Patient information leaflet

URODIE 2 mg tablets, 5 mg tablets

Terazosin base
Please read 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What URODIE is and what it is used for
What you need to know before taking URODIE
How to take URODIE
Possible side effects
How to store URODIE
Contents of the pack and other information

1. What URODIE is and what it is used for

URODIE contains the active substance terazosin, which belongs to a group of medicines
called "alpha-adrenergic receptor antagonists". These medicines induce relaxation of the
muscles of the bladder and prostate, facilitating bladder emptying.
This medicine is used to treat a condition called Benign Prostatic Hyperplasia (or BPH).
This condition is caused by an increase in prostate size.
An enlarged prostate can partially block the outflow of urine from the bladder. This
partial blockage leads to symptoms such as:

weak or intermittent urine flow;
need to urinate frequently or at night;
urgent need to urinate.

2. What you need to know before taking URODIE

Do not take URODIE

if you are allergic to the active substance, terazosin, or to other quinazoline medicines (such as prazosin, doxazosin), or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced a brief loss of consciousness while urinating or immediately after urinating. This symptom is more common if you move quickly from a sitting or lying position to a standing position;
if you suffer from low blood pressure (orthostatic hypotension).

Warnings and precautions
Talk to your doctor or pharmacist before taking URODIE.
Talk to your doctor before taking URODIE if you have or have had any of the following conditions:

fainting, feeling unsteady or dizziness (spinning sensation), due to low blood pressure when standing (upright position). This occurs more commonly: o when starting treatment; or when restarting treatment after a break of several days; or if you are elderly (aged over 65 years). Your risk of fainting while standing is higher if: o your dose of URODIE is increased rapidly; or if you are taking medicines to increase urination (diuretics) or other medicines to lower blood pressure (medicines used for hypertension). If you are about to faint, you may experience symptoms such as: dizziness, lightheadedness, drowsiness, and a noticeable increase in heart rate (palpitations). If you experience any of these symptoms, sit down or lie down. Do not stand up until the symptoms have disappeared. If you experience these symptoms while sitting or lying down, inform your doctor.
low blood pressure (hypotension). Your doctor will monitor your blood pressure;
heart problems, pulmonary edema (fluid in the lungs), heart failure, or myocardial infarction;
liver problems (impaired liver function).

If you are scheduled to undergo eye surgery due to cataract (clouding of the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken this medicine.
This is because URODIE may cause complications during eye surgery. These complications can be managed if your specialist is prepared in advance.

Other medicines and URODIE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that your doctor knows if you are taking:

medicines used to treat high blood pressure (i.e., antihypertensives, including diuretics) or benign prostatic hyperplasia;
medicines used to treat erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil). In some patients taking therapy for high blood pressure or enlarged prostate with alpha-adrenergic receptor antagonists, such as this medicine, episodes of dizziness have occurred. These sensations
may be caused by low arterial pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-adrenergic receptor antagonists, such as this medicine.

Pregnancy, breastfeeding and fertility
This medicine is intended for the treatment of a condition affecting only men, and therefore must not be used in women.

Driving and using machines
This medicine has a major influence on the ability to drive and use machines.
When you first take a dose of this medicine, or when you take the first dose after a period of treatment interruption, you may experience symptoms such as dizziness, lightheadedness, or drowsiness.
Do not drive vehicles or operate machinery requiring attention for at least 12 hours after taking the first dose or whenever your usual dose is increased.

URODIE tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

URODIE tablets contain sunset yellow FCF (E110).
It may cause allergic reactions.

