you forget to take Uronidda XL 10mg
Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop in
blood pressure, especially if you take blood-pressure lowering medicines. Take the next tablet as
directed.
If you stop taking Uronidda XL 10mg
You should not interrupt or stop taking Uronidda XL 10mg without speaking to your doctor first.
If you want to stop the treatment or have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Uronidda XL 10mg can cause side-effects, although not everybody gets them.
Assessment of the side-effects is based on the following frequencies:
Very common:
Common:
Uncommon:
Rare:
Very rare:

more than 1 in 10 patients treated
more than 1 in 100 and less than 1 in 10 patients treated
more than 1 in 1,000 and less than 1 in 100 patients treated
more than 1 in 10,000 and less than 1 in 1,000 patients treated
less than 1 in 10,000 patients treated including isolated cases

In very rare cases, a life-threatening reaction called angioedema has been reported. You should
stop taking Uronidda XL 10mg and see your doctor immediately if you experience any symptoms
of angioedema, such as:
- swollen face, tongue or throat
- difficulty in swallowing
- hives and difficulty in breathing.
Common:
Tiredness, dizziness, headache, a spinning sensation in the head (vertigo), marked drop in blood
pressure when standing up (especially when starting treatment with too high a dose and when
treatment is resumed), stomach pain, feeling sick (nausea), indigestion, diarrhoea, dry mouth,
feeling weak or ill.
Uncommon:
Feeling drowsy, problems with your vision, faster heartbeat, fainting (especially at the beginning of
treatment), sensation of pounding or racing heartbeat, runny nose, being sick, rash (hives,
exanthem), itching, urinary incontinence, swelling of the ankles and feet, reddening of the face
(flushing), chest pain.
Very rare:
Worsening or recurrence of chest pain (angina pectoris), liver damage, swelling of the skin and
mucosa, especially in the face and around the mouth, persistent and painful erection (priapism).
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.
5. HOW TO STORE URONIDDA XL 10MG
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use Uronidda XL 10mg after the expiry date which is stated on the blister and carton.
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.
6. FURTHER INFORMATION
What Uronidda XL 10mg contains:
The active substance is alfuzosin hydrochloride. One prolonged-release tablet contains 10mg
alfuzosin hydrochloride.
The other ingredients are: lactose monohydrate, hypromellose, povidone K25, magnesium
stearate.
What Uronidda XL 10mg looks like and contents of the pack:
Uronidda XL 10mg are white, round, bevelled-edged, uncoated tablets.
Uronidda XL 10mg is available in blister packs with 10, 28, 30 and 90 prolonged-release tablets.
Not all pack sizes are marketed.

POM
PL 11204/0201

Uronidda XL 10mg Tablets

Marketing Authorisation Holder and Manufacturer:
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.
Distributed by:
Genus Pharmaceuticals, Benham Valence, Newbury, Berkshire RG20 8LU, UK.
This leaflet was last approved in April 2009

* Trademark

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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