3. How to take URODIE

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is half a 2 mg tablet daily (equivalent to 1 mg of
terazosin).
The dose may be gradually increased every week or every two weeks until
the appropriate dose for you is reached. The maintenance dose is generally
between 1 and 2 tablets of 5 mg daily (equivalent to 5 mg – 10 mg of terazosin per day).
Method of administration
Take the daily dose of this medicine as a single administration. At the beginning of
treatment, take URODIE at bedtime, since there is always a risk of dizziness
or fatigue. Later on, you may take the daily dose in the morning.
Avoid sudden changes in position or any activities that may cause dizziness or
fatigue, especially if you are elderly (over 65 years of age) and/or at the beginning of
treatment.
Your doctor may adjust the dose according to your response to treatment.
Use in children
This medicine should be avoided in children because its efficacy and
safety have not been established.
If you take more URODIE than you should
If you have taken a dose of this medicine higher than prescribed by your doctor,
contact the emergency department of the nearest hospital. Bring this leaflet and the
medicine package, even if it is empty.
An excessive dose of this medicine may lower blood pressure too much and
cause other serious effects.
If you forget to take URODIE
Do not take a double dose to make up for the missed dose.
If you stop taking URODIE
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 gets them.
If you experience difficulty breathing, shortness of breath, rash or low blood pressure, contact your doctor immediately and stop taking this medicine. These may be symptoms of an allergic reaction and you may need immediate medical attention.

The following side effects have been reported with the use of this medicine:

muscle weakness (asthenia), dizziness, somnolence, headache, widespread tingling sensation (paraesthesia), inability to achieve or maintain an erection (impotence);
awareness of your heartbeat (palpitations), rapid heartbeat (tachycardia);
low blood pressure (orthostatic hypotension), fainting (syncope);
nausea;
swelling of the extremities (peripheral oedema), swelling (oedema);
inflammation of the sinuses (sinusitis);
nasal congestion (frequency not known);
difficulty breathing (dyspnoea);
decreased vision (amblyopia), blurred vision;
back pain, pain in arms and legs;
weight gain;
decreased sexual desire, depression, nervousness.

The following side effects have also been reported during concomitant use of this medicine, but it is not yet known whether they are related to treatment with URODIE:

chest pain, abdominal pain, neck pain, shoulder pain;
facial swelling (facial oedema), fever;
excessive dilation of blood vessels (vasodilation), changes in heart rate (arrhythmia);
constipation, diarrhoea, dry mouth (xerostomia), indigestion (dyspepsia), flatulence, vomiting;
gout;
joint pain and disorders, inflammation of joints (arthritis), muscle pain (myalgia);
anxiety, insomnia;
bronchitis, flu-like symptoms and cold symptoms, inflammation of the throat (pharyngitis), inflammation of the nasal mucosa (rhinitis), nosebleeds (epistaxis), increased coughing;
itching, skin rash;
sweating;
visual disturbances, eye inflammation (conjunctivitis);
ringing in the ears (tinnitus);
frequent urination, urinary tract infection and involuntary loss of urine (urinary incontinence);
reduced platelet count (thrombocytopenia), changes in blood composition (haemodilution);
prolonged and painful erections (priapism).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 URODIE

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
"Exp.". The expiry date refers to the last day of that month.
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. Package contents and other information

What URODIE contains
URODIE 2 mg tablets:

The active substance is terazosin base. Each tablet contains 2.374 mg of terazosin hydrochloride dihydrate (equivalent to 2 mg of terazosin base).
The other ingredients are lactose, maize starch, talc, magnesium stearate, sunset yellow FCF (E110).

URODIE 5 mg tablets:

The active substance is terazosin base. Each tablet contains 5.935 mg of terazosin hydrochloride dihydrate (equivalent to 5 mg of terazosin base).
The other ingredients are lactose, maize starch, talc, magnesium stearate, sunset yellow FCF (E110), indigo carmine (E132).

Description of the appearance of URODIE and contents of the pack
URODIE 2 mg tablets are supplied in a pack containing 10 tablets in blisters.
URODIE 5 mg tablets are supplied in a pack containing 14 tablets in blisters.

Marketing Authorization Holder
Laboratorio Farmaceutico S.I.T. S.r.l. – Via Cavour, 70 – 27035 Mede (PV)
Manufacturer
Special Product’s Line S.p.A. – Strada Paduni, 240 – 03012 Anagni (FR)